On March 5, 2025, the Regulation on the European Health Data Space (“EHDS”) was published in the Official Journal (see here). The text enters into force on March 25, 2025, however it only becomes applicable in a staggered manner over several years.
The section on secondary use of the EHDS only starts applying four years after its entry into force, thus on March 26, 2029. Although for some data categories, such as clinical trial and genetic data, the transition period is six years. Third countries having an interest in joining EHDS (not to be confused with researchers in third countries) have to wait for at least ten years. Those long transition periods do not mean that stakeholders can sit by idly, quite the contrary. The European Commission has several implementing acts to prepare, among others on the description of data sets, the template for making data access requests and the secure processing platforms. In parallel, an EU-funded project, Tehdas, consisting mainly of public sector bodies, is working on more detailed guidance and implementation documents. In January 2025, Tehdas launched several consultations, among others on data descriptions and data user application practices for data access.
The Commission also published an FAQ on the EHDS, available here.
In the Spring of 2024, we published several blog posts on EHDS. Now with the final text available, we updated those posts and inserted the correct references. They can be found here:
- EHDS Series – 1: Five Key Take Aways on Secondary Use of Health Data
- EHDS Series – 2: The European Health Data Space from the Health Data Holder’s Perspective
- EHDS Series – 3: The European Health Data Space from the Health Data User’s Perspective
- EHDS Series – 4: The European Health Data Space’s Implications for “Wellness Applications” and Medical Devices
- EHDS Series – 5: European Health Data Space Governance, Enforcement and Timelines