Competitiveness and innovation Framework Programme CIP-ICT-PSP-2012-6 325137 European Network fOr FALL Prevention, Intervention & Security E-NO FALLS
Project Number: 325137 Acronym: E-NO FALLS Title: European Network fOr FALL Prevention, Intervention & Security E-NO FALLS Call (part) identifier: CIP-ICT-PSP-2012-6 Start date: 28/01/2013 Duration: 37 months
D4.2.1 ‘Standardisation and interoperability analysis’
Nature1: R Dissemination level2: PU Due date: Month 19 Date of delivery: Month 20 Partners involved: FHP Associação Fraunhofer Portugal Research AAIF Fundatia Ana Aslan International, Romenia NFT Nordforce Tecnology, Sweden (Task Leader T4.2) NEN Stichting Nederlands Normalisatie Instituut (Deliverable Leader D4.2.1) McR McRoberts, the Netherlands SIV Siveco Romania (Work Package Leader WP4)
Authors: Liliana Ferreira (FhP), Ana Doscan (AAIF), Luiza Spiru (AAIF), Ileana Turcu (AAIF), Ligia Prisaca Manesi (AAIF), Stefan Strömberg (NFT), Marlou Bijlsma (NEN), Rob van Lummel (McR), Ghenadie Gandrabura (SIV)
1 R = Report, P = Prototype, D = Demonstrator, O = Other 2 PU = Public, PP = Restricted to other programme participants (including the Commission Services), RE= Restricted to a group specified by the consortium (including the Commission Services), CO = Confidential, only for members of the consortium (including the Commission Services) Competitiveness and innovation Framework Programme CIP-ICT-PSP-2012-6 325137 European Network fOr FALL Prevention, Intervention & Security E-NO FALLS
Revision history
Rev. Date Partner Description Name 0 2014-01-23 NEN 4.2.1 template Marlou Bijlsma 1 2014-01-31 NEN Preparation for meeting 5 Marlou Bijlsma feb in Delft 2 2014-02-05 NEN Agreed new structure, All chapter headings and responsibilities 3 2014-03-06 NEN Contribution chapter NFT, AAIF, NEN headings and index 4 2014-03-31 NEN Chapters and comments from Vilanova meeting 5 2014-04-17 NEN Subchapter headings for NEN comments to E-No falls partners 6 2014-06-11 NEN Chapters included for SIV, AAIF, McR, FhP, discussion at the telco on NFT, June 12. 7 2014-06-16 NEN First draft for internal NFT, AAIF, FHP, NEN review 8 2014-07-28 NEN For comments UPC Revised chapters NTF, AAIF,McRoberts, FhP, NEN and SIVECO 9 2014-08-04 NEN Draft for review E NO FALLS SIVECO, NEN consortium 10 2014-08-21 NEN Update based on NFT, AAIF, McRoberts, consortium/ partner review FHP, SIVECO and NEN 11 2014-09-01 NEN References updated AAIF, SIVECO, NFT, McRoberts 12 2014-09-04 NEN Final version Marlou Bijlsma 13 2014-09-08 UPC Final revision Jaume Romagosa 14 2014-09-08 UPC Final approval Andreu Català
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DISCLAIMER
The work associated with this report has been carried out in accordance with the highest technical standards and the E-NO FALLS partners have endeavoured to achieve the degree of accuracy and reliability appropriate to the work in question. However since the partners have no control over the use to which the information contained within the report is to be put by any other party, any other such party shall be deemed to have satisfied itself as to the suitability and reliability of the information in relation to any particular use, purpose or application.
Under no circumstances will any of the partners, their servants, employees or agents accept any liability whatsoever arising out of any error or inaccuracy contained in this report (or any further consolidation, summary, publication or dissemination of the information contained within this report) and/or the connected work and disclaim all liability for any loss, damage, expenses, claims or infringement of third party rights.
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List of Figures
Figure 1. Proportion of state contribution to pensions ...... 15 Figure 2. European pension expenditure ...... 16 Figure 3. Retirees expenditure structure ...... 16 Figure 4. The ADEQUACY challenge – Population (65+) living at risk of poverty or social exclusion, 2011 ...... 18 Figure 5. At-Risk-of-Poverty Rate (65 years or more), 2011...... 19 Figure 6. Severe material deprivation (65 years or more) by Gender, 2011 ...... 19 Figure 7. Old-Age Population Dependency Rates vs. Pension System Dependency Rates in Eastern European and Former Soviet Countries, Most Recent Year Available ...... 20 Figure 8. Attachment of the activity monitor ...... 37 Figure 9. Explanation of the report by the lung consultant ...... 37 Figure 10. Cost of care per day ...... 39 Figure 11. Clinical pathway COPD ...... 41 Figure 12. HIC health Informatics ...... 42 Figure 13. Fallers landscape ...... 43 Figure 14. Activity recognition process pipeline (Anguita, Ghio, Oneto, Parra, & Reyes-Ortiz, 2012) ...... 46 Figure 15. ISO 9241-210 (2010) Human-centered design process for iterative systems ...... 52 Figure 16. PDS diagram ...... 55 Figure 17. Concurrent use landscape ...... 73 Figure 18. Adoption of international standards in eHealth in WHO survey ...... 77
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Table of contents
1. Abstract/executive summary ...... 7 2. Introduction ...... 8 2.1 Standardisation and Interoperability ...... 8 2.2 Standardisation and Interoperability Analysis in the Work Package ...... 9 2.3 Methodology ...... 9 3. User perspectives ...... 11 3.1 Introduction ...... 11 3.2 Elders perception about falling ...... 11 3.3 Usability ...... 12 3.4 Accessibility ...... 15 3.4.1 Affordability ...... 15 3.4.2 Availability ...... 21 3.5 Other stakeholders perspective ...... 23 3.6 Conclusions ...... 25 4. Clinical Perspectives ...... 26 4.1 Introduction ...... 26 4.2 ICT in Falls Prevention - Perspectives on Europe ...... 26 4.2.1 Telecare ...... 28 4.2.2 telehealth ...... 28 4.2.3 eHealth ...... 28 4.2.4 Assistive Technology ...... 29 4.2.5 Smart Homes ...... 29 4.3 Protocols and Clinical Guides in Falls Prevention ...... 29 4.3.1 Clinical Test for Falls Prevention ...... 30 4.3.2 Impact of Falls Prevention in Primary Care ...... 31 4.4 Devices for Falls Prevention and Detection ...... 33 4.4.1 Existing Devices ...... 33 4.5 Romania Facts ...... 33 4.6 Conclusions ...... 34 5. Industrial Perspectives ...... 36 5.1 Introduction ...... 36 5.2 Market Analysis ...... 36 5.3 Technical Devices (Medical Device Directive) ...... 39 5.4 Services ...... 40 5.5 Standardisation and interoperability ...... 41 5.6 Conclusion ...... 43 6. ICT Research and Development Perspective ...... 45 6.1 Research and development on falls and activity monitoring ...... 45 6.1.1 Current Technologies ...... 45 6.1.2 Smartphone Based Solutions on Falls and Activity Monitoring ...... 46 6.1.3 Architecture and Common Standards for Mobile Solutions ...... 47 6.1.4 Usability Challenges and Recommendations for Mobile Solutions ...... 48 6.1.5 OS Specific Guidelines ...... 51 6.1.6 Design Standards ...... 52
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6.2 Framework of the Portuguese National Health System ...... 52 6.2.1 Organization of Resources, Provision of healthcare and Funding ...... 52 6.2.2 Portuguese Healthcare Data Platform – Plataforma de Dados de Saúde ...... 53 6.2.3 Architecture, Protocols and Data Protection ...... 54 6.3 Conclusions ...... 56 7. Regulatory Perspective ...... 57 7.1 Introduction ...... 57 7.2 Applicable EU Directives ...... 57 7.3 Overview of EU Regulatory Framework for Medical Devices ...... 61 7.3.1 Current Regulatory Framework ...... 61 7.3.2 Proposed Changes ...... 63 7.4 Two Alternative Regulatory Pathways to the Market for ICT Based Fall Prevention & Intervention Devices ...... 63 7.5 Is the MDD an appropriate regulatory framework for ICT based fall prevention & intervention devices? ...... 64 7.6 National Barriers for Deployment of Services/Products Resulting from falls ICT-based Solutions...... 65 7.6.1 Requirements for National Registration of Medical Devices ...... 65 7.6.2 Requirements for Standards Compliance ...... 66 7.7 Summary ...... 67 8. Standardization perspective ...... 68 8.1 Existing Standards in eHealth and mHealth...... 68 8.1.1 Medical Record Standards ...... 68 8.1.2 Messaging Standards ...... 71 8.1.3 Vocabulary Standards ...... 75 8.2 Use of Standards in ICT Solutions for Fall Prevention and Management .....76 8.2.1 Use of Standards in eHealth and mHealth ...... 76 8.2.2 Which standards are used in the ICT based fall prevention solutions? ...... 81 8.2.3 Case Study Sona ...... 81 8.2.4 Case Study Standardization Initiative Service Chain Social Care Alarms ...... 84 8.3 Conclusions discrepancy between existing standards and use of these standards in ICT solutions for fall prevention and management ...... 85 9. Conclusions ...... 88 10. References ...... 89 11. Annex ...... 96
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1. Abstract/Executive Summary
Effective use of technology for health can streamline processes as well as offering new ways providing healthcare. eHealth and mHealth provide tools and solutions to improve health systems and services, such as respecting the rights of the patient (giving them more information about, and increased control over their health choices) and efficiently utilizing human, financial and other resources.
The standardization of crucial aspects of eHealth and mHealth: interoperability, integration in existing technical systems and organizational procedures, patient safety and privacy are prerequisites for the development and deployment of ICT-based fall prevention and effective intervention solutions for elderly people in Europe.
Standards define consistent interfaces enabling the interoperability and exchangeability of different components; they define safety requirements or permit service offerings to be compared.
International and European standards are developed by ‘all parties concerned’ expert committees an published by standards bodies such as ISO, IEC, ITU, CEN, CENELEC or ETSI. Standard documents are stakeholder consensus agreements of voluntary requirements and recommendations. Standards only become mandatory if a law explicitly requires compliance with a certain standard or set of standards.
In addition to these official standards there are also “industry standards” or “de-facto standards”, “publicly available specifications”, “pre-standards” or “application guides”. These documents are developed and published by a large variety of committees, including the European Commission, WHO, IEEE, IETF, OASIS, HL7 and Continua. Compared to official standards, industry standards can often be developed and published faster since the rules for public comment and voting may be simplified. Correspondingly, industry standards often play a major role in fields where technology changes very quickly, such as Information and Communication Technology (ICT) (AALIANCE2, 2013).
This report summarizes the findings of the E-NO FALLS project with regard to the analysis of the use of standards and interoperability in the field of ICT solutions for fall prevention and management. The issues and requirements relevant for ICT solutions for fall prevention and management are presented from the perspectives of the different stakeholders: - User perspective - Clinical perspective - Industrial perspective - Researcher perspective - Regulatory perspective - Standardization perspective
Each of the chapters addresses one of the perspectives.
Competitiveness and innovation Framework Programme CIP-ICT-PSP-2012-6 325137 European Network fOr FALL Prevention, Intervention & Security E-NO FALLS
2. Introduction 2.1 Standardisation and Interoperability
The standardization of crucial aspects of eHealth: interoperability, integration in existing technical systems and organizational procedures, patient safety and privacy are prerequisites for the deployment of ICT-based fall prevention and effective intervention solutions for elderly people in Europe.
Standards define consistent interfaces enabling the interoperability and exchangeability of different components; they define safety requirements or permit services to be compared.
International and European standards are developed by ‘all parties concerned’ expert committees and published by standards bodies such as ISO, IEC, ITU, CEN, CENELEC or ETSI. Standard documents are consensus agreements with voluntary requirements and recommendations. Standards become mandatory when a law explicitly requires compliance with a certain standard or set of standards. An example is the medical device market, where the EU maintains an official list of “harmonized standards” (European Commission, 2013) which requires compliance for every product placed on the EU market that falls within the scope of the Medical Device Directive 93/42/EEC (chapter 7 of this report).
In addition to these official standards there are also “industry standards” or “de-facto standards”, “publicly available specifications”, “pre-standards” or “application guides”. These documents are developed and published by a large variety of committees, including the European Commission, WHO, IEEE, IETF, OASIS, HL7 and Continua (chapters 6 and 8 of this report). Compared to official standards, industry standards can often be developed and published faster since the rules for public comment and voting may be simplified. Correspondingly, industry standards often play a major role in fields where technology changes very quickly, such as Information and Communication Technology (ICT) (AALIANCE2, 2013).
Standards and interoperability for ICT based fall prevention and management solutions might contribute to: Fostering international standards: This creates a level playing field which strengthens competition to the benefit of consumers and the competitiveness of European industry in the global market. Fostering user/market-driven standards: Too often, the standard development process is too slow and market-agnostic. Many published standards do not fulfil the requirements of the market players and users, as technology and users' wishes have moved along. Promoting interoperability at EU and international level: In the last years, many programs and initiatives addressing ICT-based fall prevention and effective intervention solutions for elderly people have been implemented in various regions in Europe without coordination, hence resulting in a myriad of small-scale systems based on local standards which cannot communicate with each other. The lack of interoperability is a major barrier to the development of ICT-based solutions in Europe. Reducing regulatory burdens: A balanced and efficient regulatory approach is needed to allow for innovation but also for creating confidence among customers. Industry recommends a prudent use of regulatory initiatives in the areas of certification and interoperability conformity testing in order to minimize additional regulatory burdens.
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2.2 Standardisation and Interoperability Analysis in the Work Package
E-NO FALLS Work Package 4: towards Market uptake The main goal of WP4 Towards Market Uptake, is to elaborate guidelines, interoperability standards and toolkits for accelerating the deployment of innovative and ICT-based fall prevention and effective intervention solutions for elderly people, taking into account wider safety and independent living support as part of integrated solutions to prolong independent living of people at risk of falling.
WP4 concentrates efforts in three major priority areas. Each of the three tasks in Work Package 4 addresses one of these priority areas: - 4.1. Defining the framework for a sustainable business model; - 4.2. Foster standards and interoperability; and - 4.3. Enable market development
Task 4.2 has two deliverables. Deliverable 4.2.1 Standardization and interoperability analysis (this deliverable) and 4.2.2 Recommendations for standards and interoperability.
2.3 Methodology
The standardization and interoperability analysis is based on the expertise of the E-NO FALLS project partners and network members, published literature and consultation of key stakeholders that have developed ICT based fall prevention and management solutions.
The initial criteria for the analysis are the different stakeholder perspectives involved in the development and deployment of ICT based solutions for fall prevention and management. The different stakeholder perspectives are; user perspective, clinical perspective, industrial perspective, researcher perspective, legal perspective and standardization perspective. The partners in this report selected these perspectives in consensus during the kick-off meeting, organized at the start of the work on the deliverable.
For each of the perspectives the criteria of analysis do not only focus on an inventory of requirements but also on the available standards within the perspective’s scope.
Additionally each of the perspectives analyze the use of the identified standards by the ICT based solutions for fall prevention and management. The focus is on which standards are used and on the arguments for using or not using the existing standards.
Desk research is the primary data collection method. All partners performed a desk research on the analysis criteria of their perspective. The information used is from different sources; • research publications in scientific journals, • clinical protocols in the different countries, • reports and guidelines from renounced European and international organizations, such as for instance the European Commission and the World Health Organization, • standards from standards organizations (official national, European (CEN) and international standards (ISO)) as well as by industry (de facto standards, for instance Continua)), In addition publicly available specifications, pre-standards and application guides are developed and published by a large variety of committees, including IEEE, IETF, OASIS and HL7,
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• consumer requirements published in reports by consumer organizations, • country specific information is presented as illustrations to the topic.
Each of the partners to this deliverable has selected the perspective of their expertise; for instance: the research organization (Fraunhofer Portugal) has developed a chapter on the research perspective, the industrialist (McRoberts) has developed the industrial perspective and the standardization institute (NEN, Netherlands Standardization Institute) has developed the standardization perspective. By doing so the authors of the chapters are stakeholders themselves in ICT based solutions for fall prevention and management and write about their own experience and way of working. This guides and adds to the desk research on the topic.
To strengthen the aspect of the use of standards in ICT based solutions for fall preventions and management a survey was developed. The questions in the survey (provided in the annex) were guided by the different perspectives and focus on the requirements needed to address the perspective, the use of standards and the reasons why or why not using them. All partners used the responses to guide the writing of the respective chapters.
The number of successful ICT based fall prevention and management solution is limited. For this reason the standardization and interoperability analysis is much more qualitative and hardly quantitative. ‘Case studies’ are included to allow the presentation of good examples. The ‘case studies’ are not necessarily representative.
The approach of this deliverable 4.2.1 ‘Standardization and interoperability analysis’ is iterative and reflective, i.e. findings of this deliverable will be fed into the further refinement and development of deliverable 4.2.2 ‘Recommendations for standards and interoperability’.
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3. User perspectives
3.1 Introduction
In this chapter the user perspective is described regarding fall detection and prevention systems - how these system are perceived in terms of usability and accessibility, what would make these systems acceptable/tolerable by the users. In other words 1) What are the perspectives of older people regarding their own fall risk? 2) What do older people view as barriers and facilitators to adopt and participate in fall prevention programs? What these “clients” expect from these systems to be, to do, how it should behave (on use) and how much it should cost and who should pay for the use, maintenance and replacement or upgrade.
NOTE: In this chapter, the term “client” means “the intended user”.
3.2 Elders perception about falling
In order to understand their perspective on fall prevention and detection systems, first the perception of elders about falling must be understood. Elder’s perspectives on their fall risk may influence decisions about participating in prevention activities. For example, underestimation of health risks or fatalistic beliefs, can lead to assumptions that prevention efforts are not applicable or not beneficial.
A literature review revealed that elders tend to reject the status of “faller” as demeaning – they see themselves as functional members of society (Simpson et al, 2003).
Perceptions of fall risk are linked to other risks, values, beliefs, and emotions. More than often these three themes occur among elders:
• fearing vulnerability - physical losses, loss of independent living, embarrassed, and fearing personal failure (label of “faller” create negative views of older people, which in turn, create social stigma and contribute to ageism). • maintaining autonomy and independence - minimizing insecurity, and staying physically and socially active in communities. Elders that did not experience falling feel that responding to, or dedicating too much time and attention to their own fall risk might interfere with their freedom to engage in desired activities or worse, lead to restricted mobility. Elders who did experience falling tend to reflect on their fall, its cause, and future risks - that helped them to integrate precautionary actions into their lives, which in turn helped them to overcome or minimize their fears. • interpreting risk - while many people believe that information provided by organizations about falls are logical, they often feel it is not personally relevant, for wide-ranging reasons such as beliefs that: o falls are not a serious health problem o falls are an unavoidable aspect of aging Competitiveness and innovation Framework Programme CIP-ICT-PSP-2012-6 325137 European Network fOr FALL Prevention, Intervention & Security E-NO FALLS
o other older people are at more risk o the occurrence of falls, like illnesses, is in the hands of God o using common sense to assess and respond to fall risk is more acceptable than careful calculation of risk
It is important to note that one study (Older Adults' Perceptions of Clinical Fall Prevention Programs: A Qualitative Study (Calhoun R., 2011) ) revealed the existence of two major groups of elders when it comes to fall prevention programs: joiners and non-joiners.
Attitude wise, a systematic review of literature revealed that statistically, six types of attitudes towards falling can be distinguished: • beyond personal control - falls are unpredictable and unpreventable (just an accident; I am old, comes with the territory; bad luck); • rationalizing away – I’m not a faller! I just tripped! I’m too old to learn new tricks.; • salience - knowledge of risk does not necessarily translate to personal applicability or importance; • life-change and identity – being deemed at risk of falls is ‘the beginning of the end’. Accepting the need for falls prevention is seen as being associated with giving up aspects of an independent life-style, and identity as a competent and independent person; • taking control - Ability to decide if and when the choice is made to accept risk status and suggestions for falls prevention is important: “The older you get, the less you want to be told what to do.” (Yardley et al., 2006). Implementing their own ideas for minimizing risk was highly valued; • self-management - Self-management could give a sense of control, alleviate fear of uncertainty and decrease feelings of powerlessness.
It appears to be clear that elders do not necessarily accept that they are at risk of falling or accept the need for intervention, even when deemed at high risk.
The meanings associated with risk of falling centre on frailty, loss of independence and need to control life and preserve identity as able and independent. Consequently, the need to be in control and employ self-management strategies is highly valued and may be preferred to adopting prescribed interventions.
Therefore, options for falls prevention should be negotiated, taking into account the multifaceted beliefs and emotions associated with being labelled as ‘at-risk’ and individual preferences for self-management.
3.3 Usability
In this chapter the user perception on usability of the falling prevention and detection systems will be discussed.
Webster definition for usability: 1: capable of being used 2: convenient and practicable for use
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Although this definition is correct per se it will not suffice in the context of this document. Hence, a more detailed and adequate definition (and understanding) is needed.
As most of the fall prevention and detection systems rely or use ITC, the below definition is proposed:
“Usability is a quality attribute that assesses how easy user interfaces are to use. The word "usability" also refers to methods for improving ease-of-use during the design process.
Usability is defined by 5 quality components: • Learnability: How easy is it for users to accomplish basic tasks the first time they encounter the design? • Efficiency: Once users have learned the design, how quickly can they perform tasks? • Memorability: When users return to the design after a period of not using it, how easily can they re-establish proficiency? • Errors: How many errors do users make, how severe are these errors, and how easily can they recover from the errors? • Satisfaction: How pleasant is it to use the design?
There are many other important quality attributes. A key one is utility, which refers to the design's functionality: Does it do what users need?
Usability and utility are equally important and together determine whether something is useful: It matters little that something is easy if it's not what you want. It's also no good if the system can hypothetically do what you want, but you can't make it happen because the user interface is too difficult. To study a design's utility, you can use the same user research methods that improve usability.
• Definition: Utility = whether it provides the features you need. • Definition: Usability = how easy & pleasant these features are to use. • Definition: Useful = usability + utility.”
The omnipresence of ICT in our era and its influence on people everyday life is undisputable. A study conducted by Briggs and Little shows that:
“Living in an information society social inclusion is essential to be able to participate in many everyday activities [3]. Elderly people often have to overcome additional problems before they can use and benefit from a range of technologies and services. Generally technology is considered accessible if the system can be used in an identical or reasonable manner by all. Often elderly people need additional assistive technologies to be able to use systems e.g. screen readers, voice synthesizers. The embedded design of Ubicomp creates a problem if a person requires some form of assistive technology to be able to interact and use the system effectively.” (Linda Little, 2010)
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Furthermore, the study revealed a number of concerns related to the use of fall prevention and detection systems in the context of information society:
Trust – comprising: • Stakeholder credibility - Credibility is underpinned by concepts such as loyalty and reputation. • Stakeholder motivation - A key component of trust in the system, given that stakeholders were capable of monitoring goods and people. • Monitoring by stakeholders - Monitoring was considered very problematic. For example, if someone was diabetic and shopping for the family would a company decline or stop insurance because certain food was bought that he or she was not supposed to eat? • Flexibility - the extent to which systems could be trusted to faithfully reflect unpredictable day-to-day changes in human behavior. • Personalization - a personalized system would be useful and more reflective of elders needs • Transparency - linked to data storage, mining, exchange and access by third parties • Risk and responsibility – both system and/or user can be wrong or do wrong when using the system, thus generating unwanted effects.
Privacy - comprising • Informational (Relates to a person’s right to reveal personal information to others, which is not always under a person’s control). • Social (The ability to control social interactions by controlling distance between people. This dimension is associated with physical privacy and often a natural consequence of it). • Physical(How physically accessible a person is to others and can be linked to such aspects as environmental design).
Can be concluded that a system or device should be benchmarked against a set of attributes - prior it’s release – for usability.
Proposed set of attributes:
• Ergonomics – fit for human use in terms of dimensions, effort required to handle, knowledge required to use (comprise intellectual effort to understand the interface), • Learnable – elders either tend to refuse to learn new things either can’t learn. There for the devices or systems must rely on what elders already know, remember and can use as concepts, rational processes or logic. • Poka Yoke principle – people will make mistakes. The system or device must be mistake proven or statistically robust – so even if an error (of use, of function etc.) occurs, the likely effect to be bearable and easy to recover. • Satisfaction – also can be seen as effectiveness – the extent to which the device or system provides the expected results from this use of it. Psychological comfort (privacy, self-image, public image) can also be included here.
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3.4 Accessibility
For the purpose of this document, accessibility will be understood in terms of availability and affordability.
3.4.1 Affordability
From elder’s perspective, the cost of purchasing and using fall prevention and detection systems and devices is the main concern. Regardless the region, country, culture or sex, elders tend to have scarce resources available to be spent on such items or services. The fear comes from the fact that due to government’s preoccupation in reducing expenditure on health (or at least take the growth of it under control – see figure 3.1 and 3.2 for pension expenditure projection for 2050), it is most likely that the cost of these services and items will come out of their own pockets. Pockets that are already overwhelm – figure 3.1 shows that Retirees are paying more for health care than food (US).
Figure 1. Proportion of state contribution to pensions
Source: http://www.ft.com/cms/s/0/e9601116-68f4-11df-910b-00144feab49a.html#axzz2ylVZYVhw (Financial Times, 2013)
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Figure 2. European pension expenditure
Source: http://www.reuters.com/article/2010/06/16/france-pensions-idUSLDE65F0A920100616 (Reuters, 2010)
Figure 3. Retirees expenditure structure
Source: https://www.fidelity.com/viewpoints/retirement/health-care-costs-when-you-retire (Fidelity, 2014)
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A WHO report from 2011 shows:
“Health system characteristics Service provision. The use of primary care gatekeepers seemed to result in lower health expenditure. Public sector provision of health services was associated with lower health expenditure (Gerdtham et al. 1998).
Health financing. In terms of financing structure very few empirical studies found that the extent to which health care expenditure was financed by the government has a relationship with levels of health expenditure (Leu 1986; Culyer 1988; Hitiris & Posnett 1992; van der Gaag & Stimac 2008). Differences in health expenditure between tax-based vs. social-insurance based systems were examined in OECD countries and eastern European and central Asian (ECA) countries (A. Wagstaff & Bank 2009; A. Wagstaff & R. Moreno-Serra 2009). The OECD study found that health expenditure per capita was higher in countries where a social health insurance mechanism exists. The ECA study suggested per capita government health expenditure was higher in countries with social health insurance as compared to countries that relied solely on general taxation.
External funds. Recently, there has been much interest in relationship between external funds and national health expenditure in developing countries. Gaag and Stimac found that whereas there was no significant impact of health-specific official development aid (ODA) on total health expenditure, health specific ODA has an elasticity of 0.138 against public spending on health (van der Gaag & Stimac 2008). Lu et al 2010 found that health ODA channeled through the non-government sector had a positive relationship with general government health expenditure, while a negative correlation was found when it was channeled through government sector (Lu et al. 2010). Farag et al found that for a 1% increase in health ODA government health expenditure decreased by 0.027% in upper-middle income countries; 0.04% to 0.09% in lower-middle income countries; and 0.14% to 0.19% in low income countries (Farag et al. 2009).
Provider payment mechanisms. Fee-for-service systems tended to lead to higher expenditure on average than capitation systems (Gerdtham et al. 1998; Gerdtham & Jönsson 2000). A shift from financing hospitals through budgets to fee-for-services or patient-based payment mechanisms was associated with increases in both public and private components of health expenditure in a study from ECA countries (Rodrigo Moreno-Serra & Adam Wagstaff 2010). Furthermore, the ratio of in-patient expenditure to total health expenditure is positively related to health expenditures (Gerdtham & Jönsson 2000; Gerdtham et al. 1998). The total supply of doctors may have a positive effect on health expenditure (Gerdtham & Jönsson 2000; Gerdtham et al. 1998). However, the Murthy and Okunade study of African countries found no relationship between the density of doctors and health expenditure (Murthy & A. Okunade 2009).” (WHO, 2011)
Analyzing statistical data available on Eurostat and other sources, Allianz Knowledge (an Allianz Insurance and Financial Services website) draws some interesting conclusions:
“…the most pronounced differences in consumption expenditure on housing and healthcare occur in the eastern countries of the European Union. Slovakians over 60 years of age spend roughly 40% of their expenditure on housing, 9.4 percentage points more than the national household average.
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Elderly Romanians’ spending on healthcare is disproportionately high. With a share of 10.3%, they have the highest exposure to medical expenditure, which is 6.5 pp above the mean national consumption. But major differences are also apparent within the Euro zone. Finland’s older population, for example, spends 8.4 pp more on housing than the average Finnish household.
Linking pension payments to national CPI may be an inadequate way to assess the real cost of living that retirees face. This could be providing a false impression of the adequacy of pension benefits and, ultimately, may even undermine the adequacy of those benefits.” (Eurostat, 2012)
A short glimpse on elder’s poverty statistics is relevant in relation to this chapter subject: accessibility (affordability) of fall prevention and detection devices and systems – see figures 3.4, 3.5 and 3.6 below.
Figure 4. The ADEQUACY challenge – Population (65+) living at risk of poverty or social exclusion, 2011
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Figure 5. At-Risk-of-Poverty Rate (65 years or more), 2011
Figure 6. Severe material deprivation (65 years or more) by Gender, 2011
Source: http://ec.europa.eu/europe2020/pdf/themes/04_pensions.pdf (European commission, 2011)
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Figure 7. Old-Age Population Dependency Rates vs. Pension System Dependency Rates in Eastern European and Former Soviet Countries, Most Recent Year Available
Source: http://siteresources.worldbank.org/ECAEXT/Resources/publications/454763- 1181939083693/chaw_151-176_ch04.pdf (World Bank, 2007)
Some data from Romania:
In 1990, percentage of elders (>60yo) within population was 10.35% and raised to 20.31% in 2010. In July 2012 (National Council for Elders Romania, 2012): • a percent of 27.29 out of 5.3 million retired (1.448.967 people) had a social security allowance of 417 lei (considered to be the average monthly expenditure basket at the time); • 42.85% (2.275.510 people) had a pension of 562 lei (minimum survival income); • 54.99% (2.920.054 people) had under 696 lei (poverty threshold); • So only 45% of them had an income above poverty limit.
In United States of America:
In 1959 35% of elders lived under poverty line. In 1974, the elderly poverty rate fell to 15%. In 2006 the percentage was only 9.4%. This was largely attributable to a set of increases in Social Security benefits. Social Security and Supplemental Security Income benefits continue to play a key role in reducing elderly poverty, especially among women and people of colour.
However, a study conducted by Henry J. Kaiser Family Foundation reported that in 2011, 58 percent of people didn't seek treatment they needed because it was too expensive. And they concluded: “with people living longer -- men can expect to live 81.6 years, up from 66.1 and women are living to 86, up from 73.5 -- and 70 percent of people over 65 needing long-term health care, the need for a "financially viable scheme" is dire”. (Henry J., 2012)
A study conducted by AXA Wealth (a major player on Investment and retirement consulting in UK) found that:
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• Most pensioners in the survey (69%) retired earlier than they thought they would, driven by ill health – either their own or their partner’s – redundancy or offers of early retirement, and for a small number, the need to care for elderly parents. • 58% of pensioners said that they did not seek professional advice. Of those that did seek professional help, 14% waited until just before they retired. • Almost 40% of pensioners do not feel “comfortably off” in retirement and would need extra money – among them, more than half would need about an extra £4,000 a year or more. • Just under 40% of recent pensioners reported they have had to scale back their lifestyle in retirement, cutting back not only on ‘life’s little luxuries’ such as holidays but more worryingly, of those that said they have scaled back their lifestyle, 27% have cut back on essentials such as food and heating. • A third said that they had trouble making ends meet and felt anxious about money. • Almost one in five report having some difficulty paying bills in the last year. • Ultimately, three in five think that they will need to cut back further on their spending as prices continue to go up and four out of five pensioners expect the real value of their pension to decline as inflation takes its toll. • On the one hand, just 10% of pensioners see the current economic climate as an opportunity to invest - but on the other hand they need savings to generate income to top up pensions. (AXA Wealth, 2012)
As a conclusion to this sub-chapter, it can be said that joiners will adopt and will be willing to pay the price for fall prevention and detection systems and devices if it proves to be “reasonable”, while non-joiners will have a positive attitude towards these systems and devices only if they perceive them as a sweet bargain.
3.4.2 Availability
Availability can be described in a three dimension space: - service availability – includes public services and programs, private initiatives (volunteers, private clinics, etc.) - knowledge and awareness availability – includes public policies, dissemination schemes, etc. - equipment and devices availability – includes R&D, production and commercialization of goods, distribution network and supply chains
Each of these dimension should cover the three components of fall management of elders: - prevention - detection - intervention
The spread of elders fall related injuries is endemic around the world – a large part of the population is involved in one way or another with the management or/and consequences of such accidents.
It is easy to observe that in this field – prevention service – efforts have been made with good results around the world.
A study oriented on effectiveness of population-based programs revealed that they are effective and can reduce fall occurrence among elders with up to 75%!
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The study shows: „A number of countries have prepared guidelines to prevent falls in the elderly. Effective interventions are available to prevent falls and include increased physical activity and hip protectors. Strategies targeted at fall prevention include regulation, education, environmental change and population or community-based coordinated programs. A population-based intervention program shares ownership of the injury problem with the whole community, experts and community members. Joint responsibility is taken for determining priorities and appropriate interventions are widely promoted.” And they conclude: „…population-based approach to the prevention of fall-related injury is effective and can form the basis of public health practice”. (McClure RJ, 2005)
In UK, the National Institute for Health and Care Excellence (NICE) provides evidence based guidelines for “healthcare and other professionals and staff who care for older people who are at risk of falling.” And addresses “All people aged 65 or older” and “People aged 50 to 64 who are admitted to hospital and are judged by a clinician to be at higher risk of falling because of an underlying condition are also covered by the guideline recommendations about assessing and preventing falls in older people during a hospital stay.” – Guideline CG161 Falls: assessment and prevention of falls in older people. (NICE, 2013)
Many other programs and initiatives can be listed here as evidence of a widely available services – both public and private – aimed to prevent falls among elders. Here are some examples:
FallSafe (UK) The FallSafe Project: a quality improvement programme that uses specially trained nurses to introduce an evidence based care bundle to reduce inpatient falls.
It is run by the Royal College of Physicians Clinical Effectiveness and Evaluation Unit in partnership with the Royal College of Nursing, the National Patient Safety Association, the Association for Victims of Medical Accidents and South Central Regional Health Authority.
It is funded by The Health Foundation, an independent charity funded by the insurance industry, which specialises in Quality Improvement projects.
CDC – USA Develops and maintains programs and issues guides on how community based programs can be designed and managed in order to prevent elderly falling.
“How to Develop Community-based Fall Prevention Programs for Older Adults”
Source: http://www.cdc.gov/homeandrecreationalsafety/images/cdc_guide-a.pdf (National Center for Injury Prevention and Control, 2008)
Note: a more complete list of such programs can be subject of a separate research – the resulting data can be useful to draw some conclusions regarding the best practice to be implemented nations wide with regard to prevention of falling among elders. A unified and coherent approach of such programs could lead to a set of effective yet sustainable measures across Europe to prevent, detect and treat falling among elders.
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Such endeavours have been made to some extent and their results can be used.
The above examples also cover the knowledge and awareness area as each program or initiative have a strong component addressing dissemination of information, rising awareness and involving elders in adopting preventive behaviour or practices.
In terms of availability of ICT systems and devices, elders, divided in the two major groups shown above (joiners and non-joiners) have divergent perceptions. A vast majority (over 80% in Europe) will trust the doctor’s recommendations – both in terms of what they need and from where to purchase the item. The non-joiners consider that they don’t have a ‘falling problem. Admitting they become fallers is unacceptable in their view.
Both groups tend to expect that the necessary equipment should be available in specialized shops or clinics and hospitals, perceiving these devices as prosthetics. Along with the equipment, assistance and guidance for use and storage - and servicing - is expected to be provided by the seller.
3.5 Other stakeholders perspective
Family and dependents
Their power is the lowest among stakeholders – they can only decide within their group what policy, strategy or solution to adopt – if any. Their perception of their power in the matter is that there is nothing they can do to improve how falling risk is tackled or how their quality of life can be improved. Answers like: “I am too small and insignificant – there is nothing I can do to change something” are common.
However, their influence on the matter is one of the highest – in their position of close proximity with the elder at risk, emotionally and culturally connected to the elder, their tend to take control on elder decision regarding his attitude (joiner/nonjoiner) if and what solution to adopt in order to prevent falling risk. It is also important to note that in Romania, in most cases, the proxies are the one that bear the responsibility of paying for the cost of the service or device chosen. In relation with this, currently, there are no reimbursement mechanisms in place that can ease the burden of the cost –the health insurance have not listed such devices or services in the list of supported costs related to health. Most responders consider this as a major injustice towards elders who ”worked hard all their life just to be neglected at old age! They expect us to drop dead and stop waiting for charity!”
On Interest criteria this group also scores the highest (five), perceiving themselves as victims – see statement above.
They tend to have high score in Salience - which indicates that this group should be considered as primary target for any program or legal initiative related to fall prevention among elders. The perspective of the group from this point of view is that since “they worked hard all their lives” and “paid taxes and health insurance they should be reimbursed for the cost of such services and devices – they deserve a better life”.
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Production oriented business Device producers and service providers have discretionary power with regard to resources to be used. It is up to them to decide whether a device or service should be produced or offered based on their respective business interest. Since the main drive for such decision is profit generation, becomes obvious that in the absence of a trustful mechanism for payment reimbursement positive and strong decision in mass producing such devices (or services) is not to be expected. The business owners tend to consider these devices and services as niche products for rich people – those who rely on state support (public funding, health care insurance systems etc.) are not a target for their business. In this group are also included the professional care givers that are business oriented – based on profit.
Care givers In this group have been considered those entities (professional or not) that provide services to elders at risk to fall on non profit basis – humanitarians, charity, volunteers and proxies.
Although their power is low, they tend to be very influential both towards elders and decision makers.
In this groups’ perspective, the very existence of their group is the proof that “something needed to be done” since “no one else does”. They see their service and activity as a mean to compensate the lack of proper funding (reimbursement mechanisms) and proper regulations (elders at risk of falling are not medically diagnosed as in need).
In most situation this group works in close collaboration with NGO for fund raising and awareness and involvement programs.
Another notable perception of this group is that they can be the best solution for the problem: with little funding from state (getting the status of entity of public interest) and regulation support from politicians (laws and regulations), they can solve the problem of falling prevention and intervention for elders. In their perspective, the best way to improve an elder life and keep him safe from falling is not a device but another person – caring person.
Medicine In this group have been considered entities such as specialized clinics and hospitals and their medical staff.
They score the highest among stakeholders since they have the power to block any program or initiative towards the matter of elder falling (based on their unique expertise and knowledge), their opinion is the most respected and their interest is undisputable since they have to tackle with the effects of falling elders.
In their perspective, age induced fragility and vulnerability is a medical condition and should be treated as a medically diagnosed condition. It is particularly interesting to note here a statement of an orthopaedist: “since I am paid to diagnose and treat you if you have a flew, and you can get your money back from health insurance for the aspirin, I guess it’s only normal for me to get paid if I diagnose you with old age induced condition and prescribe some special device for prophylactic/preventive purpose, and is only fair that you get reimbursed by health insurance company for it – the expense is a health expenditure.”
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3.6 Conclusions
It can be concluded that fall prevention among elders have three main perspectives: business, social and moral.
Moral wise, the matter can simply not be dismissed. Old people are still humans, part of the society, and have equal right to happiness and support from society as any other member of the society.
Socially, they are an important segment of population – both by their numbers and their role in society.
But as long as economically and financially (business wise) this matter is not properly regulated, no sustainable source of funding is provided, with mechanism that are susceptible to sustain such funding long periods of time in various political and economic environments, the “problem” of “fallers” cannot be solved.
It seems that there is a general agreement among stakeholders that state involvement (through proper regulation of social security policies, health care policies and health insurance regulations) is a must.
The missing link in the matter of preventing elders of falling is a proper mechanism for reimbursement of the costs involved.
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4. Clinical Perspectives 4.1 Introduction
According to the Digital Agenda for Europe, “each year, one in three people over 65 has a serious fall, mostly in home. Often their quality of life is severely diminished: loss of mobility, severe dependency and physical disability. The cost of falls is high and will continue to rise as long as no good fall and fall prevention strategies are in place. And yet: falls are the most preventable cause of people going to nursing homes, and ICT definitely can provide solutions.” (European Commission)3
Therefore, the reduction of falls in people at risk became a critical demand and a great challenge. Among the current innovative approaches in this field, advanced technology-based solutions (sensors and software technologies) began to evolve and to prove their efficiency in fall reduction and indirectly, their ability to significantly improve the individual quality of life, the caregiver efforts and the costs of medical care. (Center of eHealth and Healthcare technology - University of Agder)4
4.2 ICT in Falls Prevention - Perspectives on Europe
The FARSEEING project (European Project-FP7) develops a comprehensive approach to better predict, prevent and manage falls based on a long-term analysis of behavioural and physiological data collected using Smartphones, wearable and environmental sensors, within the specific field of geron-technology. “Farseeing” means having or showing awareness of and preparation for the future. Following the FARSEEING approach (data collecting, analysing and processing) provides us with opportunity to make a real difference in the area of falls prevention (FARSEEING)5. The project also aims to build the world’s largest fall repository. In January 2012 a consensus process involving experts from different countries in the field of fall prevention have initiated a proposal of a standard data format on fall (Klenk, 2013)6.
Another European project, I-DONT-FALL, aims to pilot integrated and configurable fall management solutions, for providing suitable ICT- based fall management means, centred on the specific needs, root causes, risk factors and cultural factors associated with fall incidents. The I-DONT-FALL approach is expected to increase the efficiency of ICT based detection and prevention of falls, as well as to open new horizons for marketing, exploiting and sustaining fall-related ICT solutions.
3 European Commission; PSP- proposal: Fall prevention through intelligent sensors and control systems; http://ec.europa.eu/digital-agenda/en/ict-and-fall-prevention-elderly 4 Center of eHealth and Healthcare technology - University of Agder; ICT-PSP- proposal: Fall prevention through intelligent sensors and control systems; http://www.cip.gov.pl/container/ICT/Baza_Partnerow2011/Norway_fall_prevention.pdf - ICT- 5 FARSEEING; Innovation to serve the older generation towards an active and healthy ageing and to prevent falls http://farseeingresearch.eu/less-falls-better-lives/ 6 Klenk, J et al; Development of a standard fall data format for signals from body-worn sensors: The FARSEEING consensus; Zeitschrift für Gerontologie und Geriatrie; Dec2013, Vol. 46 Issue 8, p720
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Significant key facts in fall prevention, retrieved from the above initiatives may thus be concluded: - a good management in ICT implementation for fall prevention is necessary for prevention and detection; - it is important to understand that living settings (home or nursing homes) make the difference in the approach of an ICT solution for fall prevention; - electronic devices are important in fall prevention, clinical evaluation (tests, biological parameters) and the readjustment of the living space for preventing falls (more light, no carpets, furniture adaptation, etc.).
The FARAO project (Fall Risk Assessment in Older adults) - develops and tests a miniaturized body-fixed sensor that allows ambulatory measurements of body acceleration and angular velocity data. Algorithms and analyses are developed to detect impending falls (instability) and actual falls in older adults in daily life, during daily physical activities, as well as to predict overall fall risk.
The capacity of these ICT solutions to intercommunicate is a must and can be realized by using the same taxonomy.
TAXONOMY OF SERVICES
PROFOUND, a European project started in 2007 and dealing with falls prevention has developed the “Manual for the fall prevention classification system” initiating the falls prevention taxonomy based on market research. The taxonomy was developed with three main purposes: to classify and characterize the existing battery of interventions regarding falls prevention; to promote and encourage new developments in these domain and publish their results, as well as to create models for future applications.
A taxonomy database is already available on the ProFaNE website and on the Warwick Clinical Trials Unit website.
There are many products that can help people with disabilities to enhance their quality of life. Hearing aids, wheelchairs, Braille equipment, communication devices, software, urine collection systems, oxygen apparatus, and mobile hoists may help people with disability to better function in their daily life and to remain socially inserted. Subdivisions of assistive products can be found in several classifications and nomenclatures: ISO 9999 (assistive products for persons with disability – classification and terminology), (The International Organization for Standardization)7 GMDN (The Global Medical Device Nomenclature )8 and SNOMED CT-systematized nomenclature of medicine – clinical terms (International Health Terminology Standards Development Organization)9.
Another solutions proposed by IDF (I-DONT-FALL) are the IDF prevention service (exercises for gait and balance training) and cognitive improvement (attention and executive function inputs), as well as the IDF detection system able to modify various risk factors, e.g. to reduce the fear of falling through safety system devices (alarm, positive feedback, better stability and
7 The International Organization for Standardization; http://www.iso.org 8 The Global Medical Device Nomenclature (GMDN) http://www.gmdnagency.org 9 International Health Terminology Standards Development Organization http://www.ihtsdo.org
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self-sufficiency). (ICT-PSP) 10 , (Sachiyo, 2005) 11 , (United Nations (UN), 2004) 12 , (European Commission)13
The largest majority of studies related to falls management using ICT targeted fall detection, copes with fall accidents and injuries that have already occurred. Fall prevention means to avoid falls before they occur. Only few studies have investigated fall prevention by using ICT. Currently, there are no relevant studies to fall prevention by ubiquitous computing. The WHO- Europe Report “What are the main risk factors for falls amongst older people and what are the most effective interventions to prevent these falls?” elaborated in 2004, investigated the effective measures to prevent fall in the elderly, as well as the effective support that may be delivered by mobile and ubiquitous computing. (Wang, 2013)14
4.2.1 Telecare
Telecare can be defined as the continuous, automatic and remote monitoring of emergencies and lifestyle changes over time, in order to manage the risks associated with independent living.
The funds for Telecare are expected to be provided by the social ensuring system.
4.2.2 telehealth
Telehealth aims to provide "good health care" remotely, by using electronic communication means between users and clinicians. For example, a service that measure vital parameters of a subject at home, sends the recorded values via the telehealth service to be monitored by the clinician.
It is assumed that telehealth funds to be provided by the public healthcare system. (Tehnologia Informatiilor si Comunicatiile in sprijinul traiului independent si al ingrijirii persoanelor in varsta si/sau cu dizabilitati)15
4.2.3 eHealth eHealth can be defined as health related services, information and education, provided or improved via internet and other computer-related technologies. In terms of financing there have been made a distinction between the activities provided for the user and the formal user- clinician interactions. The first can be funded by the public health system, and the last in a reimbursement system, which applies in relation to health consultations.
10 ICT-PSP; I-DON'T-FALL; Integrated prevention and Detection sOlutioNs Tailored to the population and Risk Factors associated with FALLs; http://www.idontfall.eu/?q=content/deliverables 11 Sachiyo Yoshida. World Health Organization. A Global Report on Falls. Prevention Epidemiology of Falls. http://www.who.int/ageing/projects/1.Epidemiology%20of%20falls%20in%20older%20age.pdf 12 United Nations (UN); World Population Prospects: The 2004 Revision. New York, USA; 2004 13 European Commission, Eurostat, Population; http://epp.eurostat.ec.europa.eu/statistics_explained/index.php/Population 14 Wang, Weilin; Supporting Fall Prevention for the Elderly by Using Mobile and Ubiquitous Computing; Norwegian University of Science and Technology, Faculty of Natural Sciences and Technology, Department of Biology; June 2013 15 Tehnologia Informatiilor si Comunicatiile in sprijinul traiului independent si al ingrijirii persoanelor in varsta si/sau cu dizabilitati; http://andrei.clubcisco.ro/cursuri/5master/savlsi/misc/TIC%20in%20sprijinul%20persoanelor%20varstnice.pdf
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4.2.4 Assistive Technology
Assistive technology includes independent systems of technological devices able to support the accomplishment of daily living tasks. Funding may be provided by healthcare system or social services.
4.2.5 Smart Homes
Smart homes specifically customized and adapted for fall prevention are included into the category of networking systems and ICT-based control that operates at home, often being connected to external services. The funding is expected to be made in the fields of housing services, assistance services or social services assisting people with disabilities.
4.3 Protocols and Clinical Guides in Falls Prevention
Falls are coded as E880-E888 in International Classification of Disease-9 (ICD-9), and as W00- W19 in ICD-10, which include a wide range of falls including those on the same level, upper level, and other unspecified falls. (WHO)16
Another important clinical guide used in USA is the Clinical Practice Guideline: Prevention of Falls in Older Persons (2010 AGS/BGS).
A recent clinical guideline regarding falls was published in June 2013 by The National Institute for Health and Care Excellence (NICE) who provides national guidance and advice to improve health and social care. Their recomandations are for preventing falls in older peoples in their homes and for the olders during a hospital stay. (http://www.nice.org.uk/guidance/CG161) This is in fact an update of the one from 2004. We consider their recomandations regarding falls preventions assement very well structured and very useful in clinical practice.
In Romania: - Guide for Good Medical Practice in Geriatrics and Gerontology including two annexes: The Geriatric Assessment and the Medical Observation Form http://www.ms.ro/documente/FOAIE%20DE%20CONSULT%20GERIATRIC%20- %20Anexa%20la%20evaluarea%20geriatrica_8819_6817.pdf - With a Comprehensive Assessment in Geriatrics and Old Age Psychiatry, approved by the Romanian Ministry of Health Ordinance No 1454/30.11.2010 http://www.ms.ro/documente/Evaluarea%20geriatrica%20-%20Anexa_8819_6816.pdf - Curriculum and Syllabus in Geriatric Medicine, according to the Romanian Ministry of Health Ordinance 1041/2010 http://www.emedic.ro/Rezidentiat/CURRICULUM-DE- PREGATIRE-IN-SPECIALITATEA-GERIATRIE-SI-GERONTOLOGIE.htm - The Order of Nurses, Midwives and Medical Assistants in Romania; A nursing protocol for fall prevention and management (Prevenirea si coordonarea caderilor) www.oammr-sv.ro/files/doc/PROTOCOALE_NURSING.doc - Association for Osteoporosis Prevention Romania (ASPOR); The role of physical exercise for fall prevention in osteoporosis; http://www.aspor.ro/content/view/130/53/lang,ro/
16 WHO Global report on falls Prevention in older Age; http://www.who.int/ageing/publications/Falls_prevention7March.pdf
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- The management of the Postprandial hypotension (PPH) or vitamin D deficiency.
4.3.1 Clinical Test for Falls Prevention
No screening tool has been used or validated Europe-wide to assess risk of falling among older people, but there are tools that have been clinically used, (WHO, 2004) 17 such as: The STRATIFY risk assessment tool, (Oliver & et al, 1997) 18 a screening tool based on the PROFET study, (Close, 2003)19 Nandy, (Nandy)20 The Mobility Interaction Fall Chart, (Lundin- Olsson , Nyberg, & Gustafson, 2000)21 etc.
Assessment of fall risk typically involves either the use of multifactorial assessment tools (MAT) that cover a wide range of fall-risk factors, or functional mobility assessments (FMA) that typically focus on the physiological and functional domains of postural stability including strength, balance, gait and reaction times. The MAT typically consist of a checklist comprising questions used to screen the level and nature of risk based on a combined score of multiple factors known to be associated with fall-related risk. These include factors such as psychological status, mobility dysfunction, elimination patterns, acute/chronic illnesses, sensory deficits, medication use and a history of falling. FMA focus on functional limitations in gait, strength and balance and are often completed by physical therapists or physicians in outpatient or acute care settings. In most cases, the subject is required to perform a physical demonstration of ability while the assessor monitors limitations in function compared to a pre-established standard.
Another fall risk predictive test are used in clinical practice, and also clinical research such as: • Downton, the fall risk index - the test is easily to perform and useful in clinical environment / residential care, by nurses and physiotherapist; • Mobility Interaction Fall (MIF) - the aim of this screening tool is to identify older people living in residential care facilities who are prone to falling and Tandem Gait Test.
Regarding other European projects (see questionnaire in Annex) we consider that all falls risk assessment, clinical scales and clinical tests (see D2.2-5) should be easy to use and predictive for an earlier stage of risk falling. The clinical implementation of all ICT solutions will be a successful fall prevention strategy if the process will be active and helpful in the daily life of older people in their own home.
A multitude of methods for assessing the risk of fall are used and accepted in the clinical practice. Other projects, such as iStoppFalls have used different fall risk assessment tools, among which we can mention:
17 WHO Report, What are the main risk factors for falls amongst older people and what are the most effective interventions to prevent these falls? http://www.euro.who.int/__data/assets/pdf_file/0018/74700/E82552.pdf, March 2004 18 Oliver D et al. Development and evaluation of evidence based risk assessment tool (STRATIFY) to predict which elderly inpatients will fall: case-control and cohort studies. BMJ, 1997, 315:1049-1053. 19 Close, JCT et al. Predictors of falls in a high risk population - Results from the prevention of falls in the elderly trial (PROFET). Emergency medicine journal, 2003, 20,5:421-425. 20 Nandy S et al. Development and preliminary examination of the predictive validity of the Falls Risk Assessment Tool (FRAT) for use in primary care. Journal of public health and medicine, forthcoming 21 Lundin-Olsson L, Nyberg L, Gustafson Y.;The mobility interaction fall chart.; Physiotherapy research international, 2000, 5:190-201
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1. Reduction of fall risk by Short-form Physiological Profile Assessment (PPA; Lord, Menz, & Tiedemann, 2003), which includes five validated measures of physiological falls risk, such as the visual contrast sensitivity, postural sway, quadriceps strength, reaction time and lower limb proprioception; 2. Improvement of quality of life by 12-item World Health Organization Disability Assessment Schedule (WHODAS 2.0; http://www.who.int/classifications/icf/whodasii/en/) and by European Quality of Life-5 Dimensions (EQ-5D; http://www.euroqol.org/); 3. Provide an improved fall prediction and prevention assessment with balance, sit-to- stand from the Short Physical Performance Battery (SPPB; Guralnik et al. 1994) and reaction tests adapting for the iStoppFalls system; 4. History of falls by questionnaire and monthly falls calendar; 5. Gait velocity by 4 m walking from the SPPB (Guralnik et al. 1994), and 10 m walking in participants' habitual speed with 2 m for acceleration and deceleration; 6. Muscle strength and power of the lower extremities by sit-to-stand test from the SPPB (Guralnik et al. 1994) and the adaptation for the iStoppFalls system; 7. Functional mobility by Timed up and go test (TUG; Podsiadlo & Richardson, 1991); 8. Reaction time: hand and stepping choice reaction time adapted for the iStoppFalls system; 9. Balance by Maximal Balance Range (MBR; Lord et al., 1996), coordinated stability (CoStab; Lord et al., 1996), adapted balance tests (bipedal, semi-tandem, near tandem, tandem stance) from the SPPB (Guralnik et al. 1994) for the iStoppFalls system; 10. Cognitive functions which include general fluid function by Digit-Symbol-Coding (WAIS-III; Wechsler, 1997), divided and switched attention by Trail Making Test parts A and B Test (TMT A+B; Reitan, 1958) and by Attention Network Test (ANT) on PEBL, inhibition by the Victoria Stroop Test on PEBL, memory and working memory by digits forward and backward (WAIS-III; Wechsler, 1997); 11. Dual task costs by 10 walk + counting backwards by 3, sway + counting backwards by 3, sway + digit forward span; 12. Self-efficacy and fear of falling by Shortened Iconographical-Falls Efficacy Scale (Icon-FES; Delbaere, Smith, & Lord; http://www.neura.edu.au/sites/neura.edu.au/files/page-downloads/Icon- FES_10item.pdf).
Concerning the feasibility and functionality of the above mentioned available tools, demonstrations will be made by comparing them with other existent systems, as well as by data correlation from various studies and projects in which they were used as methods for fall risk assessment.
4.3.2 Impact of Falls Prevention in Primary Care
Family doctors and GPs are the first medical contact for patients within the healthcare system. For this reason, their training and education on falls prevention in elderly must be particularly envisaged. Such an endeavour was realized in Romania between 2010-2013, by the SOP-HRD 46975 Brain-Aging Project [Training in Brain-Aging Medicine and Related New Medical Technologies for Doctors and Nurses Working in Specialized Ambulatories and Hospital Departments], http://www.brainaging.ro/ro/proiect-european, under the coordination of Ana Aslan Intl. Foundation in Bucharest.
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In general, in terms of fall prevention, the Family physicians (Primary care) are assumed to be the first that people should address to. ICT solutions are however sought to be implemented and used in hospitals (Secondary care) and care centres for seniors. Studies evidenced the positive attitude in clinicians when developing and implementing ICT solutions in both the primary and the secondary care sectors. One such study (Gund, Lindecrantz, Schaufelberger, Patel, & Sjoqvist, 2012)22 conducted by the Department of Signals and Systems in Chalmers University of Technology in Gothenburg shows that most of the clinicians are interested in using ICT solutions in their daily practice, both in the primary or secondary care sector and as patients’ home as well. A positive feedback from elderly in Romania has been received when new ICT platforms have been tested (Spiru, și alții, 2014)23, (Spiru, Solheim, Turcu, Rovira Simon, & Sanchez Martin, 2014)24, (Schneider, și alții, 2013)25, (Schneider , și alții, 2013)26 between 2011 and 2014 at Ana Aslan International Foundation, one of the pilot sites involved in CONFIDENCE, MOBILE.OLD and Mobile.Sage AAL projects:
• The main objective of the CONFIDENCE project is to develop a community-based mobility safeguarding assistance service for people suffering from mild to moderate dementia. (Salzburg Research)27 • The MOBILE.OLD project provides a combined smartphone and TV-based service infrastructure with residential and outdoor services that will be delivered in a highly personalized and intuitive way and will advance the mobility of older persons. (AAL)28 • MobileSage provides to elderly people with context-sensitive, personalized and location-sensitive tools, which allow them to carry out and solve everyday tasks and problems in the self-serve society when and where they occur, “just-in-time”. (AAL MobileSage Project)29
22 Gund, Lindecrantz, Schaufelberger, Patel, & Sjoqvistt; Attitudes among healthcare professionals towards ICT and home follow-up in chronic heart failure care; BMC Medical Informatics and Decision Making 2012, 12:138 doi:10.1186/1472-6947-12-138 23 L Spiru, I Karlhuber, I Turcu, N van der Vaart, S Schurz, JM Laperal; Advanced technology services for supporting active seniors: The Mobile.Old project. Med-e-Tel 2014 Proceedings (CD-ROM); Global Telemedicine and eHealth Updates: Knowledge Resources, Vol. 7, 2014. (in press) 24 L Spiru, I Solheim, I Turcu, J Rovira Simon, V Sanchez Martin; Smart technologies for seniors’ mobility: The MobileSage project. Med-e-Tel 2014 Proceedings (CD-ROM); Global Telemedicine and eHealth Updates: Knowledge Resources, Vol. 7, 2014. (in press) 25 Schneider C, Willner V, Feichtenschlager M, Andrushevich A, Turcu I, Spiru L; A user Centred approach to analyse user requirements for a system supporting people with Dementia. Proceedings of the eHealth2013. May 23- 24; Vienna, Austria. OCG; 2013 26 Schneider C, Willner V, Feichtenschlager M, Andrushevich A, Turcu I, Spiru L; Collecting User Requirements for Electronic Assistance for People with Dementia; A Case Study in Three Countries. Proceedings of the eHealth2013. May 23-24; Vienna, Austria. OCG; 2013 27 Salzburg Research, AAL CONFIDENCE project – Mobility Safeguarding Assistance Service for People with Dementia http://www.salzburgresearch.at/en/projekt/confidence_en/ 28 AAL Mobile.Old Project http://www.aal-europe.eu/projects/mobile-old/#sthash.6IKuMg4I.dpuf 29 AAL MobileSage Project– Situated Adaptive Guidance for the Mobile Elderly; http://www.mobilesage.eu/
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4.4 Devices for Falls Prevention and Detection 4.4.1 Existing Devices
Personal devices Physical and biochemical sensors: - Invasive: implanted brain stimulators for old people with Parkinson's disease, epilepsy, depression; - Non-Invasive: glucose and cardiac activity monitoring, respiration monitoring (optical, acoustic, electric), piezoelectric sensors implanted in clothing that rely on radio frequency for detecting movements bust, impedance measurements by level of glucose, multi-parameter fusion data monitors, complex data analysis. - miniaturize: MEMS (Micro-Electro-Mechanical-Systems), WIMS (Wireless Integrated Microsystems).
Devices for assistance. - Speech technology: we recognize synthesis, text to speech, speech to text, control devices by voice, voice warning; - Recovering items lost / misplaced.
Social alarm services. - Activate "panic button" by the subject; - Automatic activation "panic button" Passive
Elderly monitoring systems at home. Several countries in Europe were launched pilot projects in this respect: - UK (Liverpool City Council Telecare Pilot) - Italy (Veneto Region Tesan system) - Sweden (Old @ Home project initiatives complex) - Denmark (CareMobil68) etc - Barilife: Romania, Israel
4.5 Romania Facts
Medical parameters should be correlated with clinical status to identify individual risks (e.g. predisposition to falls) and to estimate potential impacts of diseases / morbidity / poly- pathology, which may lead to fall.
There is no standard protocol for preventing falls in Romania (according to the Ministry of Health website), so standardization in this area would be welcome.
There is legislation in Romania in terms of interoperability standards for ICT. In the medical field the gold standard system seems to be the HL7 one, already implemented by HL7 Foundation in Romania and TeamNet. (Romania H. L.)30
30 Honeywell Life Safety Romania www.hls-romania.com
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An ITC-based system was implemented in Romania by the Honeyewell Live Safety Romania. The display and information system Clino Dashboard is used to display information, calls and alarms as part of the medical as nursing procedures of healthcare facilities. Clino Dashboard thus provides information where needed and makes sense. The networking of Clino Guard involving a nurse call system is a key feature: a wide range of functions makes it easier and safer to organize care processes – from the protection of people suffering from dementia to device tracking. In this way, an integrated solution has been created in order to combine all the required functions. It provides practical support for caring process, including audit-proof recording of all calls and alarms. (Patel, Park, Bonato, Chan, & Rodgers, 2012)31 Also, there is an application of this sort launched by Barilife Foundation and the City Hall (bracelet sensors). (Romania B. )32
The standardization activity, covering the whole national economy, began in 1928 when Romania became a member of the IEC. The Standardization Commission of the Council of Ministers of Romania was created in 1948 and marked the activity deployed in an organized manner. Starting on 31 October 1998, the Romanian Standards Association (ASRO) has taken over this position as a specialized private body of public interest in the standardization area, a not-for-profit association authorized by the Government, replacing, in this respect, the former Romanian Standards Institute. In accordance with Law 355/2002, the Romanian Government granted ASRO recognition as a National Standardization Body that develops standardization activities in all the fields of European and international standardization as member of ISO, the IEC, CEN, CENELEC and ETSI. ASRO represents Romania in the international standardization process by co-ordinating the national input, by organising the update of information on standards and by providing a wide range of services, both for the distribution of standards and accredited certification activities. (Romania A. d.)33
4.6 Conclusions
Currently, the communication technologies known as analogue telephony and television are about to be replaced by digital solutions. Many major changes planned for the health care system are opportunities for refurbishment nurse call systems, in order to transform them into modern centres capable of efficient medical care. Equipment and infrastructure must be adapted intelligently in order to achieve the easiest transition to future systems.
In the context of rapid global aging, societies or economies can no longer afford the “usual care”, but require the design of new ways of care. Advanced technologies significantly meet this need.
Technology can support and enable large-scale studies able to answer the outstanding questions about falls. As the amount of clinical resources per older person is permanently increasing, technological developments can help to streamline the spending of those resources, at the same keeping the quality of care, or even enhancing it.
31 Patel, Park, Bonato, Chan, & Rodgers,; A review of wearable sensors and systems with application in rehabilitation; Journal of NeuroEngineering and Rehabilitation 2012, 9:21 32 Barilife Romania,www.barilife.ro 33 Asociatia de Standardizare din Romania http://www.asro.ro
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To achieve significant prevention/detection and reduction of falls incidence, a holistic life-long approach combining cognitive, psychosocial and physical activities will be required. The challenges are significant, but with close collaboration between fallers, falls experts and technical experts they may be also achievable.
The actually ageing generations will have the needed technical skills and desire to educate themselves and to self-manage their falls risks, but technology must be in place for them to do so.
Primary care staff will require screening technology to identify people requiring a referral to specialized assessment centres, and will need specific training for recognizing and advising frail elders who are at risk to fall. (Kenny, Scanaill, & McGrath, 2011)34
34 Kenny, Scanaill, & McGrath, Falls Prevention in the Home: Challenges for New Technologies; Intelligent Technologies for Bridging the Grey Digital Divide, 2011
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5. Industrial Perspectives 5.1 Introduction
Healthcare companies face changes in customer behaviour, market dynamics and regulatory demands. The use of medical devices by patients in their home is developing considerably because of a policy to cut down on the length of stay in hospital. This use has already been experiencing a significant growth over the past few years (source: French National Health Insurance Agency). Whilst medical devices today are used in stand-alone fashion, developments in technology will enable them to move towards greater communication, thereby providing them with fresh possibilities helping to ensure:
1) greater patient safety, 2) continued and regular monitoring of changes in the patient’s condition, 3) prolonged independent living.
First we will analyse the potential market for industrial application of ICT based fall prevention products (market driven). The next approach is based on the potential available technology (technology driven). The third market for ICT solutions is electronic health records. At the end we will focus on the interoperability of medical devices and telehealth solutions.
5.2 Market Analysis
An industrial approach always starts by identifying markets, and then develop products for the different market segments, called Product Market Combinations (PMC).
a. Primary care Primary care refers to the work of health care professionals who act as a first point of consultation for all patients within the health care system. Such a professional would usually be a primary care physician, such as a general practitioner or family physician, a licensed independent practitioner such as a physiotherapist, or a non-physician primary care provider (mid-level provider) such as a physician assistant or nurse practitioner.
The primary care physician (family doctor) plays an important role in the prevention of falls for older adults living independently in the community. They can interfere in the several aspects of fall prevention: medication review, refer to an intervention (e.g. ergo or physical therapist) or to a personal alarming system (with or without automatic fall detection) as part of the home care. In case of more complex problems they will refer to secondary care.
b. Secondary care Secondary care is the health care services provided by medical specialists and other health professionals who generally do not have first contact with patients, for example, cardiologists, urologists and dermatologists. It includes acute care: necessary treatment for a short period of time for a brief but serious illness, injury or other health condition, such as in a hospital emergency department.
Competitiveness and innovation Framework Programme CIP-ICT-PSP-2012-6 325137 European Network fOr FALL Prevention, Intervention & Security E-NO FALLS
Outpatient service. Outpatient services are medical procedures or tests that can be done in a medical centre without an overnight stay. Many procedures and tests can be done in a few hours. Hospitals can provide an outpatient service for fall prevention. The goal is diagnose the risk of falling and to refer to therapeutic interventions. The aim of medical management is to identify factors that can contribute to falls and fracture risk such as osteoporosis, multiple medications, balance and gait problems, loss of vision and a history of falls. Also refer to a fall prevention intervention in the community is an option. An example of use of body worn sensors in an outpatient service is the use of an activity monitor to measure the burden of COPD during free living conditions 35 . Figure 8 shows the attachment of the activity monitor in the lung lab, Figure 9 shows the explanation of one of the reports by the lung consultant.
Figure 8. Attachment of the activity monitor
(Source: McRoberts)
Figure 9. Explanation of the report by the lung consultant
(Source: McRoberts)
35 See http://www.youtube.com/watch?v=ASEOjR6KhKg for the video.
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c. Tertiary care Tertiary care is specialized consultative health care, usually for inpatients and on referral from a primary or secondary health professional, in a facility that has personnel and facilities for advanced medical investigation and treatment, such as a tertiary referral hospital.
Rehabilitation Specialized rehabilitation for fall prevention is mainly indicated for diseases which have a clear fall risk. Examples are stroke, Parkinson’s disease, Huntington’s disease, lower extremity amputation, COPD and others. d. Home and community care Many types of health care interventions are delivered outside of health facilities. These services are seen as public health. The indication for a personal alarming systems is often the concern of unnoticed or unreported falls of older adults living independent. Most devices available in the market (Deliverable 4.1 chapter 5.2.2 Automatic wearable fall detector) are developed for this emerging market. It is questionable if this service is part of fall prevention as the alarm does not prevent falls but identifies falls.
The home environment can present many hazards. Common places for injurious falls are the bathtub and steps. Changes to the home environment are aimed at reducing hazards and help support a person in daily activities. Changes could include minimizing clutter, installing grab bars in the shower or tub or near the toilet, and installing non-slip decals to slippery surfaces. Stairs can be improved by providing handrails on both sides, improving lighting, and adding colour contrast between steps. Improvement in lighting and luminance levels can aid elderly people in assessing and negotiating hazards, as discussed above. Currently, there is insufficient scientific evidence to ensure the effectiveness of modification of the home environment to reduce injuries.
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e. Cost of care The relation between the different levels of care related to the cost per day can be illustrated with the following figure (Wals, 2008).
Figure 10. Cost of care per day
(Source: Jeroen Wals, Philips Research, Seminar ICT for Health & Wellbeing, 5 Nov 2008)
5.3 Technical Devices (Medical Device Directive)
For the medical industry and especially small and medium enterprises, a technological approach is often the start of an innovation. There are two main approaches to observe the behaviour of persons with a potential fall risk: dedicated body worn sensor systems, home instrumentation (smart homes) and smart phones.
Dedicated body worn sensors Since the late eighties digital and wearable monitoring systems came to the market. The first activity monitors used piezoelectric sensors which was mainstream in US market. The processing of the raw signals was in real time using simple algorithms with counts per epoch as main outcome. These systems were successful in epidemiological studies. Europe research and industrial development focussed on activity monitors with inertial sensors, raw data collection and off line analysis. The main aim was to improve the specificity of the analysis. The first method to identify classes of physical activity (sitting, standing, lying and locomotion) was developed in The Netherlands in the early nineties and published in 1994 (Veltink PH, 1994). The uptake of inertial sensors in smart phones further accelerated the development of the sensors and further lowered the price.
For body worn sensors two different applications have been developed: systems that detect falls and systems that predict the risk of falling.
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Fall detection This European tradition also made it possible to study the detection of falls using body worn sensors. This approach seemed very attractive to serve the market of personal alarming systems developing fall detection systems as add on to personal alarming systems. This is a growing and potentially huge market. Several products came to the market but clinical application is still restricted because false positive alarms are not appreciated by the subject as well as the care giver. The development of valid detection of falls if still continuing worldwide but as far as we know no valid method has been published in scientific literature.
Fall risk prediction A new approach of fall risk detection using inertial sensors is recently developed in The Netherlands (FARAO (VU Medical Centre, 2014)). In this approach older adults wear an activity monitor for a week and the analysis of instability of gait during free living conditions is added to the prediction model of falls (Rispens, 2014). This methods makes it possible to supply specific information about physical activity for better interpretation of the risk behaviour. This method seems potentially interesting because the method is easy to implement, relatively cheap and based on objective real life data. This approach will be tested by the VUmc (Amsterdam) in the mobility outpatient clinic. The method is also recognised as a potential outcome to evaluate fall prevention interventions.
Smart phones See FARSEEING.
Instrumentation in the homes (smart homes) Several technologies are available to detect falls and physical behaviour in the home environment.
5.4 Services
Cloud servers Cloud computing is a marketing term referring to a model of network computing where a program or application runs on a connected server or servers rather than on a local computing device such as a PC, tablet or smartphone. Like the traditional client-server model or older mainframe computing, a user connects with a server to perform a task. The difference with cloud computing is that the computing process may run on one or many connected computers at the same time, utilizing the concept of virtualization. With virtualization, one or more physical servers can be configured and partitioned into multiple independent "virtual" servers, all functioning independently and appearing to the user to be a single physical device. Such virtual servers do not physically exist and can therefore be moved around and scaled up or down on the fly without affecting the end user. The computing resources have become "granular", which provides end user and operator benefits including on-demand self-service, broad access across multiple devices, resource pooling, rapid elasticity and service metering capability.
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Electronic Health Record An electronic health record (EHR) is a systematic collection of electronic health information about an individual patient or population. It is a record in digital format that is theoretically capable of being shared across different health care settings. In some cases this sharing can occur by way of network-connected, enterprise-wide information systems and other information networks or exchanges. EHRs may include a range of data, including demographics, medical history, medication and allergies, immunization status, laboratory test results, radiology images, vital signs, personal statistics like age and weight, and billing information.
5.5 Standardisation and interoperability
Standardisation (clinical pathways) Clinical pathways, also known as care pathways, critical pathways, integrated care pathways, or care maps, are one of the main tools used to manage the quality in healthcare concerning the standardization of care processes. It has been shown that their implementation reduces the variability in clinical practice and improves outcomes. Clinical pathways promote organized and efficient patient care based on evidence based practice. Clinical pathways optimize outcomes in the acute care and home care settings. An example of the development of a clinical pathway COPD in The Netherlands is shown with the picture.
Generally clinical pathways refer to medical guidelines. However a single pathway may refer to guidelines on several topics in a well specified context.
Figure 11. Clinical pathway COPD
(Source: (Long Alliantie Nederland , 2013)36
36 http://www.longalliantie.nl/files/5113/7994/2952/LAN_Zorgstandaard_COPD-2013-juni.pdf
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Interoperability The faller’s landscape includes all the different care facilities: primary care, community care as well as hospital care (Figure 12).
Figure 12. HIC health Informatics
(Source: http://medicine.dundee.ac.uk/)
Interoperability is the ability of making systems and organizations to work together (inter- operate). While the term was initially defined for information technology or systems engineering services to allow for information exchange, a more broad definition takes into account social, political, and organizational factors that impact system to system performance.
Integration profile An integration profile is a major communication function that allows two or more computer systems to carry out a succession of coherent exchanges (workflow), previously identified and specified using globally recognised, operational standards. The figure shows clearly that fall detection carried out by the home care has to be communicated with the secondary care (hospital) where the patient will be transported after an injurious fall event. When the patient will be referred to residential care there is a third party involved in the care process.
Definition of core requirements Definition of the core requirement first consists, in a given domain (fall alarming at home, fall risk detection using medical devices, electronic health records), in listing the main exchange functions that we want to computerise. To do that, users are invited to define the core processes to be supported.
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Secondary care The introduction of a new medical device using ICT in a hospital needs to pass several professionals. First there is a safety check by the department of medical physics. The medical device has to be accepted by the ICT department of the hospital and outcomes have to be integrated in the electronic patient record of the hospital.
Homecare A common procedure in the practice of use of a personal alarming system shows how the different care givers are involved and should be informed about an injurious fall followed by an emergency call and transport to the first aid of a hospital. The call centre that handles the alarms might store data of all contacts with the clients. There are initiatives to use these data to identify early indicators of functional decline. The Dutch market leader for personal alarming monitors more than 800.000 persons in Europe with their call centres37.
Figure 13. Fallers landscape
(source: McRoberts)
5.6 Conclusion
The Healthcare Standardization industry is highly regulated in order to ensure the safety of the devices and their effectiveness for use. Regulators depend on published international standards to define the detail that products must comply with in order to satisfy their essential safety and effectiveness requirements. Since standards are the ‘currency’ or ‘language’ of requirements, it follows that compliance with standards is a vital means of compliance with requirements of European Medical Devices Directives and other international regulations.
Most medical devices identified in this project use body worn sensors, often integrated in personal alarming systems. Those systems are used in the community for independent living as well as institutional care. In both markets the intended purpose makes that these devices might
37 http://www.verklizan.com/content/
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classify for class 2. Early standardisation in this field can delay and even frustrate the development of innovations.
Standardisation of the supply chain aims to increase patient safety, improve quality (implementation of a quality management system) and pursuit of high reliability. Quality management systems (QMS) should be included in all medical devices that are used in clinical care. Medical devices of class 2 and higher are obliged to implement a QMS according to the Medical Device Directive.
The first application for standardisation of collected data are the personal alarming systems. This market is growing very fast and potentially can collect data about health status and risk of functional decline including risk of falling. This sector has as far as we know a low level of regulation cause they are part of home and community care. Standardisation in this market could be potentially interesting.
Implementation of standards is also related to timing. Fall detection in order to improve personal alarming systems seems to be ready for standardization because 7 systems are identified in the market (see D 4.1)are identified in the market. However the validity of the detection methods is still questionable.
When we look at the different markets the personal alarming systems as part of home and community care is reaching thousands of older adults in an average European town. Penetration is fast and therefore standardisation is relevant.
On the other side of the spectrum fall risk assessment using body worn sensors is still in a preliminary phase of development and clinical testing. Personal alarming systems are often used for vulnerable older adults still living independent during several months up to several years. A lot of potential relevant information is collected about functional decline and health status.
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6. ICT Research and Development Perspective
6.1 Research and development on falls and activity monitoring 6.1.1 Current Technologies
Recognizing human activities with sensors next to the body has become an important research area, which aims to create or improve innovative applications providing activity monitoring. The ability to record and recognize individual daily activities is essential to determine the degree of functional performance and general level of activity of a person (Karantonis D. M., Narayanan, Mathie, Lovell, & Celler, 2006). In health care field, long term analysis of human activity could be helpful in early detection of diseases (Czabke, Marsch, & Lueth , 2011) or even to encourage people to improve their activity level and to prevent the falling events. It could also be useful for physiotherapy, helping to understand if the recommended exercises are been correctly performed or even to assist those with cognitive disorders (Lopes, Mendes- Moreira, & Gama, Semi-supervised learning: predicting activities in Android environment, 2012).
One of the most used approaches to monitor human activity is based on motion capture video systems that could also be associated with pressure plates in the ground. These methods are obtrusive, require massive devices and could only be used inside a laboratory environment, requiring a high set-up and processing time as well as memory space to record it (Czabke, Marsch, & Lueth , 2011). Motion sensors have become an interesting alternative to video systems, because of their miniaturization, low cost and capability to record motion signals within unobtrusive and wearable systems. Accelerometers and gyroscopes were also used in previously studies for daily activity monitoring (Czabke, Marsch, & Lueth , 2011; Karantonis D. M., Narayanan, Mathie, Lovell, & Celler, 2006; Salarian, et al., 2004), exercise information, such as energy expenditure (Lee, Khan, & Kim, 2011), and fall detection (Qiang, et al., 2009). Most of the commercial systems available in the market for fall detection are wrist bracelets or pendants that require the user to activate an alarm button in case of falling. The system notifies a remote monitoring center that responds to the alarm. However, there are also some solutions for automatic fall detection, mainly based on wearable sensors (Bourke, OBrien, & Lyons, 2007; Bianchi, Redmond, Narayanan, & Cerutti, 2010; Chen, Zhang, Feng, & Li, 2012; Karantonis D. , Narayanan, Mathie, Lovell, & Celler, 2006; Kangas, Konttila, Lindgren, Winblad, & Jms, 2008; Bourke & Lyons, 2008). Systems based on wearable devices use body- attached sensors such as accelerometers, gyroscopes or barometers to acquire kinetic data from human motion.
In the last years, fall solutions based on the smartphone sensors (Dai, Bai, Yang, Shen, & Xuan, 2010; Abbate, et al., 2012; Sposaro & Tyson, 2009) have been growing due to the development of inexpensive Micro Electro Mechanical System (MEMS) sensors and their inclusion in smartphones. Using smartphones avoids the need to acquire other wearable sensors and since users are perceiving them as personal, smartphones are less obtrusive items (Bianchi, Redmond, Narayanan, & Cerutti, 2010). Despite the fact that elders today might still not be used to interact with smartphones, the future older users who have grown up with the technology will probably become an important market segment for this kind of applications. Smartphones are equipped with a wide range of internal sensors, including accelerometers and gyroscopes, which can be used to monitor human daily activities. These devices are practical, small and unobtrusive, becoming an ideal platform for a pervasive activity recognition system. Other desirable features
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are the possibility to be wearable, always next to the user, work in real-time and be used for long-term monitoring.
Figure 14. Activity recognition process pipeline (Anguita, Ghio, Oneto, Parra, & Reyes- Ortiz, 2012)
Although there are some smartphone applications for fall detection (Mosa, Yoo, & Sheets, 2012; Igual, Medrano, & Plaza, 2013), most of them lack a representative dataset and consensual methodologies for the validation protocol (Noury, Rumeau, Bourke, Laighin, & Lundy, 2008). iFall application (Sposaro & Tyson, 2009) is an example of the use of the smartphone built-in accelerometer to detect fall events. The algorithm is based on acceleration magnitude thresholds, timeouts and long lie detection. If a fall is detected the system sends a request for help to the caregivers. Abbate et al. (Abbate, et al., 2012) developed a waist mounted system implemented as a finite state machine followed by a classification engine using a neural network. Dai et al. proposed PerFallD (Dai, Bai, Yang, Shen, & Xuan, 2010), a pervasive fall detection system implemented on smartphones. The algorithm is based on accelerometer thresholds: the total and the vertical acceleration are compared with predefined thresholds, adjusted with collected data.
6.1.2 Smartphone Based Solutions on Falls and Activity Monitoring mHealth solutions have been discussed since the end of the 90s. The benefits for patients and doctors of solutions that ease their daily lives are obvious and well known:
• eases the life of the patient (e.g. don’t have to stay at home) • allows doctors to reduce regular visits • enables hospitals to reduce their bed capacities (patients can leave hospital earlier) • allows health insurance providers to reduce their case related expenses • improves patient outcomes through improved compliancy
The remaining question is still what impact does the new smartphone application market model created by Apple in 2008 has on the mHealth market. Will smartphone apps become the killer application of the mHealth market? To answer the question one has to understand what stopped the early mHealth market from being successful and determine what impact the new market model has on those barriers. The following list focus on the main barriers which prevented the mHealth market from growing in the past and the changes the new model will bring:
• Devices: Early solution providers had to live with limited device capabilities and in order to achieve successful market entry and profitability had to find hardware partners to develop the mobile device. Furthermore, reach was very limited for any kind of smarter phone. Many of the features that early solutions providers had to find special solutions for are now included as standard on smartphones (e.g. GPS or sensors).
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• Distribution: In the early days mHealth solutions providers had to seek partnerships with MNOs in order to gain some support with the distribution of the service or had to do it on their own. The new market model offers global reach without having to deal with an MNO. Still, traditional distribution channels like doctors, hospitals and health insurance providers are not being affected by the new model.
• Patients and doctors: The awareness of mHealth solutions was very limited. The new market model offers a better user experience along the entire value chain: discovery and access, billing and usage. The hype for smartphone apps also brings mHealth apps into the spotlight of its potential users. Still, one of the biggest target groups for mHealth solutions, the elderly, will have the biggest issues with technology adoption, although they would benefit most from mHealth application usage. This mismatch will not be changed by the new market model in the near future.
• Regulations: The new market model has only limited impact on one of the key barriers – regulation. As long as mHealth solutions and services don’t get clearance from national regulators and are thus not reimbursable by health insurance providers, patients must pay expenses themselves. Doctors won’t prescribe e.g. a pill reminder application and will have no financial incentive to propose such solutions to the majority of their patients. The market will remain a consumer driven market, which means that the full potential will remain untapped.
• Another barrier remains the discussion around security and confidentiality of data. Major projects like electronic health records (EHR) have been mandated a decade ago in some countries but implementation has been delayed until now mainly because of security and confidentiality reasons. Section 7.2 will provide further details on the current status of the Portuguese EHR.
6.1.3 Architecture and Common Standards for Mobile Solutions
The whole process for activity monitoring begins with gathering the raw data, in particular, motion data. Inertial sensors are an adequate solution to detect motion. These sensors respond to stimuli by generating signals that can be analyzed and interpreted (Wilde, 2010). Usually, sensors are placed next to the body and should be comfortable for the user (Lopes , Mendes- Moreira , & Gama, Semi-supervised learning: predicting activities in Android environment, 2012). The new generation of smartphones are equipped with a wide range of internal sensors, including accelerometers and gyroscopes, which can be used to monitor human daily activities. These devices are practical, small and unobtrusive, becoming an ideal platform for an activity recognition system. Other desirable features are the possibility to be wearable, work in real-time and be used for long-term monitoring (Lopes , Mendes-Moreira , & Gama, Semi-supervised learning: predicting activities in Android environment, 2012). These devices can acquire, process and obtain useful information from raw sensor data (Figo, Diniz, Ferreira, & Cardoso, 2010), but the key difficulty of creating useful context-aware applications is to develop algorithms that can detect context from noisy and ambiguous sensor data (Bao & Intille, 2004). Developing a smartphone application has to take into account the limited resources of smartphone as processing time, limited memory and sample rate and accelerometers are an ideal sensor because they require low processing power and energy consumption.
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Some setup protocols for human activity data acquisition have been reported in the literature (Figo, Diniz, Ferreira, & Cardoso, 2010; Bao & Intille, 2004). There are three main concerns regarding sensors: type, location and number. The majority of motion-aware systems have used inertial sensors, particularly accelerometers, to estimate the inclination of the body from the vertical and to determine the orientation and movement of the user (Wilde, 2010). The new generation of Smartphones is being considered by users as an important personal device, together with an exponential availability. These devices have an increased potential for an adequate mean of gathering motion data, to use for building human activity prediction systems. The perception of their benefits are becoming commonplace, as users have become accustomed to their ubiquity (Wilde, 2010).
A fragmented approach to solution development is one of the reasons that sustainable commercial models for mobile health have been slow to develop. To become cost-effective and commercially-sustainable for the mass-market, mobile health services will need to be based on standardized, open and interoperable solutions. There is no single standards organization that covers the complete needs of mobile health. Some organizations, such as the Continua Health Alliance and the Integrating the Healthcare Enterprise (IHE), are addressing this issue by providing interoperability guidelines that group standards together into profiles, combining data standards, security standards, messaging standards and transports together into a single certifiable solution. However, there is still some way to go before the mobile health sector has a fully interoperable set of standards that is universally-adopted, and market volumes have yet to justify the sort of equivalent investment that resulted in the mobile industry offering handsets that support roaming across multiple network protocols.
6.1.4 Usability Challenges and Recommendations for Mobile Solutions
Technology has the potential to improve the quality of life and well-being of older adults. However, this audience still has to face several challenges in order to be included in an increasingly technological society. This fact puts older adults at a disadvantage and it requires researchers and practitioners to deliver products which are suitable for them, this way ensuring that they are not excluded from the benefits that technology can provide.
The stereotype that the older population is still unwilling to use computers is deprecated, and more and more, elders use technology in their daily life. In fact, the main reason for a still lower acceptance rate of technology among older adults is the disregarding of their characteristics during the design process. Elders’ characteristics and needs are very different from the mainstream audience and the number of systems that consider these differences is scarce to non- existent. This situation brought us to an era of a “Digital Divide” between technology and the older population (Cresci, Yarandi, & Morrell, 2010). This situation can be modified by using a more creative approach (Opalinski, 2001) and if developers become “more willing to draw from gerontologists and elders as they develop, test, refine, and market their products” (Scialfa & Fernie, 2006). In doing so, the creation of systems and services that address a need or interest and that users perceive as worthwhile (Hanson, 2010) could more easily appeal to the older audience, decreasing their qualms towards technology.
Guidelines to increase acceptance When designing a product for older adults a number of considerations should be taken into account, in order to increase their acceptance level of the product. These practices are not directly related to interface design; nevertheless they are of utter importance on the design phase for a new product or service.
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Provide a humanly rich experience As older adults age, losing family and friends may force them to "reconstitute a meaningful social world" (APA, 2003). The system’s interface might be a "gate", connecting them to one of their few human contacts; it is crucial that the older adult feels satisfied with this communication.
Plan the interaction for the older adult but also for his caregivers Older adults with chronic conditions probably live accompanied. If a health system excludes the caregivers, not only it ignores an important piece of the patient’s life, it also makes the helpers feel useless.
Describe clearly the goal and the outcomes of using your product Dealing with losses – be them physical abilities or even loved ones – brings an awareness of one's limited opportunities, causing the individual to concentrate on more rewarding activities (APA, 2003). If the reward is not found relevant, the product won’t be easily accepted.
Be aware that some older adults will refuse to learn According to (Lindberg, Carstensen, & Carstensen, 2008), the ideas one has of old age affect the way that individuals learn. In particular, the willingness to learn something new is known to decrease with age.
Minimize the need to unlearn well "learned" procedures Each time a product changes, one must replace a previous procedure with a new one. Older adults have shown greater difficulties unlearning procedures (Fisk, Rogers, Charness, Czaja, & Sharit, 2009), so this should be minimized.
Maximize remote management Older adults may live in rural places with little access to resources like transports (APA, 2003). Because of this, maintenance tasks can be difficult. To deal with these situations, the system should be prepared to be managed remotely.
Plan carefully the prices of products and services for the user This audience is often coping with economic issues (Smyer, Schaie, & Kapp, 1996). For this reason, prices for the user should be carefully thought as they also determine acceptance.
Make use of behaviors developed by older adults to cope with memory loss Older adults will notice that they are losing short-term memory and will start using notes and other mechanisms to remember things. These procedures can be of great help for the user, when using a new product for the first times, so they should be encouraged.
Don’t forget older adults did not grow up using computers They may feel more intimidated and will (naturally) face more challenges because they are not familiar with many metaphors used by such devices.
Give seniors time to learn Cognitive changes are responsible for a decrease in short-term memory and a slower "processing speed". By holding a smaller amount of information, short-term memory will likely cause problems in learning.
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Don’t forget older adults wear glasses Recent studies revealed that 92% of the individuals above 70 years wear glasses (Charness & Schaie, 2003).
Provide redundant channels of communication Because of perception limitations, older adults rely more on the contextual and nonverbal aspects. Videoconference for example is better than pure-audio communication because of the visual cues it provides (Fisk, Rogers, Charness, Czaja, & Sharit, 2009).
Guidelines for device manipulation The following guidelines consider smartphones or tablet devices only. Other mobile phones are not considered.
Avoid two-handed gestures Older users have been found to hold mobile devices with two hands instead of only one, unlike their younger counterparts. This could be due to differences in grip strength (Siek, Rogers, & Connelly, 2005).
Avoid specially small devices Devices that are too small are difficult for older adults to hold comfortably. Joint stiffness can make it harder to grasp or hold small devices (Kurniawan & Zaphiris, 2005).
Include descriptions of gestures to promote discoverability Gestures that are commonly known and accepted by younger users - such as pinch and drag - may not be obvious to an older audience (Kobayashi, et al., 2011).
Adjust scrolling speed When scrolling is needed the speed rate should be slower than the standard. Scrolling can be hard for older adults for various reasons: - they may not understand the metaphor and be reluctant in using it; - Fine-motor control might be impaired making it hard, painful or tiresome to perform multiple flick/drag gestures (Fisk, Rogers, Charness, Czaja, & Sharit, 2009).
Avoid placing important actionable content at: - The top left corner or bottom right corner (for right handed users) - Opposite for left-handed users of the touch surface
These sections might be difficult to reach, especially for older users with reduced manual motor abilities.
Provide UI buttons to complete any task that would be done through gestures Older adults might have trouble in executing certain gestures, due to losses in manual dexterity, and therefore should be provided with the option to complete any action by using buttons. For example, older adults may have difficulty in performing a swipe gesture to scroll and, in order to compensate for this finding; arrows should be included in the interface for scrolling purposes.
Provide continuous scrolling When the users keep their fingers on a scrolling arrow, the content should keep scrolling in order to prevent multiple presses that might be hard or strenuous for older adults to perform.
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Adjust the tap and long press thresholds to accommodate elderly preferences Older adults generally press longer than their younger counterparts, making most systems interpret what should be a tap, as a press and hold.
Extend actionable areas (buttons, for example) so that they are larger than the actual visual target itself This compensates for miscalculations that users tend to have when aiming for a target, partly because in the case of small screens most of the target is occluded by one’s finger.
Include visual feedback It might be helpful to include proper visual feedback indicating where the user touched the screen, even if the target was missed (Kobayashi, et al., 2011).
Provide multimodal feedback Multimodal feedback has been shown to improve interaction perception and accuracy for older adults. This means that combinations of type of feedback - auditory, haptic, and visual - can be beneficial. Even though auditory feedback has been found to help most groups of users, due to the mobile character of smartphones, it might not be the best option. A combination of visual and haptic feedback may be the best solution for mobile devices.
When auditory feedback is given, background noise should be taken into account When speaking of mobile devices, you should probably prepare for loud, noisy backgrounds and set auditory feedback at 10 db higher than the background noise by default, but never over 90 db which is the upper limit for security. In addition, always provide controls that let the users define the volume of auditory feedback.
Vibration frequency should be around 25hz for older adults A significant loss in sensing high frequency vibrations occurs with the aging process (Fisk, Rogers, Charness, Czaja, & Sharit, 2009).
6.1.5 OS Specific Guidelines
Each mobile platform has unique interface components, capabilities and requirements. If a product spans multiple platforms, it should function and look as consistently as possible. Nevertheless, it must also respect platform constraints, and inherit its own unique design and interaction paradigms.
Android Further information regarding Android Design Guidelines can be found at: http://developer.android.com/design/index.html iOS Further information regarding iOS Design Guidelines can be found at: http://developer.apple.com/library/ios/#documentation/UserExperience/Conceptual/MobileHIG/ Introduction/Introduction.html
Windows Phone 7 Further information regarding Windows Phone 7 Design Guidelines can be found at: http://msdn.microsoft.com/en-us/library/hh202915(v=vs.92).aspx
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6.1.6 Design Standards
The standard ISO 9241-210(2010) provides guidance on human-centered design activities throughout the development life cycle of interactive computer-based systems. According to it, the activities are carried out in an iterative way, with the cycle being repeated until the design solutions meet the defined requirements.
Figure 15. ISO 9241-210 (2010) Human-centered design process for iterative systems
(Source: http://www.usabilitypartners.se/about-usability/iso-standards) 38
6.2 Framework of the Portuguese National Health System 6.2.1 Organization of Resources, Provision of healthcare and Funding
The provision of healthcare in Portugal is characterized by the coexistence of a National Health Service (NHS), public and private subsystems specific for certain professional categories and voluntary private insurance. The NHS is the main healthcare providing structure, integrating all aspects of healthcare, from promotion and surveillance to disease prevention, diagnosis and treatment, as well as medical and social rehabilitation.
The Portuguese Health System simultaneously includes public and private funding. The NHS is mostly (90%) funded with taxes, with subsystems funded by workers and employees, while private healthcare funds come from co-payments and direct payments from patients, as well as from health insurance premiums.
The last decade was marked by a set of reforms on the Portuguese NHS, with particular incidence on the hospital network and emergency services, on primary healthcare (CSP) and on long-term care (CCI). The hospital network in Mainland Portugal comprises 212 hospitals, 91 of which are privately-owned. The 363 Primary Care Centers were organized into 74 Groups of
38 http://www.usabilitypartners.se/about-usability/iso-standards
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Primary Care Centers (ACES). In 2012, 342 Family Healthcare Units and 186 Community Care Units were in operation. The number of available contracted beds as of 31 December 2011 in the National Long-Term Care Network was 5595. These beds were distributed according to the following types: 906 for convalescence, 1747 for medium-term and rehabilitation use, 2752 for long-term and maintenance use, and 190 for palliative care.
6.2.2 Portuguese Healthcare Data Platform – Plataforma de Dados de Saúde
The Portuguese Electronic Health Record is based on a web platform, currently in development by the Comission for Clinical Informatics (CIC, from the Portuguese Comissão para a Informatização Clínica), created by a dispatch from the Health Secretary of State near the end of 2011, and the Ministry of Health’s Shared Services (SPMS, from the Portuguese Serviços Partilhados do Ministério da Saúde), that provides a central clinical information storage and sharing system in keeping with the requirements of the National Comission of Data Protection (CNPD, from the Portuguese Comissão Nacional de Proteção de Dados). It allows access to registered users’ information by health professionals throughout the NHS. Each access to this information is restricted and registered in an access history.
The Portuguese Healthcare Data Platform, known as Plataforma de Dados de Saúde (PDS), constitutes the national health record data sharing facility, uses webservice technology to link old and new existing applications, and by this means, provides information through different Portals/areas to different stakeholders, namely:
• Citizen Portal (Portal Utente) officially launched in May 2012 – constitutes a Personal Health Record area and patient online services like ebooking, eordering and health education; This portal was launched on the 31st of May, 2012 and had on the 19th of June, 2012 over 5000 registered users. It allows the insertion of data such as emergency contacts, health data, habits, medications, allergies, diseases, authorizations/audits or health clinic/family health unit contacts. The sharing of information is managed by the user himself. The information is only be available throughout the country if the patient alows so. It also enables access to services such as the National Patient Database (RNU), the eAgenda to book medical appointments or request renewal of prescriptions for chronic patients and the program SIM-Cidadão to make suggestions, complaints, complements and acknowledgements to the NJS.
• Health professional area (Portal do Profissional) officially launched in June 2012 – provides access to patient clinical data to more than 370 institutions. The data is stored in servers and records of more than 430 institutions and over 5 central repositories, covering all primary care and all public hospitals. Expansion to social and private sector is undergoing. The information showed on this portal needs to be granted access by the patient on his PU.
• PDS will allow central institutions acess to anonymized data through the Institutional Area (Portal Institucional).
• PDS includes the International Portal (Portal Internacional) within the scope of epSOS pilot project participation. This will enable the pilot to serve as electronic patient’s summary review for professionals and extended its use cases to include patient interaction for managing his health wherever he is located in Europe (and beyond) as well as the adoption of other epSOS approaches. In the context of epSOS II, the platform will be evolved to be compliant with the epSOS core services of Patient Summary based on the Portuguese Patient Summary currently being finalised. Portugal receives EU/EEA patients throughout
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all year especially tourists. This seasonal population was 7.3 Million in 2011. Foreign students and migrant workers are another relevant group.
6.2.3 Architecture, Protocols and Data Protection
The Healthcare Data Platform (PDS) is, as referred previously, a web platform that enables sharing and recording of clinical information from the patients registered in the Portuguese Healthcare System. The platform follows the requirements of the Data Protection Commission (CNPD) and the data is shared straight from the PDS repositories, can be audited and the access can be restricted by the patient.
Architecturally, PDS is divided in 3 modules: • Portals and information sharing services; • Connections between organizations and Patient’s area; • Information repository (timeline). The first module has been described previously. The second module is built to work with web services and Representational state transfer (REST) and PDS uses both as a way to communicate with other applications or services. It uses POST for the connections between organizations like Hospitals and Primary Care Centers so it can show the episodes on the Portals and it uses web services to communicate with external applications. The REST communication uses HL7 V2 (see Section 8.1.2) in most of the cases and is encrypted using Data Encryption Standard (DES). The encryption is based on the institution code and acronym and an encryption key. When accessing patient information stored in another Institution, the patient information is always validated against the National Patient Database (RNU), to check for fraud. Also, all communication between PDS and other applications or access to data through the Portals is logged and the log can be accessed by the patient, the practitioners and the institutions where the data is recorded.
The third module works as an information repository. The data stored on the PDS is centralized: the entries on the timeline are links to the description of the episode on the institution where it occurred. Thus, we have the clinical episodes information recorded locally on the systems where they occurred and a timeline of links to the local information from the episodes centralized on the PDS.
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PDS follows the Metropolis Architecture design proposed by Rick Kazman. The core of the Metropolis is the combination of an enterprise service bus (ESB) and the Portals, as shown Figure 16.
Figure 16. PDS diagram
Moreover, the PDS platform provides a referencing bridge to healthcare institutions so that they can share information related to a patient’s care. It handles REST requests in order to provide access control functionalities and facilitate communication of duly authorized information between institutions. It does not, therefore, depend on any specific technology to be implemented by the institutions as long as the defined URL structure for the requests is followed.
The basic functionality of the protocol used can be described as follows: • The institution wishing to retrieve information from another institution constructs and sends a request with encrypted arguments according to its local PDS access configuration; • The PDS verifies the authenticity of the request and access authorization; • The PDS analyses the request by decrypting and validating its arguments; • The PDS validates the user’s identity through the national patient registry (RNU); • The PDS constructs and sends the access request to the target institution’s interface with argument encryption; • The target institution verifies the authenticity of the request and access authorization; • The target institution locally validates the user’s identity; • The target institution provides its own interface for the requested information.
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6.3 Conclusions
Most mobile health solutions are vertically-integrated and closed solutions, which makes it difficult to integrate devices and products from other providers into the solution. For mobile health to reach its full potential, healthcare system architectures will need to open up and become interoperable, both in terms of getting information into the healthcare systems and to exchange data between back-end solutions.
As described in this document, there are a number of well-defined standards and conformance profiles, including the Continua Health Alliance designs and the IHE profiles. The component standards for clinical messaging, clinical coding and communications, such as HL7, IEEE 11073, and various wireless Internet standards, are also clear and well established.
Within the scope of these standards, requirements for development seem clear. Documentation and examples provide a good starting point. However, it is clear that the scope of these standards is limited. Nevertheless, adoption of the existing standards does not preclude upgrading or migrating to more complete standards in the future. Therefore, it would seem appropriate to encourage new entrants to the mobile health ecosystem to adopt the existing well- documented standards to expedite the wider deployment of mobile health solutions.
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7. Regulatory Perspective 7.1 Introduction
ICT based fall prevention & intervention devices are relatively new on the European market and still in a maturing phase. This area is largely driven by SME´s.
The devices are predominantly used in the home setting but may also be used in an out setting during normal outdoor activities as well as in different care giver settings.
ICT based fall prevention & intervention devices may or may not be classified as medical devices, they may include alarm functionalities for the user and also for the user’s habitation, they may incorporate different means of user communication with e.g. care givers and/or relatives, positioning means, retrieving- storing and transferring of patient data etc. All of which affects which regulatory requirements will be posed upon them.
The medical and consumer spaces are converging and ICT based fall prevention & intervention devices challenge the EU regulatory framework and raises new questions and concerns in that it combines IT, telecom, medical device, home surveillance and several other technologies and applications.
It is of decisive importance that the legal framework provides means to secure that ICT based fall prevention & intervention devices are safe and efficacious, but to promote progress and be supportive of innovation it is also important that the legal framework provides an environment which does not pose unjustified regulatory burdens on the manufacturers. A balanced and efficient regulatory approach is necessary to allow for innovation but also for creating confidence among the different stakeholders.
In this context we will analyze the conditions for the current EU regulatory framework to provide an effective yet appropriate legal framework for nourishing the further advancement of ICT based fall prevention & intervention devices.
7.2 Applicable EU Directives
The Package of measures known as the "New legislative framework" was adopted in Council on 9 July 2008 and published in the Official Journal on 13 August 2008. The measures are designed to help the internal market for goods work better and to strengthen and modernise the conditions for placing a wide range of industrial products on the EU market (European Commission, 2014).39
The New legislative framework (NLF), consisting of Regulation (EC) 765/2008 and Decision 768/2008/EC, supersedes the New Approach Directive, 85/C 136/01, which has been in force since 1985.
39 http://ec.europa.eu/enterprise/policies/single-market-goods/internal-market-for-products/new- legislative-framework/index_en.htm Competitiveness and innovation Framework Programme CIP-ICT-PSP-2012-6 325137 European Network fOr FALL Prevention, Intervention & Security E-NO FALLS
From the NLF it is evident that: Essential requirements define the results to be attained, or the hazards to be dealt with, but do not specify the technical solutions for doing so. The precise technical solution may be provided by a standard or by other technical specifications at the discretion of the manufacturer. This flexibility allows manufacturers to choose the way to meet the requirements (European Commission, 2014).40
This is a very important basic principle laid down already in the New Approach Directive and maintained in the NLF because it prevents the regulatory framework from rapidly becoming obsolete in the current climate of rapid technical development and is an effort of dealing with the issue of a fast industry and slow regulators.
Having this said, applying an appropriate standard when available, in full or in part, is usually the optimal approach for demonstrating compliance with the essential requirements. If a manufacturer do choose to apply a standard harmonised with a specific Directive, complying with the standard automatically leads to product compliance with the essential requirements covered by that standard. This is called the presumption of conformity.
It is estimated that there are some 1838 EU Directives (EUABC, 2014)41 and it is the obligation of each manufacturer to assess which Directives that are applicable to a specific device and to demonstrate product compliance with the applicable Directives, a challenging task especially for SME´s.
In most cases products are covered by more than one Directive. The “New legislative framework” states that one single Declaration of Conformity (DoC) covering all relevant Directives has to be issued (Article 5, Decision no. 768/2008/EC) (THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 2008).42 For medical devices, this provision has not yet been incorporated in the Medical Devices Directive. Therefore, for now, the manufacturer has the choice to issue a single combined DoC or to provide a separate declaration for each relevant Directive (COCIR, 2013).43 If the manufacturer choose to declare product compliance in a single DoC, the name, address and identification number of the Notified Body involved per Directive should be specifically declared (Eucomed, 2013).44
The situation is further complicated by the fact that it is not the Directive(s) per se with which the manufacturer shall demonstrate product compliance, but with the national legal implementation of the respective Directive in the country in which he will first place the product on the market. The reason being that Directives relates to EU member states, not to manufacturers.
40 http://ec.europa.eu/enterprise/newsroom/cf/itemdetail.cfm?item_id=7326 41 http://en.euabc.com/word/2152 42 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:218:0082:0128:EN:PDF 43 http://www.cocir.org/site/fileadmin/Publications_2013/COCIR_Guide_on_RoHS_II_Directiv e_obligations_-_25_April_2013_final.pdf 44 http://www.eucomed.be/publications/download/224/file/130522_paper_on_rohs_ce_marking. pdf
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A brief overview of some main EU Directives applicable to ICT based fall prevention & intervention devices is given below:
EU Directive 93/42/EC concerning Medical Devices (MDD) (THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 1993)45 The Medical Devices Directive will be discussed in detail below.
EU Directive 1999/5/EC on Radio equipment and telecommunications terminal equipment (R&TTE) (THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 1999)46 eHealth devices quite frequently comprise a radio transmitter e.g. a GSM or Bluetooth transmitter. The radio transmitter may be incorporated in a third party device such as a mobile phone which the eHealth device manufacturer intends to place on the market as part of a system. He should then, as a minimum, exhibit a DoC from the third party manufacturer declaring product compliance with the R&TTE Directive.
The radio transmitter may also be incorporated in a device which is itself manufactured by the eHealth device manufacturer. In such case it should either be demonstrated that the eHealth device manufacturer has closely followed the implementation guide lines from the radio transmitting chip manufacturer wherein further testing is usually not required, or he should perform testing of the finished device in conformity with applicable essential requirements of the R&TTE Directive.
The R&TTE Directive has very few essential requirements and there are harmonised standards for all of these essential requirements. Demonstrating compliance with the R&TTE Directive therefore is a quite straightforward process.
EU Directive 95/46/EC on the protection of individuals with regard to the processing of personal data and on the free movement of such data (THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 1995)47 / The General Data Protection Regulation (GDPR) (EUROPEAN COMMISSION, 2012)48
The Data Protection Directive which was adopted in 1995 regulates the processing of personal data within the European Union. Since the Data Protection Directive was adopted in "the year of the web", it has become increasingly obsolescent. Furthermore, since it is a Directive there is a patchwork of some 30 national regulations with quite differing requirements.
The current framework remains sound as far as its objectives and principles are concerned, but it has not prevented fragmentation in the way personal data protection is implemented across the Union.
On the 25th of January 2012 the European Commission proposed an EU General Data Protection Regulation. (European Commission, 2012)49 The regulation is planned for adoption in late 2014 and, with a transition period of two years, to become effective in 2016. Since this legal instrument takes the form of a regulation instead of a Directive, it will reduce legal
45http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:EN:PDF 46 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31999L0005&from=EN 47 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31995L0046&from=EN 48 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2012:0011:FIN:EN:PDF 49 http://europa.eu/rapid/press-release_IP-12-46_en.htm?locale=en
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fragmentation and provide greater legal certainty by introducing a harmonised set of core rules for all EU member states.
EU Directive 2012/19/EC on Waste Electrical and Electronic Equipment (WEEE II) (THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 2012)50 Directive 2012/19/EU on Waste Electrical and Electronic Equipment (WEEE II) entered into force on 13 August 2012 and Member States were required to transpose the Directive into national law by 14 February 2014. At that time, Directive 2002/96/EC (the “old WEEE Directive”) was repealed.
The Directive aims to prevent or reduce the negative environmental effects resulting from the generation and management of WEEE and from resource use.
Medical devices have been excluded from the previous WEEE Directive but the WEEE II Directive is mandatory for medical device manufacturers. Still excluded are medical devices that are expected to be infective prior to end of life as well as active implantable medical devices.
From the entry into force of the WEEE II, medical devices will be subject to a recovery target of 70% and a recycling target of 50%. These targets will be increased on 15 August 2015 to 75% and 55% respectively. After the introduction of the new equipment categories on 15 August 2018 the recovery and recycling targets for medical devices will become 85% and 80% respectively for ‘Large’ equipment and remain at 75% and 55% respectively for ‘Small’ equipment. (Eucomed, 2012)51
EU Directive 2011/65/EC on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS II) (THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 2011)52 The RoHS II Directive became mandatory for medical devices on the 22 July 2014.
RoHS II is now a CE-marking Directive which means that the manufacturer must compile the necessary technical documentation to demonstrate product compliance and draw up an EC Declaration of Conformity. When addressing compliance to RoHS II, the DoC must contain a disclaimer stating that it is issued under the sole responsibility of the manufacturer underlining the manufacturer’s responsibility for compliance with the Directive.
Manufacturers must ensure that components are compliant with RoHS II. Usually, requesting a certificate from the supplier certifying RoHS II compliance will be sufficient. In case there is reason to doubt the supplier certificate though, the manufacturer has an obligation to pursue in the establishment of compliance.
In November 2012, the EN 50581 standard became harmonised with regard to the RoHS II Directive, why complying with the standard will provide a presumption of conformity to the relevant provisions of RoHS II.
50 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32012L0019&from=EN
51 http://www.eucomed.be/blog/124/104/The-impact-of-WEEE2-on-the-medical-devices- industry 52 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32011L0065&from=en
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7.3 Overview of EU Regulatory Framework for Medical Devices 7.3.1 Current Regulatory Framework
The Medical Devices Directive came into force in 1993. It has been amended several times, the most important amendment was in 2007 with which compliance became mandatory on March 21, 2010.
The MDD is a so called New Approach Directive which means inter alia that the manufacturer must demonstrate product compliance with applicable essential requirements and choose conformity assessment route in order to demonstrate compliance.
The MDD has basically four different device classes; Class I, Class IIa, Class IIb and Class III depending on the criticality of the device i.e. the risks posed to the patients and users.
For medical devices there is no pre-market authorisation by a regulatory authority as is for pharmaceutical products but instead there is a conformity assessment which, for medium and high risk devices (Class IIa, IIb, III), involves an independent third party for pre-market assessment, a so called Notified Body.
For Class I medical devices, the manufacturer must register the device with the Competent Authority in the country of which he first places the device on the market.
A very common misunderstanding among medical device manufacturers is that the MDD has different device requirements depending on the classification and most especially that Class I devices have lower requirements. However, the MDD does not differ in terms of device requirements for the different classes but only as regards the degree of Notified Body intervention in the conformity assessment. A Class I device manufacturer must also compile a complete technical documentation demonstrating product compliance with all applicable essential requirements which therefore must include e.g. a device risk analysis and a clinical evaluation.
Having this said, naturally it is usually easier to demonstrate compliance with the essential requirements for a Class I device than for devices of higher classes, but the same documents will still be required in the technical documentation.
The MDD has more than 60 essential requirements, all of which are not applicable to a single medical device, and there isn´t harmonised standards for all of these essential requirements. Demonstrating compliance with the MDD is therefore a considerably more challenging task than with e.g. the R&TTE Directive.
In general the MDD has succeeded as a legal instrument for the medical device industry with its huge spectrum of products, there are around 500,000 or more different types of medical devices on the market, and with manufacturers ranging from start-ups and SME´s to large enterprises. Main criticism has referred to differing implementation and application in the different EU member states leading to uneven competition.
The Competent Authorities have rightfully been criticized for insufficient surveillance and follow-up of Notified Bodies and of manufacturer’s compliance with the Directive. This in turn enables non-complying manufacturers cost and time savings in regulatory management which leads to uneven competition and might lead to patient and user risks.
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The inconsistent performance of Notified Bodies has also been a subject of criticism and is a concern on EU level.
Proper functioning of notified bodies is crucial for ensuring a high level of health and safety protection and citizens' confidence in the system which has come under severe criticism in recent years due to significant differences as regards, on the one hand, the designation and monitoring of notified bodies and, on the other, the quality and depth of the conformity assessment performed by them, in particular in their assessment of the manufacturers' clinical evaluation. (EUROPEAN COMMISSION, 2012)53
Medical devices have e.g. been placed in the market with a wrongfully lower classification, especially with an incorrect Class I classification in order to avoid Notified Body intervention. Medical devices have been placed in the market without sufficient clinical evaluation and products have been placed in the market as non-medical devices although the intended purpose pronouncedly has been diagnosis and/or treatment of human beings.
Apart from the insufficient and variegated performance of the Competent Authorities and Notified Bodies, the MDD is an impressively purposeful yet flexible legal framework with an adaptability to the exceedingly wide scope of medical devices. The MDD is more flexible than probably most medical device companies and especially SME´s realize.
It is the obligation as well as the privilege of the manufacturer to define the intended purpose of the device he is about to place on the market. Keeping the MDD definition of a medical device closely in consideration, the manufacturer is free to choose an intended purpose rendering the device to be classified as a medical device or not. The intended purpose may or may not affect the features and characteristics of the device.
If the manufacturer choose an intended purpose rendering the device to be classified as a medical device, the formulation of the intended purpose may still affect the MDD classification of the device and the concomitant regulatory burden.
Carefully elaborating the intended purpose of a device is not a question of dodging or circumventing the regulatory framework, it is a question of a deliberate manufacturer decision on how he intends his device to be used and which market segments he intends to approach.
The scope of the intended purpose affects potentially available market as well as the regulatory onus. A more wide scope e.g. including ambulance and helicopter use will increase the potentially available market but also increase the verification and validation required to demonstrate product compliance with applicable essential requirements and thereby likely increase time to market. A more narrow scope on the other hand e.g. restricting to hospital use only, will decrease the potentially available market but also decrease the verification and validation required and thereby likely decrease time to market.
As defined already in the New Approach Directive and maintained in the NLF, the application of standards remains voluntary on behalf of the manufacturer and the manufacturer is free to choose any other means of demonstrating product compliance with applicable essential requirements, even to choose parts of standards. This is also a very pragmatic and useful quality of the Directive.
53 http://ec.europa.eu/health/medical-devices/files/revision_docs/proposal_2012_542_en.pdf
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The MDD is quite pragmatic in how to meet the applicable essential requirements and in how to demonstrate that the requirements have been met which gives the manufacturer a substantial degree of freedom. Because of this flexibility, the requirements are not very explicit and it is not all clear how to meet the requirements or demonstrate how the requirements have been met which therefore can be quite a challenge especially for SME´s who cannot afford an experienced regulatory manager. 7.3.2 Proposed Changes
The fact that the MDD is a Directive and that each member state therefore have implemented their own corresponding national legislation has led to discrepancies. Substantial divergences in the interpretation and application of the rules have emerged since the introduction, undermining the legislation's main objectives; the safety of devices and their free circulation within the internal market. (EUROPEAN COMMISSION, 2012)54 This will be further discussed below as national barriers.
In order to rectify this situation and to inter alia strengthen the supervision of the Notified Bodies by the Member States and to guarantee the independency and the quality of pre-market assessment of devices by clarifying and enhancing the position and powers of notified bodies vis-à-vis the manufacturers, the European Commission published, on 26 September 2012, proposals for two new regulations on medical devices and in vitro diagnostic devices which will replace the existing three Directives currently regulating medical devices in the European Union. (European Commission, 2014)55
The Commission proposals will be discussed in the European Parliament and in the Council. They are expected to be adopted in 2014 and would then gradually come into effect from 2015 to 2019. As with the General Data Protection Regulation, this legal instrument also takes the form of a regulation instead of a Directive and will therefore reduce legal fragmentation and provide greater legal certainty by introducing a harmonised set of core rules for all EU member states.
7.4 Two Alternative Regulatory Pathways to the Market for ICT Based Fall Prevention & Intervention Devices
This chapter addresses the following questions: • Are ICT based fall prevention devices necessarily medical devices? • When do they become medical devices? As discussed above, the manufacturer freely determine the intended purpose of his device. For manufacturers of typical medical devices, this opportunity may seem as a mare's nest but for manufacturers of eHealth devices such as ICT based fall prevention devices, this is very much real. By carefully elaborating the intended purpose of their device, a manufacturer of ICT based fall prevention devices may decide whether his device will be regulated as a medical device or not. This is not an obvious choice but most certainly a trade-off.
If he choose an intended purpose (and possibly features of the device) in order to avoid a medical device classification, he must carefully avoid describing any features involving diagnosis, prevention, monitoring, treatment or alleviation of disease, injury or handicap in
54http://ec.europa.eu/health/medical-devices/files/revision_docs/com_2012_540_revision_en.pdf 55 http://ec.europa.eu/health/medical-devices/documents/revision/index_en.htm
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human beings. Furthermore he must carefully avoid any descriptions of a medical purpose in the marketing of the product that would render the device a medical device classification. This will highly affect the potentially available market by reducing the market segments he may approach. On the other hand he will have less to prove during the verification & validation phase of the product design which will most likely save costs and reduce time to market.
In the case the manufacturer choose an intended purpose in order not to have his device classified as a medical device, it is likely that other regulations will be applicable such as the General Product Safety Directive, 2001/95/EC (THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE, 2002)56, which may have more stringent safety requirements.
If the manufacturer on the other hand choose to have his device classified as a medical device, new segments of the market will be available, segments where product margin is usually higher inter alia because of the increased regulatory management costs. His verification & validation burden though will increase and most likely his time to market.
This is a situation these manufacturers share with many other manufacturers of products on the borderline of medical purpose e.g. health or lifestyle products and certainly eHealth products.
In recent years though, the trend from the regulators has been to include more devices within the scope of the MDD. Devices such as standalone software or apps (EUROPEAN COMMISSION, 2012)57 and electronic patient records have now been considered to be medical devices which was not evident previously. This is partly reflected in the 2007 amendment of the MDD where in the definitions for the classification rules; “Stand alone software is considered to be an active medical device” was added to rule 1.4 but also in guidance’s from Competent Authorities. (Medical Products Agency, 2014) 58 A manufacturer of ICT based fall prevention and intervention devices must keep this in mind when elaborating the product intended purpose in case he wants to avoid a medical device classification of his product.
7.5 Is the MDD an appropriate regulatory framework for ICT based fall prevention & intervention devices?
This chapter addresses the following questions: • ICT based fall prevention & intervention devices are often low risk products. Is there a tendency to over-regulate these kind of devices? • Is the MDD a barrier for the deployment of innovative ICT-based fall prevention and intervention solutions or is it merely a question of applying the MDD correctly? ICT based fall prevention & intervention devices which are classified as medical devices may still differ quite considerably in terms of features and applications with concomitant differing associated user risks. Some devices may have rather few and uncritical features rendering them a Class I classification while others may include different degrees of patient monitoring and alarm functionality such as call for ambulance, rendering them a higher risk classification.
This is not unique for ICT based fall prevention & intervention devices. The vast scope of medical devices range from e.g. simple bandages to the most sophisticated life-supporting
56 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32001L0095&from=EN 57 http://ec.europa.eu/health/medical-devices/files/meddev/2_1_6_ol_en.pdf 58 http://www.lakemedelsverket.se/malgrupp/Foretag/Medicinteknik/Klassificering/Sakerhetskrav-pa-medicinska- informationssystem/
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devices. This is the root-cause for the intrinsic flexibility of the MDD and should be equally applicable to ICT based fall prevention & intervention devices as for other medical devices.
It would therefore seem as if the main issue for manufacturers of ICT based fall prevention devices is whether to classify the device as a medical device or not and if so, to decide the product features with respect to criticality and concomitant MDD classification.
The MDD itself seem to be as an appropriate legal instrument for ICT based fall prevention devices as for other devices currently in the market.
7.6 National Barriers for Deployment of Services/Products Resulting from falls ICT-based Solutions
This section answers the following questions: • Are there national regulatory barriers within the EU for ICT based fall prevention & intervention devices? • To what extent are national barriers preventing deployment of ICT based fall prevention & intervention devices?
7.6.1 Requirements for National Registration of Medical Devices
One of the main objectives of the European Union is to promote the free movement of goods and to prevent trade barriers.
Although every medical device is registered with the Competent Authority in the country where the device is first placed on the market, Article 14 of the MDD states: For all medical devices of classes IIa, IIb and III, Member States may request to be informed of all data allowing for identification of such devices together with the label and the instructions for use when such devices are put into service within their territory.
The Italian Ministry of Health (MOH) implemented mandatory procedures for an Italian registration of medical devices as of 1 May 2007. Italy requires, in addition to the CE marking (as opposed to the essence of the CE marking which is “Free Circulation of Goods”), that ALL Medical Devices to be placed in the Italian market will go through a Device registration process. This process is similar to the pre-market notification requirement for Class I Medical Devices (as stated in the European Directive MDD 93/42/EEC Article 14); however, in Italy it is applicable for all classes, not only Class I. Local legislations, such as this one, are growing rapidly in Europe…...The registration can only be done with granted access to the Italian Database, and with the required “smart card” for the actual registration. (Wikipedia, 2014) 59
Unfortunately, the bad example of Italy has since been followed by countries such as France (Afssaps, 2010)60, Spain (AEMPS, 2010)61 and Poland (Qmed, 2014)62 and is envisaged to be followed by other member states.
59 http://en.wikipedia.org/wiki/Italian_Device_Registration 60http://ansm.sante.fr/var/ansm_site/storage/original/application/70db8dfb9035e3aa365c04b238e1287d.pdf 61http://www.aemps.gob.es/en/publicaciones/publica/regulacion_med-PS/docs/folleto-regulacion_Med-PS.pdf 62 http://www.qmed.com/consultants/new-registration-requirements-medical-devices-poland
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Currently, only entities which have a registered place of business on Polish territory are permitted to register medical devices resulting in non-Polish manufacturers being forced to have a distributor or importer with a registered office in Poland. This must be deemed an exceedingly extensive interpretation of Article 14, MDD.
Member states requiring registration of Class IIa, IIb and III medical devices for market clearance in their respective country is a nuisance and annoyance and in direct contrary to the principle of free circulation of goods within the European community. For medical device manufacturers, this is turning back the clock 20 years to the time before the introduction of the MDD. It considerably increase costs and workload on medical device manufacturers, especially SME´s, without any gain whatsoever in patient safety or device efficacy and with the risk of impeding the development of innovative uses of new technologies.
Hopefully this situation will be remedied by the European Commission proposal for new regulation on medical devices: Article 1, EC/764/2008; “The aim of this Regulation is to strengthen the functioning of the internal market by improving the free movement of goods.” The establishment of a central registration database will not only provide a high level of transparency but also do away with diverging national registration requirements which have emerged over recent years and which have significantly increased compliance costs for economic operators. It will therefore also contribute to reducing the administrative burden on manufacturers. [‘Economic operators’ shall mean the manufacturer, the authorized representative, the importer and the distributor]
7.6.2 Requirements for Standards Compliance
Requiring compliance with standards in the procurement specifications for medical devices is a bad habit by many purchasers.
Since there are national standards, requiring compliance with standards in the procurement specifications of medical devices forces European medical device manufacturers to be knowledgeable about these national standards. This poses a major effort especially for SME´s, delays product launches and is directly contradictory to one of the fundamental ideas of the EU, the New Approach/NLF and to the MDD.
Since the manufacturer is free to choose to apply standards in whole, in part or not at all when demonstrating product compliance with the essential requirements of the MDD, the purchaser in a public procurement cannot and must not request compliance with any standards whatsoever. From a regulatory point, the purchaser should only request that the device is CE marked as a medical device in accordance with the MDD. How the manufacturer has demonstrated compliance with the MDD is a matter between the manufacturer and the Notified Body or, in the case of a Class I devices, the Competent Authority of the country in which the product is first placed on the market.
Having this said, of course the purchaser is free to request any features necessary for the intended use he has in view and to determine whether the manufacturer stated intended purpose of the device correlates with his intended use.
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National implementation of the Data Protection Directive Since ICT based fall prevention & intervention devices are often retrieving-, storing and transferring patient data, although not specific for but highly affecting those devices is the different national implementation of the Data Protection Directive.
Close to 30 different legislations regarding data protection is quite a challenge for an SME to comply with. Hopefully the General Data Protection Regulation will overcome this issue.
7.7 Summary
From a regulatory point, a manufacturer of ICT based fall prevention & intervention devices has the choice to define his product as a medical device or not. The choice is his and both alternatives has their pros and cons.
The MDD is a quite flexible regulatory framework and given that manufacturers of ICT based fall prevention & intervention devices choose to classify their products as medical devices, the MDD should be as applicable for them as for other medical devices.
Directives have the disadvantage of being implemented somewhat differently in different EU member states. To some extent there seems to be a trend from EU to compose regulations instead of Directives, having the advantage of reducing or eliminating different legislation in different EU member states which highly facilitates the functioning of the internal market for goods. In some instances, manufacturers of ICT based fall prevention & intervention devices will benefit from this trend.
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8. Standardization perspective
8.1 Existing Standards in eHealth and mHealth
In order to share and aggregate data electronic information systems rely on standards. ICT based fall prevention and management solutions that collect, use and share electronic information need to collect data using standard definitions and formats. In order to exchange health data and to make use of the information, systems must include syntax and semantic content that is clear and unambiguous to both sender and receiver. Due to the broad scope of health information and multiple (and often imprecise) terminologies in common use, this can pose a significant challenge (WHO, 2012)63.
As soon as health information data are stored and exchanged a series of health informatics standards become relevant. Standards can assist to meet the requirements set by users, healthcare professionals, industry and legislation. This section describes some of the existing standards that can be used in ICT solutions for fall prevention. According to their objectives standards can be grouped into three relevant categories: • Medical record standards specify the structure, content, and organization of individual patient medical records. • Messaging standards describe protocols to communicate data. • Vocabulary standards define the terms used to describe health conditions and events.
8.1.1 Medical Record Standards
Health information is sensitive, particularly when it comes to individual health information. Therefore it is important to comply to international or national regulations and standards for the collection, storage, use and disclosure of health information.
ISO’s Technical Committee (TC) 215 and CEN Technical Committee 251 work on health information and communications technology to facilitate interoperability of health data. The Technical Committees develop standards on various aspects of electronic health records. The ISO and CE standards address a wide range of interoperability issues for patient information and device communication as well as privacy and security issues related to patient data.
Information security: ISO 27002 and ISO 27799 ISO/IEC 27002 (ISO/IEC, 2013)64 is a broad and general standard on information security. ISO/IEC 27799 (ISO/IEC, 2008)65 provides guidance for the implementation of ISO 27002 within the healthcare sector.
The ISO 27002 and 27799 standards assist healthcare organizations to ensure that the confidentiality, integrity and availability of data in their care is preserved: • confidentiality is essential when the privacy of subjects of care is to be safeguarded; • integrity of health information must be protected to ensure patient safety;
63 WHO 2012. Management of patient information. Trends and challenges in Member States http://apps.who.int/iris/bitstream/10665/76794/1/9789241504645_eng.pdf?ua=1 64 ISO/IEC 27002: 2013 Information technology — Security techniques —Code of practice for information security controls 65 EN/ISO 27799: 2008 Health informatics – information security management in health using IEC/ISO 27002
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• availability of health information is critical to effective healthcare delivery. Different healthcare providers need to have access to the health information data when needed. Health informatics systems must meet the demands to remain operational when facing system failures, natural disasters and denial-of-service attacks.
The need for effective IT security management in healthcare is made all the more urgent by the increasing use of wireless and Internet technologies in healthcare delivery. If not implemented properly, these technologies will increase the risks to the confidentiality, integrity and availability of health information.
Regardless of size, location and model of service delivery, all healthcare organizations need to have stringent controls in place to protect the health information entrusted to them.
There are several types of information whose confidentiality, integrity and availability need to be protected: a. personal health information, b. pseudonymised data derived from personal health information via a certain methodology for pseudonymous identification, c. statistical and research data, including anonymised data derived from personal health information by removal of personally identifying data, d. clinical / medical knowledge not related to any specific subjects of care, including clinical decision support data (e.g., data on adverse drug reactions), e. data on health professionals, staff and volunteers, f. information related to public health surveillance, g. audit trail data, produced by health information systems, that contain personal health information or pseudonymous data derived from personal health information, or that contain data about the actions of users in regard to personal health information, and h. system security data for health information systems, including access control data and other security related system configuration data, for health information systems.
The extent to which confidentiality, integrity and availability need to be protected depends upon the nature of the information, the use to which it is put, and the risks to which it is exposed. Risk assessment can properly determine the level of effort needed to protect confidentiality, integrity and availability.
ISO 27799 provides guidelines on data security issues like data storage, information classification, access control management, logging and authentication, incident management and business continuity.
Interoperability
The AALIANCE2 report (AALIANCE2, 2013) provides a number of reasons that standardization and interoperability is a key requirement for the success of ambient assisted living solutions. The reasons are adapted for ICT solutions for fall prevention and management based on the results of the survey: • Variety of user requirements and preferences: The elderly people, the main customer group for fall prevention solutions, have a large variety of needs and preferences. This is on the one hand due to possible physical or cognitive limitations and chronic diseases that may or may not be present, and on the other hand due to the individual experience with, and acceptance of technical systems in general, and computers in particular. This means that a “one size fits all” product will hardly be accepted on the market.
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Successful solutions will have to be modular and adaptable to individual user needs and preferences. • Need for “future proof” systems: As a user’s health status and individual limitations change over time, an ICT based fall prevention solution will have to be extended or complemented with additional modules whenever a new need arises. It is unlikely that users will accept that in each of these cases a system needs to be completely exchanged by a different one (with possibly different user interfaces). • Integration with existing infrastructure: ICT based fall prevention solutions that make use of sensors or actors embedded in the environment need to be adapted for the layout of each individual living environment. Depending on the number of rooms, doors, electrical appliances etc. the number and location of components will vary. Furthermore, in apartments where a home automation infrastructure (such as a KNX, LON or BACnet field bus) is already available, users will probably not accept that the complete network (including all cables in the walls) need to be exchanged only because the ICT based fall prevention system only supports a different home automation network. Again, this requires a significant amount of modularity in product design. • Integration with local service providers: ICT based fall prevention and management solutions will most often have to integrate with local service providers delivering services such as GP, physiotherapist, nursing care, alarm service, concierge services etc. Therefore, in each city or region the system will have to interact with different providers. Interoperability is a prerequisite as health care organizations can not and are not willing to cope with a variety of systems. • No comprehensive product program: Unlike markets such as the medical device market, where a few “big players” offer comprehensive product programs covering all needs of a potential customer, the ICT fall prevention solution sector is rather dominated by small and medium-sized enterprises (SMEs) offering innovative products. It is (AALIANCE2, 2013) unlikely that in this situation a single vendor will be able to offer a comprehensive product program covering all needs of the customer base. This in turn makes it necessary to combine products from different vendors in order to address users’ needs. • Freedom of choice: From the user perspective, interoperability is very much desirable because it enables the user to choose over different products and services, and adapt a system according to the current needs, but also to the available financial and material means, which is especially important. This is where standards come „into play“: If the interfaces between systems and system Interoperability can be addressed on several layers or levels.
ISO 11073 series of standards The 11073 series of standards are targeted at personal health and fitness devices (such as glucose monitors, pulse oximeters, weighing scales, medication dispensers and activity monitors) and at continuing and acute care devices (such as pulse oximeters, ventilators and infusion pumps). They comprise a family of standards that can be layered together to provide connectivity optimized for the specific devices being interfaced. There are five main types of ISO 11073 standards: • Communication Protocols; • Medical Devices; • Personal Health Records; • Terminologies and Semantics; • Medical Terminology
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For ICT based fall prevention and management solutions the following could be useful: • ISO/IEEE 11073- 10101:2004 Health informatics – Point-of-care medical device communication – Part 10101: Nomenclature, • ISO/IEEE 11073- 10201:2004 Health informatics – Point-of-care medical device communication – Part 10201: Domain information model, • ISO/IEEE 11073-10421:2012 Health informatics – Personal health device communication – Part 10421 Device specialization – Peak expiratory flow monitor (peak flow), • ISO/IEEE 11073 - 10442 Health informatics—Personal health device communication - Part 10442: Device specialization— Strength fitness equipment, • ISO/IEEE 11073- 10471:2010 Health informatics – Personal health device communication – Part 10471: Device specialization - Independent living activity hub, • ISO/IEEE FDIS 11073-10472 Health Informatics – Personal health device communication – Part 10472: Device specialization – Medication monitor, • ISO/IEEE 11073- 20101:2004 Health informatics – Point-of-care medical device communication –Part 20101: Application profiles – Base standard, • ISO/IEEE 11073- 20601:2010 Health informatics – Personal health device communication – Part 20601: Application profile – Optimized exchange protocol, • ISO/IEEE 11073-30200:2004 Health informatics – Point-of-care medical device communication – Part 30200: Transport profile – Cable connected, • ISO/IEEE 11073- 30300:2004 Health informatics – Point-of-care medical device communication – Part 30300: Transport profile – Infrared wireless, • ISO/IEEE FDIS 11073-30400 Health informatics – Point-of-care medical device communication – Part 30400: Interface profile – Cabled Ethernet, • ISO 11073- 90101:2008 Health informatics – Point-of-care medical device communication – Part 90101: Analytical instruments – Point-of-care test, • ISO/TS 11073- 92001:2007 Health informatics – Medical waveform format – Part 92001: Encoding rules.
8.1.2 Messaging Standards
Citizens have a right to expect safe and quality care throughout their lives and need systems that can work together. Health and care professionals are in need of systems able to represent and communicate relevant information. Concurrent Use (CEN/TC 251, 2014) of the messaging standards ContSys, HISA and EHRcom makes multi-disciplinary care planning possible. Furthermore it helps healthcare organizations to be more efficient and effective in delivering care by eliminating data silos and removing vendor lock-in. The video http://tinyurl.com/CENConUse explains the role of each of these standards.
In addition to these messaging standards that describe messaging at a higher level, the HL7 standards are used to make up the message.
EN ISO 13940 (ContSys) This standard for a system of concepts is a high level description of how health and social care operates to achieve continuity of care, which is an important aspect of quality and safety in healthcare. It describes a generic clinical process, which is focused upon the subject of care and the context in which that care takes place. This standard establishes a common conceptual framework across national, cultural, organizational and professional barriers; by doing so, ContSys provides the basis for all information and computational models necessary to deliver semantic interoperability for what is, in essence, a person-centric domain (CEN/TC 251, 2014).
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An example of use: The County Council of Skåne, Region Skåne in Sweden, has created clinical reference models from ContSys concepts to develop coherent clinical applications. The process used was to make an XML scheme/service for each reference structure, to document the specialization and to use it in an implementation.
EN ISO 12967 (HISA) This 3 part standard for Health Informatics Service Architecture enables integration and interoperability of IT systems in healthcare. It underpins a middleware of information services that are technology independent, handling the common information asset and business logic relevant for a healthcare enterprise. HISA is based on the ISO/IEC reference model for Open Distributed Processing using Enterprise, Information and Computational viewpoints and permits plug-and-play exchange of data through many types of deployment interface (e.g. web- services). In particular, HISA specifies the architecture and services for continuity of care, enabling access to, and the sharing of, the patient’s record (CEN/TC 251, 2014).
An example of use: The Italian Region of Molise is engaged in creating an integrated HISA- based regional repository containing patient’s healthcare information, unified and accessible through services, allowing the implementation of a new regional healthcare information system and the integration of multi-vendor applications.
EN ISO 13606 (EHRcom) This standard for Electronic Health Record (EHR) Communication defines the way in which clinical applications, electronic health record systems and national EHR repositories can exchange health and care records. It therefore helps to support shared patient care between healthcare and social care organizations, and enables care providers to be informed by a patient’s life-long history whenever and wherever he or she next needs care. The standard importantly also supports information about who should be allowed to access the data in each record, for example to comply with national regulations and the wishes of the patient, and enables patients to view who has been accessing their health record (CEN/TC 251, 2014).
The standard is organized in parts: Part 1: Extended architecture, Part 2: Domain term list, Part 3: Distribution rules, Part 4: Messages for the exchange of information and Part 5 interface specification.
An example of use: Every week over 11,000 patients change their general practice in England in the safe knowledge their complete life general practice record will be available at their first consultation with their new GP thanks to 13606 based messages.
Concurrent use of ContSys, HISA and EHRcom The following figure, developed by CEN/TC 251 Heath informatics, shows the landscape and interrelationship between the different standards in eHealth. The HL7 standards in this figure are represented by the ‘templates-’ and ‘archetypes-’ fields.
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Figure 17. Concurrent use landscape
Source (CEN/TC 251, 2014)
HL7 (Health Level 7: Standard for communication transfer of medical data) (HL7, 2014)66 Just as people from different countries with completely different native tongues are only able to communicate with each other if they can speak a common language, computer applications can only share data if they communicate with a common protocol. For people or computers to be able to share clinical information with one another, they must both:
1. have functions to be able to physically communicate, e.g. speak & hear, send and receive documents and data files, share data and information. This is called "functional interoperability". 2. speak a common language (in terms of nouns, verbs, grammatical structure, etc.) and share the same vocabulary that allows them to understand complex medical conditions and processes. This is called "semantic interoperability".
A group of healthcare computer systems users started developing the HL7 protocol in 1987 to create a common "language" that allows healthcare applications to share clinical data with each another. Over time the HL7 interoperability protocol became a nationally, internationally and globally accepted and accredited standard.
66 http://www.hl7.com.au/FAQ.htm
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The term ‘Health Level 7’ (HL7) is used both for the organizations involved in developing and supporting the healthcare standards as well as for the Version 2.x and Version 3 Standards themselves and other standards developed by the HL7 local organizations in some30 countries. HL7 version 3 is expressed in XML encoding syntax and allows the HL7 model to expand beyond messaging by including vocabularies from other sources.
The following HL7 standards are published by ISO: • ISO/HL7 10781:2009 (cor. 2012) Electronic Health Record-System Functional Model, Release 1.1 • ISO/HL7 21731:2006 Health informatics – HL7 version 3 – Reference information model – Release 1 • ISO/HL7 27931:2009 Data Exchange Standards – Health Level Seven Version 2.5 – An application protocol for electronic data exchange in healthcare environments • ISO/HL7 27932:2009 Data Exchange Standards – HL7 Clinical Document Architecture, Release 2 • ISO/HL7 27953-1:2011 Health informatics – Individual case safety reports (ICSRs) in pharmacovigilance – Part 1: Framework for adverse event reporting • ISO/IEEE 11073-10103:2014 (Cor. 2014-05) Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac • ISO 11073-90101:2008 Health informatics - Point-of-care medical device communication - Part 90101: Analytical instruments - Point-of-care test • ISO/TS 11073-92001:2007 EHealth informatics – Medical waveform format – Part 92001: Encoding rules • ISO 13606-3:2009 Health informatics – Electronic health record communication – Part 3: Reference archetypes and term lists • ISO/TS 15000- 2:2004 Electronic business eXtensible Markup Language (ebXML) – Part 2: Message service specification (ebMS) • ISO 21090:2011 Health informatics – Harmonized data types for information interchange.
Clinical Document Architecture (CDA) The Clinical Document Architecture (HL7, 2014)67 is a HL7 standard for the representation and machine processing of clinical documents in a way which makes the documents both human readable and machine process-able and guarantees preservation of the content by using the eXtensible Markup Language (XML) standard. It is an approach to the management of documents which make up a large part of the clinical information processing arena.
Continuity of Care Document (CCD) The Continuity of Care Document (CCD) is an HL7 XML standard for the exchange of electronic clinical records. The CCD is based on the Clinical Document Architecture (CDA) in use in the USA. The CCR (Clinical Care Record) is developed to facilitate transfer of the essential health record of an individual patient from one care provider to another through the use of a standard format and vocabulary.
The CCD represents a merger of the CCR (ASTM) and the CDA (HL7) and replaces both of these (CCD=CCR+CDA). The CCD is both “human readable” (via browser) and “machine readable” (import into EHR system) and has wide healthcare industry support.
67 http://www.hl7.org.au/CDA.htm
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The CDA and CCD documents standards are specific to the US health care system but can be adopted for use elsewhere.
8.1.3 Vocabulary Standards
Vocabularies provide a standard method of expressing health information. For clear communication it is vitally important to have each given health term precisely defined so that it will not lead to confusion or be subject to corruption when received.
Vocabularies such as SNOMED or ICD are designed for specific descriptive purposes. A country may adopt these completely or agree to use subsets. Countries might find it useful to define their own vocabulary for a data set that is used within the country such as national health indicators, routine facility reporting, or monitoring and evaluation reporting.
International Classification of Diseases (ICD) The ICD is a list of codes to classify diseases, signs, symptoms, abnormal health findings and external causes of illness or injury. It has been maintained by WHO since the first World Health Assembly in 1948. This effort built on earlier classifications going back to the late 19th century. The current version of the ICD is 10 although version 9 is still in widespread use, particularly in the USA. There have been several extensions and modifications of the ICD to provide better coverage of clinical conditions, health care procedures, and morbidity. The USA maintains the ICD-9-CM (Clinical Modifications) and is working on developing ICD-10-CM. ICD-9 contains approximately 17 000 codes whereas ICD-10 contains approximately 155 000 codes. WHO is currently working on ICD-11.
Systematized Nomenclature of Medicine (SNOMED) SNOMED (IHTSDO, 2014) is designed to provide a comprehensive nomenclature of clinical medicine for the purpose of describing records of clinical care in human medicine. It is a multi- axial and hierarchical classification system. It is multi-axial in that any given clinical condition can be described through multiple axes such as topography (anatomy), morphology, organisms such as bacteria and viruses, chemicals such as drugs, function (signs and symptoms), occupation, diagnosis, procedure, physical agents or activities, social context, and syntactic linkages and qualifiers. SNOMED is hierarchical in that each of the axes has a hierarchical tree that proceeds from general terms to more specific ones. For example topography (anatomic) terms are first divided into major organs such as lung, heart, and then into the smaller components of each.
The SNOMED CT is a collection of medical terms covering most areas of clinical information that is systematically organized to be processed by computer. It provides a terminology, developed by the International Health Terminology Standards Development Organization (IHTSDO) that is optimized to index, store, and retrieve clinical data across care boundaries and sites. SNOWMED CT consists of over a million medical concepts.
SNOMED CT contributes to the improvement of patient care by underpinning the development of Electronic Health Records that record clinical information in ways that enable meaning-based retrieval. This provides effective access to information required for decision support and consistent reporting and analysis. Patients benefit from the use of SNOMED CT because it improves the recording of EHR information and facilitates better communication, leading to improvements in the quality of care (IHTSDO, 2014).
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Logical Observation Identifiers Names and Codes (LOINC) LOINC10 is a standard for identifying medical laboratory observations. Developed by the Regenstrief Institute in the USA, it is specifically designed for use as an electronic database for clinical care and management that is suitable for use in an electronic health record. It has expanded from the original laboratory codes to include nursing diagnoses and interventions, outcomes classification, and a patient care data set.
LOINC is the preferred code set for HL7 laboratory test names in transactions. It currently contains over 58 000 observation terms.
Pofound Taxonomy ProFaNE' project published a taxonomy (Profane, 2007)68 (naming and classification system) for falls prevention interventions, as presented in chapter 4.
8.2 Use of Standards in ICT Solutions for Fall Prevention and Management
8.2.1 Use of Standards in eHealth and mHealth
WHO is monitoring the use of standards in eHealth (WHO, 2012).
Individual patient data standards Thirty-eight per cent of responding countries have standards for individual patient data. This can be anything from a small data set of demographic and basic clinical information to a complete longitudinal electronic medical record (EMR or PHR) with full professional, laboratory, radiology and ancillary service input. Most commonly, countries have defined some set of individual patient data that is useful for continuity of care, monitoring and evaluation, or aggregate data for planning or research.
Examples of international individual patient data standards are the Continuity of Care Record (CCR) and the Continuity of Care Document (CCD);
Figure 8.2 shows the uptake of international standards for eHealth across responding countries, according to a WHO survey (WHO, 2012).
68 http://www.profane.eu.org/taxonomy.html
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Figure 18. Adoption of international standards in eHealth in WHO survey
(Source: (WHO, 2012) Management of patient information. Trends and challenges in Member States http://apps.who.int/iris/bitstream/10665/76794/1/9789241504645_eng.pdf?ua=1) Note: Most of the mentioned standards in figure 8.1 are discussed in the sections above (in this chapter). The metadata standards: Dublin Core Metadata Initiative (DCMI), Data Documentation Initiative (DDI) and Statistical Data and Metadata eXchange (SDMX) are not explained in this chapter as the metadata standards at this state of implementation may be less relevant for the ICT solutions in fall prevention and management.
Use of SNOWMED Vocabularies such as SNOMED or ICD are designed for specific descriptive purposes. A country may adopt these completely or agree to use subsets. Countries might find it useful to define their own vocabulary for a data set that is used within the country such as national health indicators, routine facility reporting, or monitoring and evaluation reporting. Almost one third of the responding countries (32%) have adopted vocabularies in addition to ICD for use in their health sectors.
Twenty-five per cent of the responding countries (in the WHO survey) have adopted SNOMED. This is less than the ICD coding system and may be due to SNOMED’s complexity. Cost is also likely to be an important factor in the relatively low uptake seen – the ICD is free and SNOMED is not (WHO, 2012).
The following European countries are member of the International Health Standards Development Organisation (IHTSDO) (IHTSDO, 2014)69. In each country hospitals, vendors, researchers and public administrations can become licensees. The following list gives an overview of the deployment of SNOWMED and priorities in each country:
Belgium (0 licensees) Belgium has developed an e-health roadmap for 2013-2018, in which an important strategy is the adoption of SNOMED CT as the main health system’s clinical terminology.
69 http://www.ihtsdo.org/members/xxxx/2014-update/
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The strategic goal to use SNOMED CT in the entire Belgian healthcare system is still in the initial planning stages and a schedule is set to be determined in 2014. Efforts to work on translation and limited implementations are gaining momentum.
Czech Republic (0 licensees) In joining IHTSDO in 2012, the Czech Republic will make SNOMED CT available throughout the Czech Republic for use in electronic health records, health research, and other applications.
Denmark (29 licensees) There is a growing interest and understanding in Denmark of the possibilities for using SNOMED CT. Two of the five Danish regions have chosen a common EHR system, Epic. In connection with this, they have shown interest in knowing more about SNOMED CT. On the municipal level, the Danish municipalities are planning to use parts of SNOMED CT for the terminology in their healthcare systems.
Development of the Danish drug terminology is expected to move forward in 2014 in the following ways: Danish drug data will be added to SNOMED CT in a Danish Drug Extension; The new IHTSDO pharmacy model, which includes strength, will be implemented in the drug terminology, making Danish trade products fully defined; Establishment of a national allergy register containing SNOMED CT allergy codes is expected to start in 2014; and A number of knowledge databases – Max Dose, Risk Situation, Interactions Database and medicin.dk (drug information site) – will start using SNOMED CT substance codes
Estonia (9 licensees) SNOMED CT will be of primary focus in Estonia in 2014-2015. The overall aim is to begin implementing and using SNOMED CT nationally. The extent to which SNOMED CT will be translated and implemented is currently under evaluation.
Iceland (0 licensees) The eHealth policy in Iceland includes the implementation of an integrated EHR at a national level, which is securely accessible to authorized professionals at point of care. Furthermore, it allows people in the general public access to their own health data. This is achieved by integration of regional databases and the development of a national patient portal.
A nationwide surveillance system on communicable diseases for the office of the Chief Epidemiologist of Iceland has been in use for some years. Recently, the system was updated to allow for real-time reporting on communicable diseases. SNOMED CT terminology is utilized in the system to ensure correct registration of pathogens. Another milestone includes the launching of real-time data collection to the nationwide hospital discharge registry of the Directorate of Health. Furthermore, all prescription drugs are reported to a nationwide prescription database, which is now updated in real-time and can provide practicing physicians direct access to their patients’ prescriptions. This access, along with up to 70% of all drug prescriptions currently being delivered electronically, will support increased patient safety and surveillance of drug prescriptions.
Lituania (17 licensees) At the start of 2014, Lithuania initiated national projects in an effort to complete the translation and translation quality assurance of the majority of 40,000 concepts by year’s end. At the same time, it also began moving through the various SNOMED CT projection and development
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phases, to be completed by the close of 2015. In the second half of 2014, the pilot project SNOMED CT utility will be launched together with the polyclinic Centro Poliklinika.
A selection process took place in 2013 to choose 40,000 SNOMED CT concepts, at which time the main implementation priorities were added due to various practicalities and national e-health project requirements, such as the Tele-cardiology Project and MedVAIS. Future priorities are likely to be: primary care, cardiology, encoded cancer checklists, translation of attribute relationships, and supplementation of subsets for the quality assurance. We also implemented the main SNOMED CT translation procurement procedures and signed contracts with suppliers in 2013.
Malta (4 licensees) During 2014, the eHealth Office in Malta’s Ministry for Energy and Health will continue to evaluate the feasibility of implementing SNOMED CT on a wide basis in government health information systems. Malta’s second official language, English, remains the standard in health documentation, so there is no plan to translate SNOMED CT into Maltese.
Netherlands (51 licensees) Increasing awareness of SNOMED CT remains one of the most important activities of the NRC team. Our direction of focus is the implementation of terminology and code systems and the use of SNOMED CT in particular. Creating cross-maps between SNOMED CT and the Dutch code systems is currently one of the most useful approaches for coping with translation issues. The code systems for billing purposes in the Netherlands will be the first to be mapped to SNOMED CT.
The National IT Institute for Healthcare (Nictiz) emphasizes that mapping is only a temporary, in-between step on the way to using SNOMED CT in EHR systems and for generating billing and statistical information. The NRC does not translate SNOMED CT directly into Dutch, but it does enable users to interface with SNOMED CT in Dutch, in addition to supporting various solutions to accommodate that. Domain experts can add translations to the RefSets they create. The NRC actively supports the mapping of SNOMED CT to other code systems, such as the Dutch version of ICD-10.
Poland (0 licensees) In December 2011 Poland became an Ordinary Member of IHTSDO. In joining IHTSDO, the CSIOZ (National Centre for Health Information Systems) will make SNOMED CT available throughout Poland for use in electronic health records, health research, and other applications. Users of the terminology in Poland will also have access to new resources as they are developed. The NRC plans to conduct a tender, select a contractor and translate at least part of SNOMED CT into Polish in 2014.
Portugal (0 licensees) In January 2014 Portugal became a Member of IHTSDO.
Slovakia (0 licensees) The National Health Information Center (NHIC) faced economic constraints and organizational changes in 2012 that greatly affected continuation of the eHealth project and medical terminology work regarding the adoption of SNOMED CT in the Slovak Republic.
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Nevertheless, the Center for Medical Terminology and Standards, which is part of the NHIC and staffed by experts from the field of medicine and science, continued its terminology work, especially on translation of ICD-10 (German version), which will be used for implementing the Diagnosis Related Group system in Slovakia.
Slovenia (0 licensees) In January 2010 the Republic of Slovenia became a Member of IHTSDO.
Spain (273 licensees) In 2014, Spain’s SNOMED CT goals include development of formal ontologies for clinical safety, deployment of terminology services for the National Health System (NHS) and support for quality efforts regarding e-prescription national nomenclature and RefSets. Of central importance is the development of new software tools for improving production processes of the Spanish Extension and continued validation of archetypes and terminology binding for modeling EHR components and user interface implementation elements.
Our organization expects considerable improvement and tangible progress concerning the use of SNOMED CT assets within the NHS and the National Health System’s Digital Health Records Project (HCDSNS).
2013 activities focused on supporting development of the Spanish Drug Extension and related ontological models. We succeeded in initiating publication of the Extension and ensuring sustainable maintenance. In addition, more than 30 related specific Subsets for different clinical variables within the HCDSNS content models were published. We also completed the Extension for semantic standardization of HCDSNS dataset variables (elements for registry and observable entities).
Translation efforts involved the inclusion of new descriptions for more than 1,500 terms in the Spanish of Spain (es-ES) Extension. Ongoing translation work represents a strategic approach to ensuring adequate use and clinical acceptability of SNOMED CT within the NHS.
Sweden (215 licensees) The ongoing formalization of communication with Swedish users of SNOMED CT has meant the establishment of reference groups from different health and social care sectors. One important step to cementing this interaction was the first annual forum for the users of eHealth resources provided by the National Board of Health and Welfare (NBHW), held in March 2014. Over the course of the year, the NRC will mainly focus on user support and training stakeholders.
The NBHW has been commissioned to further develop the decision-making support doctors use to determine appropriate sickness benefits for patients. The project is studying if and how SNOMED CT might be able to play a role in this.
The task of developing a national source for reasons for prescribing a medicine, with SNOMED CT serving as the foundation for the terminology, has begun and is expected to continue in 2014. Integration of SNOMED CT concepts into national clinical guidelines published by the NBHW has been initiated, starting with breast cancer care guidelines. Other clinical areas will follow.
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United Kingdom (1500 licensees) Clinical applications incorporating SNOMED CT continue to be deployed into all healthcare sectors. For example, over three million electronic prescription messages are transacted monthly using SNOMED CT.
The UKTC is responsible for managing and distributing the UK Edition of SNOMED CT, with additional products and services to support implementation. The UK Clinical Edition is released every six months and UK Drug Extension is released every four weeks. UKTC runs a help desk for user enquiries and an online request portal for new UK Edition concepts and terms.
Shared electronic patient records remain a strategic milestone. Inclusion of SNOMED CT is required in information standards considered for national approval.
The UK Edition is now available in both RF1 and RF2 formats, with around 75,000 UK clinical concepts and 300,000 UK drugs.
8.2.2 Which standards are used in the ICT based fall prevention solutions?
From one ICT based fall solution we have made a case study. Sona is an ICT based fall prevention solution that stimulates elderly people to become more active. The Sona is used in care homes in the Netherlands and is developed by Yalp (Yalp, 2014). This case study focusses on the use of and the reasons for not using standards. The Sona pictures are provided by Yalp.
8.2.3 Case Study Sona
Sona is an interactive sound device that is specifically designed for the outdoor area. A motion camera in the top of the big orange arch registers the movements of players on the specially designed play-floor beneath. Despite all the technology Sona remains simple. With the press of a button one out of the ten games can be easily chosen. The games use music and sound as feedback. The camera registers which person moves the most active and chooses a game winner.
The Sona is also accessible with a wheelchair. The Sona is publicly accessible and is suited for deployment in activities for seniors at a nursing home or to play with the visiting grandkids.
Moving with Sona has a strong social character as it encourages people to move together.
Eleven care facilities in the Netherlands 2013 and 2014 have installed an interactive Sona or are planning to.
Requirements from user perspective The Sona is used by different user groups that each have their own user requirements: - inactive seniors: Elderly people in nursing homes structurally move insufficient. 86% to 96% of elderly, depending on the type of care (nisb, 2010), do not meet the moving standard of 30 minutes a day. For health reasons it is important that this group of elderly becomes more
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active. Movement contributes to improved balance, coordination, increases independent living and is in that way a perfect solution in fall prevention. The Sona is an attractive initiative to encourage movement.
- seniors with dementia: Fun is important to get elderly people more active. Besides the ‘fun factor’ Sona has more beneficial effects. Music has a special effect in people with dementia. Sensitivity to music continues well into the dementia process. The music of Sona helps to break passivity and encourages elderly to move together. Moving outdoors works out especially positive. People with dementia are at increased risk for depression. Exercise and outdoor work is both preventive and curative.
- grandkids (additional user group): The games of Sona are also fun for grandchildren who come to visit their grandparents. People of different age can play together under the arch, making the device connecting generations.
Meeting usability requirement Sona was originally developed for children in 2006. With 100 placed Sona's the electronics have proven their suitability for the outdoor area. In 2013 Sona was adapted for use in health care: • the games are optimized and tested in healthcare facilities; • the pace of Sona is optimized to movement of seniors; • music choice is based on the taste of the seniors and music known from the past; • the choice of word in the games is adapted and tested with seniors.
Playing games on Sona is exercising in a fun way and it will improve the moving abilities of the seniors. Four additional games will be developed in the coming year, where the seniors act as "test group".
Meeting accessibility requirements The gaming floor is flat and accessible for seniors who have difficulty walking, walk with walkers or use wheelchairs. It is advised to place benches next to Sona, so that seniors who do not participate in the game can rest and watch.
As Sona is often placed in the public space of a nursing home, free play is always possible. To encourage the use of Sona, activity counsellors should add Sona to their weekly schedule with billiard, dancing classes etc. People should at first be encouraged to participate on Sona. We know from practice that the elderly are enthusiastic after the first use of Sona and for example make use of the facility with their grandchildren by themselves.
Clinical perspective The overall project activities will be carried out by healthcare innovation agency DAZ and Yalp. Yalp is the developer of the device Sona. DAZ supports by implementing Sona in health care organizations, as they have experience with the introduction of innovations in care and communication.
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The games focus on practicing the following competencies: reaction, balance, concentration, agility, move, speed and competition. The games offer seniors a fun way to exercise. For example, seniors can dance to music they are familiar with from the past and should stop when the music stops. The person who moves last is off the game. In another game everyday life situations are simulated, such as sweeping with a broom, climbing stairs or picking up something from the ground. And there is a game that focuses on training the memory by remembering numbers. In total there are 10 games available. All games have different competence levels.
After the test period it is clear how the device is used by different groups of users, such as people with various illnesses and seniors with and without care. Sona monitors the use if the different games and users. The healthcare institutions involved are supporting this project. Management, physical therapists, occupational therapists, nurses and other staff provide residents with relevant activities around the Sona, whether or not in conjunction with municipalities, local welfare organizations or the elderly.
Payer/stakeholder perspective Healthcare institutions bear the cost of purchasing the Sona (€ 22.000) and the service subscription (€ 500 per year). The institutions get access to remote support, get technical support from Yalp and updates on new games.
To make the Sona a success after placement, a good approach is essential. Seniors will not start moving on Sona themselves. Especially at the beginning dedication and support is needed from all staff, such as physiotherapists, carers, management, etc.); someone needs to be responsible for the use of Sona and ensure that Sona is part of the exercise program and invest in it.
Industrial perspective. Sona is not a medical device. CE marking is not applicable. The Sona is equipped with an inspection certificate as required in ‘Warenwetbesluit Attraction and Play (WAS)’ – a certification method for playgrounds.
Data exchange, -protection and -security The Sona uses programmed games. The camera in the Sona registers movement. These images are not saved. Sona has a remote support system where the administrator of Sona can login to select games, set the volume or see game statistics. The advice is to select just a couple of games at once, to allow the elderly time to explore Sona. The game statistics are saved (how much time is played, what games are the most popular, etc) and visible to the administrator. There is no storage of private information. It is not possible to track the activity profile of individual players.
Conclusion Sona Sona is a creative ICT based fall prevention and management solution that is very unlike most devices earlier discussed, such as fall detectors and personal activity monitors. Sona does not make use of any health informatics standard and is not interoperable with any other devices.
To monitor individual activity patterns of elderly wearable activity monitoring devices could be added.
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8.2.4 Case Study Standardization Initiative Service Chain Social Care Alarms
Excerpts from the business plan of CEN/TC 431 show the interesting standardization project offering a working (and in Sweden tested) open internet protocol for service chain processes for technology enabled care. This is also very relevant for ICT based fall prevention solutions.
Scope CEN/TC 431 is to be responsible for the standardization of the service chain processes for technology enabled care. The firm focus is on the users; ensuring them an improved level of quality of life by enabling the users to stay longer in their own homes, remain independent and be able to participate actively in society. CEN/TC 431 achieves this by working with all interconnected parts in the entire service chain for social care alarms. All parts in the service chain are equally important.
Benefits The benefits of standardization of the service chain are multiple. Next to the benefits demonstrated in the work plan, stakeholders add through their Standardization Institutes: • Increased safety, quality of life and security for millions of elderly and people with special requirements - and their relatives - providing users the opportunity to stay in their own homes longer; • Stimulated growth in innovation and business activity due to a coordinated, comprehensive and radical technology shift of a non-sustainable analogue communication platform into a digital Internet Protocol (IP) based platform; • Decreased costs for society. • Today the market of “Protocols used in Home Care Systems” is dominated by proprietary and closed protocols, owned by the big players for Home Care Systems and Centrals. An attempt to create a standardized protocol is a big step forward. The Alarm Protocol uses open standards like XML and SIP (ASI).
Resistance The initiative has met resistance from established Technical committees (through the national standardization institutes): • The scope of attached working draft has overlap with the EN standard developed by CLC/TC 79 Alarm systems: EN 50136-1 Alarm systems - Alarm transmission systems and equipment - Part 1: General requirements for alarm transmission systems. CLC TC 79 WG4 already develops the specifications for the implementation of an open IP (Internet Protocol) based protocol for social care alarms. Plan of CEN/TC 431 has to be adapted to avoid overlapping or redundant work (NEN, BSI, DIN). • The work appears to overlap at least in part with the IEEE 11073 originated EN ISO 11073-10471:2011 Health Informatics - Personal health device communication - Part 10471: Device specialization - Independent living activity hub (ISO/IEEE 11073- 10471:2010). It looks like we should be aware of what is happening in TC 431 and let them be informed of existing standards from the Health informatics area which may have connection points to their area (CEN/TC 251) • Standardization of interfaces to products for homecare (e. g. work programme of ISO/TC 121 "Anaesthetic and respiratory equipment" and of ISO/TC 215 "Health informatics" (DIN, NEN).
Despite all comments and resistance the CEN/TC 431 has had its first meetings in 2014, additional meetings are scheduled and the participating stakeholders are determined to make the work a success.
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8.3 Conclusions discrepancy between existing standards and use of these standards in ICT solutions for fall prevention and management
Despite the many advantages of interoperability and the use of standards many of the ICT based fall prevention and management solutions have not chosen to be medical devices and hardly comply to the requirements in the standards, its data do not follow a standardized data architecture and therefore cannot be exchanged with the electronic health record. As also concluded in chapter 5 most activity monitors and fall detectors are at a stage of validating the data they gather with the actual activities and falls. Most ICT based fall prevention and management solutions are ‘not yet’ or ‘in the process of thinking of the need of’ complying with standards and interoperability.
The challenges to the use of standards are multiple. The respondents from our survey mention a number of challenges. The AALIANCE2 (AALIANCE2, 2013) project confirms some of these challenges and adds some others:
Complexity: Communication standards are often designed to support a wide range of possible use cases. This comes at a price, which is the greatly increased complexity of the specification. For example, a training device measuring strength in elderly would require a number of ISO/IEEE 11073 (interoperability) standards: ISO/IEEE 11073 part 10442 Health informatics—Personal health device communication - Part 10442: Device specialization— Strength fitness equipment”, which in turn is based on ISO/IEEE 11073- 20601 “Health informatics — Point-of-care medical device communication — Part 20601: Application profile — Optimized exchange protocol”. Together these two standards have a volume of about 166 pages and they define a highly complex communication protocol. It is understandable that implementers shy away from implementing such complexity unless this is absolutely needed or made compulsory.
Implementation cost: Since implementing a standard is expensive, the final product may be more expensive than a comparable product with a simple, proprietary interface. This problem is increased when an expensive external certification of the standards compliance of the interface is needed – this may be one of the factors limiting the market uptake of Continua based products.
Competition: Vendor-independent, standard interfaces are a double-edged sword from the perspective of a manufacturer of the device. On the one hand it may create new markets where a product can now be combined with components of other vendors, on the other hand it may permit the competition to produce compatible, and perhaps cheaper, alternatives that may threaten the market position of a product. This may be a danger especially for small enterprises producing high-quality, high-priced products, who fear of being overwhelmed by cheap competitor products mass-produced if they open their devices by standardising the interfaces. In such cases, “vendor lock-in”, while in general undesirable from the end-user perspective, is an integral part of the business model.
Interoperability problems: Different developers may well read the same standard differently and produce incompatible implementations. Opening a product’s interface to the competition makes it much more difficult for a vendor to guarantee to the customer that the product will always work as intended when combined with other products
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offering the same interface. Having a product portfolio that just “causes no trouble” may well be a reason for customers to prefer a proprietary product family.
Slow standard development process compared to the fast innovation process: The preparation and publication of a standard mostly takes about 3 years. This means that a standard, once published, by definition will be somewhat outdated in technical fields that see a rapid technological development. Furthermore, doing things “the standard way” may prevent implementation of innovative ideas not (yet) supported by the standard. Illustrative is the development of the smart watches (Box 8.1).
Slow implementation of ICT based solutions: For manufacturers and researchers to develop devices that can communicate with the Electronic Health Record is an almost impossible task as long as the Electronic Health Records between the different European countries and often within one single country are not standardized and use different clinical data architecture and semantics. The paragraph on the use of SNOWMED shows that even the use of a common vocabulary is still in the process of being implemented.
In the Medical sector the ‘evidence base’ is the paradigm to develop guidelines: Medical practitioners and researchers are looking for evidence based care for patients. The consensus model used by the standardization bodies is not appreciated, especially because health insurers and industrialists are allowed to join the Technical Committees. As a result there seems to be a lack of interest and a lack of knowledge about available standards and the standardisation processes within the research community in general and the medical research community in particular. Our chapter 6 (researcher perspective) is illustrative in this respect as it mainly draws its information from scientific publications rather than from standards.
Difficult to know which standards to use: The AALIANCE2 project has developed a 490 page repository (AALIANCE2, 2013) that lists (name of the standards with abstract) for Ambient Assisted Living. Most of these standards are relevant for ICT based solutions in fall prevention and management. The medical standards are not included in the list. The length of the list alone already discourages potential users of the relevant standards. The cost of the standards, even if negligible compared to the cost of developing the device, is inhibitive especially if it is not clear which package of standards are essential for the ICT based fall prevention and management solution.
Not all challenges are solved in the standards, f.i. mapping from one standard (e.g. ISO/IEEE 11073) to a different standard (e.g. HL7) is not defined in either standard.
The standardization communities do not like initiatives that offer alternatives to the standards, as they claim the alternatives are overlapping or not complying with existing initiatives or standards. Illustrative is the case study presented in 8.2.3.
The number and seriousness of the risks and challenges may cause developers/manufacturers of new devices to prefer closed, proprietary solutions over open standards-based ones.
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BOX 8.1
Smartwatches will revolutionise treatment for chronic conditions
Google, Apple, and Samsung are racing to develop wearable technology that could be used to to monitor and track personal health and diagnose disease Smartwatches can monitor and store fitness statistics, check vital signs and remind you to take medication. The advancements in wearable technology, specifically smartwatches and their biosensors make it possible that people seek self-knowledge through self-monitoring. Health and technology are converging to become ubiquitous in patients' and physicians' lives. This intersection of health and technology is changing the way on how long-term chronic conditions can be monitored and treated.
Exponential growth Smartwatches have explosive potential in the healthcare space thanks to their sensors, ability to sync to mobile health platforms and transmit sensor data to the cloud. Smartwatches will start to go beyond just monitoring and tracking personal wellness and will help to predict and diagnose disease.
The next generation of smartwatches will employ additional technology including the accelerometer, magnetometer, gyroscope, compass, heart-rate monitor, altimeter and an ambient light sensor, to name a few. Inside their wearable’s, Samsung and Google are already detecting body temperature as well as location, and integrating voice commands. Apple's vision is to find a way to load more into its new devices and platforms.
According to IMS Research, the wearable’s market is poised to grow from 14m devices shipped in 2011 to as many as 171m units shipped by 2016. In a more recent estimate, ABI Research foresees the wearable’s market at 485m annual devices shipped annually by 2018.
The urge for wearable’s and smartwatches is fuelled by the more than 75% of all patients expected to use digital services in the future.
Excerpt from The Guardian, 25 July 2014 (Duffey, 2014)70 Note Chapter 6 discusses the wearable’s.
70 http://www.theguardian.com/healthcare-network/2014/jul/25/smartwatches-revolutionise-treatment-chronic- conditions
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9. Conclusions
To achieve significant prevention/detection and reduction of falls incidence, a holistic life-long approach combining cognitive, psychosocial and physical activities will be required. The challenges are significant, but with close collaboration between fallers, falls experts and technical experts they may be also achievable.
The actually ageing generations will have the needed technical skills and desire to educate themselves and to self-manage their falls risks, but technology must be in place for them in order to do so.
Primary care staff requires screening technology to identify elders who are at risk to fall. A multitude of methods for assessing the risk of fall are used and accepted in the clinical practice. All countries use a variety of protocols and tools to assess fall risk.
Fall risk assessment using body worn sensors is still in a phase of development and clinical testing. Personal alarming systems are often used for vulnerable older adults still living independent during several months up to several years. Body worn sensors potentially can collect useful information about physical activity patterns of elderly.
From a regulatory point, a manufacturer of ICT based fall prevention & intervention devices has the choice to define his product as a medical device or not. Both alternatives have their pros and cons.
The MDD is a quite flexible regulatory framework and given that manufacturers of ICT based fall prevention & intervention devices choose to classify their products as medical devices, the MDD should be as applicable for them as for other medical devices.
Standardization and interoperability are key requirements for the success of ICT solutions for fall prevention and management: variety of user requirements and preferences, need for “future proof” systems, integration with existing infrastructure, integration with local service providers; no comprehensive product program, and freedom of choice.
The challenges of the use for standards and interoperability are multiple as well: complexity, implementation cost, competition, unsolved interoperability issues, slow standard development process compared to the fast innovation process and slow implementation of ICT based solutions. In the medical sector the ‘evidence base’ is the paradigm to develop guidelines and it may be difficult to know which standards to use.
Despite the many advantages of interoperability and the use of standards many of the ICT based fall prevention and management solutions have not chosen to be medical devices and hardly comply to the requirements in the standards, its data do not follow a standardized data architecture and therefore so far cannot be exchanged with the electronic health record. Most activity monitors and fall detectors are at a stage of validating the data they gather with the actual activities and falls. Most ICT based fall prevention and management solutions are ‘not yet’ or ‘in the process of thinking of the need of’ complying with standards and interoperability.
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Opgehaald van Official Journal of the European Union: http://eur-lex.europa.eu/legal- content/EN/TXT/PDF/?uri=CELEX:32012L0019&from=EN The Global Medical Device Nomenclature . (sd). Opgehaald van http://www.gmdnagency.org The International Organization for Standardization. (sd). Opgehaald van http://www.iso.org United Nations (UN). (2004). World Population Prospects: The 2004 Revision. New York. Veltink PH, V. L. (1994). Dynamic analysis using body fixed sensors. Second World Congress of Biomechanics. Amsterdam. VU Medical Centre. (2014). Fall prevention in old age (FARAO project). Opgehaald van http://www.fbw.vu.nl/en/research/examples/fall-risk-in-old-age/ Wals, J. (2008). Seminar ICT for Health & Wellbeing, Philips research. Wang, W. (2013, June). Supporting Fall Prevention for the Elderly by Using Mobile and Ubiquitous Computing. WHO. (2004). What are the main risk factors for falls among older people and what are the most effective interventions to prevent these falls? WHO. (2011). The Determinants of Health Expenditure. http://www.who.int/health_financing/documents/report_en_11_deter-he.pdf. WHO. (2012). Management of patient information. Trends and challenges in Member States . http://apps.who.int/iris/bitstream/10665/76794/1/9789241504645_eng.pdf?ua=1. WHO. (sd). Global Report on Falls Prevention in Older Age. Wikipedia. (2014). Italian Device Registration. Opgehaald van http://en.wikipedia.org/wiki/Italian_Device_Registration Wilde, A. (2010). An overview of human activity detection technologies for pervasive systems. Pervasive and Artificial Intelligence Group of University of Southampton. World Bank. (2007). From Red to Gray. The "Third Transition" of Aging Populations in Eastern Europe and the Former Soviet Union. http://siteresources.worldbank.org/ECAEXT/Resources/publications/454763- 1181939083693/chaw_151-176_ch04.pdf. Yalp. (2014). Producten - beweegtoestellen ouderen. Opgehaald van http://www.yalp.nl/senioren/beweegtoestellen-ouderen/products/70 Yardley et al. (2006). Participant quote. Oxford Journals.
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11. Annex
Questionnaire ICT based fall prevention and intervention solutions
The aim is to make an inventory and analyze best practices in standardization and interoperability from different perspectives: User perspective Clinical perspective Payers perspective Industrial perspective
What ICT solution for fall prevention have you developed? name explanation Please answer the following questions for this ICT based fall prevention solution
User perspective
What user needs/requirements have you taken into account, please identify different user groups if appropriate How have you addressed these user requirements What did you do to meet usability needs What did you do to meet accessibility needs What did you do to meet interoperability needs Did you use any existing standards to meet the user requirements Which ones Why or why not How useful were these standards Have you missed any standards, on which subjects
Clinical perspective
What clinical requirements have you taken into account, please identify different clinical purposes if appropriate How have you addressed these clinical requirements Did you make use of international clinical tests/guidelines/protocols? Which ones Why or why not How does the ICT based fall prevention solution fit in the clinical test/protocol/guideline What is the clinician’s attitude to ICT based fall prevention & intervention devices or services? What is the uptake of the ICT based fall prevention solution? Payer perspectives
How is your device/assistive technology and its service paid for
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Please describe the payment/reimbursement pathway and the roles of end-users (elderly), health care institutions, health insurances, others
Industrial perspectives
Your ICT based fall prevention & intervention device o is it available in the market with a CE marking? o is it classified as a Medical Device? Is the ICT based fall prevention solution designed for interoperability? o Protectionism/proprietary solutions o Customer driven requirements for interoperability Can the fall risk measure or falls monitoring results be exchanged with the electronic patient health record? Why or why not? Did you use any existing standards with regards to o Semantics o Clinical data architecture o Data protection and security Why or why not? How useful were these standards? Have you missed any standards, on which subjects? Since the application of harmonized or other standards remains voluntary, standards in this area must offer the manufacturer an added value in order to be applied, would the industry perceive certified interoperability as an added value? Standardization perspective
What existing standards have been useful? Is there a need for specific standardization in the area of ICT based fall prevention & intervention devices or is this area already covered by existing standards? How can standards and interoperability support/promote this field? Which areas of standardization would be beneficial to the industry?
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