A Framework for Assessing Priority in Health Investments Needed in Italy Under the Programming Period 2021/2027 of the Cohesion Policy

A framework for assessing priority in health investments needed in Italy under the programming period 2021/2027 of the Cohesion Policy

Prepared by: Prof. Milena Vainieri, Dr. Ylenia Sacco and Dr. Francesca Ferrè

Francesca Ferrè EXPERT CONTRACT NUMBER – 2020CE16BAT064; AMI expert reference: REGIO 2020-0446 Ylenia Sacco EXPERT CONTRACT NUMBER – 2020CE16BAT066; AMI expert reference: REGIO 2018-0154 Milena Vainieri EXPERT CONTRACT NUMBER – 2020CE16BAT065; AMI expert reference: REGIO 2020-0447

Version 21st August 2020

Introduction As declared by the European Council Recommendation on the 2019 National Reform Program of Italy and on the 2019 Stability Programme (pg. 12) “The outcome of the health system is overall good, despite below-Union average spending. Nevertheless, the provision of healthcare largely varies across regions, affecting access, equity and efficiency, and could be improved through better administration and by monitoring the delivery of standard levels of services. More home and community-based care and long-term care is key to provide support to people with disabilities and other disadvantaged groups”. The abovementioned assessment refers to the Italian healthcare system before the unprecedented emergency of the COVID-19 pandemic that hit countries worldwide in the first months of 2020. The Italian health system was put under significant strain, evidencing weaknesses and challenges in crisis preparedness especially due the health system governance fragmentation and highlighting gaps in health and social system integration and service digitalization. These challenges do not characterized just some Italian regions but cut across regional health systems with different degree of preparedness. Overall, the health emergency has shifted health investments at the top of the Policy Objective (PO) 4 of the Cohesion Policy (a More Social Europe). Long-term investments are required to recover and make the health system more resilient and sustainable. A proper identification of investment needs and priorities at regional level is therefore needed to ensure an effective use of EU funding opportunities. This document provides a conceptual framework for identifying specific evidence-based healthcare investment needs and gaps. The proposed framework will be use as a reference by the experts for advising on regional level unmet healthcare infrastructure. This framework is the result of the joint effort of the three experts.

Italian National (and Regional) Health Service(s) 1

The Italian National Health System (NHS), which follows the Beveridge model, is a public health system that provides universal coverage for comprehensive and essential health services through general taxation. Since the early 1990s, a strong decentralization policy has been adopted and the central government has gradually transfer fiscal, financial and organizational autonomy to the 20 Regions. At national level, the Ministry of Health (supported by several specialized agencies) sets the fundamental principles and goals of the health system, determines the core benefit package of health services guaranteed across the country (know as “Essential Level of Care”), and allocates national funds to the Regions. The regions are responsible for organizing and delivering health care. As reported in the Italian health system review of the European Observatory on Health Systems and Policies “Now most health policies are developed and implemented by Regions, with an increasing heterogeneity of institutional arrangements, provider payment rules and levels of performance in terms of the quantity and quality of care offered to citizens.” The last financial and fiscal crisis has exacerbated the regional fragmentation while highlighting the need of a central financial control. Indeed, the central government maintained a guiding role in controlling the financial sustainability of health care expenditures at both national and regional level (also through caps to specific inputs such as personnel expenditure) with a strong role of the Ministry of Finance. Meanwhile the Ministry of Health introduced monitoring the Essential Level of Care (“griglia LEA”) on a yearly base using around 30 performance indicators covering Public Health, Acute care, Primary and Secondary care. Figure 1 reports the overall score of Regions on the monitored indicators from 2012 to 2017. The last available scores are those of 2018 that reports overall improvements for almost all the Regions. If Regions are able to fulfil the standards of care and financial viability they can have access to an extra fund (“fondo premialità”) which is the 3% of the total national health fund.

Figure 1. The overall score of the Essential Level of Care.

Source: Ministry of Health. Minimum level is a score of 130 up to 2015, then the minimum level has been increased to 160 points. Despite the overall improvement obtained thanks to the monitoring and control of the Essential Level of Care and the introduction of the National Outcome Program (PNE, Programma Nazionale Esiti) that provides support for audit purposes on outcome indicators, yet there are differences across Regions in terms of access and level of care provided (see the last paragraph).

Method to design the conceptual framework From a methodological point of view, to design the framework, we followed two steps: i) a review of the principal documents and articles on this topic; ii) a face-to-face validity of the framework with key informants of the national health care system. In particular, for the review we analysed:

• All the opinions of the Expert Panel on effective ways of investing in Health (EXPH) • Selected recent documents from the OECD and the European Commission on health system challenges and opportunities; • Key peer-reviewed articles on the topic of health care system performance assessment and digital transformation in the healthcare domain; • The main national health strategic documents such as national plan for health and digital transformation, national chronic care plan, etc; • Selected documents and reports on COVID and post-COVID such as the “Iniziative per il rilancio Italia 2020-2022” also named “Piano Colao” to face the economic crisis coming from the coronavirus outbreak and the Decreto Rilancio converted in law (Kick-start law of the July 17, 2020) the latest national intervention to tackle the economic consequences of the COVID emergency. The list of articles and documents reviewed are shown in appendix 1. For the face-to-face validity of the framework analysed we made in-depth interviews with national key informants with different background:

• a responsible for the health information system • a professor in management in healthcare • a former chief executive officer of a northern Italian health authority with a medical background To collect evidence-based statistics and indicators on the dimensions listed in the framework and provide regional-based investment priorities we will use the following sources:

• Population health status: ISTAT Health for All database (National Statistical Institute https://www.istat.it/it/archivio/14562), Indagine PASSI (Istituto Superiore di Sanità https://www.epicentro.iss.it/passi/dati/attivita?tab-container-1=tab1) and IRPES (Inter- regional performance evaluation system managed by Laboratorio Management & Sanità Scuola Superiore Sant’Anna https://performance.santannapisa.it/pes/start/start.php).

• Quality, access, responsiveness/ patient-centred care and appropriateness: Monitoraggio dei LEA c.d. “Griglia LEA” (Ministero della Salute http://www.salute.gov.it/imgs/C_17_pubblicazioni_2832_allegato.pdf), Nuovo Sistema di Garanzia (Ministero della Salute http://www.salute.gov.it/portale/lea/dettaglioContenutiLea.jsp?lingua=italiano&id=5238&ar ea=Lea&menu=monitoraggioLea), Rapporto SDO (Ministero della Salute http://www.salute.gov.it/imgs/C_17_pubblicazioni_2898_allegato.pdf), IRPES (Inter- regional performance evaluation system managed by Laboratorio Management & Sanità Scuola Superiore Sant’Anna https://performance.santannapisa.it/pes/start/start.php); The tree-map selection of the National Outcome Program (PNE) https://www.agenas.gop.it/programma-nazionale-esiti-pne/indicatori-pne • Human resources (healthcare workforce): Annuario Statistico (Ministero della Salute http://www.salute.gov.it/imgs/C_17_pubblicazioni_2879_allegato.pdf). • Physical resources (infrastructure / health equipment and diagnostics): Annuario Statistico (Ministero della Salute) and analysis of regional healthcare financial statement available online (Openbdap Corte dei Conti/Ragioneria Generale dello Stato https://openbdap.mef.gov.it/) • ICT and e-health: AGID (Agenzia per l’Italia Digitale https://www.agid.gov.it/it/piattaforme/sanita-digitale), Ministero della Salute (http://www.salute.gov.it/portale/temi/p2_4.jsp?lingua=italiano&tema=Ricerca%20e%20inn ovazione&area=eHealth), IRPES (Inter-regional performance evaluation system managed by Laboratorio Management & Sanità Scuola Superiore Sant’Anna https://performance.santannapisa.it/pes/start/start.php).

The conceptual framework The model proposed is based on the OECD conceptual framework that covers the main concepts and areas of performance in health (Arah et al 2006, International Journal for Quality in Health Care) focusing on the quality of health care using a broader perspective on health and its other determinants to capture population health. Health and health care performance is determined by multiple interdependent factors, including population health status, non-health care determinants of health (behaviour and life style, socio-economic conditions, environment, personal resources) and obviously the features of the health care system (traditionally financing, delivery and governance model) and other country related determinant’s such as value and culture. The dimensions of health care performance are attributes of the systems that are related to its functioning for the improvement or maintenance of health conditions. The OECD framework includes the following three key performance dimensions: quality (effectiveness, safety, and responsiveness), accessibility and costs/expenditure as part of the efficiency equation. The performance dimensions are articulated according to healthcare needs considering the different stratification of the population: from a healthy citizen to a terminal patient. Overall, the framework by Arah et al stresses that health performance overall should aim at maintaining both an efficient and equitable system.

We purposeful modified the existing framework (reported in figure 2) to extend the dimensions of performance considering also appropriateness of care delivered to assure the delivery of high-value care (avoid under and over treatment and ensuring that only interventions with strong evidence of cost-effectiveness are used). We separated patient centeredness from quality of care emphasizing the need for personalized care based on preferences and needs of individuals and caregivers. Finally, we placed a stronger emphasis on access in terms of timely and equitable access to services. Long-term health investments should aim at sustain the achievement and improvement over time of these performance dimensions while reducing unwarranted variation. Differently from the OECD framework, we assessed the dimension of performance considering the different level / setting of care, from public health to long-term care. The different settings are interconnected and interdependent for the achievement of health outcomes, they do not operate in silos thus an integrated assessment of performance across setting should be achieved to assure continuity and coordination of care. For this reason, the framework includes the explicit reference to healthcare pathway to highlight the priority of measuring the smooth organization of care across providers and institutions for specified users over time (e.g., for cancer and chronic patients). Also, we explicitly expanded health system design characteristics and resources that impact on the delivery of services and consequently on healthcare performance both in term of quality of actions and quality of achievements (sustainable results). Among these dimensions we included the financing and payment mechanisms, the organization and provision of service, the physical resources, ICT and e-health, the human resources and governance mechanisms. Particular attention will be given to the assessment of the available physical resources in the different setting of care (territorial, hospital and long-term care) including equipment and infrastructure to identify variation in resource distribution and highlight possible investment needs. In addition, because of the renewed strategic relevance of ICT and e-health for strengthening health system performance and boosting resilience, we specify three intervention areas: digital health services for citizens; electronic health record and electronic medical record; telemedicine and advanced solutions (Artificial Intelligence, Big data, block chain). To assure effective and sustainable investments in this area it is essential that adequate cabling network systems are in place. Also, a critical assessment of interventions for the improvement of digital skills for healthcare workers will be considered. Figure 2. The conceptual framework to assess the unmet needs for investment purposes (adapted from Arah et al 2006)

Towards the assessment of the Italian health unmet needs To identify the priority areas of investments for Italian health systems we will implement the framework presented in the previous paragraph to 12 out 20 Italian Regions. Indeed, as reported in the second paragraph, in the Italian health system the Regions have a strong autonomy in organizing and providing health services and concurrent power together with the central government in planning and allocating resources. The 12 Italian regions selected for the assessment are:

• Basilicata (South) • Calabria (South) • Campania (South) • Liguria (North) • Lombardia (North) • Piemonte (North) • Puglia (South) • Sardegna (Island/South)

• Sicilia (Island/South) • Toscana (Centre) • Umbria (Centre) • Veneto (North) The regions have been selected to represent the southern Regions (including islands) and a selection of northern and central Italian Regions. They cover 3/4 of the total national population. The selected regions present a significant variability in terms of health service organization and health performance and have been differently hit by the COVID-19 pandemic. In particular, we included almost all the southern Regions for the well documented situation related to the unmet needs and North-South divide in terms of health status and satisfaction with care as reported in Figure 3. Figure 3. National statistics on (a) Infant mortality rate (male & female); (b) Life expectancy at 65 years (male); (c) Life expectancy at 65 years (female); (d) % Patient satisfied with the last hospital admission (male & female).

(a) (b)

Source: Istat Health for All (https://www.istat.it/it/archivio/14562, accessed 23 July 2020) 7

Figure (a) shows the divide in terms of infant mortality rate. Higher mortality is reported in the South compared to the North. Also, life expectancy at 65 year (Figure b and c) presents high variability among regions (with a gap of 1.9 years, for both genders, between the highest and lowest performing region) and still a substantial gender difference (+3.1 years for women compared to men). While, Figure (d) highlights the divide in terms of satisfaction of inpatients for the care received. As northern Regions we included Lombardia, Veneto and Piemonte largely hit by COVID-19 (Figure 4). Whilst as central Region we included Toscana as the first central Region with the higher total COVID cases at May 3rd, the day before the end of lockdown measures. Then we added Umbria as a central small Region. Figure 4. Map of the COVID-19 positive cases, fatalities and healed patients in Italy. Updated May 3, 2020

Source: Italian Ministry of Health, Protezione Civile.

Using the data sources listed in the method section, we will measure the indicators listed in the Appendix 2 which can monitor most of the dimensions identified in the framework (Figure 1). The list includes, among others, indicators related to physical and human resources; performance indicators per dimension and information about the use of ICT and e-health. In this list some indicators present multiple sources of information to assure a full coverage of regional health systems. Indeed, the most updated source of information about regional performance is the IRPES (2019 data) but it only covers a selection of regional health systems. For the others we will use the last year available by open access official documents at national level. Moreover, the contacts with the Regional representatives for the policy cohesion funds are quite relevant to grab information to align the priorities and the investments coming from different sources avoiding overlapping or potential gaps in funding the areas needing to be strengthened, especially in this period of emergency and eventually add indicators to the list of appendix 2. Hence, we will complement the assessment with both quantitative and qualitative information that we will collect directly from the regional authorities. In particular, the interaction with regional contact points will help gathering information on strategic plans and programs on health investments that each region is

8 putting forward also in the light of the COVID-19 emergency. It will also be an opportunity for gaining insights on regional variability regarding gaps and unmet needs for specific groups of population and care services. This analysis, together with other contacts with key informants from the national level will provide with a picture of the health investment needs in Italy. Indeed, the analysis of strategic national plans of investments in the short-medium terms are quite relevant because they highlight what has been already decided in this period of emergency, as measure to strengthen the health system. Box 1 reports the measures defined by the recent kick-start law issued in the mid of July. Box 1. Measures to strengthen the health system included in the Italian law n.77/2020

Main area Action proposed Hospital • Expansion of 3,500 new intensive care beds and about 4,225 new sub- intensive care beds. • Restructuring of ER facilities to assure independent care pathways for infected patients. • About 4,200 new scholarship for medical students (interns) Emergency system • Integration of public health and primary care for surveillance, contact tracing, identification and isolation of patients. • Strengthening the network of microbiology laboratories. • Reinforcing home care services to free up acute care facilities. • Introducing home-based oximetry monitoring equipment. • Creation of regional hub centres for the coordination of health emergencies. • Refinancing the National Emergency Fund for Civil Protection activities. Territorial services • Two-year pilot project to boost integration of care and social services through interventions focused on home care and long term care facilities • Strengthening of the territorial special care units (USCA) through the integration with other specialties (ie. Psychologists) • Introduction of Community and Family Nurses (8 per 50,000 inhabitants) • Introduction of the palliative care residency. Information systems • Strengthening and consolidating the features interoperability and privacy requirements for health and social data collection in the Fascicolo Sanitario Elettronico • Boosting acquisition of birth and death certificates within the Sistema Tessera Sanitaria (CSE)

Appendix 1 – List of references and documents reviewed

Agid Agenzia per l’Italia Digitale (2019). Piano 10ennale per l’Informatica nella Pubblica Amministrazione 2019-2021. AGID Agid Agenzia per l'Italia Digitale (2019) Rapporto AGID sulla spesa ICT nella sanità territoriale italiana. AGID Bai L., Yang D., Wang X. & Zhu, X., Bai, C. Powell (2020) Chinese experts’ consensus on the Internet of Things-aided diagnosis and treatment of coronavirus disease 2019. Clinical eHealth. https://doi.org/10.1016/j.ceh.2020.03.001 Bernd R. (2020) How to enhance the integration of primary care and public health? Approaches, facilitating factors and policy options. WHO Policy Brief No.34 Cartabbellotta N, Cottafava E, Luceri R, Mosti M (2019). 4° Rapporto GIMBE sulla sostenibilità del Servizio Sanitario Nazionale. Fondazione GIMBE Chesbrough H. (2020) To recover faster from Covid-19, open up: Managerial implications from an open innovation perspective. Industrial Marketing Management. https://doi.org/10.1016/j.indmarman.2020.04.010 Chesbrough, H., & Bogers, M. (2014) Explicating open innovation: Clarifying an emerging paradigm for understanding innovation. New frontiers in open innovation. Oxford University Press Comitato di esperti in materia economica e sociale (Piano Colao) (2020). Iniziative per il rilancio "Italia 2020-2022" - Rapporto per il Presidente del Consiglio dei Ministri Cravo T, Hashiguchi O (2020) Bringing health care to the patient: An overview of the use of telemedicine in OECD countries. OECD Health Working Papers No. 116 European Commission (2012) eHealth Action Plan 2012-20 Innovative for the 21st century. European Commission European Commission (2020) Digital Economy and Society Index (DESI) – 2019. Country Report Italy https://ec.europa.eu/digital-singlemarket/en/desi. European Forum for Primary Care (EFPC) (2020). Statement on COVID-19 from the European Forum for Primary Care:Reducing the Impacts to Vulnerable Groups. European Forum for Primary Care Expert Panel On Effective Ways Of Investing In Health (EXPH) (2014). Definition and Endorsement of Criteria to identify Priority Areas when Assessing the Performance of Health Systems. European Commission Expert Panel On Effective Ways Of Investing In Health (EXPH) (2017) Benchmarking access to healthcare in the EU. European Commission

Expert Panel On Effective Ways Of Investing In Health (EXPH) (2018) Application Of The Ern Model In European Cross-Border Healthcare Cooperation Outside The Rare Diseases Area. European Commission Expert Panel On Effective Ways Of Investing In Health (EXPH) (2018) Assessing The Impact Of Digital Transformation Of Health Services. European Commission Expert Panel On Effective Ways Of Investing In Health (EXPH) (2019) Task Shifting And Health System Design. European Commission Expert Panel On Effective Ways Of Investing In Health (EXPH) (2014). Definition of a frame of reference in relation to primary care with a special emphasis on financing systems and referral systems. European Commission Expert Panel On Effective Ways Of Investing In Health (EXPH) (2016). Disruptive innovation. European Commission Expert Panel On Effective Ways Of Investing In Health (EXPH) (2016) Typology of health policy reforms and framework for evaluating reform effects. European Commission Expert Panel On Effective Ways Of Investing In Health (EXPH) (2016). Best practices and potential pitfalls in public health sector commissioning from private providers. European Commission Expert Panel On Effective Ways Of Investing In Health (EXPH) (2016). Access to health services in the European Union. European Commission Expert Panel On Effective Ways Of Investing In Health (EXPH) (2016) Reflections on hospital reforms in the EU. European Commission Expert Panel On Effective Ways Of Investing In Health (EXPH) (2017) Innovative Payment Models For High-Cost Innovative Medicines. European Commission Expert Panel On Effective Ways Of Investing In Health (EXPH) (2017) Tools And Methodologies For Assessing The Performance Of Primary Care. European Commission Expert Panel On Effective Ways Of Investing In Health (EXPH) (2018) Vaccination Programmes And Health Systems In The European Union. European Commission Expert Panel On Effective Ways Of Investing In Health (EXPH) (2019) Defining Value In “Valuebased Healthcare”. European Commission Expert Panel On Effective Ways Of Investing In Health (EXPH) (2019) Options To Foster Health Promoting Health Systems. European Commission Expert Panel On Effective Ways Of Investing In Health (EXPH) (2020) First drafting group meeting on Public procurement in healthcare systems. European Commission Ferrè, F., Vinci, B., & Murante, A. M. (2019) Performance of care for end‐of‐life cancer patients in Tuscany: The interplay between place of care, aggressive treatments, opioids, and place of death. A retrospective cohort study. The International Journal of Health Planning and Management, 34(4), 1251-1264 11

Levesque (2013) The Interaction of Public Health and Primary Care:Functional Roles and Organizational Models that Bridge Individual and Population Perspectives. Public Health Review, Vol 35, No1 Macolo M, Banfi P, Milieu LTd (2018) Country factsheets ESI Funds _Italia ESI funds for health Ministero della Salute (2014) Telemedicina Linee Guida nazionali. Ministero della Salute Moro G, Saponaro F (2020) Paper iCom Una svolta per la sanità territorial. iCom Istituto per la competitività Noto, G, Belardi P, Vainieri M (2020) Unintended consequences of expenditure targets on resource allocation in health systems. Health Policy 124 (4):462-469. Nuti, S, Noto G, Vola F, Vainieri M (2018) Let’s play the patients music: a new generation of performance measurement systems in healthcare. Management Decision 56, (10): 2252-2272 Nuti, S., & Seghieri, C. (2014) Is variation management included in regional healthcare governance systems? Some proposals from Italy. Health policy, 114(1), 71-78 Nuti, S., & Vainieri, M. (2014) Strategies and tools to manage variation in regional governance systems. Medical Practice Variations Health Services Research. Boston: Springer Nuti, S., Seghieri, C., & Vainieri, M. (2013) Assessing the effectiveness of a performance evaluation system in the public health care sector: some novel evidence from the Tuscany region experience. Journal of Management & Governance, 17(1), 59-69 Nuti, S., Seghieri, C., Vainieri, M., & Zett, S. 2012 Assessment and improvement of the Italian healthcare system: first evidence from a pilot national performance evaluation system Journal of Healthcare Management, 57(3), 182-199. OECD (2020) Realising the potential of primary health care. OECD Health Policy Studies OECD (2020) Realsing the full potential of primary health care. OECD Health Policy Brief Scarpetta S., Colombo F., De Biennassis K., Llena-Nozal A. (2020)Workforce and Safety in Long- Term Care during the COVID-19 pandemic. OECD Tackiling CORONAVIRUS Toth F (2014) How health care regionalisation in Italy is widening the North–South gap. Health Economics, Policy and Law

Appendix 2 – List of indicators

Setting of ID reference in the data care (if Description Source(s) of data sources applicable) HEALTH STATUS

ISTAT Health for NA Gruppo.7 0270 Mortality rate per 10.000 inhabitants All IRPES -Network A1.1 Mortality rate in the first year per 1.000 regioni NA Gruppo 7.2 030 born ISTAT Health for All IRPES -Network A2 regioni NA Cancer mortality per 100.000 inhabitants Gruppo 3 1090 ISTAT Health for All IRPES -Network A3 CVD Mortality rate per 100.000 regioni NA Gruppo.8 1510 inhabitants ISTAT Health for All Influenza Mortality rate 10.000 ISTAT Health for NA Gruppo.9.1 1630 inhabitants All IRPES -Network A4 regioni NA Suicide mortality rate Gruppo. 16.2 1940 ISTAT Health for All Gruppo. 7 ISTAT Health for NA Life expectancy at birth Sez.3 6110 E 6120 All Gruppo. 7 ISTAT Health for NA Life expectancy over65 anni (M+F) Sez.3 6131 E 6133 All Gruppo 7 ISTAT Health for NA Good health rate 65+ (M+F) Sez. 1 6031 All Gruppo 5 ISTAT Health for NA One or more chronic disease rate (M+F) Sez. 1 4001 All

NON HEALTH CARE DETERMINANTS

IRPES -Network regioni NA A10.1.1 Sedentary life style Indagine PASSI (ISS) IRPES -Network A10.2.1 regioni NA % Obese SEZ. 1 2000 e 2030 ISTAT Health for All IRPES -Network A10.3.1 regioni NA % alcohol risk SEZ. 3 2170 ISTAT Health for All

Setting of ID reference in the data care (if Description Source(s) of data sources applicable) IRPES -Network A10.4.1 regioni NA % smokers SEZ. 2 2080 ISTAT Health for All NSG Ministero NA P14C Composite indicator for lifestyle Salute

HEALTH SYSTEM PERFORMANCE

Cardiovascular Outcome Acute & PNE1 AMI mortality rate30d PNE Emergency

Acute & H22C By-pass mortality rate 30d PNE Emergency

Acute & PNE15 CHF mortality 30d PNE Emergency

Acute & PNE35 Valpuloplasty mortality 30d PNE Emergency

Acute & Riparazione di aneurisma non rotto dell' PNE55 PNE Emergency aorta addominale: mortalita' a 30 giorni

Acute & PNE6 AMI: % PTCA treatment by 2d PNE Emergency Elective procedure Outcome Acute & Laparoscopic colecistectomy: % PNE999 PNE Emergency procedure > 90 cases Oncological procedure Outcome Acute & H02Z Volume breast cancer > 135 cases PNE Emergency

Acute & PNE605 Conserpatipe treatment PNE Emergency

Acute & PNE63 Lung cancer mortality rate 30d PNE Emergency

Acute & PNE82 Stomach cancer mortality rate 30d PNE Emergency

Acute & PNE83 Colon cancer mortality rate 30d PNE Emergency Maternal care Outcome Acute & PNE203 Complications during natural delipery PNE Emergency

Setting of ID reference in the data care (if Description Source(s) of data sources applicable) Acute & PNE317 Complications during csection PNE Emergency Time-dependent disease Outcome Acute & PNE18 Stroke mortality rate 30 d PNE Emergency

Acute & PNE601 Brain tumor mortality rate 30 d PNE Emergency

Acute & H13C % hip fracture operated within 2 d PNE Emergency

Acute & PNE68 Waiting time for fibula and tibia fracture PNE Emergency Chronic disease Outcome Acute & H24C COPD mortality 30 d PNE Emergency Healthcare expenditure

NA F17 Per capita cost

Acute & IRPES -Network F17.1 Per capita cost for hospital care Emergency regioni Public IRPES -Network F17.2 Per capita cost for prevention care health regioni Primary IRPES -Network F17.3 Per capita cost for territorial care care regioni Primary IRPES -Network F17.3.1 Per capita cost for outpatient care care regioni Primary Per capita cost for imaging diagnostic IRPES -Network F17.3.1.1 care care regioni Primary IRPES -Network F17.3.2 Per capita cost for primary care care regioni Acute & F18 DRG average cost Emergency

NA F1 Financial viability

Acute & Cost and revenues (legge di stabilità IRPES -Network F1.4 Emergency n.208/2015) regioni Acute & IRPES -Network D18 % PHLAMA Emergency regioni IRPES -Network NA E2 % Absenteism regioni Public B2 Health promotion health

Setting of ID reference in the data care (if Description Source(s) of data sources applicable) IRPES -Network Public regioni B2.1.2 % people suggested to lose weight health Indagine PASSI (ISS) IRPES -Network Public regioni B2.2.2 % obese suggested to lose weight health Indagine PASSI (ISS) IRPES -Network Public % people suggested to do physical regioni B2.2.3 health exercise Indagine PASSI (ISS) IRPES -Network Public regioni B2.3.2 % alcohol risk people suggested to quit health Indagine PASSI (ISS) IRPES -Network Public regioni B2.4.2 % smokers suggested to quit health Indagine PASSI (ISS) Public B5 Cancer screening health IRPES -Network Public regioni B5.1.1 Breast cancer screening invitation health ISTAT Health for All IRPES -Network Public regioni B5.1.2 Breast cancer screening test health ISTAT Health for All Public IRPES -Network B5.2.5 Cervical cancer screening invitation health regioni IRPES -Network Public regioni B5.3.1 Colorectal cancer screening invitation health ISTAT Health for All IRPES -Network Public regioni B5.3.2 Colorectal cancer screening test health ISTAT Health for All Public NSG Ministero P15C Composite screening indicator health Salute Public B7 Vaccination coverage health Public NSG Ministero P02C Measels vaccination coverage health Salute IRPES -Network Public B7.2 Influenza vaccination coverage regioni health ISTAT Health for

Setting of ID reference in the data care (if Description Source(s) of data sources applicable) All Griglia LEA

Public IRPES -Network B7.3 papilloma virus vaccination coverate health regioni

Public Influenza vaccination coverage for IRPES -Network B7.4 health healthcare professionals regioni IRPES -Network Public regioni B7.5 Meningococcal vaccination coverage health ISTAT Health for All IRPES -Network Public regioni B7.6 Pneumococcal vaccination coverage health ISTAT Health for All IRPES -Network Public regioni B7.8 Varicella vaccination coverage health ISTAT Health for All Public Vaccination coverage for (polio, difterite, NSG Ministero P01C health tetano, epatite B, pertosse, Hib) Salute Hospital - IRPES -Network emergency C16.11 Emergency call response regioni care Griglia LEA Hospital - IRPES -Network emergency D9 Patient leaving A&E regioni care Public F16 Collective prevention health Public NSG Ministero P10Z Food safety control (animal) health Salute Public NSG Ministero P12Z Food safety control health Salute Acute & C1 Hospitalization rates Emergency IRPES -Network Acute & regioni H01Z Hospitalization rate Emergency NSG Ministero Salute IRPES -Network Acute & regioni C1.1.2.1 Day hospital hospitalization rate Emergency Rapporto SDO Ministero Salute IRPES -Network Acute & regioni C1.5/ Tavola 3.3 Case mix index Emergency Rapporto SDO Ministero Salute Acute & IRPES -Network C1.6 % Surgical acute hospitalization Emergency regioni 17

Setting of ID reference in the data care (if Description Source(s) of data sources applicable) Rapporto SDO Ministero Salute

Hospital efficiency IRPES -Network Acute & C2a.M / Tavola 3.3/3.4 ALOS for medical DRG regioni-Rapporto Emergency SDO IRPES -Network Acute & C2a.C/ Tavola 3.3/3.4 ALOS for surgical DRG regioni Rapporto Emergency SDO Acute & Rapporto SDO Tavola 3.5 ALOS for patients over75 Emergency Ministero Salute Acute & Rapporto SDO Tavola 3.1 Presurgical ALOS Emergency Ministero Salute Acute & Rapporto SDO Tavola 3.4 ALOS for long term hospitalization Emergency Ministero Salute Acute & C14 Medical appropriateness Emergency IRPES -Network Acute & Medical DRG hospitalization rate regioni C4.8 Emergency (potentially inappropriate) Rapporto SDO Ministero Salute IRPES -Network regioni Acute & Hospitalization rate for diagnostic C14.2°/ C14.5 Rapporto SDO Emergency purposes Ministero Salute + Griglia LEA IRPES -Network Acute & regioni C14.4 % long term hospitalization >65 Emergency Rapporto SDO Ministero Salute Acute & C4 Surgical appropriateness Emergency IRPES -Network Acute & regioni H05Z % laparoscopic colecistectomy by 3 d Emergency NSG Ministero Salute - PNE IRPES -Network Acute & C4.7/ Tavola 2.2.4 % Day Surgery regioni- Rapporto Emergency SDO Acute & IRPES -Network C18.6 Tasso osp. stripping di vene Emergency regioni Acute & NSG Ministero H04Z Potential risk of inappropriateness Emergency Salute Acute & Inpatient satisfaction Emergency Acute & Gruppo 8 Inpatients satisfied with medical doctors ISTAT Health for Emergency Sez.7 7720 M+F All 18

Setting of ID reference in the data care (if Description Source(s) of data sources applicable) Acute & Gruppo 8 ISTAT Health for Inpatients satisfied with nurses M+F Emergency Sez.7 7750 All Acute & C6 Patient Safety Emergency IRPES -Network Acute & regioni C6.4.1 Post surgical sepsi Emergency Rapporto SDO Ministero Salute IRPES -Network Acute & regioni C6.4.2 Mortality rate within hospital wall Emergency Rapporto SDO Ministero Salute IRPES -Network Acute & regioni C6.4.3 Post surgical pulmonary emboly Emergency Rapporto SDO Ministero Salute Acute & C7 Maternal and Infant care Emergency Acute & NSG Ministero H17C Emergency % c-section in facility by 1.000 delivery Salute Acute & NSG Ministero H18C % c-section in facility with +1.000 Emergency delivery Salute Primary IRPES -Network C7.7 Hospitalization rate (< 14) care regioni Primary IRPES -Network C7.7.1 Hospitalization rate (< 1) care regioni IRPES -Network Acute & C18.1 regioni Tonsillectomy rate Emergency Tavola 4.2 Rapporto SDO Ministero Salute Primary IRPES -Network C9.8.1.1.1 Antibiotic consumption care regioni Primary IRPES -Network C9.8.1.1.2 Antibiotic consumption for children care regioni

Path C8a Continuity of care

IRPES -Network Path C8b.2 Hospitalization rate with ALOS +30 regioni IRPES -Network Path C8b.1/ SEZ. 4 7390 Emergency admission rate regioni - ISTAT Health for All IRPES -Network regioni Path C8D.1 ACSC Rapporto SDO Ministero Salute Path C10 Cancer path

Setting of ID reference in the data care (if Description Source(s) of data sources applicable) IRPES -Network Path C10.2 Breast cancer treatment regioni IRPES -Network Path C10.2.1 % nipple/skin sparing for breast cancer regioni % sentinel lynph node during breast IRPES -Network Path C10.2.2 cancer intervention regioni IRPES -Network Path C10.2.6 Breast cancer follow up regioni IRPES -Network Path C10.3 Colorectal cancer treatment regioni IRPES -Network Path C10.3.1 Reintervention for colon cancer 30d regioni IRPES -Network Path C10.3.2 Reintervention for rectal cancer 30d regioni IRPES -Network Path C10.5a Diagnostic prescription regioni IRPES -Network Path C10.5 Tumor biomarker test regioni IRPES -Network regioni Path C10D Cancer surgical responsiveness Rapporto SDO Ministero Salute IRPES -Network Waiting time for breast cancer regioni Path C10.4.7 intervention National Plan waiting times IRPES -Network Waiting time for prostate cancer regioni Path C10.4.8 intervention National Plan waiting times IRPES -Network Waiting time for colon cancer regioni Path C10.4.9 intervention National Plan waiting times IRPES -Network Waiting time for rectal cancer regioni Path C10.4.10 intervention National Plan waiting times IRPES -Network regioni Path C10.4.11 Waiting time for lung cancer intervention National Plan waiting times IRPES -Network Waiting time for uterus cancer regioni Path C10.4.12 intervention National Plan waiting times Waiting time for melanoma cancer IRPES -Network Path C10.4.13 intervention regioni

Setting of ID reference in the data care (if Description Source(s) of data sources applicable) National Plan waiting times IRPES -Network Waiting time for thyroid cancer regioni Path C10.4.14 intervention National Plan waiting times Path C11a Chronic diseases IRPES -Network regioni Path C11a.1.1 CHF hospitalization rate (50-74) Rapporto SDO Ministero Salute IRPES -Network regioni Path C11a.2.1 Diabetes hospitalization rate (35-74) Rapporto SDO Ministero Salute IRPES -Network Path C11a.2.4 Amputation rate for diabetic foot regioni IRPES -Network regioni Path C11a.3.1 COPD hospitalization rate (50-74) Rapporto SDO Ministero Salute LTC B28 Home and Long Term Care

IRPES -Network LTC B28.1.2 % elderly with a home care evaluation regioni IRPES -Network LTC B28.1.5 % home care visits during weekend regioni Home care visit for 75 after 2 day of IRPES -Network LTC B28.2.5 discharge regioni IRPES -Network LTC B28.2.9 % elderly taking in charge in home care regioni IRPES -Network regioni LTC D33Za.R3 Nursing home stay rate >=75 NSG Ministero Salute NSG Ministero LTC D22Z Home care rate (CIA 1, CIA2, CIA 3) Salute Primary C13 Imaging Diagnostic prescription care Primary IRPES -Network C13a.2.2.1 Muskoloskeletal MRI rate (≥ 65 anni) care regioni Primary IRPES -Network C13a.2.2.2 % Lumbar MRI repeated care regioni

Path C15 Mental health

Setting of ID reference in the data care (if Description Source(s) of data sources applicable) NSG Ministero Path D27Z % psychiatric repeated hospitalization Salute IRPES -Network Path C9.2 % patients drop out for statin drug regioni % patients drop out for antidepressive IRPES -Network Path C9.9.1.1 drug regioni

Path C28 Palliative care IRPES -Network Cancer patients dead who were assisted regioni Path D30Z by palliative care NSG Ministero Salute IRPES -Network regioni Path D32Z Hospice functioning NSG Ministero Salute Path B4 Consumo di farmaci oppioidi

IRPES -Network Path B4.1.1 Oppioid drug consumption regioni IRPES -Network Path B4.1.1a Territorial oppioid drug consumption regioni

HEALTH CARE SYSTEM DESIGN AND CONTEXT

NA FSE (Electronic Medical Record)

NA Implementation level Agid

NA Interoperability Agid

NA Utilization Agid

NA Citizens who activated FSE Agid

NA Digital referral in FSE Agid

IRPES -Network NA B24C.1 % privacy consent for FSE regioni IRPES -Network NA B24C.2 Num citizens who used FSE regioni IRPES -Network NA B24C.3 Num lab referral avilable on FSE regioni

NA Electronic clinical history

Setting of ID reference in the data care (if Description Source(s) of data sources applicable) Indagine di clima organizzativo gestito NA Utilization of clinical history dal Laboratorio MeS (SANT'ANNA) NA Digital tool

IRPES -Network NA B31.1.1a Outpatient digital services regioni IRPES -Network NA B31.1.2a Outpatient digital services (payment) regioni % Carte Sanitarie Elettroniche attive IRPES -Network NA B24.1 (CSE) regioni IRPES -Network NA B24b ePrescription regioni IRPES -Network NA B24b1.1 % drug dematerialization by GP regioni % outpatient dematerialization referral by IRPES -Network NA B24b1.2 GP regioni % specialists who use eprescription or IRPES -Network NA B24b3.1 dematerialization regioni % specialists who use eprescription or IRPES -Network NA B24b3.2 dematerialization regioni

NA Telemedicine

Agid National NA Governance survey Agid National NA G1 Telemedicine protocol survey Agid National NA G2 Citienzen campaign survey Agid National NA Use of the service survey Agid National NA P1 Service quality survey Agid National NA P2 Path service survey Agid National NA P3 Improvement services strategies survey Agid National NA Users survey Agid National NA U1 Informative documents survey Agid National NA U2 Training for professionals survey

Setting of ID reference in the data care (if Description Source(s) of data sources applicable) Agid National NA U3 Training for patients and caregivers survey Agid National NA R1,R2,R3 Financial resources survey Agid National NA Technology survey Agid National NA T1,T2,T3 Technological measures survey Type of services (1. Telemedicina; 2. Telemonitoraggio; 3. Teleassistenza; 4. Agid National NA Teleriabilitazione; 5. Telerefertazione;6. survey Altro) Agid National NA Specialties who use the service survey Reti di connettività per servizio (rete Agid National NA fissa (ADSL…); rete wireless; rete survey mobile (telefono); rete dedicata)

Physical infrastracture

NA F3.2 Investment policy

Obsolecence of infrastracture IRPES -Network regioni NA F3.2.2 Obsolescence of equipment Regional Financial statements IRPES -Network regioni NA F3.2.1 Leasing recourse Regional Financial statements Physical infrastracture & Human NA resources Acute & Open Data Min Hospital beds per capita Emergency Salute

Annuario statistico Acute & N facilities Ministero Salute Emergency (2017) Annuario statistico Primary ASS_DIS_MED_02 Patients per GP Ministero Salute care (2017) Annuario statistico Primary ASS_DIS_MED_03 Patients per family pediatrician Ministero Salute care (2017) Annuario statistico Primary ASS_DIS_GUA_01 Continuty of care doctors Ministero Salute care (2017)

Setting of ID reference in the data care (if Description Source(s) of data sources applicable) Annuario statistico ASS_DIS_DOM_01(I,II LTC Home care activities Ministero Salute ) (2017) Annuario statistico LTC ASS_DIS_STS_01 LTC facilities Ministero Salute (2017) Annuario statistico Primary ASS_DIS_STS_02 Outpatient facilities Ministero Salute care (2017) Annuario statistico Primary ASS_DIS_STS_03 Private outpatient facilities Ministero Salute care (2017) Annuario statistico LTC ASS_DIS_STS_05 Type of LTC facilities Ministero Salute (2017) Annuario statistico LTC ASS_DIS_STS_06 LTC beds Ministero Salute (2017) Annuario statistico Primary ASS_DIS_STS_11 (I,II) Public diagnostic equipment Ministero Salute care (2017) Annuario statistico Primary ASS_DIS_STS_12 (I,II) Private diagnostic equipment Ministero Salute care (2017) Annuario statistico Acute & ASS_OSP_STR_01 Public hospitals Ministero Salute Emergency (2017) Annuario statistico Acute & ASS_OSP_STR_02 Private hospitals Ministero Salute Emergency (2017) Annuario statistico Acute & ASS_OSP_STR_03 Public emergency services Ministero Salute Emergency (2017) Acute & Annuario statistico ASS_OSP_STR_04 Private emergency service Emergency 2017 Acute & ISTAT Health for SEZ.4 7395 Emergency services Emergency All Annuario statistico Acute & ASS_OSP_STR_07 (I,II) Diagnostic equipment in public hospital Ministero Salute Emergency (2017) Acute & Annuario statistico ASS_OSP_STR_08 (I,II) Diagnostic equipment in private hospital Emergency 2017 Annuario statistico NA PER_SSN_01 Healthcare professionals Ministero Salute (2017) Annuario statistico Healthcare professionals in private NA PER_SSN_02 Ministero Salute hospitals (2017) Annuario statistico Acute & Beds, ALOS in public hospitals Ministero Salute Emergency (2017) 25

Setting of ID reference in the data care (if Description Source(s) of data sources applicable) Annuario statistico Acute & Beds, ALOS in public hospitals for acute Ministero Salute Emergency care (2017) Annuario statistico LTC Beds, ALOS in private facilities Ministero Salute (2017) Annuario statistico LTC Beds, ALOS in public facilities Ministero Salute (2017)

Unmet Healthcare Infrastructure Needs Related to Acute Care, Community Care and Long- Term Care

Prepared by: Prof. Milena Vainieri in collaboration with Dr. Francesca Ferrè and Dr. Ylenia Sacco

EXPERT CONTRACT NUMBER – 2020CE16BAT065 AMI expert reference: REGIO 2020-0447

Updated: 7th December 2020

Table of contents Summary ...... 2 1. Introduction ...... 3 2. Health expenditure by Acute and Emergency Care, Community and Long-Term Care in the Italian Healthcare system ...... 5 3. How to identify the regional unmet needs in Acute Care, Community and Long-term Care ...... 7 4. The Italian and regional performance ...... 8 4.1 Public fixed assets and equipment ...... 8 4.2 Acute care ...... 11 4.3 Emergency care ...... 22 4.4 Long-term care and other community services ...... 24 5. Overview of national-level containment measures and investment needs in response to the Covid-19 outbreak...... 29 6. Concluding remarks ...... 31

Summary

This document provides a picture of Italian national and regional performance in acute care, community care and long-term care before the Covid-19 outbreak. It also provides the current situation regarding investment plans discussed by the Italian national and regional governments to strengthen access to and provision of these services, and the resilience of health systems to cope with COVID-19. In general, evidence, official documents and policy-makers report that there is the need to invest in the health infrastructure. In particular, for acute care, community care and long-term care, the unmet needs concern:

 the training, recruitment and retention of the health workforce. Strengthening and delivering the workforce strategy is considered essential to coping with the COVID-19 pandemic. In this case, training relates to both the treatment and prevention of coronavirus and to epidemics in general, to prepare professionals for the next event. However, training is also critical beyond crisis situations. In particular, the information collected highlights that training is needed in long-term care settings to stimulate appropriate palliative care approaches and to promote safety, quality of care and other aspects of assistance, especially in nursing homes. Specific retention strategies need to be considered for healthcare professionals working in emergency departments. Moreover, training moderates the introduction and implementation of any technological or organisational innovations; appropriate investments in training and dissemination need to be planned when implementing new strategies and technologies.  the space and substitution of usual care through new technological solutions. During the COVID-19 pandemic, the Italian government requested an increase in ICU beds and beds that can be promptly transformed into ICU beds. Effectively increasing bed capacity in this way requires flexible solutions, able to redeploy investments in a more efficient way during normal activities. Technology (mainly telemedicine) helps to activate such substitutive services, however, capacity to utilize telemedicine is not homogenous across regions. There is a need to better understand how to reduce missed diagnoses and provide the proper access to care during emergencies, especially for time-dependent diseases. Capacity constraints in non-acute settings predate COVID-19. Indeed, the multi-year trend of reducing acute hospital beds has not been accompanied by increases in intermediate care capacity to provide appropriate care in less intensive settings. Additionally, international comparisons highlight that the number of beds per population for long-term care centers is quite low, considering the ageing population.  The restart or ‘new start’ plan. The restart of standard activity following the initial COVID- 19 reconfigurations was not homogenous across regions. The capacity to react and reorganise visits and other treatments after the end of the first lockdown was uneven. A common consideration among policy-makers was to plan not the ‘restart’ but the ‘new start’, in order to change previous practices and meet (higher) standards of care. For instance, for acute care, regions should consider the relationship between volumes and outcome, which varies across the regions as highlighted by the National Outcome Program.  The integration between hospitals, primary care and community care - another need highlighted during the pandemic but already present before COVID-19. Hospitals should be considered part of a network. This network has to be vertically integrated with other settings 2

of care (namely primary care and intermediate care), and horizontally integrated with other hospitals - both public and private. This requires not only appropriate regulations and agreements between different parties but also the possibility of sharing (health) information using the latest technologies.  The governance of health systems through performance monitoring tools. While acute care is very well monitored, other areas require investment. Very little and fragmented information can be collected for long-term care (intermediate care, nursing homes) and community care. To this end, health information systems that are interconnected and interoperable, new administrative data flows, and systematic permanent surveys of service users should be put in place. This latter aspect should also include acute care settings. Patient Reported Experience Measures and/or Outcome Measures can drive reorganisation of healthcare, and can be used to introduce and evaluate new services and innovations addressing what matters to patients, instead of what is the matter with patients.  The renovation of physical infrastructure and equipment. The high obsolescence in fixed assets requires investments for modernisation of anti-seismic and fire protection, to facilitate access for people with disabilities, to eliminate the presence of asbestos, to reduce energy consumption, and to improve ventilation/air conditioning systems. The pandemic reminded us of the WHO slogan ‘Save lives. Make hospitals safe in emergencies’. This requires flexibility in access and in function, as well as the possibility of extending capacity and, in some cases, declaring it redundant. Of more concern than the situation for overall fixed assets is the obsolescence rate for equipment, at around 88%. The Italian government has set a monitoring system for some types of equipment; there is a need not only to have a proper strategy for resource allocation for new and expensive machines, but also for dismissal and renovation.  The governance of implementing new technologies strengthening the capacity to manage complex projects. This is clearer in some areas, such as capital budgeting and capital investments. However, there is a need for capacity to design investment projects and to spend capital budgets; some regions have used less than the 60% of the national investment funds allocated. Another issue relates to the governance of medical devices; the new HTA governance model, recently revised, has only been partially implemented. There is a need at the national level to coordinate a regional network. This document is structured as i) an introduction to the Italian organisation of acute and emergency care as well as to community and long-term care; ii) a picture of resource allocation across regions of the abovementioned settings of care; iii) the method applied to identify the unmet needs in these settings; iv) the Italian and regional performance in these settings using the latest data available (including some considerations coming from COVID-19); v) an overview of national-level containment measures and investment needs in response to the COVID-19 outbreak; and vi) some concluding remarks.

1. Introduction

EU official documents report the need for a coordinated economic response to the Covid-19 outbreak, identifying in particular, the need to build a more resilient health infrastructure, to increase the 3 preparedness in response to crisis events and to ensure a safe aftermath1. In particular, this document aims at providing some insights on acute and emergency care, community and long-term care before and during the coronavirus pandemic in Italy. The Italian National Health System (SSN) is a devolved system where regional administrations have extensive powers to organise and allocate resources across providers and care settings within national guidelines and with respect to national rules.

In particular, the national government finances specific investments in health infrastructures following a national plurennial plan. The current funds come from a periodical update of the 1988 plan through the annual financial laws2. Until 1999, capital expenditure was considered quite bare in light of the fact that many hospitals were built before 1960. Supplementary capital funding comes from local authorities, which can be done through bank loans (after regional authorisation) and public–private partnership3. Hence, regions may decide where to put additional resources and they should provide periodical update on the obsolescence state of equipment and map the needs for physical infrastructures related to anti-seismic and fire protection.

Acute and emergency care are provided by local health authorities and autonomous hospitals fulfilling the regional organisational laws, which in turn adopt and adapt the national regulations. At the national level, Ministerial Decree 70 of 2015 (the so called ‘regolamento Balduzzi’) provided a useful standard of care, identifying the appropriate allocation range of units per discipline on the basis of the catchment area served and the number of hospital beds per inhabitants: 3.7 acute care beds (including 0.7 for hospital rehabilitation and long hospital stays). This law led several regions, especially those in recovery plans4, to change the deployment of hospitals from acute to other type of care. Most of the regions redesigned their acute care organisations, identifying coherently with the hospital classification of the regolamento Balduzzi. Although the explicit policy was to shift care to less expensive structures, the insufficient expansion of local services has remained a question mark5. In particular, the increasing recourse to emergency services by the population can be considered a sign of rationing and/or the ineffectiveness of primary care and community services, which in turn led to higher waiting times in the Emergency Departments (EDs). In terms of acute care performance, the current national and regional monitoring systems report that regions perform differently on appropriateness, quality of care and efficiency.

The scenario related to community and long-term care is more fragmented. These two settings of care can offer an effective and efficient alternative to acute hospitals. Evidence from other countries showed that community hospitals provide a wide spectrum of health services that lie on a continuum

1 Council Recommendation on the 2020 national reform programme of Italy and delivering a council opinion on the 2020 stability programme of Italy. Amended proposal for a regulation of the European parliament and of the council on the European Regional Development Fund and on the cohesion fund – May 2020 A roadmap for recovery towards a more resilient, sustainable and fair Europe 21-04-2020 2 Corte dei Conti. Rapporto 2020 sul coordinamento della finanza pubblica (maggio 2020) 3 France, Taroni & Donatini 2005 The Italian health-care system.Health Econ. 14: S187–S202 (2005) 4 When the regional deficit exceed the 5%, on the basis of a monitoring unit set up by the State-Regions Conference, the region had to approve a recovery plan from the operating deficit, which has to be approved by the above mentioned unit. In some cases, the Regional Health System can be appointed a commissioner. Financial resources are then given after tight periodical control between Ministry of Finance and the regions. For more details, see Neri 2019 The Italian NHS after the Economic Crisis: From Decentralization to Differentiated Federalism 5 http://en.upbilancio.it/publication-of-focus-paper-no-6-the-state-of-healthcare-in-italy/ 4 between serving a ‘geographic purpose’ and having a specific population focus, mainly older people6. Also, in Italy there is a diverse range of services included in community and long-term care. In 2015, Regolamento Balduzzi stated that the community hospital should be the facility intended to ensure intermediate care (post-acute and sub-acute). This law provided some definitions of a community hospital such as the number of beds (15–20) and the professionals involved in managing these facilities (nurses and GPs or other medical staff contracted by the SSN) (see also the report on primary care and public health)7. The strengthening of intermediate care has also been considered a national strategy to make the SSN more resilient. Despite the national definition, the current implementation across the regions is different.

Also fragmented is the situation of Long-term care (LTC), which was provided by different sectors: profit, not for profit and public8. National statistics report that LTC beds per 1,000 inhabitants are on average 4.74 with a wide variation ranging from 0.76 to 109. In the majority of the regions, LTC is referred to as nursing homes for the elderly, usually called Residenze Assistenziali Sanitarie (RSA). RSA were deeply involved in the coronavirus outbreak. Indeed, a high number of Covid-19 deaths occurred there. In this scenario, the different starting points in terms of performance and physical infrastructures as well as models of organising care may have influenced the capacity of regions to respond to the outbreak.

2. Health Expenditures by Acute and Emergency Care, Community and Long-term Care in the Italian Healthcare System

Considering the information published in Health at Glance 2019 regarding per capita health expenditure and health expenditure by type of service, Italy is not spending more than the OECD average for inpatient care, and spending far less on LTC: around 180 USD PPP per capita less than the OECD average. Overall, the open data of the Ministry of Finance (https://openbdap.mef.gov.it/it/SSN/Scopri) reports the treemap of how the 116 billion euro national health fund was allocated between settings of care. In particular, health expenditures in 2018 for acute care (assistenza per acuti) was 45.1 billion euro; for emergency departments (Pronto soccorso ed altri servizi ospedalieri) it was 5.6 billion euro; for outpatients services (assistenza specialistica) (which does not include primary care) it was 20.4 billion euro, while expenditure on other long-term care and community care (Altra assistenza territoriale) was 18.4 billion euro (Figure 1).

6 Health Services and Delivery Research 2017 VOL. 5 NO. 19 DOI: 10.3310/hsdr05190 7 https://www.quotidianosanita.it/stampa_articolo.php?articolo_id=59706 8 https://www.corriere.it/dataroom-milena-gabanelli/rsa-covid-perche-case-riposo-sono-diventate-focolai- virus/c79559d4-1c5c-11eb-a718-cfe9e36fab58-va.shtml 9 Annuario statistic del Ministero 2017 ASS_DIS_STS_06 5

Figure 1- the treemap of Italian health expenditure by type of settings of care – last data available (2018) Source: Modello LA https://openbdap.mef.gov.it/it/SSN/Scopri

In particular, expeditures for long-term care and community care can be drilled down into LTC centers, namely the RSA (assistenza territoriale residenziale) expenditure was 7.3 billion euro; for other community services, including home care (assistenza territoriale ambulatoriale e domiciliare) the expenditure was 6.8 billion euro and for day care facilities where people with disabilities or elderly receive health and social care all day (assistenza territoriale semiresidenziale) the expenditure was 1.4 billion euro (Figure 2).

Figure 1- The breakdown of Italian health expenditure by community care services– last data available (2018). Source. Modello LA https://openbdap.mef.gov.it/it/SSN/Scopri

If we consider per capita health expenditures for acute care, home care, LTC and day care centers across the regions, we discover large variability (see Table 1), especially in LTC and day care centers (semi-residential care).

Day Care Acute care Home Care LTC per Center per Regions per capita per capita capita capita Abruzzo 898 € 106 € 97 € 11 € Basilicata 818 € 103 € 79 € 7 € Calabria 707 € 164 € 97 € 41 € Campania 1 015 € 106 € 29 € 20 € Emilia Romagna 846 € 141 € 166 € 25 € F. V. Giulia 946 € 159 € 136 € 34 € Lazio 807 € 124 € 79 € 22 € Liguria 827 € 113 € 163 € 19 € Lombardia 794 € 85 € 176 € 23 € Marche 838 € 84 € 177 € 19 € Molise 1 153 € 112 € 27 € 21 € P. A. Bolzano 1 089 € 173 € 147 € 3 € P. A. Trento 1 098 € 208 € 339 € 19 € Piemonte 838 € 88 € 143 € 24 € Puglia 783 € 116 € 82 € 21 € Sardegna 923 € 102 € 99 € 8 € Sicilia 849 € 113 € 73 € 27 € Toscana 851 € 116 € 120 € 19 € Umbria 907 € 136 € 111 € 23 € Valle d'Aosta 932 € 105 € 107 € 10 € Veneto 828 € 97 € 162 € 35 € Italian average 893 € 121 € 124 € 21 € Min 707 € 84 € 27 € 3 € Max 1 153 € 208 € 339 € 41 € Coefficient of Variation 0.5 1.02 2.52 1.84

Table 1- Health expenditure by selected type of services. Sources: our elaboration on modello LA data – population not weighted for age.

This different resource consumption across settings of care puts on evidence the different approach of Regions to the provision of care.

3. How to identify the regional unmet needs in Acute Care, Community and Long-term Care

To identify unmet health needs, we took into consideration the conceptual framework presented in the first deliverable. In particular, in this document we have analysed the indicators identified and collected through the available documents and reports on performance of acute, community and long- term care and well-established performance evaluation systems in use by the national and regional governments. In particular, we used the grid LEA, PNE reports, IRPES data10 and other national reports mainly coming from the Ministry of Health and ISTAT.

10 In the 2016 report on health system performance assessment, Italy was represented by three systems: LEA grid, PNE and IRPES. Wigzell, O., Rys, A. So What? Strategies across Europe to assess quality of care, Report by the Expert Group on Health Systems Performance Assessment, 2016. 7

To this analysis based on quantitative evidence, we added the recent strategic documents and considerations coming from these last months of outbreak. In particular, we reported the Covid-19 information and consideration in grey boxes. Finally, we considered the documents and the interviews done with the regional representatives contacted through the DG Regio for this purpose.

4. The Italian and Regional Performance

4.1 Public fixed assets and equipment

Before going in-depth regarding the single settings of care, it is worth noting the obsolescence rate of the health infrastructure for all settings of care in the public sector. Public health infrastructure measured as public fixed assets11 per capita varies greatly across regions. These differences may depend on a number of factors, among which are: i) the classical choice of ‘make or buy’; in some regions the presence of private health providers (as for instance in the cases of Campania, Puglia) may have led to not investing in public health infrastructure; ii) the recourse to rent instead of acquiring the infrastructure12; iii) the obsolescence rate of health infrastructure; and iv) the region size, coeteris paribus, small regions may present a higher value. Figure 3 shows the per capita financial value of the overall fixed assets (blue bar) and the equipment (yellow bar)13.

Figure 3 – The regional overall fixed assets per capita – last data available (2018). Source: Flusso SP(Assets and liability statements) https://openbdap.mef.gov.it/

On average, more than half of these fixed tangible assets are already amortised. In particular, Figure 4 highlights the variability of the obsolescence rate that goes from 51% of Umbria Region to 86%

11 It was measured considering the assets and liability statements of regional health systems published on the Ministry of Finance opendata website. 12 Among the investment choices in the last years there was an increase in the recourse at rent and leasing. In 2018 the average recourse at these forms was 48% from 28% of P.A. Bolzano to 68% of P.A. Trento. 13 Overall health infrastructures is calculated from the assets and liability statement. It considers the historical cost of fixed assets with the exclusion of land and artwork. 8 of P.A. Bolzano. The grey bar shows the investments that regions have already in place for fixed tangible assets, these can be intense activities of adaptations (e.g. fire protection), renovation, modernisation or acquisition in progress.

Figure 4 – The regional overall obsolescence rate of fixed assets and assets under construction– last data available (2018). Source: Flusso SP(Assets and liability statements) https://openbdap.mef.gov.it/

Figure 4 suggests that funds for renovation or substitutions are spare. However, there is also another phenomenon highlighted by the last report of the National Court of Auditors (Corte dei Conti): the national government increased the funds for investments (which still relies on a law from 1988) through the recent financial laws, but there is a delay in the use of these funds as well as a general incapacity of spending the capital budget agreed on at the national level. As an example, Puglia, Calabria, Sicilia and Sardegna have proposed projects to spend their allocated capital budget at less than 60%14. If we focus on equipment, Figure 5 reflects an even worse scenario: on average, 88% of equipment is already amortised. This means that in hospitals as well as in the other care settings the equipment is quite old, and there is an urgent need to map the equipment and set out new investment plans for substitutions or renovations both at the national and regional level.

14 Corte dei Conti. Rapporto 2020 sul coordinamento della finanza pubblica (maggio 2020) pp.322-326 9

Figure 5 – The regional obsolescence rate for health equipment – last data available (2018). Source: Flusso SP(Assets and liability statements) https://openbdap.mef.gov.it/

In this scenario, the analysis of the income statements shows that more and more regions have been opting for leasing, renting or even stipulating services to substitute or use new technology and equipment. On average the 2018 expenditure on leasing and rent was 48% of the total costs for the use of equipment15 (ranging from 28% to 68%) versus 38% in 2012 (ranging from 16% to 60%). This alarming situation led the national government to map the situation of a select group of equipment across the Italian regions; this sort of inventory was one of the fulfilments the regions have to provide to the national government16. The purpose was also that of conducting a fair allocation of resources for HTA analysis controlling the diffusion of new advanced equipment. Indeed, although health technology assessment has expanded considerably since the early 1990s, medical technology remained uncontrolled17. Indeed, despite the fact that the national government set a threshold at 4.4% of the national health funds18, almost all the regions overcame that percentage. Concerning heavy equipment (such as CT and MRI), an investment plan is still missing. In particular, the last reports of the Ministry of Health and its open database19 show that the linear accelerators are quite old and with a varied distribution across regions (Figure 6).

15 Calculated as the sum of leasing, rent and amortisation. 16 The last report on this equipment is that of 2017. http://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=4598&area=dispositivi- medici&menu=apparecchiature 17 France, Taroni & Donatini 2005 The Italian health-care system.Health Econ. 14: S187–S202 (2005) 18 This agreement can be revised by specific agreements between national and regional governments. Urbani A. Il Servizio Sanitario Nazionale guarda al future. 2019. Egea 19 http://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=4653&area=dispositivi- medici&menu=apparecchiature 10

Figure 6 – The distribution of the linear accelerator. Ministry of Health report 2017 Moreover, diagnostic imaging should be connected with the development of ICT and the capacity to acquire, store and retrieve information and share it. The high obsolescence rate of the heavy equipment should also lead to another issue, which is the dismissal of this equipment, including an evaluation of redeployment in different settings of care. Recently, more attention has been paid to medical devices through the creation of registries and also a higher role of the regions in monitoring medical devices. For instance, the financial law of 2016, (art. 1, comma 551 as well as in the Patto per la salute 2014–2016) asked for a new role of Health Technology Assessment (HTA) that should be done at the national or regional level. In particular, DM 12.3.2015 set up a new governance of medical devices with the Cabinet (made up of national and regional governments), which should define the priority criteria for the assessment, the coordination of the HTA activities, the methodological validation, the dissemination of the results and the monitoring stage of the impact related to the introduction of new devices. However, after the last document about medical device governance20 in 2019, the activation of this new program yet has to come.

4.2 Acute care

In relation to acute care, it is evident from Figure 7 that the Italian strategic choice is to shift from a hospital care setting model towards public health, primary and community service models. The dramatic drop in the number of beds in the last two decades led to a reduction of the hospitalisation rate but also to a smooth increase in the average length of stay, arriving at the EU average.

20 http://www.salute.gov.it/imgs/C_17_notizie_3681_listaFile_itemName_0_file.pdf 11

Figure 7– The Italian health policy to reduce the hospital beds. Source: Italian Country profile

The decrease in the hospitalisation rate is related to a tight monitoring system by the LEA grid that has been monitoring the high potential of inappropriate DRG and also by the implementation of regolamento Balduzzi that set the standard of acute care beds to 3.7 per 1,000 inhabitants. Figure 8 shows evidence of the situation in Italy compared to the other countries in terms of number of hospital beds, occupancy rate and ICU beds before the coronavirus.

Figure 8 – OECD comparison on hospital beds data. Source: Beyond Containment: Health systems responses to COVID-19 in the OECD21

21 Beyond Containment: Health systems responses to COVID-19 in the OECD – April 2020 12

Considering the three Ss (Staff, Supply and Space) to cope with the coronavirus proposed by the OECD, in terms of space, Italy has had lower acute care beds as well as ICU beds and also a higher level of efficiency (occupancy beds), which in turn has meant decreased opportunity to use beds.

Under Covid-19 Acute care was among the first on the forefront in the fight against the Covid-19. Indeed ’Surge demand has put particularly pressure on access to diagnostics, hospitalisations, and critical care treatment of the most complex cases’22. Intensive care units were the bottlenecks in several countries. Because of the long-term strategy to keep the number of beds under 3.7 per 1,000 inhabitants, Italy saturated the bed occupancy with Covid-19 patients in the short run, especially ICU beds. Indeed, in the first wave, the critical area was the bottleneck, especially in some areas. Figure 9 reports the situation of ICU beds per 100 000 inhabitants pre-Covid-19.

Figure 9 – ICU beds per 100 000 inhabitants pre-Covid-19. Source: our elaboration on Ministry of Health data

Although Italy presents a higher rate of doctors per inhabitants, the situation of the shortages and the forecast of number of residencies has been at the centre of debate. Hence, Italy had to cope not only with the search for space but also with the redeployment of staff who had to be trained to be helpful in this specialised service.

22 Idem 13

Despite the Italian governance structure, which requires the sharing of decisions between the state and the regions, ‘The response of regional health systems to the crisis was based primarily on an extraordinary mobilisation, in particular of the health workforce and local social services. This compensated for the limits of the physical infrastructure, numbers of health workers and investment in the past years aimed at improving structures and services’23. During the crisis, regional governments and municipalities have often called for and implemented tighter containment measures to redress national measures also in relation to how the different intensity of the first wave of the outbreak hit the territories. In particular, Southern regions were less hit by the first wave of Covid-19: benefits from the whole lockdown measure preserved the South from the contagion spread, providing them relatively more time to plan a response, set up a new configuration of healthcare services and plan for stricter monitoring and managing of the disease in a primary care setting24. To cope with the first wave and to prepare Italy for the second wave, the Ministry of Health issued the following measures with the Rilancio decree (d.l.34/2020):

 Increase of 3,500 new intensive care beds and 4,225 new sub-intensive care beds (half of them should be easily transformable in intensive care) and the identification of a standard: 0.14 ICU beds per 1,000 inhabitants and 0.07 sub-ICU beds per 1,000 inhabitants  Restructuring of Emergency Departments to better assure independent pathways for infected patients.  About 4,200 new scholarships for medical students (interns) In the first week of October, the increase was only of 1,279 beds, less than half of those issued in August, with a different degree of distribution across the regions as reported in Table 2 below25.

23 A roadmap for recovery towards a more resilient, sustainable and fair Europe 21-04-2020 24 HEPL blog series: Country Responses to the Covid19 Pandemic Italy’s Response to the Coronavirus Pandemic – 2020 -Iris Bosa, Adriana Castelli, Michele Castelli, Oriana Ciani, Amelia Compagni, Matteo M. Galizzi, Matteo Garofalo, Simone Ghislandi, Margherita Giannoni, Giorgia Marini, and Milena Vainieri 25 https://osservatoriocpi.unicatt.it/cpi-archivio-studi-e-analisi-l-aumento-dei-posti-in-terapia-intensiva-alcuni- chiarimenti-su-dati 14

Pre-Covid ICU beds ICU beds % ICU beds Regions ICU beds target (October) on the target Campania 335 834 427 51% Calabria 146 280 152 54% Umbria 70 127 70 55% Marche 115 220 127 58% Piemonte 327 626 367 59% Puglia 304 579 366 63% P.A. Trento 32 78 51 65% Lombardia 861 1446 983 68% Abruzzo 123 189 133 70% P.A. Bolzano 37 77 55 71% Sardegna 134 236 175 74% Sicilia 418 719 538 75% Molise 30 44 34 77% Toscana 374 536 415 77% Emilia-Romagna 449 641 516 80% Lazio 571 845 747 88% Basilicata 49 81 73 90% Liguria 180 223 209 94% Friuli Venezia Giulia 120 175 175 100% Valle d'Aosta 10 18 20 111% Veneto 494 705 825 117% Total beds 5179 8679 6458 74% Table 2-Prevision ICU beds targets and percentage of fulfillment. Sources: Osservatorio Conti Pubblici Italiani 24 October 2020.

The Regolamento Balduzzi, born during the period of financial crisis aftermath with the aim to make the SSN more sustainable26, pushed also to consider interesting indicators in the relationship between treated cases, quality and safety to patients. In particular, on the basis of scientific evidence, the National Outcome Programme (Programma Nazionale Esiti, PNE) of Agenas identified some thresholds: for instance there is evidence reporting that when hospitals treat less than135–150 cases for surgical intervention of breast cancer, the mortality rate increases. This is related to the expertise of surgeons (higher in relation to volume) but also to the hospital organisation. The control and monitoring system about the outcome of care was done by PNE. Although the last PNE release highlights27 that many outcome indicators register improvements at national levels, yet, there are areas requiring attention such as the standard of volume for cancer treatments (such as breast cancer, Figure 10) or other surgical interventions and the length of stay for laparoscopic cholecystectomy (Figure 11).

26 This decree provides useful standard of care identifying the appropriate allocation range of units per discipline on the basis of the catchment area served. 27 https://pne.agenas.it/ 15

Figure 10 –The number of wards per class of volume related to breast cancer surgery – the standard was 135interventions. Source: PNE Report Figure 10 shows the number of surgical wards that provide less than 10 breast cancer surgeries, 11– 50 breast cancer surgeries, 51–100 breast cancer surgeries, 101–134 breast cancer surgeries and more than 135 breast cancer surgeries. The gold standard identified by PNE is to run more than 135 volumes of breast cancer surgery in a year. Figure 10 shows that only 34% of wards comply with the standard for breast cancer surgery. Similar percentages come from the other surgical procedures with standards of volume included in the PNE platform. Moreover, most of these types of interventions were also monitored in terms of waiting times for surgery (see Table 3).

Figure 11 shows the variability across and within the regions for hospitals whose length of stay up to three days for laparoscopic cholecystectomy. Source PNE 2019 The variability shown in Figure 11 is also present for other indicators. The standard of 70% has been met by the majority of the regions but there is wide variation within the regions.

Because responsiveness is a major dimension of the health assessment framework around the world, the Ministry of Health in 2018 set the standards of waiting times for both diagnostic and outpatient visits as well as for surgical interventions. In particular, Table 3 identifies the % of expected patients treated by 30 days.

Standard of interventions to be Surgical interventions done by 30 days Breast Cancer 86 Prostate Cancer 58 Colon Cancer 91 Rectal tumor 83 Uterus tumor 87 Skin cancer 92 Thyroid cancer 76 CABG 91 PTCA 91 Carotid endarterectomy 70 Femure fracture 73 Lung Cancer 91 Laparoscopic colecistectomy 73 Chemiotherapy 98 Coronography 92 Liver skin biopsy 96 hemorrhoidectomy 84 Inguinal hernia repair 83 Table 3 – the standard of waiting times for specific hospital treatments28.

The Ministry of Health also allocated specific funds29 to provide for the needed technological infrastracture for the information desk to book health appointments (Centro Unico di Prenotazione, CUP). Yet some interventions and some regions have to pay attention to the waiting times for these selected lists of interventions. For instance, Figure 12 shows the distribution for melanoma.

Figure 12 – precentage of melanoma interventions done by 30 days IRPES Network 2019 data.

The PNE and the LEA grid introduced as monitoring indicators some time-dependent measures.

28 Piano Nazionale di Governo delle Liste di Attesa (PNGLA 2019-2021) http://www.salute.gov.it/imgs/C_17_pubblicazioni_2824_ulterioriallegati_ulterioreallegato_0_alleg.pdf 29 http://www.salute.gov.it/portale/listeAttesa/homeListeAttesa.jsp 17

In particular, PNE monitors the 30 days mortality rate for AMI, for stroke and the percentage of femur fractures operated on within two days. Because the mortality rate at 30 days is strictly related to the prompt intervention for AMI and Stroke, the monitoring of the mortality rate shows if regions and their providers were able to treat AMI and Stroke on time, organising the emergency care in a proper way. The percentage of femur fractures operated on within two days is an intermediary outcome indicator – a proxy of a fast recovery. Data from the last six years show that on average Italy was able to reduce the AMI and Stroke mortality rate at 30 days and increase the percentage of femur fractures operated on within two days. However, Figure 13a,b,c shows that there are some regions requiring attention such as Liguria for mortality rate in AMI, Campania and Puglia for mortality rate in Stroke, and Sardegna and Calabria for femur fractures operated on within two days.

Figure 13a,b,c show the variability across and within the regions time-dependent diseases. Source: PNE 2019 When looking at both mortality rate at 30 days and one year, we can discover that some regions improved their capacity to treat the time-dependent part of diseases (acute care) but lost years of life at one year, which could be read as a missing link with rehabilitation and community services.

Under Covid-19 One of the analyses on the side-effect of Covid-19 attention was the risk to overlook other diseases. In particular, the fragmented published monitoring data shows that there was a drop 18

in the number of breast cancer interventions as well as a drop in the number of AMI, stroke and femur fracture (see the Mimico Report30). This is also alarming considering that these are only volumes, not related yet to the prompt interventions required by such diseases. In Figure 14, we reported as an example the volumes related to AMI hospitalisations.

30 https://repo.epiprev.it/index.php/2020/07/06/monitoraggio-dellimpatto-indiretto-di-covid-19-su-altri-percorsi- assistenziali/ 19

Figure 14 – AMI hospitalisations during the first wave of Covid-19

In 2020, we can expect an increase in mortality rate for these causes. The drop in some urgent cases is related to a missed prompt diagnosis such as the eventual interruption of breast cancer screening for the reduction of breast cancer interventions (see the report on public health and primary care). Hence, during the first Covid-19 wave not only were many elective surgical interventions postponed (with a problem to better understand when and how to recover), but there is also an issue of how many urgent cases where not diagnosed.

An interesting indicator that provides information about the quality perceived by patients is the indicator of patients leaving the hospital against medical advice. Figure 15 highlights the gap between North and South about the perception of care received.

Figure 15 shows the % of patients who leave the hospitals against medical advice. IRPES Network 2019 data.

Concerning satisfaction with the care received, the last Italian regional data available comes from the ISTAT Health for All 2016. The lowest results come from the southern regions (Figure 16).

Figure 16 shows the variability across the regions for patients’ satisfaction with the care received in hospitals. Istat Health for All, 2016

Figure 16 highlights not only the quality of care perceived by patients, but it also indicates that there are different relationships between the assessment for nursing and medical assistance across regions (Sardegna, Sicilia, Campania), which identifies specific areas to be analysed. Indeed, scholars are recommending adopting patient-reported experience measures (PREMs) to provide clear factual and reliable results that can stimulate and inform quality improvement actions. The use of PREMs can determine the reorganization of healthcare, and they can be used to introduce and evaluate new services and innovations31. Recently, information coming from patients’ voices is considered as important as information coming from administrative data because PREMs are really able to capture what matters to patients so that they can be direct measures of unmet needs. This led OECD to start an initiative called PaRIS, Patient Reported Indicator Survey, to promote the introduction and use of this kind of monitoring tool32. The use of patients’ experience surveys in Italy is fragmented: some regions (Toscana,Veneto, Umbria) decided to independently collect patients’ experience for some services (mainly hospitalisations), while others do not have any tool to catch the patients’ suggestions

31 Using patient-reported measures to drive change in healthcare: the experience of the digital, continuous and systematic PREMs observatory in Italy Sabina De Rosis, Domenico Cerasuolo and Sabina Nuti. BMC Health Service Research 2020 32 https://www.oecd.org/els/health-systems/paris.htm 21 or, if any, they are driven by single hospitals (such as the case of Rizzoli in Emilia Romagna or Galeazzi in Lombardia).

4.3 Emergency care

Concerning emergency care, the Emergency Departments (EDs) live under high pressure because of the continuous increase in the number of accesses. The high rate of ED accesses can be considered a sign of the ineffectiveness of primary care services. The overall strategy of hospitalisation rate reduction and the decrease of the number of beds per population rely on the assumption of a strengthening of primary care and community services. However, when these settings of care are not able to meet population needs, they in turn go to the ED. Indeed, often non-urgent patients seek help from the ED because it can provide a full, timely service, with included diagnosis and examinations33. The higher recourse to emergency services by the population also led to increased waiting times in the EDs. To worsen this situation, there is also the problem of hiring doctors and nurses and the high turnover rate of people who will not work in EDs anymore. This is related not only to the stressful work but also to the problem of violence. A recent report of Anaao Assomed compares the results of two surveys on violence against doctors in 2018 and 2020. This study reports that 80% of the attacks are not formally reported, in particular, the 77% of doctors working in EDs declared to be attacked during their work by patients 34. Violence seems to be increased, and it is not an issue of both South and North of Italy. To cope with this personnel shortage even before Covid-19, some regions proposed hiring doctors in their last year of residency. In 2008 a new residency in Emergency medicine was established after a large debate among disciplines, but the number of scholarships were considered insufficient to close the gap of the shortage of personnel35.

Under Covid-19 In the first wave of Covid-19, the EDs registered a dramatic drop: March estimates for seven Italian regions show a reduction of 70% of overall accesses. In particular, the drop is evident for minority urgency codes whilst the really urgent ones remained almost stable as reported in Figure 17 a (urgent) b (non-urgent cases) (see the Mimico Report36).

33 Vainieri et al 2020 BMC Health Service Research 34 http://www.quotidianosanita.it/allegati/allegato6614301.pdf 35 https://www.quotidianosanita.it/lettere-al-direttore/articolo.php?articolo_id=75762 36 https://repo.epiprev.it/index.php/2020/07/06/monitoraggio-dellimpatto-indiretto-di-covid-19-su-altri-percorsi- assistenziali/ 22

a) b) Figure 20 shows the trend in Piemonte between January and March of 2020 (yellow line) and the 2018–9 average (blue line)

This led a high number of experts to speculate about the usual inappropriate recourse to EDs by the population, reinforcing the idea that people go to the ED because it provides a full, timely service, with included diagnosis and examinations. In this period many EDs were reorganized to welcome Covid-19 patients, ensuring a safety path. The importance of separating the Covid-19 path and the sanitation process was one of the main issues investigated to better understand what happened to Alzano Lombardo Hospital37. In the autumnal second wave, without a national lockdown, EDs have become the access point of suspected Covid-19 cases, leading to some problems of overcrowding. In particular ,the president of the scientific association of emergency doctors stated at the end of October that a large number of EDs have been transformed into Covid-19 wards, and the waiting times to receive care, in some cases, is five days38.

In relation to home care and long-term care we considered the indicators monitored by the Ministry of Health through the LEA grid39. In particular, home care services for the elderly (+65 years) vary across regions. In terms of access, there are some regions where the assistance (number of people cared by home care) is less than 1.88, which is the national standard, and others where home care is up to 3 per 1,000 inhabitants. In 2018, Figure 21 shows that Calabria does not achieve the standard as well as other regions that are on the border.

37 https://www.lastampa.it/cronaca/2020/10/23/news/coronavirus-inchiesta-sull-ospedale-di-alzano-non-fu-sanificato-c- e-anche-l-accusa-di-falso-1.39452705 38 https://www.ilmessaggero.it/salute/focus/covid_ospedali_pronto_soccorso_ambulanze_medici_allarme_cosa_sta_succe dendo-5543660.html 39 http://www.salute.gov.it/portale/documentazione/p6_2_2_1.jsp?lingua=italiano&id=2970 23

Figure 21 – the home care for the elderly – Griglia LEA 2018. In terms of quality and continuity, the indicators show that only a small percentage of the elderly who are assisted by home care received an assessment to build up a personalised care plan (Figure 22a) with wide variation also across the capacity to offer continuity between hospital and home care after a hospitalisation (Figure 22b).

Figure 22 – home care for the elderly with an assessment and the % of elderly patients discharged with home care access by two days – IRPES 2019.

4.4 Long-term care and other community services

Concerning long-term care and other community services, it is worth noting that Italy, one of the countries with a high percentage of elderly in Europe, has only 18.6 beds per 1,000 elderly versus an average of 43.8 (Figure 23).

Figure 23 – Beds per elderly. Source:Dataroom40

The LEA grid assesses the provision of care in terms of beds occupied in nursing homes for elderly housebound individuals. In particular, the governance of RSA (Nursing homes for elderly), is quite fragmented: municipalities manage the 26.7%, non-profits manage 48%, and for-profits manage 25%41. Apart from some observatories made up of voluntary networks of RSA, at the national and regional levels there is no control over the services provided by these facilities. The standard of care set by the LEA grid is 9.8 beds per 1,000 elderly42. Figure 24 shows the last results of the LEA grid: they go from 1.2 in Basilicata to 73.8 in Trento.

Figure 24 – Elderly assistance beds in residential centres per 1,000 elderly. The green line is the target. Source: LEA grid

40 https://www.corriere.it/dataroom-milena-gabanelli/rsa-covid-perche-case-riposo-sono-diventate-focolai- virus/c79559d4-1c5c-11eb-a718-cfe9e36fab58-va.shtml 41 https://www.corriere.it/dataroom-milena-gabanelli/rsa-covid-perche-case-riposo-sono-diventate-focolai- virus/c79559d4-1c5c-11eb-a718-cfe9e36fab58-va.shtml 42 Elderly people are considered ≥65 years old. 25

For people with disabilities, the provision of care by centres and day centres is calculated considering the number of beds per 1,000 inhabitants as reported in Figure 25 a and b.

a) b) Figure 25 – Place for people with disabilities in homes (a) and day centres (b) per 1,000 inhabitants. Green lines are the targets. Source: LEA grid

The situation of services offered for both residential and day care center services is quite limited and above the national standard for many regions.

Under Covid-19,a higher number of deaths come from nursing homes, and long-term care services in general were stressed. ‘The COVID-19 crisis is demonstrating that the important links between LTC, primary care and acute care cannot be ignored. Better coordination with acute care and safety improvements during the COVID-19 epidemic are conducive to higher care quality by ensuring early recognition of infections, implementing staff training on preventive measures and treating more severe cases who require ventilation support in hospitals’43 . The statistics collected about the Covid-19 deaths report that around 40% of deaths in the nursing homes are due to the pandemic, which in the first wave was around 10,000 deaths. In the autumnal wave, it seems there were similar numbers44. During the first lockdown, day care centres closed, which led to very high pressure on families with people with disabilities and enhanced the state of loneliness especially in urban areas.

The debate upon RSA (nursing homes) often focused on: a) the type of services to be provided (home care versus nursing homes), b) the type of funding (by general taxation or by insurance), c) the ownership (public or private) and recently d) the training of the professionals and aids. Seldom did the government focus on the quality of care provided through tools of performance management45. This latter requires interconnected health information systems, new administrative flows and the analysis of the quality of life perceived by the users. The last indicator reported in this document for the LTC concerns the number of Hospice beds related to the total number of cancer deaths. Figure 26 highlights the variability of hospice beds in

43 OECD 2020 Workforce and Safety in Long-term Care during the COVID-19 pandemic 44 https://www.lavoce.info/archives/67788/morti-da-covid-19-nelle-rsa-tutto-quello-che-non-sappiamo/ https://www.panorama.it/news/cronaca/rsa-morti-covid-19-numeri-anziani-dati https://www.panorama.it/news/salute/seconda-ondata-strage-rsa-morti-motivi 45 https://www.sanita24.ilsole24ore.com/art/aziende-e-regioni/2020-04-29/coronavirus-ricetta-tivedere-modello-rsa- 102032.php?uuid=ADhEFPN 26 relation to the number of cancer deaths in Italy. The standard of 1 bed per 100 cancer deaths was overcome by all the regions.

Figure 26 – Beds in hospice in relation to 100 cancer deaths. The green line is the target. Source: LEA grid Despite this, palliative care in long-term facilities is not yet fully integrated as reported in the last EAPC atlas; in particular, Italy presents a low percentage of LTC staff trained in palliative care (Figure 27).

Figure 27– the % staff trained in palliative care. Source: EAPC Atlas of Palliative Care in Europe 2019 p. 6546 Intermediate care has been reinforced over time since Ministerial Decree 70 of 2015, which was namely identified by the community hospital (article 10 of the decree). This facility has between 15– 20 beds managed by nurses, and in which medical care is provided by GPs (see also the report on

46 https://www.eapcnet.eu/Portals/0/PDFs/Atlas%20Europa%202019_DEF.pdf 27 primary care) or other medical staff contracted by the SSN. The average stay in the community hospital is expected to be around 15–20 days, and admission can be from the patient’s home or a residential care facility upon referral by the patient’s GP, the hospital ward or directly from the emergency room. Care is expected to be provided on a 24-hour basis by nursing and healthcare assistant staff, GPs, pediatricians and out-of-hours or continuous care physicians. The community hospital can be physically located in converted hospitals or residential care facilities. Table 4 shows that the regions interpreted the intermediate care facilities using different labels but also different ways of providing services. However, in this setting of care, as in the others of community care and LTC, there was not enough information centrally collected to make some comparisons. Regions Label of intermediate care Abruzzo, Campania, Emilia Romagna, Molise, Puglia Sardegna Community hospitals Lombardia, Umbria intermediate care Liguria Intermediate care units Lazio Nurse care units Friuli Venezia Giulia Nursing home for intensive care Country hospitals; Intermediate Marche and integrated care Piemonte Health continuity units Low care; health intermediate Toscana care; assistance intermediate care Community hospitals; Veneto Rehabilitation community units

Table 4 – The different definitions of intermediate care. Source: Rapporto 2017/2018 Pesaresi – L’assistenza agli anziani Non autosufficienti in Italia

Under Covid-19 Intermediate care was another point raised in decree 34/2020 to cope with the pandemic. In particular, during this epidemic there has been the need on one side to host Covid-19 patients requiring assistance in other facilities than hospitals, which were needed to treat more severe patients (hence post-acute facilities), and on another side, to also host positive patients with a low degree of intensity or even asymptomatic to avoid the transmission of the virus with their relatives. These last facilities were called covid hotels47. The need to activate covid hotels was more evident in the autumnal wave of the epidemic. The rilancio decree sets a number of measures to support the resilience of LTC:

 Introduction of Community and Family Nurses (8 per 50,000 inhabitants) both for LTC and Primary care (see the report on primary care);  Introduction of palliative care residency to support patients in living with pain, especially for the patients at the end of life; and

47 https://www.agi.it/cronaca/news/2020-11-12/mappa-covid-hotel-malati-coronavirus-10256131/ 28

 Reinforcing home care services to free up acute care facilities (see the USCA in the report of primary care).

5. Overview of national-level containment measures and investment needs in response to the Covid-19 outbreak

Table 5 below lists the national level containment measures and indications for investment in the healthcare system in response to the Covid-19 outbreak. The strategic national plans for the short- medium term investment are quite relevant since they highlight what has been already decided as measures to strengthen the health system in face of the Covid-19 pandemic. The Italian government made great efforts to mitigate the spread of the virus, relieve pressure on hospitals and generate additional care capacity. Primarily, the response was based on mobilisation of the workforce (both clinicians and nurses), incentives for health personnel, relaxation of the terms of working contracts (e.g., working hours), flexibility in public expenditure rules (e.g., workforce turn over) and simplification of public procurement rules 48.

48 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52020DC0512 29

Expected Main area Action proposed National document resources Integration of public health and primary care for surveillance, contact tracing, identification and isolation of patients Decree Law n.34 (19 May 2020) Public Health Strengthening the network of microbiology laboratories Additional working hours for population-based screening to manage excess waiting lists Decree Law 104 (14 August 2020) Introduction of the territorial special care units (USCA) (1 per 50 000 inhabitants) Decree Law n.14 (9 March 2020)* Recruitment of residents physicians withing general medicine and pediatricians schools Primary care services Strengthening USCA through the integration with other specialties (ie. psychologists) Additional allowance to primary care physicians and nurses Decree Law n.34 (19 May 2020) 10 million Euro Introduction of Community and Family Nurses (8 per 50 000 inhabitants) Reinforcing home care services to free up acute care facilities Healthcare Pathways Decree Law n.34 (19 May 2020) Introduction of the palliative care residency Increase in number of beds for ICU, penuomology and infectious diseases Decree Law n.18 (17 March 2020) 240 milion Euro Increase in ICU beds: standard set at 0.14 beds per 1 000 inhabitants 300 intensive care beds, divided into 4 movable structures, each of which equipped with 75 beds Acute care Decree Law n.34 (19 May 2020) Redevelopment of 4,225 beds in the semi-intensive area, with equipment to support ventilation Additional working hours for elective services to manage waiting lists Decree Law 104 (14 August 2020) Possibility to rent Covid hotel for quarantine Territorial services Decree Law n.34 (19 May 2020) Health districts personell to offer home care assistence to Covid-19 patients not hospitalized Outpatient care Additional working hours for diagnostics and outpetient visits to manage waiting lists Decree Law 104 (14 August 2020) Increase in the expenditure for public healthcare personell Decree Law n.34 (19 May 2020)

Recruiment of medical school residents (last 2 years) with a fix-term contract (6 months) Recruitment of clinicinas and nurses with a fix-term contract (6 months) in derogation of turn over freeze of public employees Decree Law n.14 (9 March 2020)* No application of the maximum limits of working hours prescribed by the national collective agreement Increase of the maximum hour/ week for services provided by outpatient specialists (SUMAI) Workforce Increase of resources for remuneration of overtime work of health care personnel employed in the activities related to the Covid-19 emergency 250 milion Euro Recruitment with a fix-term contract (3 years) of 58 doctors and 29 specialistis for prevention activities in public places (port, airports, etc) 13.5 million Euro Recruitment of 120 medical personell and 200 nurses from the military system with a fix term Decree Law n.18 (17 March 2020) contract (1 year) 19.4 milion Euro Recruitment of 16 biologist or chemist or physicist from the military system with a fix term contract (1 year) 0,1 million Euro Provision of personell and care services by accredited private hospitals and private hospitals 160 milion Euro Recruitment of 50 medical and non medical personell at ISS with a fixed term contract. 12 million Euro Pharmacies are required to supply oxygen therapy for home-based patients Ad hoc purchasing system for PPE and medical devices for the treatment of Covid-19 patients Decree Law n.14 (9 March 2020)* Medical device and Purchasing of 5 000 systems for assisted ventilation PPE Purchasing of PPE Decree Law n.18 (17 March 2020) 50 million Euro Streghtening military health services and medical devices for the management of urget cases Decree Law n.18 (17 March 2020) and biocontainment 35 million Euro Enhancement of the features of the Fascicolo Sanitario Elettronico (FSE) Digitalization Decree Law n.34 (19 May 2020) Enhancement of information exchange about birth and death certificate Activation of Regional operation centers for the coordiantion of health and social care serivces Other Decree Law n.34 (19 May 2020) and emergency services

Note: * 660 million of euro for all the actions included in Decree Law n.14 Table 5 – Overview of containment-measures and investments to strengthen the health system at the national level (last update 10 November 2020)

Together with the funding decree, the Italian national government issued a number of clinical and organisational indications to the regions since the outbreak of the pandemic, which are listed below in Italian.

Source: ALTEMS Instant Report#28, 12 November 2020. Available at https://altems.unicatt.it/altems- Altems%20Instant%20Report%20n28.pdf Other specific acts were applied by regions (usually) coherently with the national framework.

6. Concluding Remarks

The report highlighted that priority should be given to developing policies to resolve bottlenecks in the training, recruitment and retention of the health workforce. This aspect can be a transversal strategy to solve many failures of the health systems. In particular, the training has been considered a key factor to redeploy healthcare staff for the coronavirus containment as well as for medical doctors in residency, nurses and nurse aids hired for this epidemic not necessarily specialised in infectious diseases. In this occasion, training would help to ensure safety for both personnel and patients and to transfer technical knowledge and competencies. However, training and retention of the health workforce are also critical aspects beyond the epidemic phase. In this document, the information collected highlight that training is needed also in long-term care to stimulate the appropriate palliative care approach (Italy is in the last quintile) and to promote safety, quality of care and other aspects of assistance in nursing homes. Moreover, specific strategies to retain healthcare professionals in emergency departments need to be considered. Finally, training is an enabling lever of any technological or organisational innovations so that appropriate investments in training and dissemination events need to be planned when implementing new strategies. In addition to this important need related to human capital, this document lists below the dimensions requiring long-term investments for acute and emergency care as well as for community and long- term care looking at Covid-19 and beyond.

In the three S strategy (staff, space, supply), a clear need is the increase in space and the substitution of usual care thanks to new technological solutions. One the one hand, the Italian government issued an increase of ICU beds and beds that can be transformed into ICU beds promptly. This should be done while also applying flexible solutions to redeploy the investments in a more efficient way during normal activities. On the other hand, the fast introduction of telemedicine and other telecare services activated in substitution for in-person visits helped to mitigate the risk of a complete absence of care, especially for chronic patients and/or follow-ups (see reports on ICT and primary care). However, the capacity to activate telemedicine was not homogenous across regions. In addition, not all needs can be met through telecare so that a high number of the population did not receive proper assistance or diagnosis as the dramatic drop in urgent hospitalisations for time dependent diseases showed. Hence, there is still a need to better understand how to reduce missed diagnoses and provide proper access to care which leads, especially for time dependent diseases, to better outcome. In addition, the space strategy is a pre-Covid-19 need for non-acute settings of care. Indeed, the overall reduction of hospital beds has not been followed by an increase of intermediate care, which should ensure the appropriate care in a low intensive setting. Although, the regolamento Balduzzi set in 2015 expressed the need to build new community hospitals, the implementation was fragmented, and the results were evident also in the coronavirus period when these facilities may provide some relief to hospitals. In fact, the Italian government (through the Rilancio decree n.34/2020) required new investments in community hospitals. Moreover, international and Italian regional comparisons also showed evidence of the need to provide frail users (elderly, disabled, etc.) with access to long- term care assistance. Indeed, the number of beds per population for LTC centres is quite low considering other countries, the ageing population and the demographic composition of the Italian population.

The need to plan the restart or a new start emerged during the aftermath of the pandemic peaks. This is also related to non-Covid-19 diseases. In particular, the first pandemic wave was characterised by a response mainly based on acute care/hospital settings also to overcome the difficulties to promptly react of both primary care and public health (see the report on public health and primary care). Hospitals, especially ICUs, become bottlenecks so that elective activities were stopped to better reorganise the hospitals and keep safely separated tracks for Covid-19 and non-Covid-19 (urgent) patients. This led to an increase in unmet needs of the population that had to wait until the reopening of services. The restart of services was not easy because of the high safety standard measures of coronavirus protection, which reduced the normal hospital capacity. Restart was not homogenous across regions. The capacity to react and reorganise visits and other treatments after the end of the first lockdown varied between regions. The stop could have made the possibility also to reflect upon a new start, not necessarily a restart. The new start could also consider how to change the previous practices to meet the (higher) standard of care especially for some areas (such as volumes and outcome), which can be different across the regions.

The integration between hospitals and primary and community care is another need highlighted during the pandemic but already present before Covid-19. Hospitals have to be considered as part of a network, the part that treats acute care. This network has to be vertically integrated with the other settings of care, namely primary care and intermediate care, as well as being horizontally integrated with the other hospitals, both public and private. This requires not only the appropriate rules or agreements between different parties but also the possibility of sharing (health) information using the last technologies.

A well-performing system is the result of continuous, coherent and evidence-based policy support together with investments and adequate human capital that is based on the necessity of strengthening the governance of health systems through performance monitoring tools. In particular, while acute care is very well monitored, some areas require investments. Very little and fragmented information can be collected for long-term care (intermediate care, nursing home) and community care. Indeed, for these settings of care, governments collect information about the number of beds, day care and patients treated49, yet the analysis of the quality of care provided through tools of performance management is left in the hand of the single institutions, which try to receive some feedback through voluntary benchmarking networks. The heterogeneity of services labeled in different ways (such as the implementation of intermediate care) needs to be mapped and monitored to both ensure access to care and measure safety and quality of care provided. To this end, health information systems that are interconnected and interoperable, new administrative data flows and also an analysis of the quality of life perceived by the users need to be put in place. Another interesting aspect that also needs to be covered in acute care settings is a monitoring systems of the patients’ voice through specific surveys such as the Patient Reported Experience Measures and/or Outcome Measures. The use of PREMs can determine the reorganization of healthcare, and

49 These types of information are usually those needed to be financed. 33 they can be used to introduce and evaluate new services and innovations50 capturing what matters to patients instead of what matters with patients.

The governance in terms of capacity to manage complex projects is evident for some type of areas. In particular, capital budgeting and capital investments require capacity to make projects but also to spend capital budgeting. As an example, some regions have used less than the 60% of the investments’ funds allocated. Another issue related – but not limited – to the long-term investments is the governance of health technology assessment. Reformed during the last five years, yet there is not a clear definition of the governance structure for medical devices. In particular, the new governance model, recently revised has been partially implemented.

Renovation of physical infrastructures. The high obsolescence rate of fixed assets requires investments for the modernisation of anti-seismic and fire protection, to facilitate access for people with disabilities but also to eliminate the presence of asbestos, reduce energy consumption, and improve ventilation/air conditioning systems. Moreover, the pandemic reminded us also of the 2009 WHO slogan ‘Save lives. Make hospitals safe in emergencies’51. In fact, ‘A safe hospital that continues to function at optimum capacity during and after a disaster or other emergency is a safe haven that protects lives. Safe health facilities are a joint responsibility, requiring crucial support from other sectors to ensure essential life-lines. When health facilities stop functioning, it is a double blow to a devastated community’. This was quite evident in some cases like the Alzano Lombardo hospitals and the Nursing homes where thousands of elderly patients died. Hence, modernisation needs must also take into account the possibility of making the hospital ready to respond to an emergency. This also requires flexibility to access, in the function as well as the possibility of extending the space and in some cases also to be redundant. However, more alarming than the overall fixed assets is the obsolescence rate for equipment at around 88%. The Italian government has set a monitoring system for some types of equipment. Hence, there is a need to have a proper strategy of resource allocation for quite new and expensive machines but also for dismissals and renovations.

50 Using patient-reported measures to drive change in healthcare: the experience of the digital, continuous and systematic PREMs observatory in Italy Sabina De Rosis, Domenico Cerasuolo and Sabina Nuti. BMC Health Service Research 2020 51 https://www.euro.who.int/en/about-us/whd/past-themes-of-world-health-day/world-health-day-2009-save-lives.- make-hospitals-safe-in-emergencies 34

Unmet health-care infrastructure needs related to Public Health, Primary Care and Healthcare Pathways in Italy

Prepared by: Dr Francesca Ferrè, in collaboration with Prof Milena Vainieri and Dr Ylenia Sacco

EXPERT CONTRACT NUMBER – 2020CE16BAT064 AMI expert reference: REGIO 2020-0446

Updated: 30th November 2020

Table of contents Summary...... 2 1 Introduction: Public health, primary care and healthcare pathways in the Italian healthcare system ...... 4 2 Public health and primary care expenditures and workforce in the Italian healthcare system ...... 5 2.1 Expenditures ...... 5 2.2 Workforce ...... 7 3 How to identify the regional unmet needs in public health, primary care and healthcare pathways ...... 10 4 The Italian and Regional performance ...... 10 4.1 Public Health ...... 10 4.2 Primary Care ...... 20 4.3 Care Pathways ...... 28 5 Overview of national-level containment measures and investment needs in response to the COVID-19 outbreak ...... 33 6 Concluding remarks ...... 36

Summary

This document provides a picture of the differences in regional performance in public health, primary care and healthcare pathways before the COVID-19 outbreak and on the current situation in terms of investment plans discussed by both the Italian national and regional governments to strengthen access and provision to these services and the resilience of healthcare systems to cope with COVID-19. In particular, evidence, official documents and policy makers report the need to invest in:

 Training, recruitment and retention of the health workforce. Investment in workforce capacity has been considered essential to cope with epidemics. Training has been referred to both the prevention, contagion-containment and treatment of COVID-19 and epidemic preparedness in general. Specifically, proper resources for skills development in advanced epidemiological analysis (prediction not only monitoring) and data management should be envisaged. However, the training is also critical beyond this epidemic. In particular, the information collected highlight that education and training programmes are needed on vaccination awareness and safety, the extended roles of health and social care professionals and more in general on digital skills and innovation management. Specific recruitment and retain strategies need to be considered for healthcare professionals working in primary care. A shortage of GPs and their older age are critical issues with an adverse effect on the quality of care provided.  Integration between public health and primary care. Better coordination is crucial in times of epidemiological emergency for surveillance, the early recognition of infections and fast tracing. Moreover, the integration of prevention and primary care remain highly relevant to ensure the shared goal of population health improvement. Improvements in triage and referral management systems for prevention are needed to support earlier diagnoses.  ICT infrastructure for data governance and exchange. The COVID-19 emergency has shown a major limitation in the lack of a harmonised approach to data governance and exchange. This is particularly true in decentralised healthcare systems. In a situation where time scarcity represents a critical constraint, the need for real-time surveillance data and rapid early diagnosis systems can be a pivot point. Moreover, also in normal times, there is a clear need to strengthen the ICT infrastructure, boosting storage and the exchange of electronic patient data to support the integration of care across settings and professionals.  A strong collaborative network between, primary, hospital and community care to ensure continuity of care. This is another need highlighted during the pandemic, but which was already present before COVID-19. Services and professionals should be vertically integrated to provide appropriate and responsive services along the care pathway, especially for people with complex care needs (e.g. improving the involvement of community services post-discharge or limiting inappropriate access to acute facilities). The gatekeeping role of primary care should be reinforced to optimise the efficient use of specialised services. Also, horizontal integration, i.e. collaboration between primary care and specialists, is essential. In this way, strengthening multi-professional and multi-disciplinary groups of practice is a priority.  Monitoring and performance evaluation tools to support evidence-based investment towards integrated care and patient-centeredness. For this purpose, interconnected and interoperable health information systems, new administrative data flows in primary and community care and permanent systematic surveys of patient needs should be put into place. In addition, information

systems and data analytic tools for stratification and targeting of the population following a population-based approach are a priority for investment.  Substitution of the usual care through new technological solutions. Since the COVID-19 outbreak, several innovations have been proposed to support the response to the pandemic. This is especially true for digital solutions employed to monitor and manage COVID-19 cases as well as to provide medical services online (teleconsultation, tele-visits) or to ease access to services (e-prescription) or information exchange. Overall, telemedicine has gained a lot of attention during the COVID-19 pandemic and specific investment should also be considered during normal times to provide high quality care and improve accessibility and continuity of care, while supporting workflow among professionals. For instance, tele-radiology for breast cancer screening, tele-visits and tele-consultations to access primary care and other technology supporting services to improve continuity of care (tele-monitoring/remote assistance services, tele-vists) are examples in this direction.  Renovation/new physical infrastructures and equipment. The high obsolescence rate of fixed assets require investments to start or complete infrastructural work to comply with fire safety regulation and anti-seismic rules, as well as to eliminate the presence of asbestos, reduce energy consumption, and improve ventilation/air conditioning systems. Also, optimising the infrastructure available in terms of space and accessibility and planning flexible/modular spaces to cope with emergencies and surge demand (e.g. flu vaccination) is a priority. There is a need to invest in new facilities to host multi-specialist groups of practices to favour care integration. Also, more alarming than the overall fixed assets is the obsolescence rate for equipment. The substitution of diagnostic technologies for population-based screening (mammograms) is a priority to provide safe and high quality diagnostic screening. New investment for diagnostic technologies for primary care prevention and follow-up management should be promoted to increase preventive care by primary care teams and limit curative care. Investments in outdoor fitness equipment to ease and encourage physical activity are also important.  Communication and patient empowerment. Communication and awareness campaigns for prevention and health promotion should continue. Specifically, reinforcing vaccination communication and awareness campaigns, screening communication campaigns, and health- promoting messages for healthy lifestyle (also during home quarantine). These actions should be continued and personalised for the different groups of the population and through the implementation of more advanced communication tools, for instance through the web and social media. In addition, patient empowerment should be a priority investment in terms of promoting chronic disease self-management programmes.

The document is structured as follows: i) an introduction to public health, primary care and care pathways in Italy; ii) a picture of the expenditure, workforce and system capacity across regions of the abovementioned settings of care; ii) the method applied to identify the unmet needs in these settings; iii) the Italian and regional performance in these settings using the last data available (usually pre-COVID-19) and the challenges posed by the COVID-19; iv) an overview of national-level containment measures and investment needs in response to the COVID-19; and v) concluding remarks.

1 Introduction: Public health, primary care and healthcare pathways in the Italian healthcare system

The Italian National Health System is a decentralised system where regional administrations have extensive powers to organise and allocate healthcare resources across providers and care settings within national guidelines and regulations guaranteeing an Essential Level of Care (LEA). The Ministry of Health is the main institution responsible for public health1 at the national level. Immunisation and screening programmes are considered to be priorities (see National Prevention Plan) together with health promotion campaigns and addiction treatments (alcohol and tobacco). Moreover, the Ministry of Health is supported by the Consiglio Superiore di Sanità (CSS) and the Istituto Superiore di Sanità (ISS), which perform a wide range of public health interventions including surveillance and monitoring, counselling, health promotion, health planning and training. Health emergency response activities are the main responsibility of the National Centre for Disease Prevention and Control. Public health and preventive departments at regional and local levels implement public health programmes, specifically mandatory and voluntary immunisation programmes and population-based screening (HPV tests, mammography and colorectal screening), health promotion initiatives, occupational health, food and nutrition and veterinary healthcare. During the COVID-19 outbreak, regional and local public health departments have been asked to provide detailed daily surveillance data about infected patients (symptomatic and asymptomatic), hospital system capacity (Intensive Care Unit beds) to support the national emergency response. Moreover, public health departments which performed surveillance, contact tracing, identification and the isolation of patients with available ICT technologies provided this information to primary care and municipalities and managed communication with citizens. Delays and difficulties in the exchange of information have been clear weaknesses in the pandemic response. In addition, during the pandemic, some preventive services have been frozen or postponed, including oncological screening, with significant impacts on population health. Mandatory and routine immunisations continued following WHO recommendations2 and actions have been taken to increase flu vaccination coverage. Primary care3 services are delivered by health districts, the operative branches of local health authorities. Over the last 20 years, there have been attempts to reorganise the delivery of primary care, with the objective of moving from the traditional single practice model of general practitioners (GPs) to an integrated care model. A move towards team-based primary care that integrates different healthcare professionals and bridges the gap between the front-line and patients can improve health outcomes, especially for patients with chronic conditions and multi-morbidity4. However, change has been slow and regions have developed different models in primary care delivery. National statistics report on average 70% of GPs and 65% of paediatricians practice in groups/teams with high variability across regions5. GPs and paediatricians (who usually treat children up to the age of 13) perform the assessment of common health problems and play a gatekeeping role. GPs and

1 Public health is often referred as the “art and science of preventing disease, prolonging life and promoting health through the organised efforts of society” (Felix-Bortolotti 2009). Public health aims to improve the health of populations by keeping people healthy, improving their health or preventing the progression of disease. 2 “Guidance on routine immunisation services during COVID-19 pandemic in the WHO European Region” WHO 20 March 2020. 3 The term “primary care” can be defined as “the first level of professional care […], where people present their health problems and where the majority of the population’s curative and preventive health needs are satisfied” (Boerma & Kringis 2015). 4 “Realising the potential of primary health care” OECD 2020 Health Policy Studies, OECD Publishing, Paris https://www.oecd-ilibrary.org/sites/b4d1eecf-en/index.html?itemId=/content/component/b4d1eecf-en. 5 Ministry of Health, Annuario Statistico 2017. 4 paediatricians are self-employed and independent doctors, paid on the basis of capitation fee on the number of registered patients augmented by a fee-for-service component for specific activities (e.g. home visits) and additional incentives according to specific performance indicators (e.g. working in group practice). Following recent reforms, GPs should also play a key role in the control of chronic disease in coordination with hospital specialists. During the COVID-19 pandemic, primary care supported the identification and early treatment of infected patients with extreme difficulties due to a shortage of diagnostic equipment and protective supplies and access to surveillance information systems. GPs have been supported by doctors and nurses working for the “special units of care continuity” (USCA)6 in their duty to monitor and assist COVID-19 patients at home. Nonetheless, the fragmentation of primary care services and low integration with the rest of the healthcare services has been a clear weakness in the pandemic response.

Specific attention in more recent years has received the organisation and delivery of care along clinical care pathways7. The aim of a care pathway is to enhance the quality of care across the continuum by improving risk-adjusted patient outcomes, promoting patient safety, increasing patient satisfaction, and optimising the use of resources. Care pathways encompass different levels of care including GPs, ambulatory and hospital care, primary care follow-up after discharge, and home and residential care. Integration and continuity of care in this respect are the main features of care pathways, leading to positive impacts for both patients’ lives and the sustainability of the health system. A National Plan for Chronic Disease has been issued and identifies targets for managing chronic patients, promoting innovation in the organisation and management of health services. A National Cancer Plan exists and oncological regional networks have been established to assure a holistic view of the organisation and management of oncological patients. Often, regions have also developed clinical pathways for the care of specific conditions such as maternal and mental health and for time-dependent conditions such as stroke (some statistics on clinical outcome of oncological path and stroke are included in the thematic report on acute, community and LTC). During the COVID-19 emergency, continuity of care has been put at risk because of increased barriers to access services, increasing waiting times due to the postponement/delay of diagnostic services, interventions and therapies with negative effects on the population health.

2 Public health and primary care expenditures and workforce in the Italian healthcare system

2.1 Expenditures

About 126 billion Euros are spent annually on public healthcare in Italy according to the most recent information available from the open data of the Ministry of Finance. The structure of spending across the various type of care is summarised in Figure 1. About 40% of health spending can be attributed to acute care (including emergency care). Outpatient care covering specialist consultations and diagnostics accounts for 16% of the total share. Territorial care, including home-based curative services (excluding rehabilitation), residential and semi-residential care, accounts for about 15%. The same share of health spending is spent on pharmaceutical. Primary care accounts for 7.6% of all

6 USCA: small teams of medics and nurses who, equipped with all the necessary protective gear, follow suspected and confirmed cases of COVID-19 directly at home. 7 “Care pathways” can be defined as complex interventions for the mutual decision-making and organisation of care processes for a well-defined group of patients during a well-defined period. 5 health spending and prevention takes up 4.4% of the total available resources. The smallest share relate to long-term care services, less than 1% in 2018.

Figure 1. Public health expenditure by type of service, 2018

Source: https://openbdap.mef.gov.it/it/SSN/Scopri

In 2018, the available resources for primary care amounted to 9.6 billion Euros; this figure includes about 3 billion for territorial emergency care and doctor on duty (medici di continuità assistenziale). In the same year, public expenditure for prevention was 5.5 billion Euros. In particular, 50% of the expenditure for prevention were allocated to health prevention programmes (screening and vaccination) and public health and hygiene, while the remainder was spent on occupational health, legal medical services, veterinary healthcare and food and nutrition (Figure 2).

Figure 2. Public expenditure for prevention by areas of activity, 2018

Source: https://openbdap.mef.gov.it/it/SSN/Scopri

A main feature of the healthcare system is regional variation in the distribution of healthcare expenditure. Table 1 shows per capita regional public expenditure for prevention and primary care in 2018. On average, per capita spending for primary care doctor’s contract (both GPs and family paediatricians) is 118 Euros with wide variation across regions: from 86 Euros in Lombardia to 169 Euros in Molise, depending upon the regional territory (small regions and low densities of inhabitants register higher costs) and regional additional agreements. In contrast, public health Italy spends, on 6 average, 93.7 Euros per capita8, varying from 67 Euros in Friuli Venezia Giulia to 140.9 Euros in Calabria.

Table 1. Per capita regional public health expenditure for prevention and primary care, 2018

Per capita cost for PC Per capita cost for Regions doctors* Public health ** Abruzzo119,54 € 96,33 € Basilicata142,42 € 82,79 € Calabria128,95 € 140,87 € Campania112,80 € 87,11 € Emilia Romagna117,12€ 96,79 € F. V. Giulia109,61 € 67,31 € Lazio103,95 € 73,42 € Liguria101,11 € 86,91 € Lombardia86,58 € 92,55 € Marche112,69 € 78,77 € Molise168,74 € 109,31 € P. A. Bolzano118,36 € 105,93 € P. A. Trento107,99 € 76,96 € Piemonte110,63 € 88,44 € Puglia129,96 € 85,94 € Sardegna118,94 € 100,33 € Sicilia120,09 € 92,09 € Toscana112,91 € 93,27 € Umbria110,50 € 101,86 € Valle d'Aosta135,61 € 138,60 € Veneto113,56 € 75,38 € Source: Our elaboration on 2018 Flusso CE (*) and Flusso LA (**).

2.2 Workforce

Collective prevention and public health actions/policies are implemented by regions through the Departments of Health and Department of Prevention within each Local Health Authority (LHA). The public health domain has been often overwhelmed by hygiene and epidemiology aspects, until 2010 when the National Prevention Plan (Piano Nazionale della Prevenzione) called for a prevention approach in all services. The plan required the person to be considered rather than the disease; it required a bridge to be built between health promotion, risk factor eradication and disease management in an integrated manner; it also asked for a new role for the Department of Prevention (which is set in each LHA by law): leading the change in health promotion, supporting all of the units of care ensuring links with other sectoral actions. This new vision was also supported by specific projects financed by the CCM9, which is the network of the National Centre for Disease Prevention and Control. Its task is to liaise between the Ministry of Health on the one side, and regional governments on the other, with regard to surveillance and prevention, and promptly responding to emergencies, and it was set up in 2004.

8 Although health policies and budgets remain focused primarily on curative interventions, over time preventive care expenditure in Italy has increased from 69 euro per capita in 2010 to 111 euro per capita in 2018 (OECD health data). 9 http://www.ccm-network.it/ 7

Under COVID-19 Some arguments on general and specialised media focused on the fact that during the first COVID- 19 wave, Italy did not have an updated pandemic plan10. The crisis has shown the need for investing in crisis preparedness plans, in particular improved purchasing strategies, diversified supply chains and strategic reserves of essential supplies. After the first wave, the Ministry of Health introduced a number of actions to support regional health systems to cope with the autumn and winter months. In particular, in August, the Ministry of Health, ISS and regions defined a self-evaluation checklist11, assessing the risk level and response capacity to the pandemic of regional health systems. This checklist, with specific indicators, is currently used to divide regions into a three-tier colour scheme: yellow (moderate-risk), orange (high-risk), and red (very high risk).

Estimating the health-care personnel involved in the delivery of public health is not easy since the workforce tasked with public health activities is engaged across many sectors. In addition, in Italy, it is often intertwined with the general healthcare workforce, with doctors and other professionals taking on many public health service functions. A proxy used to estimate the availability of the public health workforce is the number of members of the Italian Society of Hygiene, Preventive Medicine and Public Health (SItI). In 2015, the average number of members was around 4.6 per 100,000 population12.

Primary care is managed by GPs and paediatricians and is paid via a combination of capitation and fee-for-service, sometimes related to performance, and regulated under national and regional contracts. Capitation is adjusted for age. Each GP can assist a maximum of 1500 patients while paediatricians can assist up to 800 children, with possibility of increasing this to 880. On average, in 2017, each practicing GP had 1194 patients registered, while each paediatrician assisted 883 children on average, with some variability across regions (Figure 3). PA Bolzano13 registered the highest number of children (1039) and adults (1579) assisted by each primary care physician; conversely, Calabria has the lowest number of adults assisted by each GP (1012), and Sardegna the lowest number of children assisted per paediatrician (776). All regions are characterised by a shortage of primary care physicians.

10 https://www.theguardian.com/world/2020/aug/13/italy-pandemic-plan-was-old-and-inadequate-COVID-report-finds https://www.saluteinternazionale.info/2020/04/cera-una-volta-il-piano-pandemico/ 11 Elementi di preparazione e risposta a COVID-19 nella stagione autunno-invernale – August 2020 12 Rechel, Bernd, ed. Organisation and financing of public health services in Europe: Country reports. No. 49. World Health Organisation, 2018. 13 GPs practicing in PA Bolzano have a higher threshold, they can assist up to 2 000 adults. 8

Figure 3. Average number of patients registered for each GP and paediatrician by region, 2017

1.800 1.600 1.400 1.200 1.000 800 600 N. N. patients of 400 200 _

N. of patients per GP N. of patients per pediatrician

Source: Ministry of Health Annuario Statistico 2017

Between 2000 and 2018, the share of GPs in Italy has decreased by 9%, from 47,148 to 42,987. It should be noted that, for the adult population, the reduction in the share of GPs is often coupled with an increase in the average number of patients assisted by each doctor and an upward trend in both the clinical and administrative workload. This burden might adversely affect the quality of patient care and have implications for meeting patients’ needs14. In addition, almost 74% of Italian GPs have more than 27 years of experience, thus adding complexity in introducing change and innovation. It is not easy to change this trend, since retirements exceeded the number of training GPs (specializzandi) by 400 in 2019 and 1630 in 202015. When considering primary care, on-call medical services (medici di continuità assistenziale) are also significant indicators to look at as points of contact with the primary care system during night hours and weekends. Medici di continuità assistenziale guarantee continuity of assistance during weekends and at night for emergencies by ensuring home and territorial intervention. In 2017, 3063 emergency medical points were active in Italy with 11,688 doctors or 19 doctors per 100,000 inhabitants. This activity is organised within the regional programming to meet the different needs related to the geomorphological and demographic characteristics. As expected, when looking at regional data, there is high variability both in terms of number of doctors per 100,000 population and the average number of visits performed per 100,000 population (Figure 4). Basilicata has the highest number of doctors on call per 100,000 population (63), while Valle d’Aosta has the lowest number (6). However, Sicilia, Campania, Lombardia and Calabria have the highest number of visits performed per 100,000 population.

14 “Realising the potential of primary healthcare” OECD 2020 Health Policy Studies, OECD Publishing, Paris. 15 DataRoom M. Gabanelli accessed 10 November 2020. https://www.corriere.it/dataroom-milena-gabanelli/covid-medici-di-base- tamponi-rapidi-perche-non-funzionano-cure-casa-ospedali/2d9e5d78-21e1-11eb-a759-aabb3b0952b2-va.shtml 9

Figure 4. Number of doctors on duty per 100,000 population and visits performed per 100,000 population by region, 2017

70 1.600.000 60 1.400.000 50 1.200.000 1.000.000 40 800.000 30 600.000

20 400.000 Visits per 100 Visits per 100 000 population

Doctors per 100 Doctors per 100 000 population 10 200.000 0 0

Doctors on duty per 100.000 inhabitants Visits per 100.000 inhabitants

Source: Ministry of Health Annuario Statistico 2017

3 How to identify the regional unmet needs in public health, primary care and healthcare pathways

To identify the unmet health needs, we followed the conceptual framework presented in the first deliverable. In particular, in this document we describe the indicators identified and collected through the available documents and reports on the performance of preventive, primary care and care pathways, with special attention paid to chronic care. In particular, we used the “LEA Grid”, Inter- Regional Performance Evaluation System (IRPES) run by Scuola Superiore Sant’Anna (Pisa) and other national reports, mainly coming from the Ministry of Health, including “Rapporto SDO” and “Annuario Statistico” and the National Institute of Statistic Italy (ISTAT). To this analysis based on quantitative evidence, we added the recent strategic documents and considerations in response to the COVID-19 outbreak. We also built the report including all documents and interviews done with the regional representatives contacted through the DG REGIO for this purpose.

4 The Italian and Regional performance

4.1 Public Health

Public health and preventive departments at the regional and local level implement public health programmes, specifically mandatory and voluntary immunisation programmes and population-based screening (HPV tests, mammography and colorectal screening). In Italy, coverage for all compulsory vaccinations and major recommended vaccinations has been increasing over time, which can be explained by the reinforcement of existing compulsory vaccinations (a decree-law n.73/2017). However, rates across the country are not yet uniform and do not always reach the coverage target set by the national immunisation prevention plan (Figure 5a, 5b). 10

Figure 5a. Newborn hexavalent immunisation coverage by region, 2018 5b. Newborn MMR immunisation coverage by region, 2016-2018

Source: Griglia LEA http://www.quotidianosanita.it/allegati/allegato164996.pdf Public health campaigns at the national (Ministry of Health and ISS) and local levels (prevention department) have aimed to encourage the take-up of vaccinations, with particular emphasis on reinforcing information about the safety and effectiveness of vaccination. Additional and continuous investments in communication campaigns favouring childhood immunisation should be put forward in the region where both hexavalent and MMR coverage is below the standard (e.g. Sicilia), also targeting populations that are more deprived, have difficulties accessing the vaccine (rural areas) or which register low compliance (immigrants and minorities such as Roma and Sinti communities). In addition, investment in specific training should be envisaged to increase population awareness among health professionals and for cultural mediators and voluntary associations assisting deprived and minorities16. In some regions, an investment priority is the strengthening and harmonisation of Immunisation Registries (IRs) to increase data sharing17. Data from a national survey lunched in 2016 show that 18 out of the 21 regions have fully implemented an IR (Figure 6). At the local level, 100/120 Italian LHAs (83%) were reported using IR. Among IR fully implementing regions, 11 (61%) used the same software in all LHAs. Campania and Calabria partially implemented IR (in 20% and 86% of the LHUs, respectively) while Sardegna did not implement IR at all. Moreover, a computerised tool to monitor vaccination coverage at the national level is still missing. The Ministry of Health is currently designing a national IR that could aggregate data from different regional and local IR systems.

16 https://www.adnkronos.com/r/Pub/AdnKronos/Assets/PDF/piano_prevenzione_vaccini.pdf 17 Data sharing to increase data sharing and assess and monitor accessibility, quality and outcomes of immunisation programmes both locally and nationally and support public health authorities responding to outbreaks of vaccine-preventable diseases and promoting vaccine accountability. 11

Figure 6 Existence and characteristics of the regional IRs, by region, survey data 2017

Source: D’Ancona, F., V. Gianfredi, F. Riccardo, and S. Iannazzo. "Immunisation Registries at regional level in Italy and the roadmap for a future Italian National Registry." Ann Ig 30, no. 2 (2018): 77-85.

Another significant immunisation to reduce morbidity, complication and mortality is influenza vaccination. It is necessary to achieve high influenza vaccination coverage in the target population groups, particularly in those aged over 65, in high-risk individuals and among healthcare workers. Elderly coverage across Italian regions is still unsatisfactory (Figure 7), even though the trend is encouraging (regions in violet shows the most significant increase compared to the previous year). The major shortcoming is the sill low integration of prevention and healthcare activities: both GPs and specialists (pulmonologists, oncologists, cardiologists, diabetologists, etc.) should actively recommend and offer vaccination against influenza. In addition, investments in information systems at both the national and regional level for the creation of a web-based influenza vaccination registry that is interoperable across the different regions and with other databases (resident patients, infectious disease, adverse events), and which is accessible to both clinicians and patients, could represent a valid support tool for the management of flu vaccinations18.

Figure 7. Flu vaccination coverage among population ≥65 years by region, 2016-2018

18 https://www.epicentro.iss.it/passi-argento/dati/VaccinazioneAntinfluenzale#impatto 12

Source: Griglia LEA http://www.quotidianosanita.it/allegati/allegato164996.pdf Of particular concern is the flu vaccination coverage among healthcare workers (Figure 8). The uptake rate in 2019 varied widely from 16% in Marche and PA Bolzano to over 30% in Veneto, Toscana and PA Trento. The still very low coverage requires some investment in awareness campaigns (see the HProImmune project sponsored by the DG SANCO 2008-2013) and in a computerised vaccination registry. Figure 8. Flu vaccination coverage among healthcare workers by region, 2019

Source: https://performance.santannapisa.it/pes/network/home.php

Under COVID-19

Due to the pandemic emergency, the national 2020 flu vaccination campaigns (Circolare Ministeriale 4 giugno 2020) extended the target population, strongly suggesting coverage for people between 60 and 65 years as well as children19. This vaccination policy has been envisaged to simplify the diagnosis and management of suspected COVID-19 cases, given the similar symptoms between COVID-19 and influenza. In addition, vaccination against influenza reduces complications and access to the emergency room. Regions are introducing this wider coverage for flu vaccination with different strategies: Sicilia has made it compulsory for healthcare workers and encouraged pregnant women to be vaccinated; Lazio has also tried to make it compulsory for healthcare personnel, but the TAR abolished this; and Tuscany has targeted populations living in long-term care facilities and residential homes for the elderly (Residenze Sanitarie per Anziani - RSA). Nonetheless, regions are currently registering many shortcomings in offering the influenza vaccination20. The major shortcoming relates to the purchasing of vaccines and the timely delivery to the population. On an annual basis, through tenders for the supply of flu vaccines, regions decide between the products available on the market21, and select the ones that will be used during vaccination campaigns. This year, tenders have been anticipated and were awarded in

19 http://www.salute.gov.it/portale/influenza/dettaglioContenutiInfluenza.jsp?lingua=italiano&id=686&area=influenza&menu=vuoto&tab=1 20 https://www.cittadinanzattiva.it/comunicati/salute/13598-indagine-civica-di-cittadinanzattiva-sull-approvvigionamento-da-parte-della-regione- delle-dosi-di-vaccino-antinfluenzale-solo-10-regioni-rispondono.html 21 The flu vaccines available in Italy are authorized by the European Medicines Agency (EMA) and/or Agenzia Italiana del Farmaco (AIFA), however not all are available on the market. The vaccine manufacturers define whether to make one or all of their products available in a given market. 13

September in many instances (Lazio, Puglia, Campania, Abruzzo), with an increase in vaccine doses for the period from 2020-2021 compared to the previous year11. However, there are delays in receiving vaccines and organising immunisation for the population. Traditionally, this immunisation is provided by GPs participating in the flu campaign, territorial vaccination centres (located within the Local Health Authorities facilities), and in additional vaccination points identified in accordance with municipalities in some regions (Lombardia for example). With respect to the measures aimed at facilitating access for the 2020/2021 flu campaign, regions have foreseen the following11: - Sicily and Umbria extended the opening hours of vaccination centres (at least at the beginning of the vaccination campaign), enabling vaccinations to be carried out upon discharge from healthcare facilities. - Campania established itinerant trucks to support GPs with flu injections. - Lazio identified different ways of providing the flu injection: drive-through, mobile stations, in pharmacies, the organisation of vaccination days in schools and at hospitals and sporting events, and the establishment of itinerant vaccination teams. - Marche provided the possibility of moving the vaccination centres to public arenas to allow a large number of vaccines to be delivered in compliance with COVID-19 rules. - Tuscany allowed GPs to use the premises of Local Health Authorities for vaccinations. - Emilia Romagna allowed the use of large public infrastructure such as gyms and sports facilities for vaccinations. - Valle D'Aosta, in addition to signing specific agreements with GPs and paediatricians, aimed to encourage vaccination by allowing the use of the premises of Local Health Authorities to inject the vaccine, in which will be attended by the doctors of the hygiene and public health structure of the prevention department. Across all regions, pharmacies have been also included in the delivery of vaccine for population not at risk (1.5% of doses should be available for pharmacies). Overall, investments are required in optimizing the infrastructures available for the delivery of vaccinations though traditional access points both within healthcare facilities and other public facilities and in establishing flexible access points.

When we consider screening programmes, regions are involved in the organisation and delivery of free population-based screening programmes for breast (mammography), colorectal (faecal occult blood test and recto sigmoidoscopy in some programmes) and cervical cancer (pap test with transition to HPV-DNA test22). More than 300 programmes are active across the country. Figure 9 shows the level of the targeted population screened for cancer in 2016-2018 across regions with a clear north- south divide. Figure 9. % coverage cancer screening programmes (breast, colorectal and cervical) by region, 2016-2018

22 The progressive conversion from Pap test to Hpv test was recommended in 2013 by the Ministry of Health to the Regions. 14

Source: Griglia LEA http://www.quotidianosanita.it/allegati/allegato164996.pdf It is worth noting that constant expansion has been observed over time for all cancer-screening programmes (Figure 10a, 10b, 10c). However, population coverage is lower in the southern regions (yellow line in the Figures). Figure 10a. Extent of breast cancer screening, 2011-2018 10b. Extent of colorectal cancer screening, 2011-2018 10c. Extent of cervical cancer screening, 2011-2018

Source: https://www.osservatorionazionalescreening.it/ Data suggest possible difficulties in access for some groups of the population, posing an equity issue. For example, for breast and cervical screening, coverage is significantly higher in younger women (50–69 years old and 35–49 years old respectively), in those married or living with a partner, in those with a higher level of education and in those without reported economic difficulties. Coverage is also higher among Italian women or those from other advanced development countries than for foreign women from countries with a strong migratory pressure23. To this respect, investments in screening communication campaigns towards foreign women also providing dedicated information material and consultation should continue to implement more advanced communication tools through the internet and social media. Considering the current health emergency, it is vital to avoid the exclusion of existing vulnerable groups from population-based preventive care. There are shortcomings in current cancer screening programmes which are often related to the capacity to quickly report the outcome of screening and provide timely access to subsequent diagnostic phases, as well as to the quality of the diagnostic screening performed due to the obsolescence of the diagnostic technology. For instance, the time between the mammogram and the reporting of a negative screening outcome, or for cases with diagnostic doubt, the time when an in-

23 https://www.osservatorionazionalescreening.it/sites/default/files/allegati/Rapporto%202019_0.pdf 15 depth session or surgery is carried out, are key indicators of the quality of a screening program. Table 2 shows that a large number of Italian programmes still report difficulties with ensuring good performance for these indicators over time, and the values remain well below the acceptable level (GISMA standard), with all three indicators showing a trend towards worsening. This evidence suggests the need to investigate the possible causes; for example, by evaluating the system capacity in terms of time dedicated to breast cancer screening by radiologists. Referral time could be boosted by investments in tele-radiology (an in-depth analysis of telemedicine solutions is provided in the thematic report on ICT and e-health). Table 2. Quality of breast cancer screening programmes based on referral time, 2012-2018

Source: https://www.osservatorionazionalescreening.it/sites/default/files/allegati/Rapporto%202019_0.pdf There is also room for investments in the renewal of diagnostic technologies used for screening purposes, especially mammograms, to increase the safety and accuracy of screening. In total, 1459 mammographs are available across public healthcare facilities in Italy. Figure 11 shows the rate of mammograms available for every 10,000 women aged 50–69 years old in the different regions. Data show significant variability for the number of mammographs available per population, even though it would be of interest to know the average productivity level of each technology in order to assess their efficiency before purchasing new equipment.

Figure 11. Rate of mammographs available every 10,000 women aged 50–69 years by region, 2016

3,0 2,7 2,7 2,5 2,5 2,4 2,4 2,1 2,0 2,0 1,8 1,6 1,4 1,5 1,3 1,4 1,4 1,4 1,4 1,5 1,2 1,2

1,0

0,5 0,3

women women aged 50-69 years 0,0 Rate of Rate mammogram every 000 10

Source: our own elaboration based on www.dati.salute.gov.it/dataset/apparecchiature sanitarie.jsp and Istat Popolazione residente al 1 gennaio 2016

A national survey carried out by the Ministry of Health in 201724 showed that, on average, 37% of mammographs are less than 5 years old, 33% are 5 to 10 years old and 30% are more than 10 years old (a regional analysis on obsolescence rate across medical technologies is provided in the thematic report on acute, emergency and LTC). Currently, both digital and analogical mammography are used (30% of the total 1459 mammograms are still analogue), although a transition to digital technologies is highly recommended to decrease toxicity exposure and increase precision in diagnostic imaging (reducing false positives), thereby reducing the time to treatment and improving patient outcomes. Moreover, digital mammographs assure higher productivity and lower maintenance with a positive impact on healthcare costs.

Under COVID-19

The COVID-19 outbreak has posed significant challenges to the continuity of population- based cancer screening programmes. These screening programmes were stopped during the months of March and April 2020 as a preventive measure to reduce access to healthcare facilities, albeit not homogenously across all regions. Starting from May 2020, screening programmes were reactivated, with different timings, intensities and modes both across regions and within regions25. This drastic interruption of screenings has serious implications for diagnosis and clinical outcomes for cancer patients and is creating pressure on regional screening programmes for managing and organising the screening considering the accumulated delay.

Overall, Italy performs well on health promotion strategies related to weight loss, physical exercise and smoking habits (Table 3), with over 30% of people receiving the suggestion to take action to improve their health condition. Special attention is devoted to smoking cessation, with an average of 52% of smokers being encouraged to quit with some degree of variability across regions. Also, weight loss is gaining attention. An average of 47% of people are encouraged to lose weight, even though some southern regions (Basilicata, Calabria and Puglia) still report lower percentages, albeit a higher percentage of the obese adult population compared to the national average. In these regions, investments in outdoor fitness equipment in public spaces to ease and encourage physical activity as well as multifunctional spaces to host health prevention and promotion actions should be envisaged. Such an unmet need has already been reported within the strategic document “Piano per il Sud 2030”26, proposed by the Ministry for Southern Italy and Territorial Cohesion. Table 3. Health promotion strategies: weight loss, physical exercise, alcohol consumption and smoking, 2016-2019

Italy LAZIO EMILIA- GIULIA LIGURIA MOLISE PUGLIA SICILIA UMBRIA VENETO ABRUZZO CALABRIA MARCHE PIEMONTE TOSCANA BASILICATA CAMPANIA ROMAGNA LOMBARDIA SARDEGNA PA BOLZANOPA TRENTO FRIULI-VENEZIA- VALLE D'AOSTA % People suggested to lose weight 47 42 36 37 48 53 48 50 45 45 46 54 53 36 56 45 47 50 37 50 40 46 % People suggested to do physical exercise 30 28 22 22 30 35 30 33 24 31 30 34 31 20 37 27 33 35 21 35 24 27 % Alcohol high-risk people suggested to reduce consumption 6 8 6 10 766958386665756745 % Smokers suggested to quit 52 48 49 39 61 50 46 53 48 43 43 43 53 49 59 52 57 50 58 49 38 42 Source: https://www.epicentro.iss.it/passi/dati/temi

24 http://www.salute.gov.it/imgs/C_17_pubblicazioni_2678_allegato.pdf 25 https://www.osservatorionazionalescreening.it/sites/default/files/allegati/Rapporto_ripartenza-maggio_2020_def_0.pdf 26 http://www.ministroperilsud.gov.it/media/2003/pianosud2030_documento.pdf 17

Under COVID-19

To cope successfully with the COVID-19 emergency, community engagement, supported by digital opportunities for safe communication, is key. As such, health promotion actions have a central role to play in empowering communities and individuals to adopt effective responses and manage the psychosocial impacts of the multi-layered consequences of this pandemic27. Reinforcing community actions, through the activation of multidisciplinary task force teams supporting the most vulnerable (elderly, people with pre-existing conditions, migrant and refugees) and socially deprived is a real need. In addition, investments in health promoting messages for healthy lifestyles during home quarantine (e.g. nutrition, physical activity, hydration, sufficient sleep, etc.) should be a priority. This communication should consider the fact that there are subgroups within the population that suffer from low health literacy. Therefore, health recommendations should not only be based on sound scientific evidence, but also be consistent and formulated in a way that makes them easy to understand and culturally appropriate.

Epidemiological surveillance systems are essential for identifying the health needs of the population and the priorities on which to act.

Under COVID-19

During the COVID-19 outbreak, regional and local public health departments have been asked to provide detailed daily surveillance data about infected patients (symptomatic and asymptomatic) and hospital system capacity (intensive care unit beds) to support the national emergency response. Delays and difficulties in the exchange of surveillance data has been a clear weakness in the pandemic response. Indeed, the lack of a computerised system with intercommunicating platforms and the consequent circulation of information in a paper format, has caused organisational problems, delays, and difficulties with the exchange of information and epidemiological data, with important consequences on the timeliness of the implementation of control measures28. Investments in the ICT infrastructure for epidemiological surveillance systems and in a coordinated crisis monitoring system at a regional level are fundamental for the correct management of the pandemic. Also, proper resources for skills development in advanced epidemiological analysis (prediction not only monitoring) and data management should be envisaged. Moreover, public health departments performed surveillance, contact tracing and the identification and isolation of patients with available ICT technologies, provided this information to primary care and municipalities and managed communication with citizens. In the first stages of the outbreak, a big challenge in the identification of patients was supply shortages for diagnostic testing (swabs, reagent and test kits) and limited testing lab capacity. Despite improvements in the logistics of diagnostic testing supplies, investments are required in

27 Luis Saboga-Nunes, Diane Levin-Zamir, Uwe Bittlingmayer, Paolo Contu, Paulo Pinheiro, Valerie Ivassenko, Orkan Okan, Liane Comeau, Margaret Barry, Stephan Van den Broucke, Didier Jourdan (2020). A Health Promotion Focus on COVID-19: Keep the Trojan horse out of our health systems. Promote health for ALL in times of crisis and beyond! EUPHA-HP, IUHPE, UNESCO Chair Global Health & Education. Available at: https://eupha.org/repository/sections/hp/A_Health_Promotion_Focus_on_COVID- 19_with_S.pdf 28 https://www.epicentro.iss.it/coronavirus/sars-cov-2-esperienza-servizi-prevenzione 18

diagnostic technologies and training of personnel to operate it to maximise the capacity of public health laboratories. Lab capacity should also be strengthened by supporting collaboration among laboratories (e.g. private and public and/or across regions) and collaboration among laboratories and equipment manufacturers. It is not clear the need to establish new, high-capacity laboratories.

In the second stage of the outbreak (autumn), the challenge has moved to sample collection: where to test patients and who can/should test patients. Testing traditionally takes place in hospitals and clinics but the extremely high number of patients needing to be tested has required testing sites to be expanded, establishing alternative spaces like drive-in, walk-through and mobile testing centres. Investments in flexible/mobile testing centres should be suggested. At-home sample-collection methods are also emerging and could be another option. Due to the extremely high number of patients needing to be tested since the end of October 2020, GPs have been called upon to perform rapid antigen tests on suspected patients and related asymptomatic close contacts for an additional pay of 12 to 18 Euros per test performed. Individual protection is provided to GPs (the special commissioner Domenico Arcuri began the distribution of 50,000 kits a day and over 3 million pieces per week of PPE, including masks, visors, gloves and overalls).

In addition, another current challenge is contact tracing to help with controlling the spread of COVID-19. Currently, contact tracing is performed by telephone and, in some regions, with the support of the contact tracing mobile app Immuni, which was advanced by the Presidency of the Council of Ministers, the Ministry of Health and the Ministry of Innovation and Digitalisation. However, high case counts (both symptomatic and no symptomatic cases) are making contact- tracing efforts very challenging due to the shortage of personnel. About 9250 contact tracers are active across the entire county (+275 during the last eight months); however, in some regions (Abruzzo, Calabria and Friuli), the number is below the standard set by the Ministry of Health (Decree Law n.28, 30 April 2020)29 of one for every 10,000 inhabitants30 (see graph below).

29 http://www.assosoftware.it/attachments/article/2594/Decreto%20Ministro%20della%20salute%2030.04.2020.pdf 30 https://www.ilsole24ore.com/art/solo-9mila-tracciatori-trincea-cosi-e-piu-difficile-fermare-virus-ADLSxGw?refresh_ce=1 19

Together with an increase in personnel, there is the need to train contact tracers in contagion- containment training activities for the rapid identification and isolation of cases. COVID-19 will unfortunately be with us for many months to come, so contact tracing should be considered a medium-term investment.

4.2 Primary Care

A well-established proxy indicator to assess the efficiency of primary care is level of avoidable hospitalisations both for adult and child population. For instance, is interesting to note the variability across regions in terms of hospitalisations for asthma and gastroenteritis among children (<18 years) (Figure 12). In 2018, Lombardia reported the highest hospitalisation rate per 100,000 inhabitants (233), albeit with a decreasing trend, while Toscana had the lowest hospitalisation rate (34). The target was set at 141 hospitalisation every 100,000 children. Higher hospitalisations for asthma and gastroenteritis suggests that paediatricians are not always successful at keeping children out of hospitals. Figure 12. Standardised hospitalisation rate per 100,000 inhabitants for asthma and gastroenteritis among children (<18 years) by region, 2016-2018

Source: Griglia LEA http://www.quotidianosanita.it/allegati/allegato164996.pdf Also, the share of the adult population with hospital admissions due to chronic conditions (COPD, asthma, diabetes, heart failure and hypertensive disease) can provide a measure of efficiency of primary care and is often used at the international level for primary care system benchmarking. Figure 20

13 shows the hospitalisation rate for COPD and heart failure among the adult population across Italian regions; the performance is satisfactory. Indeed, all regions met the required standard of fewer than 400 hospital admissions per 100,000 inhabitants, with Molise and PA Bolzano being on the upper limit. The best-performing regions, also looking at longitudinal data, were Piemonte, Liguria and Toscana. Figure 13. Standardised hospitalisation rate per 100,000 inhabitants for COPD and heart failure among adults (>18 years) by region, 2016-2018

Source: Griglia LEA http://www.quotidianosanita.it/allegati/allegato164996.pdf Table 4 shows the hospitalisation rates for other chronic conditions that should be managed by primary care physicians or nurses but often are referred to hospitals because of a lack of local services, barriers to access or inefficient prevention and/or follow-up strategies. Asthma, diabetes, flu in the elderly and alcohol-related illnesses report low hospitalisation rates even though variability across regions is significant. PA Bolzano had the highest hospitalisation rates, except for asthma, where the worst performers were Lombardia, Liguria, Umbria and Campania. Compared to 2017, avoidable hospitalisations were constant or decreasing, with the exception for flu in the elderly. Greater efficiency can be expected. Table 4. Preventable hospitalisations per 100,000 inhabitants by region, 2018

Source: Ministry of Health, Rapporto SDO 2018

Overall, with better organisation and focus, good primary healthcare can prevent many of these hospitalisations, increasing the efficiency of health systems and improving people’s wellbeing. In addition, sources of waste and low efficiency can be assessed by considering inappropriate prescribing since primary care has a gatekeeping role. One example is the appropriate use of antibiotics in primary healthcare. In 2017, the average volume of all antibiotics prescribed in primary care in Italy was 19.7 defined daily doses (DDD) per 1000 inhabitants per day, with a reduction of 2.2% compared to 2016 and a decrease in per capita drug expenditure of 3.3% (Table 5). In 2017, the volume of all antibiotics ranged from 10.5 in PA Bolzano to 28.1 in Campania. There is a clear north-south gradient in DDD consumption, albeit some regions in the South (Puglia, Campania and Molise) recorded a significant reduction compared to 2016. Data that are more recent confirm the decreasing trend in Puglia.

Table 5. Volume of antibiotics prescribed (DDD/1000 per day) in primary care by region, 2013-2017 Figure on the right shows 2019 data for a selection of regions.

Source: https://www.aifa.gov.it/sites/default/files/Rapporto-L'uso_degli_antibiotici_in_Italia_2017_0.pdf Graph on the right: https://performance.santannapisa.it/pes/network/home.php Finally, the inappropriate prescribing of diagnostic tests can also highlight inefficiencies in primary care. Figure 14 shows musculoskeletal magnetic resonance (MR) prescribed to people over 65 years per 1000 inhabitants31 for selected regions. In 2019, Toscana and Puglia registered fewer than 20 prescriptions per 100, although with an increasing trend. Veneto, Friuli Venezia Giulia and PA Bolzano showed higher prescription rates but with a decreasing trend over time. On the other hand, Marche Liguria and Umbria showed no reduction in potentially inappropriate diagnostic prescriptions, even at a higher prescription rate. Figure 14. Rate of musculoskeletal MR prescribed to people over 65 years per 1000 inhabitants by region, 2019

31 In people aged 65 or older musculoskeletal magnetic resonance (MR) is often used for the in-depth diagnosis of degenerative osteoarthritis problems. However, the procedure is not conclusive and the pathology could be diagnosed through alternative tests. A high rate can indicate the potentially inappropriate prescription of MR exam. 22

Source: Inter-Regional Performance Evaluation System of Scuola Superiore Sant’Anna (Pisa) https://performance.santannapisa.it/pes/network/home.php

In light of this evidence, the gatekeeping role of primary care should be reinforced as a mean to optimise the efficiency of use (both over use and under use) of specialised services. Investments can include improvements in triage and referral management systems and an increased number of GPs and primary care nurses for prevention and follow-ups. In particular, referral management system solutions are needed to support earlier diagnoses, including the revision and implementation of better referral guidance, improved access to diagnostic tests, and dedicated pathways for chronic and fragile patients and specific groups of the population (e.g. immigrants) who often access acute care with advanced health problems. Early diagnosis by GPs can also benefit from investments in medical equipment and diagnostic technologies for prevention and diagnosis. Despite evidence demonstrating the contribution of primary healthcare to health systems in terms of improving efficiency over time, primary healthcare is not achieving the expected results in terms of responsiveness and continuity of care. A proxy of continuity assistance is adherence to therapy measured by the annual DDD consumption of hospital-territory drugs (farmaci di continuità assistenziale ospedale-territorio PHT). Lombardia and Abruzzo still have the lowest level (<50% adherence) while Marche, Emilia Romagna, Liguria and Piemonte register over 90% adherence to therapies (Figure 15).

Figure 15. % annual DDD consumption of hospital-territory drugs (farmaci PHT) by regions, 2016- 2018

Source: Griglia LEA http://www.quotidianosanita.it/allegati/allegato164996.pdf

Problems with the co-ordination of care between preventive, primary healthcare, specialists, and hospitals are often reported, especially for the management of chronic patients. According to OECD data, on average in Italy, more than 26% of patients suffering from certain chronic conditions did not receive any preventive tests in the previous 12 months32. In general, evidence suggests a decrease in preventive care by primary care teams with an increase in curative care. Italy saw the most significant decreases of more than 50% from 1993 to 201231.

Overall, to support a more efficient and comprehensive primary care system, regions are moving towards an integrated care model. The simpler model is team-based primary care (Aggregazioni Funzionali Territoriali - AFT). AFTs are compulsory networks of GPs that are expected to apply clinical governance principles to continuously improve the quality of services and safeguard high standards of care33. National statistics report that an average of 70% of GPs practice in teams with high variability across regions (only 34% in Calabria and more than 80% in Emilia Romagna, Veneto, PA Trento and Toscana). Also, on average, 65% of paediatricians are organised in teams with high variability across regions (Figure 16). Friuli Venezia Giulia and Sardegna register that more than 50% of paediatricians still work in solo practice, while Liguria, Veneto and PA Trento report more than 75% of paediatricians working in teams.

Figure 16. % of GPs and paediatricians working in mono-professional teams by region, 2017

Source: Ministry of Health, Annuario Statistico 2017 A more advanced integration model is created from multi-professional and multi-disciplinary groups of practice around GPs (also involving nurses and social-care workers) and is intended to provide comprehensive and continuous medical care to patients within a defined community (to ensure proximity). Multi-professional groups are based on the collaboration between GPs and specialists such as diabetologists, cardiologists, pulmonologists, oculists and nephrologists, among others. This is in addition to outpatient healthcare providers. This model requires the structural integration in health facilities of multi-specialist professionals (GPs, specialists, nurses, social care workers, administrative staff, etc.). This arrangement is referred to as Primary Care Complex

32 https://www.oecd.org/health/realising-the-potential-of-primary-health-care-a92adee4-en.htm 33 Santos R, Barsanti S, Seghieri C. Pay for performance in primary care – the use of administrative data by health economists. In: Data-driven policy impact evaluation. Cham: Springer; 2019. p. 313–332. 24

Aggregation (Unità Complessa di Cure Primarie - UCCP) but is known by different names across regions (Table 6).

Table 6. Name of Primary Care Complex Aggregation across regions Region Definition ABRUZZO Presidio territoriale di assistenza (PTA) BASILICATA Assistenza territoriale integrata per la Basilicata (ATIB) CALABRIA Centro di assistenza primaria territoriale (CAPT) CAMPANIA Struttura polifunzionale per la salute (SPS) EMILIA ROMAGNA Casa della Salute (CdS) FRIULI V GIULIA Centro di assistenza primaria (CAP) LAZIO Unità di Cure Primarie (UCP) LIGURIA Casa della Salute (CdS) LOMBARDIA Unità Complesse di Cure Primarie (UCCP) MARCHE Casa della Salute (CdS) MOLISE Casa della Salute (CdS) PIEMONTE Presidi territoriali assistenziali (PTA) SARDEGNA Casa della Salute (CdS) SICILIA Presidi territoriali assistenziali (PTA) TOSCANA Casa della Salute (CdS) UMBRIA Casa della Salute (CdS) VALLE D AOSTA Casa della Salute (CdS) VENETO Unità territoriale di assistenza primaria (UTAP)

At the forefront of the implementation of UCCP are the Emilia Romagna and Toscana region. Casa della Salute or Community Health Centre (CHC) model was introduced in Emilia Romagna in 2010, currently 120 CHCs are running. Since their implementation, CHCs have reduced inappropriate emergency access and hospital admissions for preventable hospitalisation by 25% and 4.5%, respectively34. In addition, Toscana has adopted the CHC model with the opening of 70 Case della Salute, which is expected to increase to 116 by the end of 202135. The document “Piano per il Sud 2030”36 proposed by the Ministry for Southern Italy and Territorial Cohesion highlights the need to invest in CHCs in the regions of the Mezzogiorno to improve territorial health and social services. Within the next three years, LHAs should identify areas in which to build these facilities, and should design and implement interventions to activate such arrangements. The expected expansion of facilities offering multi-specialist primary care is a potential area of investment in renewal/refurbishing and/or building for Primary Care Complex Aggregation (UCCP).

The presence of specialists in these facilities also requires investment in medical and diagnostic equipment; specifically, echocardiographs, ultrasounds, ECGs, RX and spirometers. Table 6 shows the availability of diagnostic services in a sample of Community Care Hospitals gathered from a recent survey.

Table 7. % of diagnostic services available in a sample of Community Health Centres in Italy, 2019

34 https://www.regione.emilia-romagna.it/notizie/2020/settembre/case-salute-dati 35 https://www.toscana-notizie.it/-/case-della-salute-sempre-pi%C3%B9-vicine-alle-esigenze-dei-cittadini 36 http://www.ministroperilsud.gov.it/media/2003/pianosud2030_documento.pdf 25

Source: https://www.fpcgil.it/wp-content/uploads/2020/07/ReportCreaCaseSalute2020.pdf

To boost integration among professionals, investment in the use of tele-consultation should be envisaged (an in-depth analysis of telemedicine solutions is provided in the thematic report on ICT and e-health). It is crucial to enhance the connection/interconnections between professionals working in different settings and across levels of care (primary and specialists). To support structural integration, investments in redesign and enhancing information flows should be achieved, as a pivotal component on which to build the integrated process to take care of patients along the hospital-territorial continuum. Overall, there is a general need for investments to enhance the quality and interoperability of information systems to promote collaboration between the various components of the care system. Investments for the renewal of the ICT infrastructure (hardware) within GP practices to promote the rapid storage and exchange of electronic patient data within the Electronic Medical Record infrastructure (FSE - Fascicolo Sanitario Elettronico) by updating the “patient summary” is an example of this. Investments to facilitate the use and development of other clinical decision support systems and investments to strengthen information systems supporting the evaluation of care provided (e.g. harmonisation of database for preventive, primary and specialist care for record linkage, collection of patient-reported experience and outcome data, etc.) should also be considered. Also, resources for training healthcare workers on the use and potential of these tools and for the enhancement of digital skills should be enhanced. Finally, investments to improve access and responsiveness to primary care services should be a priority. Investments in the promotion of the use of telemedicine for tele-visits and e-prescriptions to facilitate patient’s access to high quality primary care are needed. Indeed, many people do not even make it to the GP’s office due to barriers in access to care (among them waiting times, and distance and transportation)37; an in-depth analysis of telemedicine solutions and e-prescriptions is provided in the thematic report on ICT and e-health.

37 https://www.oecd.org/publications/health-for-everyone-3c8385d0-en.htm 26

Under COVID-19

The COVID-19 pandemic is challenging primary care organisations and their capacity. To enhance contact tracing and primary care home assistance to COVID-19 patients, the Government introduced the USCAs in law (Unità Speciali di Continuità Assistenziale) (Decree Law n.14, 9 March 2020). USCAs are run by single GPs, paediatricians or on-call doctors (medico di continuità assistenziale) who receive 40 Euros/hour (gross salary) for this service. Each USCA operates 7 days a week from 8am to 8pm. The Decree sets the standard to 1 USCA per 50,000 inhabitants. Lombardia, Piemonte and Emilia Romagna were the first regions to activate USCAs in mid-March. Out of the 1200 USCAs planned and financed with 721 million Euros, only half have been established (see map below). A subsequent Decree Law (n.34, 19 May 2020) provides for the strengthening of the Prevention Department and the introduction of Family and Community Nurses, also working in the USCA team. Family and community nurses work a maximum of 35 hours/week with a gross salary of 30 Euros/hour. The Decree sets the standard of 8 nurses for every 50,000 inhabitants. The introduction of family and community nurses allows the strengthening of home care services for both COVID-19 patients and patients with frailty, disability and chronicity problems.

Additionally, primary care professionals have been asked to closely monitor their fragile and chronically severe patients through home visits or telephone (Decree Law n.23, 8 April 2020) with an incentive to their salary of 3 Euros per patient. Moreover, additional duties have been asked of primary care professionals. Indeed, due to the extremely high number of patients to test since the end of October 2020, GPs have been called

upon to perform rapid antigen tests on their suspected patients and related asymptomatic close contacts for an additional pay of 12 to 18 Euros per test performed (see above section 4.5).

During the first wave of the emergency, the shortage of protective personal equipment (PPE) has been the main challenge for primary care professionals to protect themselves against the virus (including masks, gloves and gowns). Since the request to perform rapid antigen tests, individual protection has been provided to GPs (the special commissioner Domenico Arcuri began the distribution of 50,000 kits a day and over 3 million pieces a week of masks, visors, gloves and gowns).

4.3 Care Pathways

Care pathways, clinical pathways or patient pathways form a multi-disciplinary healthcare management tool based on the configuration of a plan for a specific group of patients with a predictable clinical course that is aimed at overcoming fragmentation problems by linking or coordinating services from different provides along the care continuum38. Most care pathways are based on the configuration of Diagnostic, Therapeutic and Care Pathways (Percorsi Diagnostici Terapeutici Assistenziali - PDTA), clinical management tools that define the typical patient pathway across services, treatments with clear indication of performance indicators. Another clinical management tool aiming at improving outcomes and reducing unwarranted variation is the Individualised Care Plan (Piano Assistenziale Individuale –PAI) for the management of chronic patients. Chronic conditions are typical conditions for which care pathways and care integration are promoted, since chronic illnesses require the development of care delivery systems that bring together a range of professionals and skills from the healthcare, long-term and social care sectors. In Italy, about 38% of the population declare that they are living with at least one chronic condition39. A National Plan for Chronic Diseases (Ministry of Health 2016)40 has been issued and identifies targets for managing chronic patients, promoting innovation in the organisation and the management of health services with the aim of harmonising interventions at a regional and local level41. Regions have implemented the National Plan following heterogeneous chronic care models with different results. Lombardia has invested a lot in the introduction of a comprehensive chronic care model, considering not only organisational changes but also changes in financing/incentives, patient focus/empowerment and stakeholder engagement (Regional Decree Law 23/2015). Other regions have primarily worked on service redesign, implying changes in the organisation of workflows, workforce development and resource allocation to provide more responsive and appropriate care

38 https://ec.europa.eu/health/sites/health/files/systems_performance_assessment/docs/2017_blocks_en_0.pdf 39 Censis using ISTAT 2013, statistic included in the National Plan for Chronic Diseases. 40 National Plan for Chronic Diseases http://www.salute.gov.it/imgs/C_17_pubblicazioni_2584_allegato.pdf 41 “The document has been approved by all Regions and represents now the main strategic reference for all interventions and policies aimed at improving the quality of life of individuals affected by chronic diseases and their families. The document is structured in two parts. The first contains general principles for policymaking in the field, while the second contains disease-specific recommendations for the implementation of Percorsi Diagnostici Terapeutici Assistenziali, (PDTA) for the following diseases/conditions: renal, rheumatic, gastrointestinal, cardiovascular, neurodegenerative, respiratory and endocrine (see some examples in Table 2 below). For each condition, the plan provides a brief epidemiological overview, a list of major critical issues in the current organisation and the definition of the recommended interventions in that particular area, including general and specific objectives, expected results and indicators for monitoring effectiveness and efficiency of the care provided”. Italy: Emerging policy developments in the long-term care sector. Available from: https://www.researchgate.net/publication/329338053_Italy_Emerging_policy_developments_in_the_long- term_care_sector. 28 delivery. Often, service redesign implies placing emphasis on the patient, re-orienting the focus of care from the hospital to the patient. Different indicators or proxies can be used to assess the effectiveness and cost-effectiveness of such reforms and help to measure the level of care continuity and integration from a clinical perspective. For example, it is interesting to benchmark the hospitalisation rate for Ambulatory Care Sensitive Conditions (ACSCs), the length of stay in hospital, the setting of discharge from hospitals and the emergency admission rate. High values for these indicators can show the potentially inappropriate use of acute services, highlighting weaknesses in the ability to manage/treat patients in non-acute settings (primary care, residential, home care) and pointing to limited (vertical) integration across settings. Indeed, the recurrent challenge across Italian regional health systems is the fragmentation of services; specifically, a weak hospital - community care (territorial) integration and still unsatisfactory primary - specialist care integration (see above section 4.6 on primary care) above all. Figure 17 shows the hospitalisation rate for a series of chronic and non-chronic conditions, which (according to international guidelines and standards) must be managed in outpatient setting avoiding the inappropriate use of hospitals. Regional variability is high; there is an almost three-fold variation between Veneto (3.3%) and Umbria (10.2%) meaning that patients with ambulatory care sensitive conditions in Veneto use hospitals less often than patients in the other regions monitored, thus optimising resources and relieving pressure on hospitals. Low rates of avoidable admissions for chronic conditions are a proxy of strong primary care systems (ability to keep people well and treat most uncomplicated cases).

Figure 17. Hospitalisation rate for Ambulatory Care Sensitive Condition (ACSC) per 1,000 population by region, 2019

Source: Inter-Regional Performance Evaluation System of Scuola Superiore Sant’Anna (Pisa) https://performance.santannapisa.it/pes/network/home.php

At the same time, it is important to monitor lengths of stay in hospital. Such measures provide a proxy of the capacity of community and social care to take charge of chronic care patients and the degree of continuity of care between hospitals and territories. High numbers of patients with a length of stay exceeding 30 days highlight poor organisations at the territorial level for the management of health and social needs. In Italy, weaknesses lie in the still limited availability of community 29 services such as Community Hospitals (ospedali di comunità) for the monitoring and treatment of non-acute events in chronic patients and the long-term care sector (an in-depth analysis of community and LTC is provided in the thematic report on acute and long-term care). Figure 18 shows a high rate of long stay hospital admissions in Veneto and Friuli Venezia Giulia (on average 1.3 hospital admissions per 1,000 exceed 30 days), while Toscana, Basilicata, Puglia and Umbria register fewer than one hospital admission with a long stay per 1000 resident population.

Figure 18. Hospitalisation rates with a length of stay >30 days by region, 2019

Source: Inter-Regional Performance Evaluation System of Scuola Superiore Sant’Anna (Pisa) https://performance.santannapisa.it/pes/network/home.php

It is also interesting to look at the discharge setting once patients leave the hospital to understand the pathway followed. Table 8 gives an overview of post-discharge support for any type of condition. Most of the time, people return home (87.6%), while a few are transferred to other acute services (2.3%) or transferred within the hospital to sub-acute care (2.2%) or rehabilitative care (2.2%), whereas a limited percentage end up in residential home (1.5%), or receive integrated home care (1%). There is a clear north-south gradient in the support from residential home post- discharge, with Trento, Friuli Venezia Giulia and Liguria being the regions with the highest percentage. In contrast, integrated home care is often very limited in all regions, with the exception of Basilicata, Umbria and Abruzzo, where the support is well above average (an in-depth analysis of community and LTC is provided in the thematic report on acute and long-term care). Community services should play an increasing role in supporting chronic populations and older adults who are discharged from hospital with ongoing non-acute care needs. An investment priority should consider the strengthening of hospital discharge with clear pathways and indications for patients (supported by operation management staff), and the involvement of community services post-discharge.

Table 8. Type of setting/service after hospital discharge by region, 2018

Source: Ministry of Health, Rapporto SDO 2018.

Finally, another proxy indicator on the effectiveness of primary and home care assistance along a care pathway is access to the Emergency Department (ED) (Figure 19). Regions show high variation: Basilicata and Puglia register fewer than 280 ED admissions per 1000 inhabitants, while Bolzano have over 400 ED admissions. There was no significant change over time. Higher rates can indicate poor integration and weaknesses in diagnosis and assistance in primary care and outpatient community care.

Figure 19. Standardised emergency department admission rate per 1000 inhabitants by region, 2019

Source: Inter-Regional Performance Evaluation System of Scuola Superiore Sant’Anna (Pisa) https://performance.santannapisa.it/pes/network/home.php

A good representation of the performance of chronic care pathways in terms of evidence-based indicators on adherence to therapies, preventable hospitalisation and outcomes is included in the report by the Inter-Regional Performance Evaluation System of Scuola Superiore Sant’Anna (Pisa) (https://performance.santannapisa.it/pes/network/home.php). Figure 20 shows the performance of heart failure, diabetes and CODP patients in Umbria region, where indicators falling in the red band indicate poor performance and indicators falling in the dark green band indicate good performance. Figure 20. Performance of chronic care pathway in Umbria region (as example), 2019

Source: Inter-Regional Performance Evaluation System of Scuola Superiore Sant’Anna (Pisa) https://performance.santannapisa.it/pes/network/home.php

Overall, the management of chronic care conditions shows room for improvement in all regional health systems. In some instances, chronic care models appear to have improved the appropriateness of access to hospital for ACSC and hospital length of stay, although primary care, community services, and long-term care do not always work in an integrated way. Regions have worked towards service redesign, often pushing to integrate GP practices into multi-disciplinary teams (see above section 4.6), for inter-organisational departments for the care of chronic and fragile conditions and a shift from disease-centred hospitals to intensive care hospitals. However, the organisation of workflows between primary care and specialists is still uncoordinated, and the involvement of community and long-term care in post-acute care is patchy. Some regions have also promoted case management programmes as an integrated care approach for the management of chronic disease (e.g. Lombardia). Nonetheless, the uptake of such models requires time and investment the in organisation of workflows (especially sharing of health information), workforce development and resource allocation to provide more response care delivery. Indeed, the implementation of integrated care solutions often requires the redesign of the role of health and social care professionals and the creation of new roles to ensure continuity of care. Investments can also target dedicated education and training programmes on extended roles. A central tool supporting the integration of care services to chronic patients has been the introduction of Individualised Care Plan (Piano Assistenziale Individuale –PAI) following a more patient- cantered care. However, the sharing of care plans and other health information between providers to enable collaboration is sometimes difficult because of interoperability and privacy issues or a delay in the investment in ICT infrastructures. An example is the integration of individualised care plans within the existing eHealth service of Electronic Medical Records (Fascicolo Sanitario Elettronico) to support information exchange. Investments in this area are needed (see thematic report on ICT and e-health for more detail). Another area of investment for ICT is information systems and data analytical tools for the stratification and targeting of patients following a population-based approach. Nonetheless, monitoring and performance evaluation systems should evolve with the new care pathways and services introduced to support integrated care and be able to assess quality, cost, access and citizen experience to support evidence-based investment. Emphasis on the patient and the need to re-orient the focus of care from the hospital to the patient is another critical element of service redesign. Supporting services to ease patient access are implemented such as regional-based booking centres (Centro Unico di Prenotazione - CUP) as a single entry point to all healthcare services, and e-booking and e-payments, to give web-based real- time services.

Investment should be planned to favour a more homogeneous introduction and harmonised offer of such systems to widen equity in access (they should be promoted widely as a means to access supporting services in rural/remote areas). Also, patient empowerment should be a priority investment in terms of promoting chronic disease self-management programmes (i.e. education programmes aiming to build patient confidence in managing their health and keep them active and engaged in their lives) which is already a pillar of the chronic care model in some regional health systems (see Toscana Sanità di iniziativa).

Under COVID-19

During the COVID-19 emergency, continuity of care for non-COVID-19 patients was put at risk, especially because of the increased barriers to access services, increasing waiting times due to postponements/delays in diagnostic services, interventions and therapies, with negative effects on population health. Indeed, non-urgent hospital and outpatient interventions and treatments have been delayed and postponed (see Circolare Ministry of Health 16 March 2020). The deferral involves a substantial lengthening of waiting lists, which requires the reprogramming of activities based on clinical priority, equity and efficiency principles. Regions have worked to reorganise non-COVID-19 related health services using digital solutions to provide medical services online (e.g. tele-consultations and tele-visits) or by providing lab testing at home (e.g. blood sampling) or drug delivery at home (this happened for oncological patients). In addition, tele-monitoring for chronic disease patients has been used to remotely monitor patients. However, these are recurrent examples referred by professionals; we have not assisted in a well-organised and homogeneous implementation across the country. Currently, heavy privacy regulations and a lack of clear guidelines, together with the lack of reimbursement, hinder the implementation of effective telemedicine solutions42 (see the thematic report on ICT and e-health for further details). Finally, regions should also start developing and designing clinical pathways for the clinical follow-up of COVID-19 patients.

5 Overview of national-level containment measures and investment needs in response to the COVID-19 outbreak

The Table 9 below lists the national level containment measures and indications for investment in the healthcare system in response to the COVID-19 outbreak. The strategic national plans for the short- to-medium term investment are quite relevant since they highlight what has been already decided as a measure to strengthen the healthcare system in the face of the COVID-19 pandemic. The Italian government made great efforts to mitigate the spread of the virus, relieve pressure on hospitals and generate additional care capacity. Primarily, the response was based on mobilisation of the workforce (both clinicians and nurses)43, incentives for health personnel, relaxations of the terms

42 Omboni, S. (2020). Telemedicine during the COVID-19 in Italy: a missed opportunity?. Telemedicine and e-Health. https://www.liebertpub.com/doi/full/10.1089/TMJ.2020.0106 43 On top of recruitment of personnel, the government announced in the Decree Law n.18 (17 March 2020), with subsequent updates, that retired doctors and nurses as well as medical students in their last year of training could be hired by the national health service for six months to boost the health workforce during the emergency – the aim was to recruit about 20 000 additional staff. 33 of working contracts (e.g. working hours), flexibility in public expenditure rules (e.g. workforce turn over) and the simplification of public procurement rules. As reported by the European Council Opinion on the Recommendation 2020 National Reform Programme of Italy and the 2020 Stability Programme of Italy EU Council, “…this compensated the limits of the physical infrastructure, numbers of health workers and investment in the past years” aimed at improving structures and services. A longer-term containment strategy is now being developed to ensure the safe return to productive activity. In addition to improving governance processes and crisis preparedness plans, post-COVID policies should aim to alleviate the public investment gap in healthcare. In the medium-to-long term, developing a strategic investment plan will be key to improving the resilience of the Italian healthcare system, and to guarantee the continued provision of accessible care. Table 9. Overview of containment-measures and investments to strengthen health system at national level (last update 10 November 2020)

Note: * 660 million of euro for all the actions included in Decree Law n.14

Given the devolution of power to regional health systems, Italian regions have moved autonomously in the implementation of the national-level measures because regions are also characterised by different regional healthcare system capacity and models for organising care. As reported by the European Council Opinion on the Recommendation 2020 National Reform Programme of Italy and the 2020 Stability Programme of Italy “especially at the onset of the pandemic, the health system governance fragmentation and coordination between central and regional authorities slowed down the implementation of some containment measures”. Below is the list of clinical and organisational indications issued by the Ministry of Health to the regions since the outbreak of the pandemic (Table 10). Table 10. List of clinical and organisational indications issued by the Ministry of Health to the regions since the outbreak of the pandemic in chronological order

Source: ALTEMS Instant Report#28, 12 November 2020. Available at https://altems.unicatt.it/altems- Altems%20Instant%20Report%20n28.pdf

6 Concluding remarks

The Council Recommendation on the 2020 National Reform Programme of Italy and the delivering of a Council opinion on the 2020 Stability Programme of Italy stated that some medium-to-long term investments are necessary to improve the resilience of the Italian healthcare system and to guarantee the continued provision of accessible care. In the face of current health workforce projections, priority should be given to developing policies to resolve bottlenecks in the training, recruitment and retention of the health workforce”44. The call for investment in workforce capacity has been considered essential to cope with the epidemic. Training refers to both the prevention, contagion- containment and treatment of COVID-19 and the epidemic preparedness in general. During the last few months, public health workers and primary care professionals have been asked to take up new activities (e.g. containment, contact tracing) and have often been redeployed and asked to collaborate across multidisciplinary teams. This has raised the need to provide training to take up specific skills (e.g. infection prevention and control, emergency preparedness, data management) and other socio- emotional and soft skills to cope with COVID-19 and post-COVID-19. In this light, proper resources for the development of skills should be available. However, the training is also critical beyond this epidemic. In particular, the information collected in this document highlights that education and training programmes are needed among public healthcare workers, primary care and specialists on vaccination awareness and safety, the promotion of screening programmes and healthy lifestyles, and more generally on digital skills and innovation management. In addition, specific recruitment and retention strategies need to be considered for healthcare professionals working in primary care. Indeed, the shortage of GPs and their older age are critical issues posing adverse effects on the quality of care provided.

In addition to this important need related to human capital, in this document we have provided evidence supporting the need for long-term investments for public health and primary care, as well as healthcare pathways, also considering the emerging needs posed by COVID-19. The COVID-19 crisis is demonstrating the important links between public health, primary care, hospital care and LTC that cannot be ignored. The better integration of public health and primary care is crucial in times of epidemiological emergency for surveillance (collaborative use of data and analysis), the early recognition of infections and fast tracing. Moreover, the integration of prevention and primary care remain highly relevant to assure the shared goal of population health improvement. Improvements in triage and referral management systems for prevention are needed to support earlier diagnosis.

As reported internationally, the COVID-19 emergency has showed a major limitation across healthcare systems with the lack of an ICT infrastructure for data governance and exchange45. This is particularly true in decentralised healthcare systems, like the Italian one in which regions have developed their own healthcare information infrastructure and governance, which is typically not in alignment with other regions, and thus is incapable of informing a unified response. In a situation where time scarcity represents a critical constraint, the need for real-time surveillance data and fast early diagnosis systems can be a pivot point that can solve both the patients’ need for a quick diagnosis

44 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52020DC0512 45 Beyond containment: Health systems responses to COVID-19 in the OECD http://www.oecd.org/coronavirus/policy- responses/beyond-containment-health-systems-responses-to-covid-19-in-the-oecd-6ab740c0/ 36 and the practitioners’ needs for a rapid assessment of patient conditions. Moreover, also in normal times, there is a clear need to strengthen ICT infrastructures, boosting the storage and exchange of electronic patient data to support the integration of care across settings and professionals. Also, a strong collaborative network between primary, acute care and community care is crucial for the management of more severe cases during the pandemic and is recognised to be conducive to higher care quality (increased appropriateness and responsiveness) and sustainable systems. This is also true in times of non-emergency situations where the goal is to assure the appropriate level of care to those who are in need (value-based healthcare). Services and professionals should be vertically integrated to provide appropriate and responsive services along the care pathway, especially for people with complex care needs (e.g. improving involvement of community services post-discharge or limiting inappropriate access to acute facilities). The gatekeeping role of primary care should be reinforced to optimise the efficient use of specialised services. Also, horizontal integration, i.e. collaboration between primary care and specialists, is essential. In this view, strengthening multi- professional and multi-disciplinary groups of practice is a priority.

The central issue with health service delivery in Italy is the heterogeneity of regional arrangements for primary care and for the care of people with long-term conditions. In general, northern and central regions appear to keep pace with institutional, organisational and professional developments aligned with best international practices and in line with central government orientations, while southern regions appear to lag behind46. These gaps can be reduced with investments in monitoring and performance evaluation tools to support evidence-based investment towards integrated care and patient-centeredness. For this purpose, health information systems that are interconnected and interoperable, new administrative data flows on primary and community care and systematic permanent surveys on patient needs should be put into place. In addition, a priority for investment is information systems and data analytic tools for stratification and targeting of the population following a population-based approach.

Patient-centeredness also implies continuous investments in communication and patient empowerment. Communication and awareness campaigns for prevention and health promotion should continue and be personalised for the different groups of the population and through the implementation of more advanced communication tools, for instance through web and social media. In addition, patient empowerment should be a priority investment in terms of promoting chronic disease self-management program.

There is also a need to invest in new facilities to host multi-specialist group of practices to favour care integration and optimise accessibility and the capacity of existing facilities to cope with emergencies and surge demand. Overall, there is a need for renovation/new physical infrastructures and equipment. The high obsolescence rate of fixed assets require investments to start or complete infrastructural work to comply with fire safety regulation and anti-seismic rules, and to also eliminate the presence of asbestos, reduce energy consumption, and improve ventilation/air conditioning systems. Besides, more alarming than the overall fixed assets is the obsolescence rate for equipment. The substitution of diagnostic technologies for population-based screening and new

46 https://www.euro.who.int/__data/assets/pdf_file/0003/263253/HiT-Italy.pdf 37 investments in diagnostic technologies for primary care prevention and follow-up management should be promoted to increase preventive care by primary care teams and limit curative care.

Moreover, COVID-19 is posing an additional burden to the national and regional healthcare systems who have changed their priorities in response to the emergency. All regional healthcare systems have focused on measures to contain the pandemic limiting/postponing ordinary activities for non COVID- 19 patients (e.g. hospital admissions for elective surgery, outpatient visits and diagnostic exams, prevention programmes, home support) with consequences on population outcomes (some preliminary results on number of access to hospital and ED during the COVID-19 are reported in the thematic report on acute, community and LTC). There is the need to focus on reorganising non- COVID-19 related health services, to get back to day-to-day operations. Making the system more resilient is the current priority, i.e. strengthening the capacity to “absorb, effectively respond and adapt to shock while sustaining day-to-day operations”47. In light of this, resilient systems have responded with innovations, substituting the usual care through new technological solutions. During the COVID-19 outbreak, some innovation processes have experienced a quick evolution and have been introduced into the healthcare system (often bypassing the pilot and assessment phases) to support the response to the pandemic, as well as substitution of the usual care through new technological solutions. This is especially true for digital solutions employed to monitor and manage COVID-19 cases, as well as to provide medical services online (tele-consultation, tele-visits) or to ease access to services (e-prescription) or information exchange (FSE). Overall, telemedicine has gained a lot of attention during the COVID-19 pandemic and specific investment should also be considered during normal times to provide high quality care and improve accessibility, care continuity, and support workflow among professionals. For instance, tele-radiology for breast cancer screening, tele-visits and tele-consultation for access to primary care and other technology-supporting services to improve continuity of care (tele-monitoring/remote assistance services, tele-vists) are examples in this direction. This momentum should not be wasted. To this end, improvements in the interoperability of digital services and access to fast and reliable digital infrastructures (e.g. fibre-to- the-premises coverage) are key to ensuring effective and accessible services.

47 https://ec.europa.eu/health/sites/health/files/expert_panel/docs/026_health_socialcare_covid19_en.pdf 38

Unmet healthcare infrastructure needs related to ICT & e-health

Prepared by: Dr Ylenia Sacco, in collaboration with Dr Francesca Ferrè and Prof. Milena Vainieri

EXPERT CONTRACT NUMBER – 2020CE16BAT066 AMI expert reference: REGIO 2018-0154

Updated: 30th November 2020

Table of contents Summary ...... 2 1. Introduction ...... 4 2. Digital competitiveness of the Italian system as a whole and some key indicators for measuring the transformation process applied to the Italian healthcare system ...... 8 3. How to identify the regional unmet needs in eHealth & ICT ...... 11 4. Italian and regional performance ...... 11 4.1 FSE – Fascicolo Sanitario Elettronico...... 12 4.2 Telemedicine & IT advanced solutions (AI, Big Data etc.) ...... 20 4.3 Digital health services ...... 48 5. Trends of investments in health technologies before and during the coronavirus outbreak ...... 51 6. Concluding remarks ...... 53

Summary

This document provides a picture of the digital transformation process in the Italian public health system, taking into account key trends before the Covid-19 outbreak and the most recent information available related to the current situation of the pandemic in terms of emerging needs in both national and regional settings, so as to identify possible areas of investment for supporting the Italian health care system. The document provides information and data about key areas of health digitalisation at the national level, and also reports measures and figures for identifying regional health needs and their effects in terms of the digital transformation process involving citizen access to health services, and regional/local healthcare systems at whole. The document particularly highlights, starting from official documents, policy lines and the results of evidence-based e-solutions, the need to invest in: - ICT and digital infrastructure. The Covid-19 outbreak has highlighted the crucial role of new technological applications in healthcare systems, for the timely support of the increased demand for hospital services and data exchange, for contact tracing, and for accelerating remote care with the aim of mitigating the spread of the virus. “Enabling infrastructure” such as FSE-INI (Fascicolo Sanitario Elettronico - Infrastruttura Nazionale per l’Interoperabilità), digital identity (SPID – Sistema Pubblico di Identità Digitale), and integrated telemedicine solutions is essential for overcoming the fragmentation of the decentralised regional systems in Italy, and for strengthening a unified digital health strategy nation-wide. Today, from a mid-term perspective, real-time data exchange, bio-surveillance, and home care are essential, due to the pandemic. Tomorrow, from a long-term perspective, it will be valuable to use such advanced solutions to ensure the continuity of care between primary, hospital, and territorial settings/health professionals for the management and treatment of chronic diseases. - Telemedicine. Healthcare systems worldwide were extremely challenged by the pandemic. Telemedicine solutions enable a wide range of possibilities, including long-distance care, remote diagnosis services, low cost clinical education, and teleconsultations providing useful insights into the broad range of telemedicine applications, creating, de facto, new opportunities to cope with the healthcare needs of patients, GPs and hospitals. Italian regional health systems demonstrated a wide heterogeneity of telemedicine solution implementation, and specific investment should also be encouraged beyond the pandemic so as to address emerging needs for care accessibility and to support the reshaping of a new workflow between healthcare settings and professionals. Future resource allocation for telemedicine solutions

should take into account both the local health determinants, and the long-term perspective of technical reusability and economic sustainability. - IT advanced solutions (AI, Big Data, Blockchain etc.). Despite the huge expansion of the advanced digital health sector in Italy (with a 7% increase in 2019 compared to 2018, i.e. 1.39 billion Euro1), digital health strategies are decentralised, resulting in inconsistent utilisation across different regions. Prioritising future investment lines nationally (such as the Recovery Plan and the Digitalisation Strategic Plan) for 5G and fibre for connectivity will facilitate the diffusion of, and access to such advanced solutions across healthcare systems. The widespread use of advanced IT solutions through higher connectivity should therefore be reinforced to optimise the efficiency of healthcare systems and to boost clinical and scientific data and knowledge exchange with the aim of supporting integration across regions, care settings and disciplines. - Digital literacy. The last DESI Index for Italy confirms very low levels of basic and advanced digital skills in the Italian population. The Covid-19 emergency has particularly highlighted that it is essential that citizens and health professionals have adequate digital skills to enable suitable access to information and health services, including remotely. Support and investment for different target users (citizens, GPs and healthcare operators) should be promoted following a “life-long learning” approach in order to overcome this gap and facilitate a long-lasting and efficient use of digital tools, with the objective of increasing digital tools access and diffusion, especially in the healthcare domain. - Workforce ability to use IT and digital skills. It is necessary, particularly, within local health authorities, hospitals and regional offices, that eHealth solutions should be properly handled not only during the coronavirus crisis but also beyond this epidemic. Key profiles such as ICT specialists, project managers, data analysts and computer scientists are rare in the workforce of public health organisations and authorities and increasing their presence should be a priority in the management of complex ICT-based health and innovation projects.

The document is structured to include the following: i) a picture of the health digitalisation process in Italy; ii) the method applied to identify unmet needs, taking into account different regional settings; iii) Italian and regional performance in these settings, using the most recent data available (usually pre-Covid-19), and the challenges posed by Covid-19; iv) overview of the current strategies put in place at national and regional levels to strengthen system resilience, and; v) concluding remarks.

1 Source: Osservatorio Innovazione Digitale in Sanità 54

1. Introduction

Italy is characterised by a high administrative decentralisation, so regional health governments play a relevant role in the process of technological innovation, particularly if applied in the healthcare domain, with all its dimensions (public health, primary care, acute care, long term care etc.). This is a big challenge, especially during the Covid-19 emergency, as the decentralised health systems have developed subnational areas with their own IT and government infrastructure, often not completely aligned with other regions, and therefore not optimal for providing a unified response. Several national authorities, including the Ministero dell’Innovazione Tecnologica2, Agenzia per l’Italia Digitale3 (AGID) and Dipartimento per la Trasformazione Digitale,4 together with the Ministero della Salute,5 play key roles in planning guidelines and investment to integrate innovative actions in a common and proportional way that addresses the various regional health systems. After the” Decreto Rilancio “Cura Italia” (n.76, 16th July 2020) which converted national interventions to tackle the economic consequences of the Covid-19 emergency to law, further key documents and plans were launched by the Ministero dell’Innovazione. The stated objective is to put in place the conditions for a change in elements relevant to the digital transformation of the Italian public administration, and therefore also of the health systems, which comprises a significant proportion. The central idea is to relaunch investments and mitigate the economic and social impact of the pandemic crisis, implementing important reforms, including the digital transition process, which assumes primary importance. The latest documents to be taken into account in a brief picture of the digital transformation phase in Italy are: - Piano Triennale per l’Informatica nella Pubblica Amministrazione 2020-20226 (July 2020); - The MID Book 20257 (September 2020, Law n. 120, 11th September 2020, Urgent measures for simplification and digital innovation) The simplified representation of the strategic model (reported below) allows the digital transformation to be described in a functional way. This representation consists of two transversal levels: the interoperability and security of information systems, and vertical levels of services, data, platforms and infrastructure.

2 https://innovazione.gov.it/ 3 https://www.agid.gov.it/ 4 https://innovazione.gov.it/it/chi-siamo/dipartimento/ 5 http://www.salute.gov.it/portale/home.html 6https://www.agid.gov.it/sites/default/files/repository_files/piano_triennale_per_l_informatica_nella_pa_2020_2022.pdf 7 Strategia per l’Innovazione tecnologica e la digitalizzazione del Paese 2025 https://innovazione.gov.it/assets/docs/MID_Book_2025.pdf 54

Fig. 1: Strategic evolution model of the information system of the Italian Public Administration The two transversal levels (interoperability and security of information system) represent the assumptions and common framework for the implementation of the vertical levels (services, data, platforms and infrastructure) for the benefit of citizens, and for the sustainability of the whole ecosystem. Interoperability and information system security The data interoperability of public databases ensures easier and faster data exchange between public databases, and facilitates access to information and services for citizens and public(/health) operators. For example, the introduction of the Public System for Digital Identity (SPID - Sistema Pubblico d’Identità Digitale) allows every citizen/patient to acquire their own digital identity and thus obtain secure, fast and free access to their data and services according to the "once only" principle8, that is, unique for all public databases. A SPID digital identity means that payment can be made for services or drugs through the national PagoPA platform, which is also accessible at public health companies and all public offices through the national Data Digital Platform for Data Sharing (PDND – Piattaforma Digitale Nazionale Dati). Information system security is essential for preventing and promptly detecting cyber-attacks and/or incidents following the Network and Information Security Directive (NIS) and national law. The aim is to reinforce cyber protection measures, increasing the degree of cyber resilience in “national cyberspace” and applying the capabilities of the information systems installed in Italian territory to protect data and information. The “national cyberspace” is then the ideal place for citizens and operators to keep their most sensitive data and host key functions for their core businesses/services, and where they can also better develop the functioning of the various sectors of essential activities, such as health, research, defence, and industry. Infrastructure, services, platforms, data

8 The once-only principle is an e-government concept that aims to ensure that citizens, institutions, and companies only have to provide certain standard information to the authorities and administrations once. By incorporating data protection regulations and the explicit consent of the users, the public administration is allowed to re-use and exchange the data with each other. The once-only principle is part of the European Union's (EU) plans to further develop the Digital Single Market by reducing the administrative burden on citizens and companies. 54

The central point of both plans according to the “Iniziative per il rilancio Italia 2020-22”9 is the improvement of the digital infrastructure, making it secure, fast, energy-efficient and economically sustainable. The necessary first step is to lay the foundations for the development of one unique and neutral network (i.e. that does not bring an advantage to one technology rather than another), which provides broadband and ultra-broadband connectivity everywhere the Italian territory. The internet allows “data transport”, but it is necessary to create data-centres for the data to be stored and used, and to strengthen the use of cloud technology. The cloud has enormous potential to improve the quality of public services, and is able to significantly reduce costs and contribute to increasing energy- efficiency and environmental sustainability. Investing in this technology is a priority, and also in a network of highly reliable data-centres in Italian territory, in line with European guidelines and with the European Gaia-X Infrastructure10. Enabling platforms" will be strengthened and developed in order to promote greater dissemination and use of digital public services offered to citizens, which is useful for simplifying the provision of public services such as healthcare. “Enabling platforms” are solutions that offer fundamental, transversal and reusable functionalities in different public services (potentially all), enable a common delivery mode. They relieve regional governments and public local authorities of the need to purchase and/or implement common functionalities from multiple software systems, simplifying the design, reducing the time and costs of set up new services, and ensuring greater IT security. Examples include the SPID (public system for digital identity) which identifies and authorises the user (citizen/patient) to access online services and the platforms such as PagoPA, ANPR (Anagrafe nazionale della popolazione residente) and also the “IO.it” app which will be an access channel for some public digital services11 from citizens. The app is expected to increase the uptake of some public services, at both the national and local level, by making them easily accessible through mobile devices12. The central idea is to use a part of the Recovery Fund and other available resources for investment to improve the quality of services, to disseminate standard models, to use guidelines for setting up new services, for the modernisation and digitalisation of those already existing, and to rationalise the

9 Also named “Piano Colao” and which is the basis of the Law “Decreto Rilancio”, 16th July 2020. 10 https://www.data-infrastructure.eu/GAIAX/Navigation/EN/Home/home.html.Italy is part of the initiative coordinated by Germany and France.

11 The Law n. 120 of 11th September 2020 (Conversion into law, with amendments, of the decree-law 16 July 2020, n. 76, containing urgent measures for simplification and digital innovation), introduces an obligation to make public services available on the network through the IO application. Public structures are required to initiate digital transformation projects by 28 February 2021. 12 The app has been already tested in some public authorities at regional and local level, and it is due to be fully rolled out in the course of 2021. 54 number of platforms used by the different public units and regional governments. Following European Commission recommendations, the objective is to stop digital fragmentation and the lack of interoperability of services and data that characterises the Italian system13. The actions to be implemented according to the “Piano per l’informatizzazione e la trasformazione digitale” and MID 2025 follow the guidelines of the new European planning 2021-2027, the principles of the eGovernment Action Plan 2016-2020 and the eGovernment Declaration of Tallinn (2017-2021), whose indicators measure the level of digitisation and the use of digital services by citizens, companies and the public sector. Indeed, local and regional public authorities will have to proceed with actions to achieve the objectives contained in the plan and to measure the results, following a detailed plan with timelines for each action. The culture of measurement, and consequently of data quality, is one of the main criteria of this transformation. In summary, the key points of the digital transformation process are (see Figure 2 below): - Digital & mobile first for services accessible exclusively with digital identity systems defined by the legislation ensuring at least access via SPID; - cloud first (cloud as the first option): public authorities, when defining a new project and developing new services, primarily adopt the cloud paradigm, taking into account the need to prevent the risk of lock-in; - inclusive and accessible services able to meet the different needs of people and the different territories, and interoperable by design so that they can operate with integrated modality; - security and privacy by design: digital services designed and delivered securely and guaranteeing personal data protection - user-centric, data driven and agile: administrations develop digital services, providing agile methods of continuous improvement, starting from the user experience and based on the continuous measurement of performance and use, also making digital public services available across borders according to the cross-border principle; - once only: public administrations must avoid asking citizens for information already provided; - open code: public authorities must preferentially use open code software and, in the case of software developed on their behalf, the source code must be made available.

13 National recovery and resilience plan – Hearing in the Constitutional Affairs Commission of the Senate – 6th October 2020 Minister of Innovation Paola Pisano. 54

Fig. 2: The 20 (+1) actions for the Italian digital transformation “Italia 2025” – MID Book 2025

2. Digital competitiveness of the Italian system overall and some key indicators for measuring the transformation process applied to the Italian healthcare system

The most recent DESI Report14 for periodically measuring the digital competitiveness of European Member countries was published in October 2020. The DESI Index makes it possible to identify progress and gap areas that require interventions and investments. Starting from 2015, the DESI country reports combine quantitative evidence from the DESI indicators across five main dimensions: broadband connectivity, digital skills at the society level, use of internet services, integration level of the digital technologies, and digital public services. Italy ranks 25th out of 28 EU Member States (in 2019 it ranked 23rd), as reported in the ranking scheme below:

14 The Digital Economy and Society Index (DESI) is a set of reports that includes both country profiles and thematic chapters. https://ec.europa.eu/digital-single-market/en/news/digital-economy-and-society-index-desi-2020

Fig. 3 Overview – DESI 2020 Ranking Data for 2020 shows that Italy ranks highly for 5G preparedness (3rd compared to the other EU countries; 94% of the spectrum harmonised at EU level for wireless broadband has been assigned in Italy) but needs to improve the deployment of very high capacity networks (VHCN). The country performs poorly in digital skills. Although it ranks relatively highly in its offer of e-government services, public take-up remains low. Further progress is needed in digital skills, especially since the Covid-19 crisis has shown that it is essential that citizens have adequate digital skills, in order to access information and services. It records very low levels of basic and advanced digital skills. The number of ICT specialists and ICT graduates is also well below the EU average. These gaps in digital skills are reflected in the low use of online services, including digital public services. Only 74% of Italians are regular internet users. Similarly, Italian enterprises lag behind the use of technologies such as the cloud and Big Data, as well as in the uptake of e-commerce.

The figure below shows Italian performance by dimension, compared to the EU average:

Fig.4: DESI 2020 – Italian relative performance by dimension

The impact of the current Covid-19 crisis is relevant to key societal indicators relating, for example, to the use of internet services by citizens. This is not yet reported in the latest 2019 official statistics as recorded in DESI 2020 - Italy. The DESI 2020 data provides general indications related to the need to increase digital skills and support access to ultrafast connections and related services, but specific data and evaluations related to the health digitalisation process are not provided. As a result of the extraordinary demand for digital infrastructure and services during the COVID breakout, the Italian government adopted specific measures to facilitate the increase in consumption of electronic communications services and network traffic (for example, to facilitate the greater number of people working from home). Free wi-fi connections were provided to public hospitals, and simplified procurement measurements15 were put in place to facilitate the purchase of IT tools and services by public authorities at regional and local level. “DESI 2019 – Italy” reported key indicators related to the health digitalisation under the “Digital Public Services” dimension. As reported in Figure 5 below, in 2019 Italy ranks 18th compared to the other EU Member countries. Italy performs very well in open data and e-health services, however, there is a low level of online interaction between public authorities and citizens: only 37% of Italian internet users needing to send forms did so online. In 2018, Italy performed better than in 2017 as regards services involving pre-completed forms, e-government users and digital public services for businesses. It was the EU's fourth best performer on open data, with a score of 80%. Italy ranks eighth in the EU for e-health services; 24% of Italians have used health and care services provided online. Thirty two per cent% of general practitioners use e-prescriptions. In 2018, 13 of 20 Italian regions had adopted electronic health records, which enables patient health records to be available to both patients and doctors (including information on hospitalisations, medicines prescribed and clinical examinations) in electronic format (although only a minority of such records cover all health services). Eleven regions have adopted interoperable health records which can dialogue with each other.

15 The Law n. 120 of 11th September 2020 (Conversion into law, with amendments, of the decree-law 16 July 2020, n. 76, containing urgent measures for the simplification and digital innovation). 54

Fig. 5: “Digital public services” dimension of DESI 2019 Italy and some key indicators about the health digitalisation process”

3. How to identify the unmet regional needs in eHealth & ICT To identify the unmet health needs we took into consideration the conceptual framework presented in the first deliverable “A framework for assessing priority in health investments needed in Italy under the programming period 2021/2027 of the Cohesion Policy”. We analyse the indicators identified and collected through the available documents and reports on performance and technical features of established performance evaluation systems in use by the national and regional governments and other statistics on technical capacity and standards. We added the recent strategic documents, reports and considerations in response to the Covid-19 outbreak to this analysis based on quantitative evidence.

Finally, we considered the documents and the interviews undertaken with the regional representatives contacted through the DG REGIO for this purpose.

4. Italian and regional performance From 2019 there was increased focus on boosting the digitisation of the Italian system through new initiatives at political level, such as the establishment of a new Ministry for Technological Innovation and Digitalisation with a lead role in coordinating an integrated digital transformation team composed 54 of the Digital Italy Agency (AGID), in charge of implementing the Italian Digital Agenda, and the Health Ministry for eHealth area interventions. In this scenario, the Covid-19 emergency is a heightened reason to strengthen digital health solutions and services in order to monitor (even at a distance) and track patients with coronavirus and/or affected by chronic diseases. Following the definition of “sanità digitale” provided from AGID16, we identify three main interventions areas, as also reported in the framework (Deliverable 1) of our analysis: 1) Electronic Health Record (Fascicolo Sanitario Elettronico – FSE) such as the “enabling platform” of the Italian healthcare system at the national and regional level; 2) Telemedicine & some trajectories for advanced IT solutions (such as AI, Big Data etc.) applied to the healthcare domain; 3) Digital health Services (e.g.: ePrescriptions; digital health services etc.) as examples of simplifying the interaction between citizens and healthcare authorities

We analyse each area through specific indicators from national sources and other validated measurements available, with the aim to identify the main features and emerging unmet needs in eHealth and digital tools for improving the management of the regional healthcare systems. 4.1 FSE – Fascicolo Sanitario Elettronico17 The Electronic Health Record (FSE) is digital infrastructure that is able to contain a patient's clinical history represented by a set of digital health and socio-health data and documents related to the current and past clinical events of each patient. FSE is one of the public health services of the Italian SSN – Sistema Sanitario Nazionale (Law n. 178 of 29th September 201518). AGID and the Ministry of Health have defined a series of indicators according to Italian regions that are able to monitor and check the progress and the state of implementation and dissemination of the FSE nationally and in each region. This helps the monitoring process for assessing the state of the art of the FSE implementation thanks to two different groups of indicators: a) Implementation indicators b) Usage indicators The first group a) takes into account the components that enable access by patients, GPs, paediatricians (PLS – Pediatri di Libera Scelta), healthcare authorities and hospitals. It also includes

16 https://www.agid.gov.it/it/piattaforme/sanita-digitale

17 https://www.fascicolosanitario.gov.it/

18 Decree of the President of the Council of Ministers of 29th September 2015, n. 178, Regulation on electronic health records. 54 interoperability conditions, the management of, and access to laboratory reports, and management and update of the Patient Summary. The most recent data from the AGID shows the overall scenario for each set of indicators in the Italian regions.

Fig. 6: FSE Implementation Indicator in all Italian Regions As reported in the AGID monitoring dashboard, except from Calabria, the FSE is technically implemented from a minimum of 14% in Sardegna to a maximum of 100% in Lombardia, Puglia, Sicilia, Toscana and Valle d’Aosta. FSE implementation in the 12 regions in our report reaches the following levels: Basilicata (92%), Calabria (0%), Campania (98%), Liguria (86%), Lombardia (100%), Piemonte (87%), Puglia (100%), Sardegna (14%), Sicilia (100%), Toscana (100%), Umbria (85%), Veneto (95%). The second group of indicators b) takes into account the real level of the usage and dissemination of the FSE, considering different “user” categories: Patient (Cittadini), GP/Paediatrician (Medici), and Healthcare operators in the healthcare authorities and hospitals (Aziende sanitarie). FSE Usage Level by “Cittadini” Taking into account the level of usage by “Cittadini” (patients) the indicator shows the level of FSE activation (at minimum one access) in the 12 regions, see Figure 7 below.

Fig. 7: Level of FSE activation (at minimum one access) by citizens in the 12 regions The FSE usage indicator shows the level of usage by citizens in the last 90 days.

Fig. 8: Level of FSE usage in the last 90 days by citizens in the 12 regions

FSE Usage Level by “Medici” GPs/Paediatricians) Taking into account the level of usage by “GPs/Paediatricians” (Medici), the indicator shows the level of FSE activation (at minimum one access) in the 12 regions, see Figure 8 below.

Fig. 9: Level of FSE activation (at minimum one access) by “Medici” in the 12 regions The indicator below shows the level of usage by “Medici” feeding with data the FSE:

Fig. 10: Level of usage by “Medici” feeding with data the FSE in the 12 regions FSE Usage Level by Health Operators at “Aziende sanitarie” Taking into account the level of the usage by authorised health operators at “Aziende sanitarie” the indicator shows the level of FSE activation (at minimum one access), in the 12 regions see Figure 9 below.

Fig. 11: FSE usage level by authorised health operators at “Aziende sanitarie” The indicator below shows the level of usage by health operators at “Aziende sanitarie” feeding with data the FSE:

Fig. 12: Usage level by “Aziende sanitarie” feeding with data the FSE

Figure 13 shows an overview of the all indicators in the 12 regions. We observe a high implementation level for the FSE from a technical point of view in all regions except Calabria. The usage levels, however, also show discrepancies among the regions with relatively high levels in each indicator. The regions with the highest levels, Lombardia, Toscana, Veneto, Puglia and Piemonte, show relatively high levels in the Citizen and Aziende Sanitarie usage indicators regarding activation (at least one access), but the indicators for the frequency of data usage in terms of “feeding” by health operators is already low in most of the regions. This means from the point of view of “routine care use” that the habit of consulting and managing the FSE is not yet rooted in people. We observe relative higher percentages for the “use and feeding of data” within “Aziende sanitarie”, but the levels are rather low in territorial services (by GPs/Paediatricians). In the few regions where usage by GPs/PLS is relative higher, the feeding of data remains low, which means that the habit of use in routine care is not yet in place, although they have activated and consulted the FSE at least once.

Fig. 13: Overview of FSE Implementation and usage levels in the 12 Italian regions.

Elaborated by the author from the official data for FSE Indicators of AGID reported in the previous figures.

Source:https://www.fascicolosanitario.gov.it/monitoraggio/

4.1.1 FSE interoperability and new elements for a more widespread diffusion Each region and autonomous province in Italy must establish an electronic health record (FSE) through a technological infrastructure capable of interoperating with the other regional FSE solutions, providing appropriate services that allow a series of interregional processes to be set up. The interoperability of services make it possible to carry out the search, recovery, registration, and cancellation of documents, and transfer of the FSE index as indicated in the national law of 201519. The National Infrastructure for Interoperability (INI) was created in 2017 with the aim of simplifying the interoperability of regional FSE systems20. The INI has the task of ensuring the interoperability of the regional FSE, identifying the assisted person through alignment with the National Registry of Patients (ANA – Anagrafe Italiana Assistiti), the interconnection of the subjects envisaged for the telematic transmission of data, and the management of national and regional codes established and made available by the administrations and health authorities that hold them. So, at the moment all the regions have adopted interoperable FSE can dialogue with each other. The functional model of the regional FSE systems is based on the functional FSE profile obtained from the Italian localization of the HL7/ISO EHR-S FM R2 (Electronic Health Record - System Functional Model Release 2). The functional profile for the regional FSE is illustrated in the white paper “Functional Profile of the Regional Electronic Health Record (FSE)” published by HL7 Italy21. The main objective of the functional model22 concerns the possibility of allowing, through a regional network, the continuous “feeding” of the FSE by different operators in the Regional Health Service (SSR) who take charge of the patients and the consultation of documents of its competence respecting the will of the patient. To allow FSE “feeding”, the regional system must therefore be connected with local systems (health facilities, GPs/PLS, etc.) distributed throughout the regional territory.

19 Law n. 178 – DPCM of 29th September of 2015 20 Legge di Bilancio 2017 21 http://www.hl7italia.it/sites/default/files/Hl7/docs/public/HL7Italia-PF_FSE_Regionale-v01.00-WP.pdf; http://www.hl7italia.it/sites/default/files/Hl7/docs/public/HL7Italia- Estratto_PF_FSE_regionale_Funzioni_di_prima_applicazione-v01.00-WP.pdf 22 https://www.fascicolosanitario.gov.it/1.Modello-funzionale-del-FSE

https://www.fascicolosanitario.gov.it/il-fascicolo

The exchange of patient data among local health systems was a key factor in improving the timeliness of intervention in emergencies or remote care for patients affected by Covid-19 and/or other chronic diseases during the pandemic.

Italian law n.77/2020 and Law n.34/2020 see consolidating the interoperability and privacy requirements for health and social data collection in the FSE as one of the investment priorities in order to strengthen the resilience of the health system during the pandemic and beyond.

The latest investment measures on FSE through the converted in law Decreto Rilancio23 are:

23 Decreto-Legge n. 34/2020 convertito con modificazioni dalla L. 17 luglio 2020, n. 77 54

 extension of the types of health and social-health data that flow into the FSE: this also includes data relating to services provided outside the national health system (NHS), not only those within the NHS;  the activation and feeding of the FSE will become automatic and easier. Citizens/patients will no longer have to request the opening of their FSE and give their consent to access/feeding, but will always be able to decide who can access their health data, through the explicit consent mechanism. Furthermore, the right to know which accesses have been made to one's FSE remains guaranteed;  the "subsidiarity" functions of the National Infrastructure for the Interoperability of Electronic Health Records (INI) are extended to all regions that have not yet activated the FSE or some of its services. Over time, the FSE can be fed through the INI with health data already available on organ donation, vaccinations and visit reservations contained in the Transplant Information System, the regional vaccination registers and in the CUP (Centro Unico Prenotazioni) of each region or autonomous province  the FSE National Portal may publish, with the authorisation of the "Garante della Privacy", the technical specifications of the FSE documents and the pharmaceutical dossier.

4.2 Telemedicine & IT advanced solutions (AI, Big Data etc.) 4.2.1 Telemedicine (TM) TeleMedicine (TM) is an area of eHealth: it concerns the provision, through ICT, of health and care services, regardless of where the people involved are located (health providers and users). Considering particularly the demographic change dynamics strongly marked by ageing as is the case of Italy24, these services can play an important role in responding to the health problems of the elderly population, among whom some pathologies are chronic and widespread. Beyond a greater need for “continuative” assistance, which in some cases requires highly complex care pathways, this population may have increasing difficulty accessing health centres, and their caregivers may also accrue additional social costs for transfer and assistance. The implementation of the TM Italian national guidelines in 201525 opened a new phase for the development of these services in Italy.

24 As regards the incidence of people aged 65 or over on the total population, Italy (22.6%) and Greece (21.8%) recorded the highest percentages related to the EU-28 values. https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Mortality_and_life_expectancy_statistics

25 Intesa tra il Governo, le Regioni e le Province autonome di Trento e Bolzano sul documento recante “ Telemedicina - Linee di indirizzo nazionali. (Repertorio Atti n. 16/CSR del 20/02/2014). http://www.salute.gov.it/imgs/C_17_pagineAree_2515_1_file.pdf 54

The TM guidelines represent a first national reference and the importance of TM services is recognised as facilitating fair access to health care, protecting the right to health, ensuring better quality health care and achieving higher levels of effectiveness, efficiency and appropriate care. The national TM guidelines provide the regions with the general framework for the management of TM services. The implementation and sustainability of TM services in the care practice is entrusted to each region and to its healthcare authorities and hospitals. National guidelines define the following general aspects: - priority areas for the application of telemedicine (identifying three macro areas26); - analysis of models, processes and ways of integrating telemedicine services into clinical practice (with the support of the Tavolo Tecnico of Istituto Superiore della Sanità27) - defining common taxonomies and classifications

Some applications of TM were taken into account in the LEA until 2017, and from 2018 the regions can apply the guidelines in their regional regulations for locally managing the regulatory profiles (e.g. for health operator training) and for the economic sustainability of TM services and performance. In collaboration with the local health authorities, each region may define its own conditions of coverage and provision of the TM service by referring to the national guidelines, by implementing the service in the local health settings independently and based on the availability of its budget and/or with the support of external funding. TM solutions are therefore currently mostly pilot projects or TM systems that are integrated and included in healthcare services at the local level. Last but not least, there has been increased awareness in recent months that the spread of these services can play an important role during the Covid-19 pandemic with the aim of containing gatherings in hospital rooms, reducing transmission risk, reducing the rate of face-to-face routine visits and, through some applications, tracing and monitoring contagion28.

4.2.2 Mapping telemedicine solutions 2019 in the Italian regions: features and trends of the development before the coronavirus outbreak

26 SPECIALIST TELEMEDICINE: (e-consultation/visit); REMOTE HEALTH (primary care); TELEASSISTANCE (taking charge of the elderly or frail person at home) 27 https://www.iss.it/gruppi-di-studio-in-telemedicina 28 https://innovazione.gov.it/telemedicina-e-sistemi-di-monitoraggio-una-call-per-tecnologie-per-il-contrasto-alla- diffusione-del-covid-19/ . With the launch of a fast call on March 2020, the government launched a call to identify telemedicine solutions for Covid-19 tracing and data analysis. The IMMUNI app was selected as a national tracing solution, but use among the population has not reached a sufficient percentage for efficiently mapping and tracing contagion levels. 54

The most recent official mapping of the telemedicine solutions took place in 2019. It involved the Italian regions and healthcare authorities from the Istituto Superiore della Sanità (ISS) in collaboration with the Health Ministry. The questionnaire, divided into 65 questions, was designed with the aim of identifying all the telemedicine experiences in Italy in 2018. It is based on the MAST model (Model for the Assessment of Telemedicine), already used in several European projects29. All the regions and autonomous provinces provided feedback and the mapping revealed 282 telemedicine experiences active in Italy in 2018, distributed as follows:

Fig.14: Distribution of the 282 active telemedicine solutions in 2018 per region

The analysis of the national and regional data provides an evaluation of the telemedicine experiences which also consider future perspectives and new needs emerging from the pandemic. The analysis is made by the author taking into account the data from the Excels Mapping DB made available by the Health Ministry30. Analysis of the survey revealed: - when classifying the projects according to the most commonly used service, Teleconsulto (29.08%), Telerefertazione (23.40%), and Telemonitoraggio (21.63%) comprise 74% of the most requested telemedicine services, with 209 projects.

29 The MAST model identifies seven evaluation domains, each of which is structured according to different questions relating to the particular field of analysis: 1) description of the pathology and features of the application; 2) safety; 3) clinical efficacy; 4) perception of the patient; 5) economic aspects; 6) organisational aspects; 7) Socio-cultural, ethical and legal aspects. 30 http://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=2515&area=eHealth&menu=vuoto

This is the distribution of services at national level:

- The figure below shows the service distribution among the 12 regions. “Teleconsulto” involved the highest number of patients (273,514), followed by “telerefertazione” (214,774) and telemonitoraggio (8,991).

Fig. 15: Distribution of typologies of TM service per region

- Cardiology and Radiology are the areas of clinical care where telemedicine services are most widespread (121 and 54 projects respectively). In particular, remote monitoring is mostly used in the field of cardiology and “telerefertazione” in radiology.

Fig. 16: Distribution among medical specialities

- It has been assessed whether types of activities were provided to patients totally/partly as telemedicine, or whether they were part of experimental pilot projects. 33.3% of the services are provided partially by telemedicine, and 28.4% are provided entirely remotely. 19.5% of services are pilot projects mainly based on research background.

Fig. 17 Modality of TM provision: distribution at national level

Fig. 18 Modality of TM provision: distribution at regional level

- In the following figures we observed the service provision regime at national level: 60.36% (fully charged SSN), the other 40% is mainly covered by ticket (8.36%) and external funding (30.91%). The second figure represents the provision regime distribution among the 12 regions.

Fig. 19 TM service provision regime at national level

Fig. 20 TM service provision regime at regional level

- The method of pricing services also needs to be considered. Only 13% of pricing is related to service refunds according to national rates, and is therefore included in the traditional typology of SSN pricing. The most relevant percentage is related to “Other” or “No pricing”, suggesting that the method of service pricing is extremely heterogeneous, and is not based on a single national regulatory framework with common classifications and requirements. This gap needs to be carefully taken into account for future development and a broader spread of the telemedicine services.

Fig. 21 Method of pricing services – national distribution

Fig. 22 Method of pricing services – regional distribution - From a technical point of view the type of service centre (hosting, security, help desk, maintenance) and supporting TM activity is located within the health structure/hospital in 51.42% of the cases. The other service centres are distributed among external providers and other technical solutions.

Fig. 23 Types of service centre supporting TM activity – national distribution

Fig.24 Types of service centre supporting TM activity – regional distribution - It is also valuable to take into account, from a technical point of view, the level of interoperability between the TM solutions and other digital tools such as FSE, GP electronic health records (EHRs), hospital EHRs, and national EHRs. TM services are only integrated with all digital tools of the analysis in Lombardia, and Piemonte nearly so (except for GP electronic records). In all the other cases, the regions have integrated a maximum of one or two EHRs. Integration with hospital EHRs is most common in 8 out of 12 regions.

Fig. 25 Level of integration with FSE and EHRs - Only 31 (11%) of the 282 projects have considered all the qualitative indicators of the MAST model. The “economic sustainability of the solution in the future” dimension is the “least used” dimension in all regions. This is probably related to difficulties in planning and budgeting the service as a real part of the SSN without yet including the TM service under LEA or similar forms of “official” pricing rates and performances.

Box 1: Application of MAST to telemedicine projects 2018

4.2.3 Features and trends in telemedicine during the coronavirus outbreak In the absence of a specific therapy or a vaccine for Sars-Cov-2 patients, social distancing is one of the main measures used to combat the Covid-19 pandemic, and telemedicine is gaining momentum as the key technology for safe and efficient communication between health operators and patients. Indeed, telemedicine may directly flatten the curve of demand on healthcare systems around the world, slowing transmission and spreading disease incidence over a longer period of time. At the international level, the World Health Organization (WHO) has described telemedicine as an essential service in its policy for "strengthening the response of health systems to Covid-19”31. According to this policy, telemedicine should be an alternative model for clinical services and clinical decision support as part of the action to optimise service delivery. It should be noted, however, that telemedicine does not replace traditional medicine, but supports and integrates it with new communication channels and innovative technologies, with the aim of improving health services and helping citizens to access and obtain the best possible care. In the Italian context, the reduction in human exposure between healthcare operators and patients is even more important in light of the fact that healthcare operators are increasingly of higher average age32 and that they are at the forefront of the management of the Covid-19 epidemic, with the highest

31 World Health Organization, Regional Office for Europe. Strengthening the Health Systems Response to COVID-19. Technical guidance #1 “Maintaining continuity of essential health care services while mobilizing the health workforce for COVID-19 response” (1 April 2020). 32 As indicated in the following report: Università Cattolica del Sacro Cuore, Osservatorio Nazionale sulla salute nelle regioni italiane. Rapporto Osservasalute 2018 “Stato di salute e qualità dell’assistenza nelle regioni italiane” (2019). 54 risk of infection. Telemedicine can help mitigate this risk by minimising the number of face-to-face interactions between healthcare professionals and patients. In Italy, telemedicine is still in an early phase of development and accelerated action was necessary in the first months of the health emergency, to define the areas of application and the characteristics of the most suitable solutions for the NHS in the management of such widespread and serious public emergency. The Istituto Superiore di Sanità (ISS) has issued “interim guidelines” to define the general conditions and characteristics of the remote assistance services to be implemented in the emergency health situation. A fast call for contributions33 was therefore launched through the "Innova per l’Italia"34 initiative to identify existing technological solutions and/or those easily convertible for use and dissemination in the various regional territories. The evaluation criteria selected apps and technological solutions capable of providing support to territorial medicine through active surveillance activities for patients at home, both for diseases related to Covid-19, and also for diseases of a chronic nature (i.e. towards those subjects exposed to a greater risk of complications once the virus is contracted). 504 proposals were received and five target solutions35 were identified for emergency management support by the inter-ministerial "data- driven working group for the Covid-19 emergency". A scheme containing the most useful indications was provided to the regions for the implementation of telemedicine solutions, also called “soluzioni tecnologiche di teleassistenza”. This is a brief summary of its strengths and weaknesses36.

33 https://innovaperlitalia.agid.gov.it/#come-funziona

34 Ministero della Salute, Direzione Generale della Prevenzione Sanitaria – Ufficio V Prevenzione delle malattie trasmissibili e profilassi internazionale. Nota circolare n. 5443 del 22 febbraio 2020 avente ad oggetto “COVID 2019. Nuove indicazioni e chiarimenti” (Prot. 0005443 – 22/02/2020 – DGPRE – DGPRE – P). Gruppo di Lavoro data-driven per l’emergenza COVID-19 nell’ambito dell’iniziativa interministeriale ‘Innova per l’Italia’. 35 5 selected solutions presented by private providers or “in-house” society: CO4Covid -19; Smart Assistance Covid-19 Control eLifeCare Covid-19 LazioDoctor Ticuro Reply 36 Report sottogruppo di lavoro 5 – MID – Gruppo di lavoro data-driven per l’emergenza COVID-19 nell’ambito dell’iniziativa interministeriale “Innova per l’Italia” 54

Implementation indications for regions from MID 1) acquire a single centralised technological infrastructure at the disposal of all healthcare authorities at the regional level through an organisational procedure that clearly identifies roles and responsibilities in the care process 2) guarantee the integration and interoperability of the solution with the existing infrastructure and standards relating to the registry of patients (ANA) and with the system of "tessera sanitaria" (health card)37 3) manage credentials and access control for both citizens and health operators through the integration of the various existing "Identity and Access Management" services with national infrastructure (SPID, TS-CNS, CIE) implemented at the regional level 4) prefer cloud computing infrastructure and services (AgID qualified) in compliance with the recommendations in the 2019-2021 three-year plan for information technology in the public administration and in the strategic policy document "MID 2025 Strategy for technological innovation and digitisation of the country".

Key strengths and weaknesses of the telemedicine solutions Strengths Weaknesses Supporting integration with FSE and other Does not support integration with SPID- existing regional information systems, through CNS/CIE for user authentication the HL7, FHIR standards Source code of public property, available for Limited resources for supporting the solution's reuse in other health settings or at central level reuse in other regions or at central level Existing integration with FSE or key-parts of it Remote monitoring kit only available with self- configured tablet/smartphone Solutions already implemented in regional Solutions not yet implemented in regional settings38 Italian settings

We reported below information about regional telemedicine solutions introduced in recent months during the pandemic for tracing and/or monitoring patients with Covid-19. It includes and reflects the main features and also key points provided by MID, as mentioned above. We tried to combine them

37 ex art. 50 DL 269/2003 Anagrafe nazionale degli assistiti (ANA) art. 62-ter del Codice dell’amministrazione digitale (CAD).

38 As in the case of: Co4Covid-19, LazioDoctor, Ticuro Reply (three of the five telemedicine solutions selected by the inter-ministerial initiative “Innova per l’Italia”. 54 with currently available information, taking into account the main technical and functional parameters in some regions. As each telemedicine solution was only introduced a few months ago in regional settings, it is too early to provide an assessment of results or benchmarking, and they represent examples and in some cases “good practices” for the management of the emergency situation during the pandemic.

Piemonte Name of Solution Link GesCovid19 https://developers.italia.it/it/software/r_piemon-regione-piemonte- (Piattaforma Gestione gescovid19 Covid-19) http://www.sistemapiemonte.it/cms/privati/in-evidenza/363-attiva-la- piattaforma-covid-19-realizzata-da-csi-piemonte

The GesCovid19 platform is completely open source and is based on a cloud infrastructure. Its main functions are: request and results of swabs, registration of serological tests on school staff, treatment of people under observation (discharge, transfers, management of quarantines and fiduciary isolations), updates to the clinical diary of patients, tracking the chain of contacts at risk. In Piedmont, the platform is currently used by 18 ASLs (Local Health Authorities - LHAs) and 28 public and private analysis laboratories accredited to the NHS. Access credentials have been issued to more than 12,000 users so far, including health workers, mayors, representatives of the police, and members of the regional crisis unit. Information and data are easily accessible by mobile devices in order to facilitate monitoring activities. It is valuable that the platform is available on “Developers Italia” which is the national portal of AGID and the Digital Transformation Department of MID. Developers Italia hosts the main Italian technological projects and it is the reference point for public administration software following the “reuse” and “open source” principles.

Veneto Name of Solution Link Eng-DE4Bios https://www.eng.it/case-studies/digital-enabler-veneto-covid-19 https://www.azero.veneto.it/-/emergenza-coronavirus

Eng-DE4bios is an advanced ecosystem platform based on open source components of Fiware. The platform offers a unique overview for regional governance with different access levels according to competencies and roles (task force members, health authorities, health operators, GPs etc.). The aim is to identify citizens who need early swabs control in real-time, starting from the positive cases, mapped at each local laboratory. This is possible by crossing the health and demographic data contained in different territorial databases. It is fully integrated with the health information system of Regione Veneto and Azienda Zero through the technical support of a private provider39. The ability to immediately view positive cases and their relationships has proved to be valuable in containing the contagion, and is unique among regional control systems. The possibility of acting on integrated data has also allowed Veneto to implement various epidemiological models, and thus to better manage the crisis thanks to the ability to make very reliable forecasts, about both trends in the hypothesised curve - and therefore the peak - and the management of intensive care in each hospital. The bio-surveillance system also seems to be valuable for the current Phase 2 of the pandemic because it allows capillary control of the territory by monitoring the emergence of new clusters among both families and in the workplace, allowing the application of the protocols provided by the region and the national government for the safe resumption of production and social activities.

Puglia Name of Solution Link #Accasa https://www.sanita.puglia.it/web/aress/news-in-primo-piano_det/- /journal_content/56/45631926/-accasa-la-telemedicina-pugliese-ai- tempi-del-covid

https://press.regione.puglia.it/-/-accasa-il-monitoraggio-del-virus-a- domicilio-diventa-digitale-la-regione-puglia-vara-la-piattaforma-di- teleassistenza-clinica

https://www.dedalus.eu/ripartire-e-possibile-accasa-regione-puglia/

39 Engineering S.p.A. https://www.eng.it/en/case-studies/digital-enabler-veneto-covid-19

#Accasa is an advanced telemonitoring solution for patients "at home” in quarantine for Covid-19, thanks to a remote assistance platform. The solution is based on a double level of assistance, which intervenes with different targets: - a web app for use by citizens, to carry out a first informative self-diagnosis through a questionnaire, establishing contact with a GP who, if appropriate, will contact them again to perform a telephone pre-triage; - a web portal for healthcare professionals that allows them to analyse and categorise the information provided by citizens during pre-triage to monitor symptoms, plan any specialised supportive home interventions (e.g. swabs, drugs and tools) and, consequently, to activate teleconsultation (audio and/or video) and telemonitoring; - diagnostic-instrumental devices for the transmission of clinical data from the patient's home to the platform (Bluetooth pulse oximeters were provided on a large scale to patients for parameter self- detection from the beginning of the outbreak). The early implementation of #Accasa on a regional level from the beginning of the pandemic was possible thanks to prompt collaboration between public-private organisations (Regione Puglia40, AReSS41, local health authorities and a private technological provider42).

Finally, a recent analysis of the ALTEMS43 research team of the Università Cattolica del Sacro Cuore in Rome shows the latest telemedicine initiatives put in place by the local health authorities throughout the entire Italian territory after the 1st of March 2020. The main features and orientations in the organisation of services and user preferences can be identified, starting from the first months of the Covid outbreak (see the figures below).

40 DGR n.1088 16th of July 2020 – “Indirizzi operativi per la promozione e la diffusione della telemedicina nel servizio sanitario. Istituzione della Centrale Operativa Regionale per la Telemedicina delle cronicità e delle reti cliniche” (DGR n.1231/2016). 41 Deliberazioni n. 75/2020 and 84/2020 AReSS Puglia (Agenzia Regionale Strategica per la Salute ed il Sociale). https://www.sanita.puglia.it/web/aress/news-in-primo-piano_det/-/journal_content/56/45631926/-accasa-la- telemedicina-pugliese-ai-tempi-del-covid

42 https://www.dedalus.eu/en/restarting-is-possible-accasa-apulia-region/

43 ALTEMS “Alta Scuola di Economia e Management dei Sistemi Sanitari” 54

Fig. 26 “Analisi dei modelli organizzativi di risposta al Covid-19” – Source: Altems May 2020

Fig. 27 Typologies of tools used Fig. 28 Typologies of tele-services provided Source: Altems May 2020

Figure 27 shows the various tools used in telemedicine solutions in this time frame, and a preference for tools such as the internet and phones (61%). The distribution among the typologies of the teleservices provided (Figure 28) shows 77% of teleservices provided televisits and monitoring controls. Combining the two figures demonstrates that the preferences are focused on visits and monitoring activities at a distance by phone and the internet, favouring fast and poorly structured forms of telemonitoring and care.

4.2.4 Lessons learned and possible perspectives on investment for emerging needs , Telemedicine has proved to be a scalable solution during Covid-19 pandemic and alleviate the workload for first-line clinicians. Many countries in the world adopted, or expanded, their 54 telemedicine services in hospitals to increase high-quality care services. The main reasons to adopt such technology are to avoid gatherings in hospital rooms, reduce transmission risk, reduce the rate of face-by-face routine visits, decrease the amount of physical PPE used and maximise the availability of clinical resources44. Three city hospitals in Seattle (USA), installed tele-ICU carts in their facilities, equipped with IoT technologies for monitoring purposes and cameras to allow remote bed visits45. From a broader perspective, telemedicine opens a wide range of possibilities, including long-distance care, remote diagnosis services, low cost clinical education and support to mitigate the negative psychological effects of social isolation through teleconsultations46. Telemedicine provides, de facto, new opportunities and a broad range of applications to face the increasing healthcare needs of patients, GPs and hospitals, especially in the primary care and territorial services (see the thematic report on public health, primary care and healthcare pathways for more detail). The global response to the use of telemedicine varies. Countries such as France, China, the UK, Germany and Australia, and many USA states heavily invested in these technological solutions almost immediately after the breakout and institutionally supported their utilisation and diffusion with legislative measures47, but other countries, such as Brazil, Italy and Spain faced, implementation barriers in the first phases of the epidemic, related to the lack of coordination within their healthcare systems, and legislative issues. Italy and Spain acted to support the implementation of telemedicine across the country using ad-hoc measures, but telemedicine is still illegal in Brazil. If we focus on Italy, starting from the data reported in the previous paragraph, it is possible to a relatively high number of telemedicine solutions (284 in 2018) can be highlighted throughout the entire country, with a balanced distribution among the regions. 138 new telemedicine initiatives were registered from the start of the Covid-19 outbreak. The pandemic has been a decisive factor in accelerating implementation of telemedicine solutions not only on a local scale but regionally, however, some issues and new needs have emerged. We believe

44 Ohannessian R., Duong T.A., Odone A., (2020). Global Telemedicine Implementation and Integration Within Health Systems to Fight the COVID-19 Pandemic: A Call to Action. JMIR https://doi.org/10.2196/18810 Vaishya, Raju & Javaid, Mohd & Khan, Ibrahim & Haleem, Abid. (2020). Artificial Intelligence (AI) applications for COVID-19 pandemic. Diabetes & Metabolic Syndrome: Clinical Research & Reviews. 14. 10.1016/j.dsx.2020.04.012. WHO, (2010), Telemedicine: opportunities and 45 Leite, Higor & Hodgkinson, Ian & Gruber, Thorsten. (2020). New development: 'Healing at a distance'-telemedicine and COVID-19. Public Money & Management. 10.1080/09540962.2020.1748855. 46 Leite, Higor & Hodgkinson, Ian & Gruber, Thorsten. (2020). New development: 'Healing at a distance'-telemedicine and COVID-19. Public Money & Management. 10.1080/09540962.2020.1748855. 47Ohannessian R., Duong T.A., Odone A., (2020). Global Telemedicine Implementation and Integration Within Health Systems to Fight the COVID-19 Pandemic: A Call to Action. JMIR https://doi.org/10.2196/18810 Luciani, Lorenzo & Mattevi, Daniele & Cai, Tommaso & Giusti, Guido & Proietti, Silvia & Malossini, Gianni. (2020). Teleurology in the Time of Covid-19 Pandemic: Here to Stay? Urology. 10.1016/j.urology.2020.04.004.

54 that the following are key in promoting an adequate allocation of resources and investments in the near future:

- There are many local experimental solutions but there is no quantum leap towards solutions on a large scale that are fully integrated with the SSN; - The national legislation identifies guidelines and the general technical characteristics, but there are still no specific regulatory references to the regions in terms of: . defining common organisational processes and the roles/responsibilities of operators in telemedicine services (e.g.: targeting pathologies and/or care pathways); . defining an “ad hoc regulation” on procurement/contracts for the supply of telemedicine systems to speed up and standardise the selection and assignment processes; . defining common pricing and remuneration of the service and operators to ensure the sustainability and continuity of the service after the experimental phase, guaranteeing inclusion in both regional and LHA budgets (central identification of which services are included in or omitted from the LEA) . procurement methods through partnerships between public and private (valuable synergies and efficient services were born where the regions clearly defined the partnership process,48) . 5G connectivity (through the coverage of recovery fund) can promote the quality of interconnections between devices, places and people, even at a distance . encouraging the use of "interoperable by design" technological platforms, that are natively conceived as a set of software components and services capable of integrating with the information systems of the local health authorities (LHA) and hospitals. . the interoperability "core" must follow standards such as HL7, FHIR, 2.X and IHE49 according to the national and European guidelines

48 As described previously in the case of the telemonitoring solution #Accasa for Covid-19 patients in Apulia. 49 This is a key point for facilitating a real integration with healthcare infrastructures such as CUP, FSE, INPS, INAIL at both national and regional levels. 54

During the Covid emergency, regions were differently oriented regarding telemedicine solutions in relation to starting conditions and local synergies. Regions with historically more integrated health information systems and larger hospital networks, such as Piedmont, Lombardy and Veneto, generally opted for remote monitoring and management solutions. Regions that instead gained experimental experiences of integrating treatments for chronic diseases converted existing systems for the Covid-19 emergency in order to facilitate remote assistance and limit the crowding of health facilities, for example in Puglia, and Sicily. The table below lists the regional laws issued by different regions (11 regions out of 21 in Italy) in the definition of local conditions for the implementation of telemedicine services according to national guidelines since the outbreak of the pandemic. The overview reveals high heterogeneity in content, timing and local implementation measures.

Fig. 29 Iniziative normative per la formalizzazione delle modalità di erogazione delle prestazioni in telemedicina, ad integrazione di quanto definito nelle «Linee Guida Nazionali» definite dal Ministero nel 2014 e recepite dalla Conferenza Stato-Regioni il 25-02-2014 Source: Altems – October 2020

4.2.5 Trajectories for advanced IT solutions (AI, Big Data, machine learning etc.) applied to the Italian healthcare domain 54

The most recent AGID report on “ICT expenses in public healthcare” is from the end of 201950. It shows the implementation trends of advanced IT solutions such as AI, Big Data, blockchain and so on during 2018 and 2019. The survey collected data from 76% of all local health authorities (LHA) and hospitals in Italy, and covers 86% of beds available in the public health services, so it offers a quantitative measure of the presence of advanced IT solutions in Italian public health settings. No other official and validated reports are currently available for monitoring and evaluating the trend in the diffusion of such as advanced solutions in hospitals and other healthcare settings.

The figure 30 below shows the percentages of the most advanced IT solutions in Italian public healthcare settings: AI solutions were implemented in just 5% of organisations in 2018, 7% in 2019 and a prospective 16% in 2020. The use of Big Data is strongly related to AI and was implemented in 4% of health organisations in 2018, 7% in 2019 with potentially 18% in 2020. Blockchain projects were not implemented at all in 2018; they represented just 2% in 2019, and a prospective 5% in 2020. Potential fields of application for blockchain, in LHA or hospitals include projects related to the traceability of drugs (particularly the personalised and extremely expensive ones), checking therapeutic adherence to the protocols for different pathologies, and secure data checking for treatment outcomes and costs for patients stratification analysis.

The survey data show a non-significant presence of advanced IT solutions such as AI, Big Data and so on in terms of applications in 2018-19. At the end of 2019, when the survey was published (before the coronavirus outbreak), the potential increase in 2020 was appreciable, and it will presumably strongly increase in light of the new monitoring and tracing needs after the Covid-19 emergency.

50 Rapporto AGID sulla Spesa ICT nella Sanità territoriale italiana 2019 54

Fig. 30: IT advanced solutions 2018-2020. Source: NetConsulting cube, 2019

In Italy, although the sector is growing strongly, it is seen as "newborn", or a little more. According to the latest report by the Artificial Intelligence Observatory of the Politecnico di Milano51, the artificial intelligence market in Italy was worth about 200 million euros at the end of 2019 and the healthcare sector is estimated to be approximately 5% (see the figures below). The sector is destined to grow in the coming years, not only as a result of the increasing urgency due to the pandemic, but also thanks to Italian membership52 (as a founding partner) in the Global Partnership on Artificial Intelligence (GPAI) 53 in May 2020. The European Union also focuses on AI as a key sector and intends to adopt a risk-based approach to AI regulation. In particular, it proposes to focus on “high-risk” AI applications in the short term, that is, high-risk sectors such as healthcare.

51 https://www.osservatori.net/it/ricerche/osservatori-attivi/artificial-intelligence

52 https://innovazione.gov.it/news-joint-statement-ita/. Italy is founding country of GPAI from May 2020.

53 The GPAI was recently created with the aim of promoting the use and responsible development of artificial intelligence, in line with the indications in the OECD Recommendations on AI. In particular, the GPAI aims to encourage the development of AI technologies in order to respect human rights, inclusion, diversity, innovation and economic growth. The founding countries, together with Italy, are Australia, Canada, France, Germany, India, Japan, Mexico, New Zealand, Republic of Korea, Singapore, Slovenia, the United Kingdom, and the United States of America. 54

Fig. 31: The Italian market for AI in 2019

Fig.32: Market distribution for typologies of solutions

Fig.33: Market distribution for sectors

Italy's accession to the GPAI is considered essential for giving further impetus to the development of AI technology in our country. As stated in the paper "Proposals for an Italian

strategy for artificial intelligence" from the Ministry for Economic Development (MISE)54, the diffusion of services related to AI is still slow and the value of the domestic market, although rapidly growing, is not comparable with that of the United States or China. However, Italy has a strong specialisation in what is defined as “embedded AI”, the sector of artificial intelligence combined with advanced tools such as sensors, intelligent devices, robotics, automation and so on. The working group of the AI paper commissioned by the MISE has also identified six sectors on which Italy should focus its investments and the future efforts. Specifically, the development of artificial intelligence should include:

- IoT (Internet of Things), manufacturing and robotics; - Services (healthcare, finance etc.); - Transport, agrifood and energy; - Aerospace and defence; - Public administration; - Culture, creativity and digital humanities.

The second point of the list includes the healthcare domain as the first one among "services".

4.2.6 Current examples of advanced technologies/systems applied to the healthcare domain in Italy and abroad

AI can be used to support other technologies, plays a relevant role and is identified as a decisive technology with which to analyse and provide decision making support, mimicking human intelligence. The combination of AI with medical imaging technologies, such as the scan of human bodies with computer tomography (CT) or magnetic resonance imaging (MRI), helps to provide faster decision making, diagnosis and treatments. AI can be a reliable source of projection analysis used in the prevention and management of disease. Technologies in the healthcare sector have been consistently upgraded to meet clinical requirements, and new applications have been extensively explored to support society in a pandemic situation.

54 https://www.mise.gov.it/images/stories/documenti/Proposte_per_una_Strategia_italiana_AI.pdf

In this section, we try to understand the contribution made by advanced technologies during the breakout. Of course, no report can include every kind of technology in existence, several innovative applications of technologies are already implemented, and many others will take be used in the future, exploiting their untapped potential, but we describe some technologies involved in this process with examples from all over the world, including Italy. This can help to identify future trajectories of EU investments for improving the regional health systems of Italy in terms of development and resilience.

The communication and reliability of information through access to Big Data were great challenges since the first discovery of Covid-19. Public awareness of the disease and the consequent need to integrate all information available on the virus across the globe led to many solutions that helped healthcare systems, knowledge workers and entire populations to access nearly real time data and raise awareness. Taskforces of experts created in every country affected by the virus played an important role in public communication systems, and in particular they interpreted data from ICT technologies through internal communication systems and explained the results to the public to promote the clarity and reliability of information. Surveillance systems were adopted worldwide, relying on ICT solutions and Big Data analytics. In Italy one of the first biosurveillance platform was introduced in the Veneto Region (as mentioned previously) to support both the healthcare system as well as governmental bodies. Eng-DE4Bios is based on existing technology and was specifically designed to organise, coordinate and integrate Big Data to support decision makers, healthcare governance and regional crisis units that also use predictive analysis. As shown in figure 34 below, the solution developed many areas for the specific surveillance purpose, proposing a solution for the control of epidemics from both a clinical and a social point of view. Multiple stakeholders are also involved for this purpose through the integrated regional information system databases: from GPs to occupational doctors, from healthcare operators to governmental taskforces.

Fig. 34: Eng-De4Bios Bio Surveillance Platform (Engineering the new normal, 2020)

In Italy the platform Talisman is an example of a successful IoT based solution implemented in the Apulia Region through a public-private project consortium of 16 partners using access to the ESF-ERDF Operational programme 2014-2020 (PON of MIUR – Ministero dell’Istruzione, dell’Università e della Ricerca). The solution relies on a combination of technologies, enabled by the internet and dependent on ICT. It is an advanced multipathology platform integrated in the regional “Care Puglia” chronic care model 55 for supporting the treatment and monitoring of patients affected by several chronic diseases (rare, oncological and haematological diseases involving their own regional networks of specialists). Talisman utilises multiple technologies, such as IoT and medical equipment combined. It is based on a powerful multi-purpose application able to provide data and coordinate the division of labour in treatment and monitoring (even at distance) among different healthcare professionals involved at the primary care level (GPs, care managers) and territorial services (Distretto socio-sanitario): see Figures 35 and 36 below.

Fig. 35: Care Puglia: il sistema clinico-operativo per la cronicità

55 “Care Puglia 3.0” is the Chronic Care Model of Apulia Regione DGR n. 1935 of 2018 54

Fig. 36: Devices for patient telemonitoring through Talisman

Another application of a combination of existing technological solutions with Big Data analytics is the platform developed by the Johns Hopkins University (JHU) Centre for Systems Science and Engineering (CSSE). In this case the project started as a web-based dashboard to track Covid-19 in real time cases from the “Worldometer.info” site, then was implemented by CSSE, also integrating data collected from the Chinese National Health Commission (NHC), WHO, the European Centre for Disease Prevention and Control (ECDC), US Centres for Disease Control and Prevention (CDC) and other state and national government health departments, as well as sites such as: the Chinese dxy.cn, 1point3acres.com, worldometers.info, bnonews.com, the COVID Tracking Project and other local media reports. This integration allowed a techno-driven open service to be built (see Figure 37 below), providing not only data insights, but also modelling studies for “nowcasting” and “forecasting” and interactive charts, giving a powerful tool to health authorities for health planning and control policies adoption56.

Fig. 37: Covid-19 Dashboard, CSSE at John Hopkins University, 2020

56 Ting, D.S.W., Carin, L., Dzau, V. et al. (2020). Digital technology and COVID-19. Nature Medicine 26, 459–461. https://doi.org/10.1038/s41591-020-0824-5 54

ICT is considered a pillar of the technological strategy adopted during the pandemic. Big Data is “highly useful for analysing and forecasting the reach and impact of the coronavirus on people”57. AI, combined with the multiple applications of Big Data for medical purposes, is reported in the following examples that show how AI solutions have been adopted not only for diagnostic assistance, but also to predict Covid-19 cases or to provide treatment suggestions. The “DarkCovidNet” model, for example, is designed for the automatic detection of COVID-19 using X-ray images, without requiring any individually designed feature extraction techniques58. The system was trained to classify, with an accuracy of 98%, X-ray images from databases in COVID-19 cases, normal cases (no findings) and pneumonia cases. It also provides heatmaps to emphasise focal areas to be further analysed by radiologists. This technology is a support that delivers advantages to both patients and clinicians. DarkCovidNet can be used by practitioners for a fast AI-assisted diagnosis, and exposes patients to less radiation than CT due to the utilisation of X-ray.

Fig.38: DarkCovidNet Diagnosis Process assisted by AI application

The Defence Advanced Research Projects Agency (DARPA) Pandemic Prevention Platform Program, has developed an AI based system through a Canadian biotechnology company to scan immune cells and discover antibodies that are potentially suitable for future Covid-19 therapies59. AI and its combined applications can be used in many ways as the examples mentioned so far show, from triage to radiological diagnostics, from robots to applications, as a second opinion

57 Javaid, Mohd & Haleem, Abid & Vaishya, Raju & Bahl, Shashi & Suman, Rajiv & Vaish, Abhishek. (2020). Industry 4.0 technologies and their applications in fighting COVID-19 pandemic. Diabetes and Metabolic Syndrome Clinical Research and Reviews. 14. 10.1016/j.dsx.2020.04.032. 58 Ozturk, T., Talo, M., Yildirim, E. A., Baloglu, U. B., Yildirim, O., & Rajendra Acharya, U. (2020). Automated detection of COVID-19 cases using deep neural networks with X-ray images. Computers in Biology and Medicine. https://doi.org/10.1016/j.compbiomed.2020.103792 59 https://www.darpa.mil/program/pandemic-prevention-platform

provider. The adoption of AI in the healthcare sector also fosters a particular concern: the ethical usage of this advanced technology. This is an open point in both the Italian and European AI strategy, which must be taken into account carefully for the assignment of the future investments at all levels. A potential solution relies on an open innovation approach that can be applied to both fight the virus and to address the ethical usage with collaborative attitudes. The massive technological deployment during this pandemic crisis may have substantial consequences in the way people relate and interact each other. Covid-19 epidemics have opened many ways to release the vast potentialities of technological applications. Public and private collaborative mindsets may be considered a good pathway to innovation and for the deployment of common solutions according to the upcoming institutional guidelines about AI and IT advanced solutions in healthcare settings at national and European levels.

4.3 Digital health services

The implementation of digital tools or platforms to improve the relationship between citizens/patients and the provision of services is important for healthcare companies and hospitals operating in the regional healthcare systems. This issue becomes increasingly important in a rapidly evolving healthcare system in relation to the care of patients, and sectors such as valuable healthcare, or a system that generates measurable benefits for its citizens/patients as in the cases of primary care and healthcare pathways (see the thematic report on public health, primary care and healthcare pathways for more detail). It also becomes relevant for "patient empowerment" which implies that a citizen is called upon to take all possible actions to stay or return to health, even in emergency situations such as the recent ones. Data available to analyse current digital solutions is scarce and not provided in an aggregated manner by regional and ministerial sources, so this chapter contains an analysis based on information available and referable from two main sources: the most recent AGID Report60 and the data from the Ministry of Health on ePrescriptions diffusion 61. According to the AGID Report “sulla Spesa ICT nella Sanità territoriale italiana” 2019, 60% of health organisations report allowing their patients to consult their dossiers and reports online, 12% have introduced it in experimental mode and 10% expect implementation by 2020

60 Rapporto AGID sulla Spesa ICT nella Sanità territoriale italiana 2019 61 http://www.salute.gov.it/portale/temi/p2_6.jsp?id=2514&area=eHealth&menu=vuoto

having already allocated the related budget (see Figure 39 below). This means that on the whole the consultation of dossiers and reports online is a widespread service and is in the process of being completed for more than 80% of public health facilities throughout the country.

Fig.39: Utilizzo di piattaforme digitali 2019

Even the possibility of online payment for services is relatively widespread, although with margins for further coverage: 53% of health companies offer this ability to their citizens, 14% have introduced the functionality in an experimental phase and 12% foresee its introduction by 2020, having already made a budget allocation. The situation relating to other digital systems for improving the relationship and providing services does not improve in these cases:

- the use of smart totems for fast-tracking patients at reception, integrated with online booking, acceptance and payment systems is now made available by 16% of health companies and in an experimental mode by a further 11%. However, with regard to the reception and management of patients, only 17% of respondent organisations expect introduction by 2020, and 16% have not yet allocated a budget in this regard but plan to introduce it in the medium term. Forty per cent of health companies do not foresee its introduction, or have no plans for it. - The situation can also greatly improve, as reported in detail in the previous chapter, for telemedicine platforms, both in the logic of taking charge of the patient (typically chronic) and the provision of remote monitoring as a part of the services provided for care and case

management, both in the case of teleconsultation or visits. In the first case, only 10% of companies have introduced services, while 19% adopt telemonitoring in an experimental model, which hardly manages to reach a wide scale of diffusion. In the second case, however, the adoption of solutions for teleconsultation or visits involved only 6% of the health companies interviewed, 17% are adopting it on an experimental basis and 10% expect to introduce it by 2020. A large proportion of the health companies have no official plans to introduce telemedicine as part of the budgeting: 53%. The survey data, however, was related to 2019, and therefore before the pandemic crisis and the new, emerging health needs related to this.

4.3.1 ePrescriptions The electronic prescription, introduced by the Inter-ministerial Decree of 2 November 2011, is now a widely used tool for citizens to access pharmaceutical and outpatient services of the Italian NHS. ePrescription has made it possible to ensure the circularity of pharmaceutical prescriptions under the conventional regime throughout Italy: a citizen can go to a pharmacy in another region and be entitled to the supply of drugs. ePrescriptions have reached a very high level of diffusion in the pharmaceutical sector. The latest data available through the "Tessera sanitaria" system, for 2018, shows that there is a very high level of ePrescriptions coverage compared to all pharmaceutical prescriptions, at around 85-90%62. The Covid-19 emergency then gave further input to the dematerialisation of medical prescriptions. The ability to send e-prescriptions by email or by SMS to patient smartphones was introduced, with the aim of ensuring the availability of drugs to the most fragile people and, in general, to reduce the presence of medical outpatients. The new rules of March and April 202063 introduced digital reminders to support ePrescriptions instead of paper reminders. Finally, the “nota of 14th May 2020” also included narcotic and psychotropic drugs in ePrescriptions, including those intended for pain therapy64 (see thematic report on acute, emergency and long-term care for more detail).

62 As reported in the NSIS http://www.nsis.salute.gov.it/portale/temi/p2_6.jsp?id=2514&area=eHealth&menu=vuotoRapporto%20DESI%20- %20Indicatore%205%20Servizi%20pubblici%20digitali%20pag.%2013-14

63 Decreto interministeriale del 25 marzo 2020; Ordinanza del capo della protezione civile del 19 marzo 2020 64 http://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=4744

The Table below presents a summary of all steps for facilitating a broader spread use of the ePrescriptions introduced during the pandemic:

Law reference Measure Ordinanza del capo della Introduction of the digital reminder to support ePrescriptions protezione civile (19th instead of paper reminders in order to reduce the number of March 2020) patients accessing to medical facilities of the NHS Decreto interministeriale Extended the eprescription for drugs with the AIFA th (25 March 2020) therapeutic plan, to medicines distributed on behalf of the NHS, and extended the alternative digital tools to the paper reminder beyond the emergency phase

Nota (6th May 2020) Introduction of the eprescriptions by doctors of the Sanitary Assistance Service for Navigators (SASN)

5. Trends in investment in health technologies before and during the coronavirus outbreak The analysis of data about investments in the short and medium terms is important, because they highlight what has been already decided before the period of emergency (2018-2020), and the trends in future investment at a national level as measures to strengthen the regional health systems. Considering the information published in the “Rapporto 2020 sul coordinamento della finanza pubblica” – Corte dei Conti65 about infrastructural needs and investments in health technologies, Italy has needs involving the renewal and enhancement of health technologies of about €1.5 billion in relation to 1,799 machines (2018-2020). Some 1,401 machines need to be replaced at a cost of over €1.1 billion and 398 new technologies to be acquired for the upgrade of the health technologies for an expense of €404.3 million. The survey carried out in the regions about their needs for the 2018-2020 three-year period concerned the number of systems to be acquired as both new acquisitions (to enhance the offer) and as replacements for obsolescence, for which the relative resources are not financially available (see the box below with the needs distribution per region).

65https://www.corteconti.it/Home/Organizzazione/UfficiCentraliRegionali/UffSezRiuniteSedeControllo/RappCoord/Ra ppCoord2020

Under Covid-19

Due to the pandemic emergency, the national guide lines “Piano nazionale di ripresa e resilienza - PNNR66” (sent from the Government to the Chambers on 15 September 2020) introduced key chapters for investment in health needs (considering the future Recovery Funds allocation). They suggest “Missione 6 Salute” investments on digitalisation of health services for citizen, FSE implementation and diffusion, telemedicine solutions, digital tools for supporting chronic diseases management as priority. The priority “Missione 1 Digitalizzazione, innovazione e competitività del sistema produttivo” introduces the “digitalisation” asset in terms of connectivity (coverage of fibre and 5G), the availability of data centres and the cloud for the interconnection of services, and digital identity (SPID, Tessera sanitaria). The PNNR guidelines do not report the amount of investment allocation per priority and subchapters, but the Recovery Funds should be about €208.6 billion in total, of which some €2 billion are for digitalisation (1.4 for the health system and 0.6 for social and health interventions in the country).

66 http://www.politicheeuropee.gov.it/media/5378/linee-guida-pnrr-2020.pdf

6. Concluding remarks The Covid-19 emergency and the consequent limited response time caused considerable pressure in favour of the adoption of new technological applications, accelerating, de facto, the process of technological transformation taking place in the Italian healthcare sector. In this report we have tried to identify key enabling factors to facilitate the implementation of technical solutions during the pandemic in Italy and some actions put in place by the regional health systems in order to respond to the new and emerging needs. The underlying idea is that technologies, if properly managed, can help the health system in all its dimensions, national, regional and local, to face the radical changes that have occurred due to the Covid-19 outbreak. The investment lines of the Recovery Plan in Italy and of the strategic Digitalisation Plan of the Innovation Ministry will sustain as first priority digital infrastructure: 5G, fibre for connectivity and the FSE-INI, digital identity (SPID, Tessera sanitaria) for improving the capacity of access to healthcare services, and data exchange. Stimuli for the adoption of new technologies in the healthcare sector, were provided by the many COVID-19 related needs, including the need to support hospital management systems due to increased demand for hospital services, time constraints, the need to mitigate the spread of the virus, the need for remote care, a strong collaborative network among primary and acute care, the demand for digital literacy and many other direct and indirect factors that foster technological efforts as supportive measures for society (for example, social distancing measures required an alternative communication system). The main lines of complementary investments that we consider appropriate for Italian healthcare systems, considering the emerging regional needs, and taking into account all the information and data provided in this report, can be summarised as follows: - Support for the diffusion of digital tools by promoting integrated solutions with both local databases (regional and of each health authority) and with the national infrastructure available (e.g. FSE-INI; PagoPA etc.).

o As far as the FSE is concerned, for example, it has been highly implemented from a technical point of view nation-wide but the usage level is low among all user types, particularly citizens and GPs in most of the regions. The new access rules concerning an easier consent management by patients and health professionals can be enabling factors to be strengthened. - Aiming for and strengthening the diffusion of telemedicine solutions. Supporting the reusability of telemedicine solutions developed during the pandemic through integration

with regional systems for further use and deployment especially in the management of chronic diseases. Supporting the definition of common technical parameters through national regulation. It is necessary to define pricing and procurement systems in order to guarantee service planning as an integral part of the SSN and therefore its sustainability over time (overcoming the experimental/pilot phase conditions of the most telemedicine solutions implemented at the local level so far) - Support widespread AI applications in the healthcare domain. It is crucial to strike a balance between making these new advanced technologies for diagnostics, predictive models etc. widely available, especially in low-resource contexts, while continuing to monitor and evaluate their accuracy, robustness and validity in real-world settings - Overcoming or at least mitigating the digital divide (which is high in Italian society as indicated in the DESI report). Disparities among people in terms of e-inclusion may be a potential threat to the diffusion and use of digital solutions. The adoption of digital care in a sensitive environment such as healthcare may imply discrepancies between the group of individuals who have access to technologies and know how to use them and those who do not have digital literacy or use a particular digital solution for the first time. Integration and training are not only possible solutions but also opportunities to increase the potential reach of technologies and also a matter of social equity. These two solutions, however, are dependent on the personal abilities of individuals and are heavily conditioned by the natural learning curve for mastering digital abilities. It will thus be important to invest in information and training for different target users (citizens, GPs and healthcare operators) with the aim of enhancing digital skills to increase access to digital tools and their diffusion. - Increase workforce capability with IT and digital skills within local health authorities, hospitals and regional offices in order to properly manage eHealth services beyond the Coronavirus outbreak. A service redesign with fully integrated ICT components implies planning a new workflow for care pathways and the provision processes. They need to be managed by multi-professional teams composed of key profiles such as ICT specialists, project managers, data analysts and informatics, who are currently a minor part of the workforce capability, and in some cases not really available within public healthcare organisations and regional governments. - Regional health systems must be strengthened to become capable of providing data at the national level that is useable and available in near real-time for surveillance and emergency response, across national and regional borders. Health data governance frameworks are also needed to safeguard privacy, including having systems for secure data exchange,

automatic data extraction from clinical records, and also secure data access mechanisms for research and innovation purposes. - encouraging the construction of public-private partnerships in the management and implementation of advanced ICT solutions (such as in the case of telemonitoring regional systems during the emergency) following the MID performance parameters with the aim of accelerating implementation times and the quality and cost/effectiveness of the chosen technical solution.