The European Health Data Space (EHDS) is a health specific ecosystem comprised of rules, common standards and practices, infrastructures and a governance framework that aims at empowering individuals through increased digital access to and control of their electronic personal health data, at national level and EU-wide, and support to their free movement, as well as fostering a genuine single market for electronic health record systems, relevant medical devices and high risk AI systems and by providing a consistent, trustworthy and efficient set-up for the use of health data for research, innovation, policy-making and regulatory activities.

While the proposal for a Regulation on the EHDS is being negotiated between the European co-legislators, there are a number of initiatives that have already been launched to prepare the ground for its rollout. In this presentation, the European Commission will give an overview of the state of play of the implementation of the EHDS.

Most notably, in primary uses of health data, the MyHealth@EU infrastructure, which allows for the exchange of health data across borders, is live with 12 countries (as of February 2024), and over 20 projects have just started to expand its services and geographical coverage. Joint action Xt-EHR, alongside with several other projects, the eHealth Network and the eHealth Member State Expert Group, is working on the specifications for the European Electronic Health Record exchange Format (EEHRxF). In secondary uses of health data, a pilot project is developing the first version of HealthData@EU in collaboration with the Commission, and over 20 projects have been launched to set up or strengthen health data access bodies. Additionally, the follow-up to the TEHDaS joint action is expected to start in 2024.