eHealth Ministerial Declaration: European Co-operation on eHealth

Tuesday, 16 March 2010

The importance of ensuring that the deployment of ICT in healthcare, to be successful has to be accompanied by the necessary organisational reforms, driven by leadership and supported by adequate skills.

Therefore we welcome

• Recent efforts by Member States to reform the governance arrangements for eHealth in Europe through a new mechanism of cooperation - the European eHealth Governance Initiative,
• The forthcoming update of the Commission Communication on the "eHealth Action Plan"
• The Commission Consultation on the European Digital Agenda
• The Council Conclusions on the "Post-i2010 Strategy"
• The agreed programme of priorities of the TRIO Presidencies (2)

To build on these developments and achieve the overall objective of enhancing quality and sustainability of healthcare systems, to make them to benefit from ICT deployment in the best interest of patients, healthcare professionals and society, we consider that the following points should be addressed:

1. Political and strategic commitment

• To use eHealth as an instrument to address health care goals and priorities both at European and National level
• The European eHealth Governance Initiative should reinforce European cooperation at a high level to strengthen the common eHealth area. It should aim at removing barriers to the deployment of eHealth, enhance quality, access and safety in healthcare Europe wide. The Initiative should also contribute to mainstream e-Health in EU policies and instruments
• Collaboration with States outside the EU, is also welcome, for example in the quest for internationally recognised standards for eHealth including tools and processes.

2. Building confidence and acceptance

• To evaluate eHealth, as much as possible in a standardised manner, with respect to health outcomes, benefits and cost effectiveness, including patient safety, accessibility to care and quality of care
• To further develop and support, the involvement of healthcare providers, health professionals, patients and their representative organisations in order to encourage awareness and development of eHealth;
• To enhance the cooperation between authorities, healthcare providers, health professionals as well as between health professionals and patients, also taking into account ethical and privacy related aspects
• To create interactive platforms of stakeholders, to facilitate common understanding of health needs, benefits and risks of innovative solutions. The platform should aim at involving stakeholders in policy planning, implementation and evaluation of deployment and usages;
• To improve confidence in eHealth solutions by using common EU or international standards and share components
• To make recommendations to improve confidence in and acceptance of eHealth.

3. Bringing legal and ethical clarity and ensuring protection of personal health data

• Create and support mechanisms enabling exchange of information about current national provisions for licensing, accreditation and the regulation of eHealth services to enable the development of eHealth, and to propose improvements
• Facilitate common approaches to identification, authentication and access of health professionals and patients accessing and using personal health data, especially in the context of cross border eHealth services (i.e. epSOS)
• Address the legal and ethical constraints for the safe exchange of medical data across national borders, respecting the need to protect health data including the integrity of the patient data.
• Address the levels of consent given by patients for different uses of their medical data from the perspective of patients’ rights.
• Clarify the existing legal framework for eHealth, in particular on: telemedicine, including across borders; and the application of the recently amended Directive on medical devices (3)

4. Solving interoperability issues

• Resolve legal, regulatory and organisational barriers to eHealth interoperability
• Support semantic interoperability and define a medium term strategy based on existing or emerging EU and international standards
• Develop internationally-recognised common standards and certification of testing to facilitate their deployment and use in all eHealth applications.

5. Linking eHealth policy to competitiveness, innovation and research as well as to cohesion and inclusion policies

• Promote further collaboration between the European Commission and Member States, to support the implementation of health goals and priorities using eHealth
• Promote networking and cooperation among public procurers in the development process of ICT solutions for health, to learn from best practices and to incorporate ICT standards in requirements for eHealth systems
• Strengthen the links between the EU policies for health, research and innovation, competitiveness and regional development, including relevant criteria for eHealth development in those European, national and regional initiatives.
• Support the deployment of a mobile communication infrastructure to fully enable eHealth in general and telemedicine, in particular. Research on mobile health (4) has to be pursued in relationship with the broadband package and infrastructure development.

In conclusion we:

• Call for policy coordination amongst the various areas where eHealth can have an impact on citizens' health in order to enhance benefits for patients, healthcare systems and society.
• Recognise the need for stronger synergies with policy areas like competitiveness, research and regional development both at European and national levels
• Call for the importance of eHealth to be underlined in the framework of the European Digital Agenda; (5)
• Aim at using ICT tools for Health to scale up benefits to patients, healthcare systems and society. Therefore welcome large scale actions at European level to link research, innovation and deployment and invite the Commission to report on progresses made in this area. Such types of actions could contribute to tackle issues such as technical feasibility, legal certainty, awareness and convincing business cases.
• Recognise the importance of involving all stakeholders, in the strategic planning, validation and implementation of eHealth;

1. Ministers and High Level Representatives responsible for eHealth
2. Council of the European Union, Brussels, 27 November 2009, 16771/09, POLGEN 219: note from the future Spanish, Belgian and Hungarian Presidencies, to Coreper/Council. Subject : Draft 18 month programme of the Council
3. 2009/C 293/02 Commission communication in the framework of the implementation of Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (1)(Publication of titles and references of harmonised standards under the Directive) 34; 2009/C 293/03 Commission communication in the framework of the implementation of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (1)(Publication of titles and references of harmonised standards under the Directive). 39 2009/C 293/04 Commission communication in the framework of the implementation of Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in-vitro diagnostic medical devices (1)(Publication of titles and references of harmonised standards under the Directive)
4. Mobile health should be understood as devices enabling access to health services also at distance and on the move i.e. PDA and mobile phones as tool to access health services.
5. In this context Member States welcome the inclusion of eHealth in the World Conference on IT, Amsterdam May 2010.