European Union: European Health Data Space Regulation (2025/327) enters into force
Description
European Health Data Space Regulation (2025/327) enters into force
On 26 March 2027, specific provisions of the European Health Data Space (EHDS) Regulation (2025/327) come into force. These include the adoption of common specifications for EHR systems, which will set requirements for interoperability, security and data quality. Health Data Access Bodies will also be designated to handle requests for access to health data and issue data authorisations. In addition, rules on sanctions for non-compliance will enter into force, requiring Member States to impose effective, proportionate and dissuasive measures. Provisions on record cataloguing and data quality labels will be introduced to improve the standardisation and transparency of electronic health data across the EU. Some individual rights to access, rectify and control electronic health data will also start to apply. However, full implementation, in particular for secondary use of data, cross-border exchange and additional categories of electronic health data, will take place in later phases.
Original source