European Health Data Space Regulation (EHDS) (EHDS)

European Health Data Space Regulation (EHDS)

Adopted, applies laterEHDS

Summary

It creates a common space to use health data for care (primary use) and for research, innovation and AI training (secondary use). Health data holders will have to make data available to access bodies, and electronic health record systems with AI features face their own requirements.

Who it applies to

Health data holders (hospitals, health insurers, digital health companies) and makers of electronic health record systems. Micro-enterprises are exempt as data holders.

Penalties

Set by each Member State; the regulation provides for fines for secondary-use breaches.

Official name: Reglamento (UE) 2025/327 del Parlamento Europeo y del Consejo, de 11 de febrero de 2025, relativo al Espacio Europeo de Datos de Salud
Official reference: Reglamento (UE) 2025/327, DO L de 5.3.2025; en vigor el 26.3.2025
Regulator: National health data access bodies and digital health authorities (to be designated in Spain)
Official source: Check the sourceHow we verify sources

Key dates

March 26, 2025Entry into force
March 26, 2027General application date and deadline for key implementing acts
March 26, 2029Secondary use and exchange of first data categories begin
March 26, 2031Second wave of data categories (imaging, lab results, discharge reports)

Obligations and dates

Obligations table
Obligation	Article or citation	Status	Date	Who it applies to	Verification
Prepare health data for secondary use and EHR systems	Reglamento (UE) 2025/327, caps. III y IV; art. 105	Adopted, applies later	March 26, 2029	Healthcare organizations with 10 or more people that hold electronic health data or sell EHR systems.	Verified in the official source on November 2, 2026

Prepare health data for secondary use and EHR systems

Reglamento (UE) 2025/327, caps. III y IV; art. 105Adopted, applies later

Applies from March 26, 2029

When it relates: Healthcare organizations with 10 or more people that hold electronic health data or sell EHR systems.
What the rule provides: Inventory health datasets and describe them for the national catalog.
Set up processes to respond to health data access body requests.
If you sell EHR systems with AI features, meet both EHDS and AI Act requirements.
Typical evidence: Dataset inventory and data sheets.
Request-handling procedure.
Related base documents: Data Governance Guidelines for AI
Supporting documents: Dataset Datasheet
AI Model and Dataset Inventory Policy
Verification: Verified in the official source on November 2, 2026Checked on the Commission's official health website. Correction: the research gave Mar 26, 2027 as the main date, but that is mainly the implementing-acts deadline; most operational obligations (secondary use and first data categories) start in March 2029, with a second wave in March 2031.