EHDS — European Health Data Space Regulation
Overview
Regulation (EU) 2025/327, adopted on 11 February 2025 and in force from 26 March 2025, establishes the European Health Data Space — the EU’s first sector-specific data space and a stated cornerstone of the European Health Union. It creates a unified legal, technical, and governance framework for accessing, sharing, and reusing electronic health data across all EU Member States, covering both primary use (direct patient care) and secondary use (research, innovation, policy, public health). Most obligations do not apply immediately: general provisions and EHR interoperability requirements apply from March 2027, and secondary use provisions for most data categories from March 2029.
Two Pillars
Primary Use
Grants EU citizens new rights to access, download, and transmit their electronic health records across borders via the MyHealth@EU interoperability platform. Mandates EHR system interoperability and certification across all Member States, with technical specifications to be defined through implementing acts.
Secondary Use
Requires data holders to make health data available to researchers, innovators, and policymakers through national Health Data Access Bodies (HDABs) and the HealthData@EU federated infrastructure. Data in scope includes EHRs, medical imaging, lab results, genomic data, clinical trial data, registries, and claims data. Data holders may be compensated for making data available.
Implementation Timeline
The regulation entered into force on 26 March 2025, marking the start of a phased transition. Member States have 12 months to designate national Digital Health Authorities (by March 2026). General provisions and EHR interoperability requirements begin to apply from March 2027, which is also the deadline for the Commission to adopt key implementing acts. From March 2029, secondary use rules apply for most data categories (EHRs, registries, claims), and the first cross-border primary use functionalities go live, covering patient summaries and ePrescriptions. From March 2031, secondary use extends to clinical trial and human genetic data, and the second group of primary use data categories becomes operational, including medical images, lab results, and discharge reports. A further milestone, approximately ten years after entry into force, opens HealthData@EU participation to third countries and international organisations.
Key Bodies Established
The EHDS Board coordinates implementation across Member States, with two representatives per Member State, one responsible for primary use and one for secondary use. Each Member State must establish at least one Health Data Access Body (HDAB) to receive and process secondary use requests, grant or refuse access, maintain a national dataset catalogue, and operate or designate a secure processing environment (SPE) in which approved analyses are carried out. The HDAB is the single national gateway through which researchers, innovators, and public bodies apply for access to health data held by data holders in that country. In France, this body is referred to as the ORAD (Organisme Responsable de l’Accès aux Données de Santé), with the Health Data Hub as the primary candidate for designation given its existing role operating the national secure Datalab and managing access to the SNDS. Digital Health Authorities are responsible for national oversight of EHR system certification and EHDS implementation. At the infrastructure level, MyHealth@EU is the Commission-operated cross-border platform planned for primary use, and HealthData@EU is the decentralised federated infrastructure planned for secondary use, connecting national HDABs once member state implementation is complete.
Standards and Interoperability
HL7 FHIR is the designated standard for EHR data exchange under the EHDS, with a European EHR exchange format to be defined through implementing acts. OMOP CDM is recommended by the TEHDAS joint action for secondary use data standardisation and is the de facto common data model being adopted across Member States for HealthData@EU, though it is not explicitly named in the Regulation text. SNOMED CT is a referenced clinical terminology for EHR content. The secondary use infrastructure is aligned with the FAIR Principles.
Connections
- Data protection framework: GDPR
- Part of: EU Data Strategy
- French implementation: Health Data Hub (national HDAB candidate), ORAD, SNDS (designated reference dataset)
- Standards: HL7 FHIR, OMOP CDM, SNOMED CT