The EC is presenting a regulation to set up the EHDS, that supports individuals to take control of their own health data, supports the use of health data for better healthcare delivery, better research, innovation and policy making and enables the EU to make full use of the potential offered by a safe and secure exchange, use and reuse of health data. The EHDS is a health specific ecosystem that aims at empowering individuals through increased digital access to and control of their electronic personal health data, nationally and cross-borders, as well as support to their free movement, fostering a genuine single market for electronic health record systems, relevant medical devices and high risk artificial intelligence (AI) systems (primary use of data) and providing a consistent, trustworthy and efficient set-up for the use of health data for research, innovation, policy-making and regulatory activities (secondary use of data).
Trust is a fundamental enabler for the wide adoption of the EHDS by users and health sector. The EHDS will provide a trustworthy setting for secure access to and processing of a wide range of health data. It builds further on the General Data Protection Regulation (GDPR). While the benefits of its use are clear to users, the complexity of and the effective protection by the EHDS security provisions for the user to exercise control over their data is essential, and the communication on EHDS features and usage will be of prime importance for its adoption.
EHDS is technically challenging, constraining acceptable data storage and access procedures; furthermore, over time more data sources will become available providing additional valuable medical relevant data; this requires a flexible, open architecture with effective trustworthy security designed in.
Eva Kaili European Parliament Vice-President and EIF Steering Committee member
Andrzej Rys, Director 'Health systems, medical products and innovation', DG SANTE, European Commission
Francesco Buonarroti, Chair of Executive Council for Health, DIGITALEUROPE
Annemieke Ålenius, Deputy Director General, Swedish eHealth Agency
Richard Price, Head of Policy, European Cancer Organisation
Maria Rosa Gibellini, Director General, European Internet Forum
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