On 5 March 2025, Regulation 2025/327 (EHDS Regulation), creating a European Health Data Space (EHDS), was published in the European Union Official Journal (EU Official Journal), marking the end of the legislative process of the EHDS Regulation.
As set out in a previous blog, the EHDS Regulation allows Life Sciences companies to apply for access to health data for secondary use while requiring them to share certain health data when acting as data holders.
The EHDS Regulation will become law on March 25, 2025, 20 days after its publication in the EU Official Journal.
For details on the key elements of the EHDS Regulation for Life Sciences companies, see our Advisory here.