EU Health Data Space Regulation to be implemented throughout the next 4 years 

EU Health Data Space Regulation to be implemented throughout the next 4 years 

On 5 March 2025, the European Health Data Space (EHDS) Regulation was officially published in the Official Journal of the European Union. It entered into force on 26 March 2025, which marks the beginning of the transition phase towards application.

The EHDS Regulation aims to establish a common framework for the use and exchange of electronic health data across the EU. It enhances individuals’ access to and control over their personal electronic health data, while also enabling certain data to be reused for public interest, policy support, and scientific research purposes. It fosters a health-specific data environment that supports a single market for digital health services and products. Additionally, the regulation establishes a harmonised legal and technical framework for electronic health record (EHR).

When a Regulation is published, it typically establishes the main principles and objectives. However, to make these principles operational, additional implementing acts are needed. These implementing acts provide more detailed rules and specifications that help to put the regulation into practice. The European Commission (EC) is expected to publish these implementing acts by March 2027, and the application of the Regulation to actually unfold between 2029 and 2034.

The European Health Data Space Regulation available here.

More information on the European Health Data Space Regulation is available here.