The EU regulation designed to facilitate secondary use of clinical data for research brings benefits for health research, but also poses challenges for companies.

By Deniz Tschammler, Danielle van der Merwe, Oliver Mobasser

On 5 March 2025, Regulation 2025/327 creating the European Health Data Space (the EHDS Regulation) was published in the Official Journal of the European Union and entered into force on 26 March 2025. The European Commission also published FAQs on the European Health Data Space