What EU European Health Data Space Regulation (Regulation (EU) 2025/327) requires
Regulation (EU) 2025/327 of the European Parliament and of the Council establishes the European Health Data Space (EHDS). It was published in the Official Journal of the European Union on 5 March 2025 and entered into force on 26 March 2025. Application is phased: core provisions begin to apply from 26 March 2027, with later milestones in 2029, 2031 (when secondary use of genomic data and other priority categories applies), and 2035. The EHDS Regulation creates a horizontal legal framework for the use of electronic health data including genomic data across two pillars: primary use of electronic health data for the provision of healthcare to natural persons (MyHealth@EU); and secondary use of electronic health data for research, innovation, policy-making, regulatory activities, patient safety, personalised medicine, official statistics, and education and training (HealthData@EU). The Regulation establishes the Health Data Access Bodies (HDABs) in each Member State to grant data permits and data requests for secondary use. Chapter II creates rights for natural persons including the right to receive electronic health data, the right to transmit data to a recipient of choice, and the right to opt out of secondary use processing in accordance with national law. Chapter III establishes mandatory interoperability and security requirements through the European Electronic Health Record Exchange Format. Chapter IV creates the secondary use framework with HDABs evaluating data permit applications, processing data through secure processing environments, and ensuring de-identification or pseudonymisation. Genomic data is covered as a category of electronic health data and is subject to enhanced safeguards with secondary use applying from March 2031. The Regulation complements the General Data Protection Regulation (EU) 2016/679 and does not derogate from it.
Pillar: Biotech & Genomics · Authority: European Commission Directorate-General for Health and Food Safety · Version: 1.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/eli/reg/2025/327/oj/eng
SHA-256 integrity: 935b9c5c70232c9a183c4f34ec27f1dc51c9719b203261de99c3d1812b3d8db4
Primary Citations — 7 traced to source
- Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847.
- EHDS Regulation Chapter II - rights of natural persons relating to electronic health data including access, transmission, and opt-out from secondary use.
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