European Health Data Space (Regulation 2025/327)

adoptedJurisdiction: EUOfficial source

Description

The European Health Data Space (EHDS), Regulation (EU) 2025/327, is an adopted EU regulation establishing common rules for electronic health data. It covers “primary use”—people’s access to and sharing of their health data for care—and “secondary use”, such as permitted research, public-health, policy and statistical work.

Key dates

  1. Entry into force
  2. Applies from
  3. General application; selected secondary-use provisions (Arts 55(6),70,73(5),75(1),(12),77(4),78(6))
  4. Primary use rights + EHR systems for priority categories (a)-(c) (patient summaries, ePrescriptions/eDispensations); Chapter IV secondary use applies
  5. Priority categories (d)-(f) (imaging, lab results, discharge reports) and EHR systems put into service under Art 26(2)
  6. Art 75(5) applies

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