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Deep Dive | European Health Data Space Regulation

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28/05/2025

On 26 March, a historic milestone came into force: the European Health Data Space (EEDS) Regulation, the first major common sectoral data space in the European Union, as set out in the ambitious European Data Strategy.

This new legal framework marks a turning point in the way electronic health data will be managed, shared and utilised across the EU. Its impact will be transformative for citizens, professionals, researchers, and public and private institutions alike.

In this session on the European Health Data Space Regulation, we had the pleasure of hearing from Itziar Alkorta, Senior Lecturer in Civil Law at the University of the Basque Country (UPV/EHU) and a recognised expert in bioethics and the regulation of new technologies.

What have we covered in this session?

The European Health Data Space (EHDS) is a European Union proposal aimed at promoting secure access to and use of health information. It is based on three objectives: optimising healthcare (primary use), establishing standards for interconnected electronic health record systems, and facilitating the use of data for research, innovation and public policy (secondary use).

Timeline for the exchange of health data:

  • By 2029, data holders must describe and be ready to share most datasets, and users will be able to start requesting access to them.
  • By 2031, this will be extended to the remaining categories, thereby completing availability and access.

Access the recording and presentation from the session.