Council of the EU Creates European Health Data Space
- 22/01/2025
- News
On 21 January 2025, the Council of the European Union adopted the Regulation establishing the European Health Data Space (EHDS). This marks the end of a legislative process that started in May 2022 (see, Van Bael & Bellis Life Sciences News and Insights of 4 May 2022) and promises individuals access to and control over their personal electronic health data, while business, academia and policy makers will be given the possibility to re-use specific health data for research, innovation, and policy purposes. The Regulation will create a health-specific data environment that will ensure cross-border access to digital health services and products within the EU (see, Van Bael & Bellis Life Sciences News and Insights of 29 March 2024). This will be achieved by an obligation on Member States to cause all electronic health record systems to comply with the specifications of the European electronic health record exchange format, ensuring the interoperability of the health data at EU level. Additionally, Member States will have to establish a digital health authority to implement the new framework and oversee the data use.
The Council and the European Parliament will now sign the Regulation which will enter into force 20 days after its publication in the Official Journal of the EU (which is expected to happen over the next few days). The European Commission must detail the new rules in several implementing and delegated acts. Most of these should be in place by the end of 2026 or early 2027. This would pave the way for the first exchanges of health data under the umbrella of the EHDS in late 2028 or the beginning of 2029.
