European Union: European Health Data Space Regulation (2025/327) including provisions on primary and secondary use of electronic health data enters into force

On 26 March 2031, specific provisions of the European Health Data Space (EHDS) Regulation (2025/327) come into force. Specifically, Articles 3 to 15, Article 23(2) to (6), Articles 25, 26, 27, 47, 48, and 49 of the EHDS Regulation will apply to priority categories of personal electronic health data under Article 14(1)(a), (b), and (c). This encompasses patient summaries, electronic prescriptions, and medical imaging reports, in addition to EHR systems designed to process these data categories. The Articles establish rules for electronic health data access, interoperability, and security, outline cross-border health data exchange obligations, set compliance requirements for EHR systems and AI integration, and regulate wellness application labelling, interoperability with EHR systems, and the EU registration database for digital health solutions. Furthermore, chapter IV of the EHDS Regulation will become applicable. However, specific provisions such as Article 55(6), Article 70, Article 73(5), Article 75(1) and (12), Article 77(4), and Article 78(6) will be applicable from 26 March 2027, while Article 51(1)(b), (f), (g), (m) and (p) will apply from 2031 and Article 75(5) from 2035. Chapter IV of the EHDS Regulation establishes the framework for the secondary use of electronic health data. It delineates the procedures to be followed by health data access bodies in handling requests, issuing data permits, and ensuring compliance. The chapter incorporates provisions pertaining to data processing, pseudonymization, anonymization, and access controls, in addition to storage, cross-border data sharing, and third-country transfers. The remaining provisions will apply at subsequent stages, extending the scope of the Regulation in 2031 and beyond.