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Legislations.
European UnionEuropean UnionLawLawRegulation (EU) 2025/327

European Health Data Space Regulation

Gives people control over and cross-border access to their electronic health data and sets a framework for the secondary use of health data for research, innovation and policy making.

Where it stands

In forceIntroducedCommitteeFloorLawIn force

Enters into force (EUR-Lex date; the Commission page gives 26 March 2025)Mar 25, 20251 year ago

Body
European Parliament and Council
Session
10th parliamentary term
Introduced
May 3, 2022
In effect since
Mar 25, 20251 year ago
DataPrivacy
Official page Source: EUR-Lex; European Commission; European Parliament Legislative Observatory On Regulations: European Health Data Space (EHDS)

Timeline

  1. Mar 26, 2035 in 8 years

    Final partial application date scheduled under Article 105

  2. Mar 26, 2031 in 4 years

    Scheduled application for the second group of priority data (medical images, lab results, discharge reports) and secondary use of remaining categories such as genomic data

  3. Mar 26, 2029 in 2 years

    Scheduled application of key parts, including exchange of patient summaries and ePrescriptions and secondary use rules for most data categories

  4. Mar 26, 2027 in 6 months

    Regulation applies in general; deadline for the Commission to adopt key implementing acts

  5. Mar 25, 2025 1 year ago

    Enters into force (EUR-Lex date; the Commission page gives 26 March 2025)

  6. Mar 5, 2025 1 year ago

    Published in the Official Journal

  7. Feb 11, 2025 1 year ago

    Final act signed

  8. Jan 21, 2025 1 year ago

    Council adopts the act

  9. Apr 24, 2024 2 years ago

    Parliament adopts the agreed text

  10. Mar 22, 2024 2 years ago

    Provisional agreement reached in trilogue

  11. Dec 13, 2023 2 years ago

    Parliament adopts its negotiating position

  12. Nov 28, 2023 2 years ago

    Joint ENVI and LIBE committee vote, 1st reading

  13. May 3, 2022 4 years ago

    Commission proposal COM(2022) 197 published, procedure 2022/0140(COD)