En En Amendments 1

European Parliament 2019-2024

Committee on the Environment, Public Health and Food Safety

2019/2804(RSP)

18.11.2019

AMENDMENTS 1 - 130

Draft motion for a resolution (PE641.385v02-00)

Enabling the digital transformation of health and care (2019/2804(RSP))

AM\1192663EN.docx PE643.214v01-00

EN United in diversityEN AM_Com_NonLegRE

PE643.214v01-00 2/59 AM\1192663EN.docx EN Amendment 1 César Luena, Nicolás González Casares

Draft motion for a resolution Citation 1 a (new)

Draft motion for a resolution Amendment

– having regard to the Commission communication of 30 April 2004 - e- Health - making healthcare better for European citizens: an action plan for a European e-Health Area (COM(2004)356 final);

Or. en

Amendment 2 Frédérique Ries, Nils Torvalds, María Soraya Rodríguez Ramos, Irena Joveva, Susana Solís Pérez, Fredrick Federley

Draft motion for a resolution Citation 1 a (new)

Draft motion for a resolution Amendment

– having regard to the Commission communication of 30 April 2004 - e- Health - making healthcare better for European citizens: an action plan for a European e-Health Area (COM(2004)0356),

Or. en

Amendment 3 Frédérique Ries, Nils Torvalds, María Soraya Rodríguez Ramos, Irena Joveva, Susana Solís Pérez, Fredrick Federley

Draft motion for a resolution Citation 1 b (new)

Draft motion for a resolution Amendment

AM\1192663EN.docx 3/59 PE643.214v01-00 EN – having regard to the Commission staff working document of 21 December 2007 - Action plan of the lead market initiative in the area of eHealth - Annex I to the communication - A lead market initiative for Europe (COM(2007)0860,SEC(2007)1730),

Or. en

Amendment 4 Frédérique Ries, Nils Torvalds, María Soraya Rodríguez Ramos, Irena Joveva, Susana Solís Pérez, Fredrick Federley

Draft motion for a resolution Citation 1 c (new)

Draft motion for a resolution Amendment

– having regard to the Commission Recommendation of 2July 2008 on cross- border interoperability of electronic health record systems(notified under document number C(2008) 3282)1a ______1a OJL 190, 18.7.2008, p. 37–43

Or. en

Amendment 5 Frédérique Ries, Nils Torvalds, María Soraya Rodríguez Ramos, Irena Joveva, Susana Solís Pérez, Fredrick Federley

Draft motion for a resolution Citation 1 d (new)

Draft motion for a resolution Amendment

– having regard to the Commission communication of 4 November 2008 on telemedicine for the benefit of patients, healthcare systems and society (COM(2008)0689),

PE643.214v01-00 4/59 AM\1192663EN.docx EN Or. en

Amendment 6 Frédérique Ries, Nils Torvalds, María Soraya Rodríguez Ramos, Irena Joveva, Susana Solís Pérez, Fredrick Federley

Draft motion for a resolution Citation 1 e (new)

Draft motion for a resolution Amendment

– having regard to the Commission communication of 6 December 2012 - eHealth Action Plan 2012-2020 - Innovative healthcare for the21st century (COM(2012)0736),

Or. en

Amendment 7 César Luena, Nicolás González Casares

Draft motion for a resolution Citation 6 a (new)

Draft motion for a resolution Amendment

– having regard to the Commission staff working document of 21 December 2007 - Action plan of the lead market initiative in the area of eHealth - Annex I to the communication - A lead market initiative for Europe {COM(2007) 860 final SEC(2007) 1730};

Or. en

Amendment 8 César Luena, Nicolás González Casares

Draft motion for a resolution Citation 6 b (new)

AM\1192663EN.docx 5/59 PE643.214v01-00 EN Draft motion for a resolution Amendment

– having regard to the Commission Recommendation of 2 July 2008 on cross- border interoperability of electronic health record systems (notified under document number C (2008) 3282)1a; ______1a OJ L 190, 18.7.2008, p. 37–43

Or. en

Amendment 9 César Luena, Nicolás González Casares

Draft motion for a resolution Citation 6 c (new)

Draft motion for a resolution Amendment

– having regard to the Commission communication of 4 November 2008 on telemedicine for the benefit of patients, healthcare systems and society (COM(2008)689 final);

Or. en

Amendment 10 César Luena, Nicolás González Casares

Draft motion for a resolution Citation 6 d (new)

Draft motion for a resolution Amendment

– having regard to the Commission communication of 6 December 2012 - eHealth Action Plan 2012-2020 - Innovative healthcare for the 21st century (COM(2012)0736 final);

Or. en

PE643.214v01-00 6/59 AM\1192663EN.docx EN Amendment 11 Margrete Auken

Draft motion for a resolution Citation 7 a (new)

Draft motion for a resolution Amendment

– having regard to Directive (EU) 2016/1148 of the European Parliament and of the Council of 6 July 2016 concerning measures for a high common level of security of network and information systems across the Union

Or. en

Amendment 12 Nathalie Colin-Oesterlé

Draft motion for a resolution Citation 7 a (new)

Draft motion for a resolution Amendment

– having regard to Special report no 7/2019 of the European Court of Auditors: EU actions for cross-border healthcare: significant ambitions but improved management required

Or. fr

Amendment 13 Nathalie Colin-Oesterlé

Draft motion for a resolution Citation 7 b (new)

Draft motion for a resolution Amendment

– having regard to Commission Recommendation (EU) 2019/243 of 6 February 2019 on a European Electronic

AM\1192663EN.docx 7/59 PE643.214v01-00 EN Health Record exchange format,

Or. fr

Amendment 14 Frédérique Ries, Nils Torvalds, María Soraya Rodríguez Ramos, Irena Joveva, Susana Solís Pérez, Fredrick Federley

Draft motion for a resolution Recital A

Draft motion for a resolution Amendment

A. whereas Europe’s health and care A. whereas Europe’s health and care systems face serious challenges in the systems face serious challenges in the context of an aging society that are creating context of an aging society that are creating concerns about the sustainability of future concerns about the sustainability of future provision of healthcare but, on the other provision of healthcare but, on the other hand, are creating new opportunities due to hand, are creating new opportunities due to the emergence of new technologies; the emergence of new technologies; whereas in this context a paradigm shift is needed towards proactive and responsive health care systems, where maintenance of good health is the prime focus rather than disease management;

Or. en

Amendment 15 Tudor Ciuhodaru

Draft motion for a resolution Recital A

Draft motion for a resolution Amendment

A. whereas Europe’s health and care A. whereas Europe’s health and care systems face serious challenges in the systems face serious challenges in the context of an aging society that are context of an ageing society, with an ever- creating concerns about the sustainability increasing threat from infectious illnesses of future provision of healthcare but, on the as a result of growing resistance to other hand, are creating new opportunities antibiotics, creating concerns about the due to the emergence of new technologies; sustainability of future provision of healthcare but, on the other hand, are creating new opportunities due to the

PE643.214v01-00 8/59 AM\1192663EN.docx EN emergence of new technologies;

Or. ro

Amendment 16 Esther de Lange

Draft motion for a resolution Recital A

Draft motion for a resolution Amendment

A. whereas Europe’s health and care A. whereas Europe’s health and care systems face serious challenges in the systems face serious challenges in the context of an aging society that are creating context of an aging society, higher life concerns about the sustainability of future expectancy and consistently lower birth provision of healthcare but, on the other rates that are creating concerns about the hand, are creating new opportunities due to sustainability of future provision of the emergence of new technologies; healthcare but, on the other hand, are creating new opportunities due to the emergence of new technologies;

Or. en

Amendment 17 Margrete Auken

Draft motion for a resolution Recital A

Draft motion for a resolution Amendment

A. whereas Europe’s health and care A. whereas the emergence of new systems face serious challenges in the technologies creates both opportunities context of an aging society that are and challenges to the development of creating concerns about the sustainability better health care, as concerns about the of future provision of healthcare but, on sustainability of future provisions of the other hand, are creating new healthcare are rising due to Europe's opportunities due to the emergence of new aging societies technologies;

Or. en

AM\1192663EN.docx 9/59 PE643.214v01-00 EN Amendment 18 Frédérique Ries, Nils Torvalds, María Soraya Rodríguez Ramos, Irena Joveva, Susana Solís Pérez, Fredrick Federley

Draft motion for a resolution Recital B

Draft motion for a resolution Amendment

B. whereas health systems need to B. whereas spending on healthcare maximise the effectiveness and efficiency grows fast and accounts for 9.6% of GDP of health services and long-term care, in the EU as a whole; whereas health deliver seamless care across services and systems need to maximise the effectiveness providers, and deliver improvements that and efficiency of accessible, resilient and matter to patients and their changing care sustainable health services and long-term needs; care, deliver seamless care across services and providers, and deliver improvements that matter to patients and their changing care needs;

Or. en

Amendment 19 Margrete Auken

Draft motion for a resolution Recital B

Draft motion for a resolution Amendment

B. whereas health systems need to B. whereas health systems need to maximise the effectiveness and efficiency maximise the effectiveness and efficiency of health services and long-term care, of health services and long-term care, deliver seamless care across services and deliver seamless care across services and providers, and deliver improvements that providers, and deliver improvements that matter to patients and their changing care matter to patients and their changing care needs; needs considering their differences in internet connectivity, digital competences and health literacy

Or. en

Amendment 20 Sara Cerdas, Carlos Zorrinho, Monika Beňová, Biljana Borzan, Manuel Pizarro, Nicolás González Casares, Simona Bonafè, Tudor Ciuhodaru, Demetris Papadakis,

PE643.214v01-00 10/59 AM\1192663EN.docx EN César Luena

Draft motion for a resolution Recital B

Draft motion for a resolution Amendment

B. whereas health systems need to B. whereas health systems need to maximise the effectiveness and efficiency maximise the effectiveness and efficiency, of health services and long-term care, equitable access and sustainability of deliver seamless care across services and health services and long-term care, deliver providers, and deliver improvements that seamless care across services and matter to patients and their changing care providers, and deliver improvements that needs; matter to patients and their changing and growing health and care needs, well-being and quality of life;

Or. en

Amendment 21 Tudor Ciuhodaru

Draft motion for a resolution Recital B

Draft motion for a resolution Amendment

B. whereas health systems need to B. whereas health systems need to maximise the effectiveness and efficiency maximise the effectiveness and efficiency of health services and long-term care, of health services and long-term care, deliver seamless care across services and provide new services in line with the providers, and deliver improvements that evolution of society, deliver seamless care matter to patients and their changing care across services and providers, and deliver needs; improvements that matter to patients and their changing care needs;

Or. ro

Amendment 22 Sara Cerdas, Carlos Zorrinho, Monika Beňová, Biljana Borzan, Manuel Pizarro, Nicolás González Casares, Simona Bonafè, Tudor Ciuhodaru, Demetris Papadakis, César Luena

Draft motion for a resolution Recital C

AM\1192663EN.docx 11/59 PE643.214v01-00 EN Draft motion for a resolution Amendment

C. whereas innovative digital solutions C. whereas innovative digital solutions for health and care can boost health and for health and care can boost prevention of quality of life of citizens and enable more diseases and promotion of healthy efficient ways of organising and delivering lifestyles, improve citizens’ quality of life health and care services; and enable more efficient ways of organizing and delivering health and care services;

Or. en

Amendment 23 Joanna Kopcińska

Draft motion for a resolution Recital D

Draft motion for a resolution Amendment

D. whereas data concerning the health D. whereas data concerning the health of EU citizens is a key enabler for digital of EU citizens is a key enabler for digital transformation; whereas the availability of transformation, and must be strictly data varies greatly across Member States, protected against misuse; whereas the and whereas, due to the lack of availability of data varies greatly across interoperability and market fragmentation Member States, and whereas, due to the across health systems, citizens cannot yet lack of interoperability and market fully benefit from the digital single market; fragmentation across health systems, citizens cannot yet fully benefit from the digital single market;

Or. pl

Amendment 24 Tiemo Wölken

Draft motion for a resolution Recital D a (new)

Draft motion for a resolution Amendment

Da. whereas healthcare digitalisation will not be limited to greater use of mobile health apps, but also include analysing

PE643.214v01-00 12/59 AM\1192663EN.docx EN large data sets also known as data mining, that serve as a foundation for artificial intelligence (AI) and machine learning;

Or. en

Amendment 25 Frédérique Ries, Nils Torvalds, María Soraya Rodríguez Ramos, Irena Joveva, Susana Solís Pérez, Fredrick Federley

Draft motion for a resolution Recital E

Draft motion for a resolution Amendment

E. whereas the organisation and E. whereas the organisation and delivery of health and social care is the delivery of health and social care is the responsibility of the Member states; responsibility of the Member states; whereas the Union can support the whereas the Union can support the cooperation between Member States in cooperation between Member States in promoting public health and prevention of promoting public health and prevention of disease and improving the disease, improving the complementarity of complementarity of their health services their health services cross-border, as well cross-border; as supporting and enabling research and development in smart health in Europe;

Or. en

Amendment 26 Sara Cerdas, Carlos Zorrinho, Monika Beňová, Biljana Borzan, Manuel Pizarro, Simona Bonafè, Tudor Ciuhodaru, Demetris Papadakis

Draft motion for a resolution Recital F

Draft motion for a resolution Amendment

F. whereas patients’ expectations are F. whereas patients’ expectations are rising, and there is a need for more ways rising, and there is a need for an for people to interact with health services empowerment of citizens regarding their and health professionals; health through user-centred services and more ways for people to interact with health services and health professionals;

Or. en

AM\1192663EN.docx 13/59 PE643.214v01-00 EN Amendment 27 Margrete Auken

Draft motion for a resolution Recital F

Draft motion for a resolution Amendment

F. whereas patients’ expectations are F. whereas patients’ expectations and rising, and there is a need for more ways desire to monitor one’s own health are for people to interact with health services rising, the need for more ways for people and health professionals; to interact with health services and health professionals are rising accordingly;

Or. en

Amendment 28 Frédérique Ries, Nils Torvalds, María Soraya Rodríguez Ramos, Irena Joveva, Susana Solís Pérez, Fredrick Federley

Draft motion for a resolution Recital F

Draft motion for a resolution Amendment

F. whereas patients’ expectations are F. whereas patients’ expectations are rising, and there is a need for more ways rising, and there is a need for more for people to interact with health services preventive, personalised and responsive and health professionals; ways for people to interact with health services and health professionals;

Or. en

Amendment 29 Frédérique Ries, Fredrick Federley, María Soraya Rodríguez Ramos, Irena Joveva, Susana Solís Pérez

Draft motion for a resolution Recital G

Draft motion for a resolution Amendment

G. whereas in the progressive G. whereas the progressive digitalization of the society, patients, digitalisation of society will increasingly

PE643.214v01-00 14/59 AM\1192663EN.docx EN caregivers and healthcare professionals lead patients, caregivers, healthcare face the challenges of using information professionals and potentially all the actors technology and the digital infrastructure of of the healthcare chain to face the patient records in the context of personal challenges of using information technology data security; and the digital infrastructure of patient records, raising questions of personal data security and privacy;

Or. en

Amendment 30 Frédérique Ries, Nils Torvalds, María Soraya Rodríguez Ramos, Irena Joveva, Susana Solís Pérez, Fredrick Federley

Draft motion for a resolution Recital G a (new)

Draft motion for a resolution Amendment

Ga. whereas personal health data are of a particularly sensitive nature and should be subject to strict ethical requirements and the citizens' informed consent with regards to their collection, processing, use and storage;

Or. en

Amendment 31 Frédérique Ries, Nils Torvalds, María Soraya Rodríguez Ramos, Irena Joveva, Susana Solís Pérez, Fredrick Federley

Draft motion for a resolution Recital G b (new)

Draft motion for a resolution Amendment

Gb. whereas the trust of the citizens in the safety and confidentiality of the collection, processing, use and storage of their personal health data is of the utmost importance;

Or. en

AM\1192663EN.docx 15/59 PE643.214v01-00 EN Amendment 32 Joanna Kopcińska

Draft motion for a resolution Recital H

Draft motion for a resolution Amendment

H. whereas the implementation and H. whereas the implementation and use of digital health are at different levels use of digital health are at different levels between Members States, including the use between Members States, including the use of updated technology, support of updated technology, support infrastructures to digital transformation and infrastructures to digital transformation and the use of electronic health records in the use of electronic health records in healthcare services; healthcare services; whereas the establishment of a comprehensive digital healthcare system will be hugely expensive in many countries;

Or. pl

Amendment 33 Frédérique Ries, Nils Torvalds, María Soraya Rodríguez Ramos, Irena Joveva, Susana Solís Pérez, Fredrick Federley

Draft motion for a resolution Recital I a (new)

Draft motion for a resolution Amendment

Ia. whereas science, research and innovation play a vital role in Europe’s competitiveness and resilience; whereas exponential leaps in data availability and computing fuel research initiatives to understand, prevent, and treat diseases and medical conditions; whereas data managements techniques can help identify care gaps, risks, trends and patterns in a complementary or more effective way;

Or. en

PE643.214v01-00 16/59 AM\1192663EN.docx EN Amendment 34 Margrete Auken

Draft motion for a resolution Recital I a (new)

Draft motion for a resolution Amendment

Ia. whereas people along lower social gradients tend to have higher health needs, they are also more vulnerable to become excluded by the digitalisation of health care

Or. en

Amendment 35 Sara Cerdas, Carlos Zorrinho, Monika Beňová, Biljana Borzan, Manuel Pizarro, Nicolás González Casares, Simona Bonafè, Demetris Papadakis, César Luena

Draft motion for a resolution Paragraph 1

Draft motion for a resolution Amendment

1. Welcomes the Commission 1. Welcomes the Commission communication on enabling the digital communication on enabling the digital transformation of health and care in the transformation of health and care in the Digital Single Market which aims to Digital Single Market which aims to promote health, prevent and control promote health, prevent and control disease, help address patients’ unmet needs disease, help address citizens’ unmet and make it easier for citizens to have needs, represent an opportunity to equal access to high quality care through improve the sustainability of health the meaningful use of digital innovations; systems and make it easier for citizens to have equal access to high quality care through the meaningful use of digital innovations;

Or. en

Amendment 36 Tiemo Wölken

Draft motion for a resolution Paragraph 1

AM\1192663EN.docx 17/59 PE643.214v01-00 EN Draft motion for a resolution Amendment

1. Welcomes the Commission 1. Welcomes the Commission communication on enabling the digital communication on enabling the digital transformation of health and care in the transformation of health and care in the Digital Single Market which aims to Digital Single Market which aims to promote health, prevent and control promote health, prevent and control disease, help address patients’ unmet needs disease, help address patients’ unmet needs and make it easier for citizens to have and make it easier for citizens to have equal access to high quality care through equal and affordable access to high quality the meaningful use of digital innovations; care through the meaningful use of digital innovations;

Or. en

Amendment 37 Tiemo Wölken

Draft motion for a resolution Paragraph 1 – point 1 (new)

Draft motion for a resolution Amendment

(1) Points out that while digital health holds a lot of potential, it also has a lot of unresolved issues when it comes to privacy, security and safety

Or. en

Amendment 38 Tiemo Wölken

Draft motion for a resolution Paragraph 1 – point 2 (new)

Draft motion for a resolution Amendment

(2) Underlines that to fully benefit from the potential of digital health tools it is of upmost importance to implement digital health elements with a high consideration of data privacy, security, accuracy and inclusion of patient needs

PE643.214v01-00 18/59 AM\1192663EN.docx EN Or. en

Amendment 39 Nathalie Colin-Oesterlé

Draft motion for a resolution Paragraph 1 a (new)

Draft motion for a resolution Amendment

1a. Notes that compliance with EU legislation on data protection should be the precondition to this digital transformation of health and care in the Digital Single Market;

Or. fr

Amendment 40 Tudor Ciuhodaru

Draft motion for a resolution Paragraph 2

Draft motion for a resolution Amendment

2. Considers that the actions proposed 2. Considers that the actions proposed by the Commission can contribute to by the Commission can contribute to strengthening the resilience and strengthening the resilience and sustainability of Europe’s health and care sustainability of Europe’s health and care systems but also to stimulating growth and systems but also to stimulating growth and promoting the European industry in the promoting the European industry in the domain, in particular by helping to domain, in particular by helping to maximise the potential of the digital single maximise the potential of the digital single market with a wider deployment of digital market with a wider deployment of digital products and services in health and care; products and services in health and care, as well as the deployment of new services, especially for isolated and inaccessible areas with inadequate medical staff and services;

Or. ro

AM\1192663EN.docx 19/59 PE643.214v01-00 EN Amendment 41 Frédérique Ries, Nils Torvalds, María Soraya Rodríguez Ramos, Irena Joveva, Susana Solís Pérez, Fredrick Federley

Draft motion for a resolution Paragraph 2

Draft motion for a resolution Amendment

2. Considers that the actions proposed 2. Considers that the actions proposed by the Commission can contribute to by the Commission can contribute to strengthening the resilience and provide more preventive, personalised and sustainability of Europe’s health and care responsive healthcare to the European systems but also to stimulating growth and citizens, strengthen the resilience and promoting the European industry in the sustainability of Europe’s health and care domain, in particular by helping to systems, but also to stimulate growth and maximise the potential of the digital single promote the European industry in the market with a wider deployment of digital domain, in particular by helping to products and services in health and care; maximise the potential of the digital single market with a wider deployment of digital products and services in health and care;

Or. en

Amendment 42 César Luena, Nicolás González Casares, Sara Cerdas

Draft motion for a resolution Paragraph 2

Draft motion for a resolution Amendment

2. Considers that the actions proposed 2. Considers that the actions proposed by the Commission can contribute to by the Commission can contribute to strengthening the resilience and strengthening the efficiency, equitable sustainability of Europe’s health and care access, sustainability and resilience of systems but also to stimulating growth and Europe’s health and care systems but also promoting the European industry in the to stimulating growth and promoting the domain, in particular by helping to European industry in the domain, in maximise the potential of the digital single particular by helping to maximise the market with a wider deployment of digital potential of the digital single market with a products and services in health and care; wider deployment of digital products and services in health and care;

Or. en

PE643.214v01-00 20/59 AM\1192663EN.docx EN Amendment 43 Nathalie Colin-Oesterlé

Draft motion for a resolution Paragraph 3

Draft motion for a resolution Amendment

3. Is of the opinion that the digital 3. Is of the opinion that the digital transformation of health and care needs to transformation of health and care needs to be patient-centred; be patient-centred; that this transformation should allow for the exchange of information on patient records, electronic prescriptions, laboratory test results, medical imaging and discharge summaries, as well as information on the cost of medicines in each Member State and, in particular, how they are covered and reimbursed;

Or. fr

Amendment 44 Sara Cerdas, Carlos Zorrinho, Monika Beňová, Biljana Borzan, Manuel Pizarro, Simona Bonafè, Tudor Ciuhodaru, Demetris Papadakis

Draft motion for a resolution Paragraph 3

Draft motion for a resolution Amendment

3. Is of the opinion that the digital 3. Is of the opinion that the digital transformation of health and care needs to transformation of health and care needs to be patient-centred; support citizen-centred services as well as empowering citizens to play a more active role in disease prevention and promotion of health, as well in health and care services, answering the needs of citizen;

Or. en

Amendment 45 Joanna Kopcińska

Draft motion for a resolution

AM\1192663EN.docx 21/59 PE643.214v01-00 EN Paragraph 3

Draft motion for a resolution Amendment

3. Is of the opinion that the digital 3. Is of the opinion that the digital transformation of health and care needs to transformation of health and care needs to be patient-centred; be patient-centred; stresses, at the same time, that the needs of patients who are unable to keep up with the digital transformation must not be disregarded;

Or. pl

Amendment 46 Frédérique Ries, Nils Torvalds, María Soraya Rodríguez Ramos, Irena Joveva, Susana Solís Pérez, Fredrick Federley

Draft motion for a resolution Paragraph 3

Draft motion for a resolution Amendment

Or. en

Amendment 47 César Luena, Nicolás González Casares

Draft motion for a resolution Paragraph 3 a (new)

Draft motion for a resolution Amendment

3a. Highlights that national health systems are the main providers of the fundamental right to access to health and are based on the principle of solidarity whereby "healthy people finance the care of sick people", and that is key to make possible an efficient and equitable system;

PE643.214v01-00 22/59 AM\1192663EN.docx EN states therefore that there is a shared property of these systems and of what is produced in them;

Or. en

Amendment 48 Stanislav Polčák

Draft motion for a resolution Paragraph 4

Draft motion for a resolution Amendment

4. Believes that there is a need to 4. Believes that there is a need to ensure a key role for public health systems ensure a key role for public health systems in the governance and the policymaking on in the governance and the policymaking on digital health and care; digital health and care; stresses, in this regard, the importance of cooperation and interconnectedness between the databases of healthcare establishments and insurance companies with municipal authorities and social security and social welfare bodies;

Or. cs

Amendment 49 Frédérique Ries, Nils Torvalds, María Soraya Rodríguez Ramos, Irena Joveva, Susana Solís Pérez, Fredrick Federley

Draft motion for a resolution Paragraph 4

Draft motion for a resolution Amendment

Or. en

AM\1192663EN.docx 23/59 PE643.214v01-00 EN Amendment 50 Tiemo Wölken

Draft motion for a resolution Paragraph 4

Draft motion for a resolution Amendment

4. Believes that there is a need to 4. Believes that there is a need to ensure a key role for public health systems ensure a key role for patient organisations in the governance and the policymaking on and networks, public health systems in the digital health and care; governance and the policymaking on digital health and care;

Or. en

Amendment 51 César Luena, Nicolás González Casares

Draft motion for a resolution Paragraph 4 a (new)

Draft motion for a resolution Amendment

4a. Believes that public health systems are the best-placed authorities to manage and/or supervise the collection, anonymization and pseudonymization, custody and exploitation of health data while protecting patients’ privacy as well as the efficiency, equitable access and sustainability of health and care sector;

Or. en

Amendment 52 Sara Cerdas, Carlos Zorrinho, Monika Beňová, Biljana Borzan, Manuel Pizarro, Nicolás González Casares, Simona Bonafè, Tudor Ciuhodaru, Demetris Papadakis, César Luena

Draft motion for a resolution Paragraph 4 a (new)

Draft motion for a resolution Amendment

PE643.214v01-00 24/59 AM\1192663EN.docx EN 4a. Stresses that the future of digital health will need to develop secure and effective anonymization and pseudonymization techniques enabling sensible data to be used in health research;

Or. en

Amendment 53 Joanna Kopcińska

Draft motion for a resolution Paragraph 5

Draft motion for a resolution Amendment

5. Stresses that health data could be 5. Stresses that health data could be used for research, to implement evidence used for research, to implement evidence based health policies and for a better based health policies and for a better understanding of diseases and early understanding of diseases and early detection of events that threaten public detection of events that threaten public health; health, whilst complying with the principles of patient confidentiality;

Or. pl

Amendment 54 Tiemo Wölken

Draft motion for a resolution Paragraph 5

Draft motion for a resolution Amendment

5. Stresses that health data could be 5. Stresses that health data could be used for research, to implement evidence used for scientific health research, to based health policies and for a better implement evidence based health policies understanding of diseases and early and for a better understanding of diseases detection of events that threaten public and early detection of events that threaten health; public health;

Or. en

AM\1192663EN.docx 25/59 PE643.214v01-00 EN Amendment 55 Margrete Auken

Draft motion for a resolution Paragraph 5

Draft motion for a resolution Amendment

5. Stresses that health data could be 5. Stresses that fully anonymised used for research, to implement evidence health data could be used for research to based health policies and for a better implement evidence based health policies understanding of diseases and early and for a better understanding of diseases detection of events that threaten public and early detection of events that threaten health; public health;

Or. en

Amendment 56 Tiemo Wölken

Draft motion for a resolution Paragraph 5 a (new)

Draft motion for a resolution Amendment

5a. Stresses that the use of anonymised health data should be favoured; Points out that if anonymization is not possible, data should be pseudonymised, so that it can not be directly connected to a specific person

Or. en

Amendment 57 Sara Cerdas, Carlos Zorrinho, Monika Beňová, Biljana Borzan, Manuel Pizarro, Nicolás González Casares, Simona Bonafè, Tudor Ciuhodaru, Demetris Papadakis, César Luena

Draft motion for a resolution Paragraph 5 a (new)

Draft motion for a resolution Amendment

5a. Stresses that a Commission

PE643.214v01-00 26/59 AM\1192663EN.docx EN proposal on sharing information and data governance is necessary to tackle the implications for national health systems;

Or. en

Amendment 58 Tiemo Wölken

Draft motion for a resolution Subheading 2

Draft motion for a resolution Amendment

The need to secure access to and sharing of The need to secure access to and sharing of personal health data personal health data, whilst applying the GDPR rules thoroughly

Or. en

Amendment 59 César Luena, Nicolás González Casares

Draft motion for a resolution Paragraph 6

Draft motion for a resolution Amendment

6. Stresses that citizens have the right 6. Stresses that citizens have the right to access and share their personal health to access and share their personal health data in accordance with the General Data data in accordance with the General Data Protection Regulation; Protection Regulation for better health care; points out that the recent regulation on data protection of the EU improves the right of patients to access information on aspects of their health and protect their privacy; regrets, however, that this regulation does not go further on data property or other new rights for patients; remarks that the aim of a patient-based system is to improve citizens` health, and that the national health systems must guarantee it for the sake of common interest;

AM\1192663EN.docx 27/59 PE643.214v01-00 EN Or. en

Amendment 60 Frédérique Ries, Nils Torvalds, María Soraya Rodríguez Ramos, Irena Joveva, Susana Solís Pérez, Fredrick Federley

Draft motion for a resolution Paragraph 6

Draft motion for a resolution Amendment

Or. en

Amendment 61 César Luena, Nicolás González Casares, Sara Cerdas

Draft motion for a resolution Paragraph 6 a (new)

Draft motion for a resolution Amendment

6a. Stresses that it is indispensable that secure and effective anonymization and pseudonymization techniques are developed, which enable sensitive data to be used in health research without compromising the privacy of patients; draws attention to the importance of pseudonymization techniques allowing the re-identification of the data donors in cases where their health is at risk;

Or. en

Amendment 62 César Luena, Nicolás González Casares, Sara Cerdas

PE643.214v01-00 28/59 AM\1192663EN.docx EN Draft motion for a resolution Paragraph 6 b (new)

Draft motion for a resolution Amendment

6b. Considers that due to the sensitive nature of health data, the right to protection of privacy must be specially regulated, which requires special measures to avoid not only cyberattacks but also an inadequate use of such data by utilities;

Or. en

Amendment 63 César Luena, Nicolás González Casares, Sara Cerdas

Draft motion for a resolution Paragraph 6 c (new)

Draft motion for a resolution Amendment

6c. Acknowledges that there are significant economic interests in the exploitation of data from the health and care sectors; calls therefore on the Commission and Member States to clearly define responsibilities in data governance, putting in place a new public-private paradigm;

Or. en

Amendment 64 Tudor Ciuhodaru

Draft motion for a resolution Paragraph 7

Draft motion for a resolution Amendment

7. Regrets that, at present, many 7. Regrets that, at present, many citizens in Europe have limited electronic citizens in Europe have limited electronic

AM\1192663EN.docx 29/59 PE643.214v01-00 EN access to their personal health data, in access to their personal health data, in particular in cross-border -healthcare particular when they need to have provision; recourse to cross-border medical care;

Or. ro

Amendment 65 Margrete Auken

Draft motion for a resolution Paragraph 7

Draft motion for a resolution Amendment

7. Regrets that, at present, many 7. Regrets that, at present, many citizens in Europe have limited electronic citizens in Europe have limited or no access to their personal health data, in electronic access to their personal health particular in cross-border -healthcare data, in particular in cross-border - provision; healthcare provision;

Or. en

Amendment 66 Tiemo Wölken

Draft motion for a resolution Paragraph 8

Draft motion for a resolution Amendment

8. Calls on the Commission to 8. Calls on the Commission to continue improving cybersecurity, continue improving cybersecurity, reducing the risk of privacy breaches and reducing the risk of privacy breaches and unauthorised use of health data; unauthorised use of health data across the Union;

Or. en

Amendment 67 Tiemo Wölken

Draft motion for a resolution Paragraph 9

PE643.214v01-00 30/59 AM\1192663EN.docx EN Draft motion for a resolution Amendment

9. Agrees with the Commission that 9. Agrees with the Commission that citizens should have secure access to a citizens should have secure access to a comprehensive electronic record of their comprehensive electronic record of their health data, and should remain in control of health data, and should remain in control of and be able to share their personal health and be able to share their personal health data securely with authorised parties, while data securely with authorised parties, while unauthorised access should be prevented in unauthorised access should be prohibited accordance with data protection legislation; in accordance with data protection legislation;

Or. en

Amendment 68 Tudor Ciuhodaru

Draft motion for a resolution Paragraph 10

Draft motion for a resolution Amendment

10. Calls on the Commission to 10. Calls on the Commission to continue promoting the cooperation of continue promoting the cooperation of Member States’ health authorities to Member States’ health authorities to connect to the eHealth digital infrastructure connect to the eHealth digital infrastructure in order to extend its use to also cover the in order to extend its use to also cover the interoperability of Member States’ interoperability of Member States’ electronic record systems by supporting the electronic record systems by supporting the development and adoption of a European development and adoption of a European electronic health record exchange format; electronic health record exchange format, particularly when patients have recourse to gross-border medical care;

Or. ro

Amendment 69 Stanislav Polčák

Draft motion for a resolution Paragraph 10

Draft motion for a resolution Amendment

AM\1192663EN.docx 31/59 PE643.214v01-00 EN 10. Calls on the Commission to 10. Calls on the Commission to continue promoting the cooperation of continue promoting the cooperation of Member States’ health authorities to Member States’ health authorities to connect to the eHealth digital infrastructure connect to the eHealth digital infrastructure in order to extend its use to also cover the in order to extend its use to also cover the interoperability of Member States’ interoperability of Member States’ electronic record systems by supporting the electronic record systems by supporting the development and adoption of a European development and adoption of a European electronic health record exchange format; electronic health record exchange format, which, in order to serve the patients' interest, ought to contain the most comprehensive information possible concerning health status;

Or. cs

Amendment 70 Sara Cerdas, Carlos Zorrinho, Monika Beňová, Biljana Borzan, Manuel Pizarro, Nicolás González Casares, Simona Bonafè, César Luena

Draft motion for a resolution Paragraph 10

Draft motion for a resolution Amendment

10. Calls on the Commission to 10. Calls on the Commission to continue promoting the cooperation of continue promoting the cooperation of Member States’ health authorities to Member States’ health authorities to connect to the eHealth digital infrastructure connect to the eHealth digital infrastructure in order to extend its use to also cover the in order to extend its use to also cover the interoperability of Member States’ interoperability of Member States’ electronic record systems by supporting the electronic record systems by supporting the development and adoption of a European development and adoption of a European electronic health record exchange format; electronic health record exchange format, taking into account the Union’s multilingualism as well as user with disabilities;

Or. en

Amendment 71 César Luena, Nicolás González Casares

Draft motion for a resolution Paragraph 10

PE643.214v01-00 32/59 AM\1192663EN.docx EN Draft motion for a resolution Amendment

10. Calls on the Commission to 10. Calls on the Commission to continue promoting the cooperation of continue promoting the cooperation of Member States’ health authorities to Member States’ health authorities to connect to the eHealth digital infrastructure connect to a public eHealth digital in order to extend its use to also cover the infrastructure in order to extend its use to interoperability of Member States’ also cover the interoperability of Member electronic record systems by supporting the States’ electronic record systems by development and adoption of a European supporting the development and adoption electronic health record exchange format; of a European electronic health record exchange format;

Or. en

Amendment 72 Stanislav Polčák

Draft motion for a resolution Paragraph 13

Draft motion for a resolution Amendment

13. Calls on Member States’ health 13. Calls on Member States’ health authorities to make use of EU financing authorities to make use of EU financing instruments, such as the European instruments, such as the European Structural and Investment Funds and the Structural and Investment Funds and the European Fund for Strategic Investments, European Fund for Strategic Investments, for the deployment of interoperable for the deployment of interoperable electronic health records at national and electronic health records at national and regional level which will enable citizens to regional level which will enable citizens to access their personal health data for access their personal health data for investment in building solid and reliable investment in building solid and more infrastructure which supports the digital reliable infrastructure which supports the transformation, and helps to reduce the digital transformation, and helps to reduce digital divide between all Member States; the digital divide between all Member States; calls for the benefits brought by the digitisation and digitalisation of health records to help improve access to and the quality of medical care in both urban and rural areas;

Or. cs

AM\1192663EN.docx 33/59 PE643.214v01-00 EN Amendment 73 Esther de Lange

Draft motion for a resolution Paragraph 13

Draft motion for a resolution Amendment

13. Calls on Member States’ health 13. Calls on Member States’ health authorities to make use of EU financing authorities to make use of EU financing instruments, such as the European instruments, such as the Active and Structural and Investment Funds and the Assisted Living (AAL) programme that European Fund for Strategic Investments, aims to create better quality of life for for the deployment of interoperable older people, the European Structural and electronic health records at national and Investment Funds and the European Fund regional level which will enable citizens to for Strategic Investments, for the access their personal health data for deployment of interoperable electronic investment in building solid and reliable health records at national and regional infrastructure which supports the digital level which will enable citizens to access transformation, and helps to reduce the their personal health data for investment in digital divide between all Member States; building solid and reliable infrastructure which supports the digital transformation, and helps to reduce the digital divide between all Member States;

Or. en

Amendment 74 Frédérique Ries, Nils Torvalds, María Soraya Rodríguez Ramos, Irena Joveva, Susana Solís Pérez, Fredrick Federley

Draft motion for a resolution Paragraph 14

Draft motion for a resolution Amendment

14. Calls on the Commission and 14. Calls on the Commission and Member States to support projects that use Member States to support projects that use real-world data leading to favourable real-world data leading to favourable health outcomes; health outcomes; in this view, further calls on the Commission to develop guidance to promote the secondary use of data for research and ensure fair, transparent and non-discriminatory access to data throughout Europe;

Or. en

PE643.214v01-00 34/59 AM\1192663EN.docx EN Amendment 75 Margrete Auken

Draft motion for a resolution Paragraph 14

Draft motion for a resolution Amendment

14. Calls on the Commission and 14. Calls on the Commission and Member States to support projects that use Member States to support projects that use real-world data leading to favourable real-world data and develop criteria for health outcomes; the quality of data gathered in a non- controlled environment in order for real- world data to help achieve favourable health outcomes;

Or. en

Amendment 76 Frédérique Ries, Nils Torvalds, María Soraya Rodríguez Ramos, Irena Joveva, Susana Solís Pérez, Fredrick Federley

Draft motion for a resolution Paragraph 14 a (new)

Draft motion for a resolution Amendment

14a. Calls on the Commission to support projects aiming at developing technologies needed to anonymise or pseudo-anonymise data to allow for their exploitation without risks of compromising the privacy of patients, as well as technologies needed to create synthetic data for Artificial Intelligence algorithm training;

Or. en

Amendment 77 Margrete Auken

Draft motion for a resolution

AM\1192663EN.docx 35/59 PE643.214v01-00 EN Paragraph 14 a (new)

Draft motion for a resolution Amendment

14a. Calls for the Commission and Member states' use of real world data for regulatory decisions on medicines to complement evidence from randomised- controlled clinical trials.

Or. en

Amendment 78 Frédérique Ries, Nils Torvalds, María Soraya Rodríguez Ramos, Irena Joveva, Susana Solís Pérez, Fredrick Federley

Draft motion for a resolution Paragraph 14 b (new)

Draft motion for a resolution Amendment

14b. Calls on the Commission to launch a wide European reflection on the ethical aspects of the digital transformation of health and care, actively involving the citizens and all other actors of the healthcare chain, with a view to develop ethical standards and regulations to protect the citizens’ rights while providing security to researchers and the medical technology industry, in particular with regards to the exploitation of health data and the use of Artificial Intelligence;

Or. en

Amendment 79 Frédérique Ries, María Soraya Rodríguez Ramos, Irena Joveva, Susana Solís Pérez

Draft motion for a resolution Paragraph 15

Draft motion for a resolution Amendment

15. Calls on the Commission and 15. Calls on the Commission and

PE643.214v01-00 36/59 AM\1192663EN.docx EN Member States to ensure the establishment Member States to ensure the establishment of appropriate training and skills of appropriate training and skills development in privacy and security development in privacy and security measures for those processing personal measures for those processing personal health data, which are in line with health data, which are in line with prevailing standards and data processing prevailing standards and data processing techniques; techniques; further calls on the Commission to launch an EU-wide educational campaign on the benefits of and mechanisms for health data sharing to break down misconceptions and support the actions put forward by its Communication on enabling the digital transformation of health and care in the Digital Single Market;

Or. en

Amendment 80 Margrete Auken

Draft motion for a resolution Paragraph 17

Draft motion for a resolution Amendment

17. Stresses the importance of 17. Stresses the importance of standardising regulation of healthcare standardising regulation of connected devices, such as mHealth and eHealth healthcare devices, assuring their data devices, assuring their data accuracy and accuracy, precision and safety; precision;

Or. en

Amendment 81 Frédérique Ries, Fredrick Federley, María Soraya Rodríguez Ramos, Irena Joveva, Susana Solís Pérez

Draft motion for a resolution Paragraph 17 a (new)

Draft motion for a resolution Amendment

17a. Calls on the Commission to set up a platform for Competent Authorities,

AM\1192663EN.docx 37/59 PE643.214v01-00 EN Notified Bodies and the pharmaceutical and medical technology industry regarding the application of the Medical Devices Regulation to digital therapeutics and combination products with specific attention to the needs of start-ups and SMEs;

Or. en

Amendment 82 Tudor Ciuhodaru

Draft motion for a resolution Paragraph 18

Draft motion for a resolution Amendment

18. Calls on the Commission to 18. Calls on the Commission to step up facilitate European coordinated action to European coordinated action to support the support pooling and secure exchange of secure exchange in practice of genomic genomic and other health data in order to and other health data in order to advance advance research and personalised the progress of researchers and medicine, while ensuring full compliance personalised medicine and thereby identify with data protection legislation and ethical the best treatments, while ensuring full principles; compliance with data protection legislation and ethical principles;

Or. ro

Amendment 83 Frédérique Ries

Draft motion for a resolution Paragraph 18

Draft motion for a resolution Amendment

18. Calls on the Commission to 18. Calls on the Commission to facilitate European coordinated action to facilitate European coordinated action to support pooling and secure exchange of support pooling and secure exchange and genomic and other health data in order to linkage of genomic and other health data in advance research and personalised order to advance research and personalised medicine, while ensuring full compliance medicine, while ensuring full compliance with data protection legislation and ethical with data protection legislation and ethical

PE643.214v01-00 38/59 AM\1192663EN.docx EN principles; principles;

Or. en

Amendment 84 Sara Cerdas, Carlos Zorrinho, Monika Beňová, Biljana Borzan, Manuel Pizarro, Nicolás González Casares, Simona Bonafè, Demetris Papadakis, César Luena

Draft motion for a resolution Paragraph 19

Draft motion for a resolution Amendment

19. Calls on the Commission to 19. Calls on the Commission together proceed with the testing of specific with the Member States to proceed with applications for cross-border health data the testing of specific applications for exchange for research and health policy to cross-border health data exchange for improve prevention, diagnosis and research and health policy to improve treatment of diseases; prevention, diagnosis and treatment of diseases in order to help health systems to meet current and future challenges;

Or. en

Amendment 85 Tudor Ciuhodaru

Draft motion for a resolution Paragraph 19

Draft motion for a resolution Amendment

19. Calls on the Commission to 19. Calls on the Commission, together proceed with the testing of specific with the Member States and accredited applications for cross-border health data institutions, to proceed with the testing of exchange for research and health policy to specific applications for high-security improve prevention, diagnosis and cross-border health data exchange for treatment of diseases; research and health policy to improve prevention, diagnosis and treatment of diseases;

Or. ro

AM\1192663EN.docx 39/59 PE643.214v01-00 EN Amendment 86 Frédérique Ries, Nils Torvalds, María Soraya Rodríguez Ramos, Irena Joveva, Susana Solís Pérez, Fredrick Federley

Draft motion for a resolution Paragraph 20

Draft motion for a resolution Amendment

20. Considers that the move towards 20. Considers that the move towards digitalisation is an opportunity to launch an digitalisation is an opportunity to launch an ambitious capacity-building programme for ambitious capacity-building programme for citizens; citizens; further considers that promoting the development of skills for the uptake and effective use of smart health products and services is of the utmost importance at all levels of the health value chain (patients, health professionals, regulatory bodies, payers and authorities);

Or. en

Amendment 87 Esther de Lange

Draft motion for a resolution Paragraph 20

Draft motion for a resolution Amendment

Or. en

Amendment 88 Stanislav Polčák

Draft motion for a resolution Paragraph 20

PE643.214v01-00 40/59 AM\1192663EN.docx EN Draft motion for a resolution Amendment

Or. cs

Amendment 89 Cristian-Silviu Buşoi

Draft motion for a resolution Paragraph 20 a (new)

Draft motion for a resolution Amendment

20a. Is of the opinion that ensuring a fit for purpose regulatory environment is a key element to protect public health and provide access to high quality medicines. The effective use of Information Technology systems will improve regulatory efficiency across Europe; therefore, urges the Commission to optimize the European regulatory framework by harmonising regulatory telematics projects with a focus on data quality, interoperability and inter- dependency of the European regulatory framework.

Or. en

Amendment 90 Sara Cerdas, Carlos Zorrinho, Monika Beňová, Biljana Borzan, Manuel Pizarro, Nicolás González Casares, Simona Bonafè, Tudor Ciuhodaru, Demetris Papadakis, César Luena

Draft motion for a resolution Paragraph 21

Draft motion for a resolution Amendment

AM\1192663EN.docx 41/59 PE643.214v01-00 EN 21. Believes that the development of a 21. Believes that the development of a shared framework to harmonise the shared standards to harmonise the collection of health data, storage and use in collection of health data, storage and use in the EU could improve the quality of the EU could improve the quality of research and health services provided to research and health services provided to citizens, also facilitation universal access; citizens, also facilitation universal access;

Or. en

Amendment 91 Frédérique Ries, Fredrick Federley, María Soraya Rodríguez Ramos, Irena Joveva, Susana Solís Pérez

Draft motion for a resolution Paragraph 21

Draft motion for a resolution Amendment

21. Believes that the development of a 21. Believes that the development of a shared framework to harmonise the shared framework to harmonise the collection of health data, storage and use in collection of health data, storage and use in the EU could improve the quality of the EU could improve the quality of research and health services provided to research and health services provided to citizens, also facilitation universal access; citizens, also facilitating universal access;

Or. en

Amendment 92 Joanna Kopcińska

Draft motion for a resolution Paragraph 22

Draft motion for a resolution Amendment

22. Considers that there is a need to 22. Considers that there is a need to better advance health promotion, prevent better advance health promotion, prevent disease and deliver integrated services disease and deliver integrated services based on people’s needs, especially during based on people’s needs, especially during pandemics; pandemics, and that the European Centre for Disease Prevention and Control (ECDC) must play a central role in these efforts;

Or. pl

PE643.214v01-00 42/59 AM\1192663EN.docx EN Amendment 93 Nathalie Colin-Oesterlé

Draft motion for a resolution Paragraph 22

Draft motion for a resolution Amendment

22. Considers that there is a need to 22. Considers that there is a need to better advance health promotion, prevent better advance health promotion, prevent disease and deliver integrated services disease and deliver integrated services based on people’s needs, especially during based on people’s needs, especially in the pandemics; event of pandemics or medicine shortages;

Or. fr

Amendment 94 Nathalie Colin-Oesterlé

Draft motion for a resolution Paragraph 22 a (new)

Draft motion for a resolution Amendment

22a. Calls on the Commission and Member States to consider setting up a dedicated and protected IT system for the purpose of exchanging information between national authorities on the cost of medicines in each Member State in order to shed light on patients' decision- making in this regard;

Or. fr

Amendment 95 Edina Tóth, András Gyürk

Draft motion for a resolution Paragraph 23

Draft motion for a resolution Amendment

23. Considers that digital healthcare 23. Considers that digital healthcare

AM\1192663EN.docx 43/59 PE643.214v01-00 EN tools are well positioned to address tools may be well positioned to address challenges of accessibility to health challenges of accessibility to health information and health literacy, both information and health literacy, both essential for health promotion, better essential for health promotion, better disease prevention and more effective disease prevention and more effective disease management; considers that these disease management; considers that these tools, when built with the contribution of tools, when built with the contribution of the appropriate health professionals and the appropriate health professionals and civil society users, allow for more accuracy civil society users and are in conformity and completeness of information enabling with all the relevant legislation, allow for the promotion of healthy habits and more accuracy and completeness of prevention activities, as well as the support information enabling the promotion of to decisions in health and patient adherence healthy habits and prevention activities, as to treatments. well as the support to decisions in health and patient adherence to treatments.

Or. en

Amendment 96 Stanislav Polčák

Draft motion for a resolution Paragraph 23

Draft motion for a resolution Amendment

23. Considers that digital healthcare 23. Considers that digital healthcare tools are well positioned to address tools, such as portable patient information challenges of accessibility to health cards, are well positioned to address information and health literacy, both challenges of accessibility to health essential for health promotion, better information and health literacy, both disease prevention and more effective essential for health promotion, better disease management; considers that these disease prevention and more effective tools, when built with the contribution of disease management; considers that these the appropriate health professionals and tools, when built with the contribution of civil society users, allow for more accuracy the appropriate health professionals and and completeness of information enabling civil society users, allow for more accuracy the promotion of healthy habits and and completeness of information enabling prevention activities, as well as the support the promotion of healthy habits and to decisions in health and patient adherence prevention activities, as well as the support to treatments. to decisions in health and patient adherence to treatments.

Or. cs

PE643.214v01-00 44/59 AM\1192663EN.docx EN Amendment 97 Margrete Auken

Draft motion for a resolution Paragraph 23

Draft motion for a resolution Amendment

23. Considers that digital healthcare 23. Considers that digital healthcare tools are well positioned to address tools are well positioned to address challenges of accessibility to health challenges of accessibility to health information and health literacy, both information and health literacy, both essential for health promotion, better essential for health promotion, better disease prevention and more effective disease prevention and more effective disease management; considers that these disease management; considers that these tools, when built with the contribution of tools, when built with the contribution of the appropriate health professionals and the appropriate health professionals, civil society users, allow for more accuracy citizens and civil society users, allow for and completeness of information enabling more accuracy and completeness of the promotion of healthy habits and information enabling the promotion of prevention activities, as well as the support healthy habits and prevention activities, as to decisions in health and patient adherence well as the support to decisions in health to treatments. and patient adherence to treatments.

Or. en

Amendment 98 Frédérique Ries, Nils Torvalds, María Soraya Rodríguez Ramos, Irena Joveva, Susana Solís Pérez, Fredrick Federley

Draft motion for a resolution Paragraph 23

Draft motion for a resolution Amendment

23. Considers that digital healthcare 23. Considers that digital healthcare tools are well positioned to address tools are well positioned to address challenges of accessibility to health challenges of accessibility to health information and health literacy, both information and health literacy, both essential for health promotion, better essential for health promotion, better disease prevention and more effective disease prevention and more effective disease management; considers that these disease management; considers that these tools, when built with the contribution of tools, when built with the contribution of the appropriate health professionals and the appropriate health professionals and civil society users, allow for more accuracy end-users, allow for more accuracy and and completeness of information enabling completeness of information enabling the the promotion of healthy habits and promotion of healthy habits and prevention

AM\1192663EN.docx 45/59 PE643.214v01-00 EN prevention activities, as well as the support activities, as well as the support to co- to decisions in health and patient decisions in health-related matters and adherence to treatments. patient adherence to treatments.

Or. en

Amendment 99 Sara Cerdas, Carlos Zorrinho, Monika Beňová, Biljana Borzan, Manuel Pizarro, Nicolás González Casares, Simona Bonafè, Tudor Ciuhodaru, Demetris Papadakis, César Luena

Draft motion for a resolution Paragraph 23

Draft motion for a resolution Amendment

23. Considers that digital healthcare 23. Considers that digital healthcare tools are well positioned to address tools could address challenges of challenges of accessibility to health accessibility to health information and information and health literacy, both health literacy, both essential for health essential for health promotion, better promotion, better disease prevention and disease prevention and more effective more effective disease management; disease management; considers that these considers that these tools, when built with tools, when built with the contribution of the contribution of the appropriate health the appropriate health professionals and professionals and civil society users, allow civil society users, allow for more accuracy for more accuracy and completeness of and completeness of information enabling information enabling the promotion of the promotion of healthy habits and healthy habits and prevention activities, as prevention activities, as well as the support well as the support to decisions in health to decisions in health and patient adherence and patient adherence to treatments. to treatments.

Or. en

Amendment 100 César Luena, Nicolás González Casares, Sara Cerdas

Draft motion for a resolution Paragraph 24

Draft motion for a resolution Amendment

24. Stresses the importance of person- 24. Stresses the importance of keeping centred approaches to organising health the national/regional role in the and care, including by using digital organization of health and care systems,

PE643.214v01-00 46/59 AM\1192663EN.docx EN solutions and tools which have a great including by using digital solutions and potential in improving the quality of health tools which have a great potential in services but also people’s health and well- improving the quality, equity and being; sustainability of health services but also people’s health and well-being;

Or. en

Amendment 101 Frédérique Ries, Nils Torvalds, María Soraya Rodríguez Ramos, Irena Joveva, Susana Solís Pérez, Fredrick Federley

Draft motion for a resolution Paragraph 24

Draft motion for a resolution Amendment

24. Stresses the importance of person- 24. Stresses the importance of person- centred approaches to organising health centred approaches to organising health and care, including by using digital and care, including by using digital solutions and tools which have a great solutions and tools which have a great potential in improving the quality of health potential in improving the quality of health services but also people’s health and well- services but also people’s health and well- being; being, while increasing patient empowerment;

Or. en

Amendment 102 Margrete Auken

Draft motion for a resolution Paragraph 24

Draft motion for a resolution Amendment

24. Stresses the importance of person- 24. Stresses that while the use of centred approaches to organising health digitalisation holds great potential in and care, including by using digital improving people's health, person-centred solutions and tools which have a great approaches to health and care remains potential in improving the quality of irreplaceable for many patients health services but also people’s health and well-being;

Or. en

AM\1192663EN.docx 47/59 PE643.214v01-00 EN Amendment 103 Sara Cerdas, Carlos Zorrinho, Monika Beňová, Biljana Borzan, Manuel Pizarro, Nicolás González Casares, Simona Bonafè, Tudor Ciuhodaru, César Luena

Draft motion for a resolution Paragraph 24

Draft motion for a resolution Amendment

24. Stresses the importance of person- 24. Stresses the importance of person- centred approaches to organising health centred approaches to organising health and care, including by using digital and care, including by using digital solutions and tools which have a great solutions and tools which have a great potential in improving the quality of health potential in improving the quality, equity services but also people’s health and well- and sustainability of health services but being; also people’s health and well-being;

Or. en

Amendment 104 Tiemo Wölken

Draft motion for a resolution Paragraph 24 – point 1 (new)

Draft motion for a resolution Amendment

(1) Stresses the importance of providing information to patients and supporting them to make a meaningful decision regarding their health; pointing out that digital platforms must be user- friendly, digitally accessible and provide barrier free information for patients and health care professionals in multiple languages

Or. en

Amendment 105 Frédérique Ries

Draft motion for a resolution

PE643.214v01-00 48/59 AM\1192663EN.docx EN Paragraph 25

Draft motion for a resolution Amendment

25. Calls on the Commission to work 25. Calls on the Commission to work with relevant actors to support more with relevant actors to support more cooperation across borders and enlarge the cooperation across borders and enlarge the deployment of digitally enabled care deployment of digitally enabled care models; models; considers, in this respect, that the European Reference Networks can be excellent vehicles to show how digital health can contribute to improve health outcomes and well-being across borders, as they provide a trusted environment in which health professionals and patients are already working together and exchanging health data cross-borders to achieve their goals.

Or. en

Amendment 106 Stanislav Polčák

Draft motion for a resolution Paragraph 25

Draft motion for a resolution Amendment

Or. cs

Amendment 107 Margrete Auken

Draft motion for a resolution Paragraph 25

AM\1192663EN.docx 49/59 PE643.214v01-00 EN Draft motion for a resolution Amendment

25. Calls on the Commission to work 25. Calls on the Commission to support with relevant actors to support more the digitalisation of regulatory agencies cooperation across borders and enlarge the and to work with relevant actors to support deployment of digitally enabled care more cooperation across borders and models; enlarge the deployment of digitally enabled care models;

Or. en

Amendment 108 Joanna Kopcińska

Draft motion for a resolution Paragraph 25

Draft motion for a resolution Amendment

25. Calls on the Commission to work 25. Calls on the Commission to work with relevant actors to support more with the relevant actors to support more cooperation across borders and enlarge the cooperation across borders and enlarge the deployment of digitally enabled care deployment of digitally enabled care models; models, and to do this without encroaching on Member State competences;

Or. pl

Amendment 109 Sara Cerdas, Carlos Zorrinho, Monika Beňová, Biljana Borzan, Manuel Pizarro, Nicolás González Casares, Simona Bonafè, Tudor Ciuhodaru, Demetris Papadakis, César Luena

Draft motion for a resolution Paragraph 25

Draft motion for a resolution Amendment

25. Calls on the Commission to work 25. Calls on the Commission to work with relevant actors to support more with relevant actors, especially national cooperation across borders and enlarge the health systems, to support more deployment of digitally enabled care cooperation across borders and enlarge the models; deployment of digitally enabled care models;

PE643.214v01-00 50/59 AM\1192663EN.docx EN Or. en

Amendment 110 Frédérique Ries, Nils Torvalds, María Soraya Rodríguez Ramos, Irena Joveva, Susana Solís Pérez, Fredrick Federley

Draft motion for a resolution Paragraph 26

Draft motion for a resolution Amendment

26. Calls on the Commission and 26. Calls on the Commission and Member States to ensure that health Member States to ensure that health professionals improve competences and professionals improve competences and skills; skills, including by defining requirements for digital health curricula for healthcare professionals, creating life-long training centres of excellence for specific digital skillsets, and building up the capacity of regulatory bodies to assess smart health products and services in a rapidly evolving technology environment;

Or. en

Amendment 111 Nathalie Colin-Oesterlé

Draft motion for a resolution Paragraph 26

Draft motion for a resolution Amendment

26. Calls on the Commission and 26. Calls on the Commission and Member States to ensure that health Member States to support health professionals improve competences and professionals in the context of the digital skills; transformation of healthcare systems, to step up exchanges of relevant good practice and to consider harmonising training;

Or. fr

AM\1192663EN.docx 51/59 PE643.214v01-00 EN Amendment 112 Tudor Ciuhodaru

Draft motion for a resolution Paragraph 26

Draft motion for a resolution Amendment

26. Calls on the Commission and 26. Calls on the Commission and Member States to ensure that health Member States to ensure that health professionals improve competences and professionals improve competences and skills; skills by means of regular training programmes that take into account the rapid evolution of the IT sector;

Or. ro

Amendment 113 Sara Cerdas, Carlos Zorrinho, Monika Beňová, Biljana Borzan, Manuel Pizarro, Nicolás González Casares, Simona Bonafè, Demetris Papadakis, César Luena

Draft motion for a resolution Paragraph 26

Draft motion for a resolution Amendment

Or. en

Amendment 114 Tudor Ciuhodaru

Draft motion for a resolution Paragraph 27

Draft motion for a resolution Amendment

27. Calls on the Commission to work 27. Calls on the Commission to work with Member States and regions to with Member States and the regional and develop networks to educate citizens in the local authorities to develop networks to

PE643.214v01-00 52/59 AM\1192663EN.docx EN use of digital healthcare, enabling universal educate citizens in the use of digital access; considers that, in order to achieve healthcare, enabling universal access; that goal, there is a need to improve considers that, in order to achieve that goal, systems’ interoperability and users skills, there is a need to improve systems’ with the highest possible protection of interoperability and users skills, with the sensitive data with tools and mechanisms highest possible protection of sensitive data provided by the public health systems; with tools and mechanisms provided by the public health systems;

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Amendment 115 Sara Cerdas, Carlos Zorrinho, Monika Beňová, Biljana Borzan, Manuel Pizarro, Nicolás González Casares, Simona Bonafè, César Luena

Draft motion for a resolution Paragraph 27

Draft motion for a resolution Amendment

27. Calls on the Commission to work 27. Calls on the Commission to work with Member States and regions to develop with Member States and regions to develop networks to educate citizens in the use of networks to educate citizens in the use of digital healthcare, enabling universal digital healthcare, enabling universal and access; considers that, in order to achieve equitable access; considers that, in order to that goal, there is a need to improve achieve that goal, there is a need to systems’ interoperability and users skills, improve systems’ interoperability and with the highest possible protection of users skills, with the highest possible sensitive data with tools and mechanisms protection of sensitive data with tools and provided by the public health systems; mechanisms provided by the public health systems;

Or. en

Amendment 116 Joanna Kopcińska

Draft motion for a resolution Paragraph 27

Draft motion for a resolution Amendment

AM\1192663EN.docx 53/59 PE643.214v01-00 EN digital healthcare, enabling universal digital healthcare, enabling universal access; considers that, in order to achieve access; considers that, in order to achieve that goal, there is a need to improve that goal, there is a need to improve systems’ interoperability and users skills, systems’ interoperability and users skills, with the highest possible protection of with the highest protection of sensitive data sensitive data with tools and mechanisms with tools and mechanisms provided by the provided by the public health systems; public health systems;

Or. pl

Amendment 117 Sara Cerdas, Carlos Zorrinho, Monika Beňová, Biljana Borzan, Manuel Pizarro, Nicolás González Casares, Simona Bonafè, Tudor Ciuhodaru, César Luena

Draft motion for a resolution Paragraph 27 a (new)

Draft motion for a resolution Amendment

27a. Calls on the Commission and Member States to ensure that all measures to improve citizens digital skills and access to and use of their health data take into consideration sensitive groups such as older citizens, info- excluded people and people with disabilities;

Or. en

Amendment 118 Cristian-Silviu Buşoi

Draft motion for a resolution Paragraph 28 a (new)

Draft motion for a resolution Amendment

28a. Patients should benefit from the most up to date information regarding their medicines, therefore urges the Commission to develop further electronic product information, including thee- leaflet to improve regulatory efficiency and empower patients with up to date

PE643.214v01-00 54/59 AM\1192663EN.docx EN information on medicines.

Or. en

Amendment 119 César Luena, Nicolás González Casares

Draft motion for a resolution Paragraph 29

Draft motion for a resolution Amendment

29. Calls on the Commission to assist 29. Calls on the Commission to assist Member States and regions in raising Member States and regions in raising awareness about innovative procurement awareness about innovative procurement and investment possibilities for digital and investment possibilities for digital transformation in public health and care transformation in public health and care; and in leveraging public and private investment for the large-scale deployment of digitally enabled, integrated person- centred care;

Or. en

Amendment 120 Tudor Ciuhodaru

Draft motion for a resolution Paragraph 29

Draft motion for a resolution Amendment

29. Calls on the Commission to assist 29. Calls on the Commission to assist Member States and regions in raising Member States and the awareness about innovative procurement regional authorities in raising awareness and investment possibilities for digital about innovative procurement and transformation in public health and care investment possibilities for digital and in leveraging public and private transformation in public health and care investment for the large-scale deployment and in leveraging public and private of digitally enabled, integrated person- investment for the large-scale deployment centred care; of digitally enabled, integrated person- centred care;

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AM\1192663EN.docx 55/59 PE643.214v01-00 EN Amendment 121 Frédérique Ries, Nils Torvalds, María Soraya Rodríguez Ramos, Irena Joveva, Susana Solís Pérez, Fredrick Federley

Draft motion for a resolution Paragraph 29 a (new)

Draft motion for a resolution Amendment

29a. Calls on the Commission and the Member States to support the scaling up of smart health pilot and demonstration projects to accelerate learning curves;

Or. en

Amendment 122 Frédérique Ries, Nils Torvalds, María Soraya Rodríguez Ramos, Irena Joveva, Susana Solís Pérez, Fredrick Federley

Draft motion for a resolution Paragraph 29 b (new)

Draft motion for a resolution Amendment

29b. Calls on the Commission to study the possibility of setting up a European smart health innovation hub to assess and promote smart health initiatives, and provide a platform for all actors of the health chain to establish consortia to realise ambitious large-scale projects;

Or. en

Amendment 123 Frédérique Ries, Nils Torvalds, María Soraya Rodríguez Ramos, Irena Joveva, Susana Solís Pérez, Fredrick Federley

Draft motion for a resolution Paragraph 29 c (new)

Draft motion for a resolution Amendment

PE643.214v01-00 56/59 AM\1192663EN.docx EN 29c. Calls on the Commission and the Member States to promote the sharing of best practices and evidence of early adopters of innovative solutions in healthcare, in particular by making a full use of Interreg Europe projects and its Policy Learning Platform;

Or. en

Amendment 124 Frédérique Ries, Nils Torvalds, María Soraya Rodríguez Ramos, Irena Joveva, Susana Solís Pérez, Fredrick Federley

Draft motion for a resolution Paragraph 29 d (new)

Draft motion for a resolution Amendment

29d. Calls on the Commission to continuously monitor, benchmark, and promote the sharing of good practices between Member States and regions to incentivise effective reforms and track progress towards value-based healthcare and sustainable healthcare systems;

Or. en

Amendment 125 Frédérique Ries, Nils Torvalds, María Soraya Rodríguez Ramos, Irena Joveva, Susana Solís Pérez, Fredrick Federley

Draft motion for a resolution Paragraph 30

Draft motion for a resolution Amendment

30. Calls on the Commission to assist 30. Calls on the Commission to assist Member States in creating strategies to Member States in creating contingency avoid total dependency on electronic data, strategies to address any potential in the event of blackouts; temporary or permanent unavailability of health data resulting from an accident or attack on the infrastructure, systems or software used for the collection,

AM\1192663EN.docx 57/59 PE643.214v01-00 EN processing or storage of said data;

Or. en

Amendment 126 Joanna Kopcińska

Draft motion for a resolution Paragraph 30

Draft motion for a resolution Amendment

30. Calls on the Commission to assist 30. Calls on the Member States to Member States in creating strategies to create strategies to avoid total dependency avoid total dependency on electronic data, on electronic data, in the event of in the event of blackouts; blackouts;

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Amendment 127 Joanna Kopcińska

Draft motion for a resolution Paragraph 30 a (new)

Draft motion for a resolution Amendment

30a. Supports the efforts of the European Centre for Disease Prevention and Control (ECDC) to develop strategies to make better use of existing computerised systems, to use data to limit the spread of infectious diseases, and to help Member States gather and process data;

Or. pl

Amendment 128 Frédérique Ries, Nils Torvalds, María Soraya Rodríguez Ramos, Irena Joveva, Susana Solís Pérez, Fredrick Federley

Draft motion for a resolution

PE643.214v01-00 58/59 AM\1192663EN.docx EN Paragraph 30 a (new)

Draft motion for a resolution Amendment

30a. Stresses that a successful digital healthcare transition will require strong political leadership, a long-term vision, and sustained investments at both national and European levels;

Or. en

Amendment 129 Nathalie Colin-Oesterlé

Draft motion for a resolution Paragraph 31 a (new)

Draft motion for a resolution Amendment

31a. Calls on the Commission and Member States to establish a clear timetable of the changes planned in order to create a digital health Europe, with mid-term assessments, and to set targets;

Or. fr

Amendment 130 Nathalie Colin-Oesterlé

Draft motion for a resolution Paragraph 31 b (new)

Draft motion for a resolution Amendment

31b. Calls on the Commission and the Member States to implement the Commission's recommendations of February 2019 on a European Electronic Health Record exchange format;

Or. fr

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