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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 electronic health record (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. Article 14 defines two priority categories of health data phased in on separate timelines for cross-border exchange (see Implementation Timeline).

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.

graph TD
  ehds([EHDS])
  ehds -->|primary use| mha([MyHealth@EU<br/>patient access])
  ehds -->|secondary use| hdab([national HDABs])
  hdab -->|federated via| hde([HealthData@EU])
  mha -.->|designated format| fhir([HL7 FHIR])
  hde -.->|recommended format| omop([OMOP CDM])

EHDS splits into two pillars, primary use for patient access and secondary use for researchers, each converging on a designated exchange format.

Implementation Timeline

The EHDS phases in its obligations over roughly a decade from entry into force.

DateMilestone
26 March 2025Regulation enters into force
March 2026Member States designate national Digital Health Authorities
March 2027General provisions and EHR interoperability requirements apply, and the Commission adopts key implementing acts
March 2029Secondary use rules apply for most data categories (EHRs, registries, claims), and primary use priority category 1 becomes operational (patient summaries, ePrescriptions/eDispensations)
March 2031Secondary use extends to clinical trial and human genetic data, and primary use priority category 2 becomes operational (medical imaging and reports, lab results, discharge reports)
~10 years after entry into forceHealthData@EU opens 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. Member States must designate their HDAB by 26 March 2027, though it does not begin processing secondary-use requests until the secondary-use rules generally apply from March 2029. 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. In the Netherlands, Health-RI is building the Dutch HDAB, coordinating with cohorts such as Lifelines via BBMRI-NL. 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.

Different Member States are building their HDAB through different existing infrastructure, but converge on the same two standards for exchange.

graph TD
  ehds([EHDS regulation])

  ehds -->|France| hdh([Health Data Hub])
  hdh -->|portal over| snds([SNDS])
  hdh -.->|is developing| hdabfr([designated HDAB])
  snds -.-> hdabfr

  ehds -->|Netherlands| hri([Health-RI])
  hri -->|coordinates via BBMRI-NL| lifelines([Lifelines cohort])
  hri -.->|is developing| hdabnl([designated HDAB])
  lifelines -.-> hdabnl

  hdabfr -.-> fromop([OMOP CDM<br/>*secondary reuse*])
  hdabfr <-.-> fhir([FHIR<br/>*primary data exchange*])
  hdabnl <-.-> fhir
  hdabnl -.-> nlomop([OMOP CDM<br/>*secondary reuse*])

  fromop -.-> comb([combined data reuse])
  nlomop -.-> comb

Different national infrastructure paths converge on the same two standards, FHIR for primary exchange and OMOP CDM for secondary reuse, enabling combined cross-border data reuse.

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. Bridging the two, since FHIR structures primary-use exchange and OMOP CDM structures secondary-use analysis, has been an active technical focus of the TEHDAS2 joint action, developing FHIR-to-OMOP transformation pipelines as of early 2026. SNOMED CT is a referenced clinical terminology for EHR content. The secondary use infrastructure is aligned with the FAIR Principles.

Clinical Trial Data

Clinical trial data relates to EHDS through three distinct layers, easily conflated. A trial’s conduct and registration are governed entirely separately, under the EU Clinical Trials Regulation (536/2014) via CTIS, and EHDS does not alter this. Sharing a completed trial’s individual patient data (IPD) already has an established route through sponsor-run platforms such as VIVLI and the YODA Project, operating on a voluntary, contractual basis. EHDS adds a third, regulatory route: from March 2031, clinical trial data becomes a designated EHDS secondary-use category, requiring data holders to make it available through national HDABs and HealthData@EU for purposes beyond the original trial. This route is mandatory rather than sponsor-discretionary, and applies alongside, not instead of, the existing voluntary platforms. See Clinical Trials for the standards and registries governing trial conduct and existing IPD-sharing infrastructure.

Connections

  • relatedTo: GDPR (EHDS special-category rules for health data supplement GDPR Article 9)
  • relatedTo: CNIL (EHDS routes supervisory oversight through existing GDPR national authorities under Article 36)
  • relatedTo: Health Data Hub (primary candidate for France’s national Health Data Access Body under EHDS)
  • relatedTo: ORAD (French designation for the national health data access body EHDS requires each Member State to establish)
  • relatedTo: Health-RI (building the Dutch national Health Data Access Body under EHDS)
  • relatedTo: SNDS (key French health data asset in scope for EHDS secondary use framework)
  • relatedTo: HL7 FHIR (designated standard for EHR data exchange under EHDS primary use pillar)
  • relatedTo: TEHDAS (recommendations informed the EHDS regulation and continue to guide its technical implementation)
  • relatedTo: OMOP CDM (TEHDAS joint action recommended OMOP CDM for HealthData@EU secondary use harmonisation)
  • relatedTo: SNOMED CT (referenced clinical terminology for EHDS EHR content)
  • relatedTo: VIVLI (EHDS secondary-use access for clinical trial data operates alongside VIVLI’s existing voluntary IPD-sharing platform)
  • relatedTo: YODA Project (EHDS secondary-use access for clinical trial data operates alongside YODA’s existing voluntary IPD-sharing platform)

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