eHealth Users’ Stakeholders Group – Comments to the EC Draft Recommendation on eHealth Interoperability

The eHealth Users’ Stakeholders Group is an Advisory Group of the i2010 Subgroup on eHealth, working under the coordination of DG INFSO. It represents users of IT in health settings, including health professionals, patients and citizens (Members of this group are listed in annex 1).

General Comments The Group would like to welcome the opportunity to submit comments to the Draft Recommendation on eHealth Interoperability.

We welcome the fact that the Recommendation clearly states that because Member States are the ones in charge of healthcare in their own countries a single European solution should not be imposed. By leaving the necessary flexibility for Member States to pursue the models and systems which are most appropriate for their national needs and strategies while making sure that these systems can communicate with each other (i.e. be interoperable) in the future seems to be a reasonable approach although we are convinced this will take several years to achieve. Nonetheless, the Recommendation and the political commitments it may trigger will certainly contribute to achieving this goal.

Secondly, the document is written in a different "tone" than previous documents, stating the need for all of us to work together and not to continue to develop isolated solutions. As an eHealth Users’ Stakeholders Group we are pleased to see that the draft Recommendation addresses not only technical interoperability issues, but also the challenges for the political, legal, organisational and financial contexts. Addressing this issue at the European level is not only right but is also likely to enable representatives of the users of eHealth (health professionals as well as citizens and patients) to actively contribute to pursuing the objectives of the Recommendation.

Thirdly, we agree with the approach of the document as it pursues the objective of free circulation of people, goods and services in the field of eHealth. Interoperability of eHealth infrastructures and services is without doubt beneficial to (mobile) citizens, who may become patients, and (mobile) health professionals as well.

In the Group’s opinion, the Recommendation should indeed aim at encouraging/stimulating all concerned stakeholders (i.e. policy makers, the healthcare industry, health professionals, health managers, funding agencies and health insurers, patients’ organisations), in making existing or under development eHealth infrastructures and services interoperable across the Union.

The draft Recommendation on the whole is very comprehensive and we found useful the definitions of the main concepts and the mapping of current and previous European projects. We would suggest adding a reference to the future EU Health Strategy and go beyond solely mentioning the Health Systems Working Party (page 13). There are in fact several working groups within the Commission whose work should be further integrated in pursuing the European health information space, namely the patient safety and the health professionals’ working groups of the High Level Group on Health Services and Medical care.

In our analysis, we have noted some confusion on the domains covered by the text. It seems to us that the document is sometimes dealing with healthcare-related issues without making explicit the link with the need for eHealth interoperability. Similarly, in some sections, the document is promoting eHealth without an explicit link to the interoperability issue. We therefore suggest that the Recommendation makes the following linkages explicit:

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 The transformation of the healthcare systems is recognized as needed and eHealth is considered as one of the possible enablers of this transformation;

 For maximizing the benefits, eHealth requires health IT data and systems to interoperate.

Furthermore, in this context, the Recommendation should reserve the use of the term “interoperability” to the eHealth domain and use another term for describing the functioning of a “European health space”. We suggest to use the term “cooperation” instead, e.g. in Section 5 – Background “Resolving contemporary and future challenges to European healthcare is conceived of as at least partly possible through the growth of the cooperation between the Union’s health systems and services”. Indeed users are less concerned by “interoperability of eHealth data and services” than by an improvement in the 4 C principle (i.e. Continuity, Collaboration, Communication, and Confidentiality).

Our Group supports the idea of an Interoperability Observatory mechanism as a follow-up measure of the Recommendation. In our opinion, this observatory should measure progresses in the Member States by issuing a report and presenting it to the public at a yearly event. Since interoperability of national and regional healthcare IT infrastructures is an issue for all stakeholders, the Interoperability Observatory report should reflect the progresses from the viewpoint of each of them, including representatives of health professionals and patients. Similarly, the yearly event should be designed to gather all type of stakeholders.

In addition, we would like to welcome and support the views of the eHealth Industry Stakeholder Group when they state that “The challenges in the interoperability field lie in the communication of personal medical information. It is essential therefore that the discussion is based on clearly defined use cases with relevance for the day to day work of healthcare professionals. The communication of personal medical information only makes sense, if the information in question is being looked for by health professionals and healthcare providers”.

Finally, and as we have stated in previous submissions, the Group wishes to state its support for the creation and development of EHR systems as means of answering to the principles of our respective health systems (e.g., universality, quality, access, safety, efficiency and sustainability), as well as those of wider public health objectives. The protection of the individual’s rights and privacy are key tenets of these health systems, and must continue to be respected. Achieving such a balance is feasible through such means as EHR systems, and the added value of collaborating on this at EU level should not be underestimated nor unnecessarily hindered.

Specific Comments Page 5 In point 7. it is mentioned that “(…) the forthcoming liberalization of services (although it at present excludes health services)”. We would prefer a more neutral wording such as “(…) the forthcoming liberalization of services (which currently excludes health services)”.

Page 7 The first paragraph after the heading “Hereby recommends that” states that “since eHealth is essential to providing quality healthcare”. Without willing to remove the strength of such an assumption, we believe it would be more appropriate to word it as follows “Considering that eHealth can have an essential role in providing quality healthcare”. The provision of quality of healthcare cannot be resumed to eHealth alone. In its current reading, it seems that without

29 August 2007 2 eHealth Users’ Stakeholders Group – Comments to the EC Draft Recommendation on eHealth Interoperability eHealth it is not possible to provide quality healthcare, which we assume is not the intention of the statement.

In addition, it is important to stress that, in the interoperability framework, the information should be transferred with patients’ and, when necessary, with carers’ consent.

Page 9 Under heading “3. Objectives”, we would suggest to move objective 2. as the first of the seven identified objectives. In our opinion, to provide Europeans with the appropriate kinds and levels of healthcare should be the macro objective. The other objectives then follow into more detailed action.

Page 10 Under heading “4. Benefits”, we do not understand the use of both “cost-effectiveness” and “economic” in the same statement. We would think that “cost-effectiveness” would fully express the need to ensure the correct use of investments in improving the provision of health services, rather that emphasizing the need for economizing which could be misinterpreted as drastic cost cutting in essential areas.

Also under this heading, we would add that besides improving patient safety, eHealth interoperability, while endeavoring to connect not only systems but also – and most importantly – people throughout the continuum of care, would also contribute to improving patient outcomes.

Page 12 In the last paragraph of heading “6. Actions on the part of the European Commission, Member States, and stakeholders” we would suggest either to say simply “a wide variety of stakeholders”, without a specific mentioning to Industry, or “a wide variety of stakeholders, including European users and industry”.

Page 13 We welcome the inclusion of the stakeholders’ groups under the implementation mechanisms. The Users’ Stakeholders Group is particularly engaged in contributing to developing the so- called “use cases” and as we mentioned earlier in this submission, we would welcome the Group’s involvement on a future Interoperability Observatory.

Moreover, we believe that the stakeholders’ groups could be further involved on incoming conferences as members of their advisory programme committees, considering the fact they could provide interesting suggestions of topics and speakers.

Page 14 Under heading “1. The overall (political/legal) level of Health interoperability” we would like to warmly welcome the references made in bullet points 5, 6 and 7. We would nevertheless point out the following:

 In bullet point 6 “Build on stakeholder involvement (…)” we believe it would be clearer to have several examples of stakeholders and we would like to see patients and health professionals’ organizations explicitly mentioned. Members States should be strongly and explicitly recommended to invite all these organizations to share their unique and direct experience since the very onset of the process; they should be given real and equal opportunities to input alongside other stakeholders.

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 In bullet point 7 “Accompany the eHealth implementation by (…)” we feel it would be important to specify what “users” covers. In particular, we would suggest to stress the need to closely involve patients, health professionals and health managers’ organizations in all the phases of the process: planning, design, validation, implementation, evaluation, training, information and education, and change management.

Moreover, we would like to state that the implementation of e-health applications is indeed very costly. Actual costs of e-health applications must be known in advance. If as suggested in point three, adequate resources to invest in e-health need to be taken out of the annual health budget instead of increasing the budget accordingly, thorough planning and evaluation must take place in advance in order to prevent the actual health budget being strained. Financing of e-health applications via the structural funds is a welcomed suggestion.

Page 15 Under heading “1.1 Privacy and confidentiality”, we would like to draw attention to the first bullet point “Identify the relevant, different stakeholders (…) hospitals, social services, physicians, general practitioners, (…)”. As a Users’ Group, representing different health professionals, we would recommend to use the general term “health professionals” instead of stating only one of the several health professionals who will contact with the patient throughout his/her journey along the continuum of care and who will need to access and exchange health information in order to ensure the provision of best care to the patient.

In the third bullet point “Formulate clear agreements concerning the process by which citizens can give and revoke consent to access to or transfer of information (…)” we would suggest to expand it as follows: “Formulate clear agreements, after consulting patients’ groups, including potentially marginalised and under represented patients, concerning the process by which citizens can give and revoke consent to access to or transfer of information (…).”

Page 16 Under heading “3. Applications (including semantic) interoperability”, we would like to highlight the fact that the “relevant use cases” mentioned in the first bullet point should, in our opinion, be identified and developed in collaboration with health professionals, patients, health managers and public health researchers.

Similarly, and although it is not clearly stated in the draft recommendation, we would welcome the text to further expand on the “patients and health professionals identifiers” in the sense that also within this area, collaboration with health professionals, patients, health managers and public health researchers should be encouraged.

Page 18 Under heading “5. Monitoring and evaluation”, we would like to express the Group’s strong interest and willingness to contribute to strengthening and expanding the opportunities for annual checkpoints to share experiences, progress, and good practices.

Page 19 Under the previous heading, the fifth bullet point “assess the eventual benefits (…)” should, in our opinion, not only highlight economic and cost-effectiveness benefits but also refer to health gains, patient outcomes, health professionals satisfaction with increased eHealth interoperability and motivation to further contribute to its development. We believe that collecting such

29 August 2007 4 eHealth Users’ Stakeholders Group – Comments to the EC Draft Recommendation on eHealth Interoperability information would be useful for identifying future actions and encourage Member States to continue their efforts for achieving the different milestones towards a full eHealth interoperable system in the EU.

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ANNEX 01 AGE – European Older People’s Platform

AGE - the European Older People's Platform is a European network of organisations of people aged 50+ and represents over 22 million older people in Europe. AGE aims to voice and promote the interests of the 150 million inhabitants aged 50+ in the European Union and to raise awareness of the issues that concern them most. Rue Froissart 111, B-1040 Brussels – Belgium Tel: +32 2 280 14 70 – Fax:+32 2 280 15 22 E-mail: [email protected] - Web: www.age-platform.org

AIM – Association Internationale de la Mutualité

AIM brings together 43 social health insurance organisations in 29 countries. These organisations provide coverage against sickness and other social welfare risks to around 175 million people, either by participating directly in the management of compulsory health insurance, by providing voluntary health insurance or by delivering directly health care and social services through own facilities. 50 rue d’Arlon ● B-1000 Brussels Tel.: +32 2 2345700 ● Fax: +32 2 2345708 E-mail: [email protected] - Web: www.aim-mutual.org

CPME – Standing Committee of European Doctors

The Standing Committee of European Doctors (CPME) is the representative body of about 2 million physicians in Europe. Its aims are: a) to promote the highest standards of medical training and medical practice, through advocating: i) public health; ii) the relationship between patients and doctors; iii) the free movement of doctors and patients within the European Union; b) to achieve the highest quality of health care in Europe. It is composed of the most representative non-governmental national medical organisations in EU/EEA countries, that is to say 30 National Medical Associations. It also unites associated members, observers and associated organisations (specialised European medical organisations). Rue Guimard 15, B-1040 Brussels – Belgium Tel. : + 32 2 732 72 02 – Fax: + 32 2 732 73 44 Email: [email protected] - Web: http://www.cpme.eu

EFN – European Federation of Nurses Associations

The European Federation of Nurses Associations (EFN) was established in 1971. EFN represents over one million nurses and is the independent voice of the profession.

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The mission of EFN is to safeguard the status and practice of the profession of nursing and the interests of nurses in the EU and Europe. Clos du Parnasse, 11A - B-1050 Brussels – Belgium Tel.: +32 2 512 74 19 - Fax: +32 2 512 35 50 Email: [email protected] - Web: www.efnweb.org

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EFMI – European Federation for Medical Informatics

The objectives of the European Federation for Medical Informatics (EFMI) founded in 1976 are: to advance international co-operation and dissemination of information in Medical Informatics on a European basis; to promote high standards in the application of medical informatics; to promote research and development in medical informatics; to encourage high standards in education in medical informatics; to function as the autonomous European Regional Council of IMIA. Currently, 30 countries have joined the Federation. Telemedicine and Electronic Health Record, medis-Institute, GSF National Research Centre, Ingolstaedter Landstr. 1, München/Neuherberg Germany 85764 Tel.: +49 89 3187 4138 - Fax: +49 89 3187 3008 Web: http://www.efmi.org

EHMA – European Health Management Association

The European Health Management Association is a network of health organisations throughout Europe. Its objective is to improve health through better management by: building bridges between countries, academia, managers, policy makers and health professionals; sharing knowledge between experts and health organisations so that we can influence policy in Europe.

4, Rue de la Science, Brussels 1000, Belgium Tel.: +32 2 502 6525 Email: [email protected] - Web: www.ehma.org

EHTEL – European Health Telematics Association

EHTEL (European Health Telematics Association) is a neutral, not-for-profit association of all healthcare actors, for the promotion of telematics solutions in healthcare across Europe.

Maison Européenne de la Protection Sociale (M.E.P.S.), 50 Rue d'Arlon B-1000 Brussels, Belgium Tel: +32 2 230 9650 - Fax: +32 2 230 7773 Email: [email protected] - Web: www.ehtel.org

EPF – European Patients Forum

EPF is an umbrella organization of patients’ organizations - and a strong patients' voice to drive better health in Europe. Our vision is patient-centred, equitable healthcare throughout the European Union. Twenty-seven patient organisations are currently members.

European Patients Forum "Park Leopold", Rue Wiertz 50/28, B 1050 Brussels Tel.: +32 2 401 61 71;+32 2 401 61 72 Fax.: +32 2 401 68 68 Email: [email protected] - Web: www.eu-patient.eu

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HOPE – European Hospital and Healthcare Federation

HOPE seeks to promote improvements in the health of citizens throughout the countries of the European Union, and a uniformly high standard of hospital care throughout the European Union and to foster efficiency, effectiveness and humanity in the organisation and operation of hospital services and of the health systems within which they function.

Bd. A. Reyers 207-209, b7, 1030 Brussels, Belgium Tel.: +32 2 742 13 20 - Fax: +32 2 742 13 25 Email: [email protected] Web: www.hope.be OPEN EHR – Open EHR foundation

The openEHR Foundation is an independent, non-profit community, facilitating the sharing of health records by consumers and clinicians via open-source, standards-based implementations.

Email: [email protected] Web: http://www.openEHR.org

PGEU – Pharmaceutical Group of the European Union

The Pharmaceutical Group of the European Union (PGEU) is the European Association representing community pharmacists in 29 European countries including EU Member States, EU candidate countries and EFTA members. Through its members the PGEU represents over 400.000 pharmacists in Europe. Rue du Luxembourg 19-21 - 1000 Brussels - Belgium Tel: +32 2 238 08 18 - Fax: +32 2 238 08 19 Email: [email protected] - Web: www.pgeu.eu

UEMS – European Union of Medical Specialists

The European Union of Medical Specialists (UEMS) was established in 1958 and currently represents 1.5 million specialist doctors in 34 countries through its National Medical Associations and its 37 Specialist Sections and Boards. The UEMS represents the professional interests of European Medical Specialists, notably by setting standards for high quality healthcare practice, harmonizing the highest level of medical training and promoting the free movement of specialist doctors within the EU. Avenue de la Couronne, 20 - BE-1050 Brussels - Belgium Tel: +32 2 649 51 64 - Fax: +32 2 640 37 30 Email: [email protected] - Web: www.uems.eu

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