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Ordinary legislative procedure First reading

European Health Data Space

A proposed EU law. Parliament and the Council must agree on the same text: Parliament adopts its position, then negotiates with the Council.

Where it stands: Completed: published in the Official Journal on 5 March 2025 and now EU law.

  1. ✓ Referred to committee 6 June 2022
  2. ✓ Committee work Report adopted 28 November 2023
  3. ✓ Tabled for plenary 5 December 2023
  4. ✓ Negotiations with the Council Deal approved in committee 9 April 2024
  5. ✓ Plenary vote Adopted 24 April 2024
  6. ✓ Published as law 5 March 2025
How a file moves through Parliament

A file is referred to one lead committee (others may give an opinion). Its rapporteur writes a draft report, committee members table amendments, and the committee votes to adopt the report. The report is then tabled for all MEPs; political groups can table further amendments, which are voted on before the final vote in plenary. For a law, Parliament’s adopted text is its first-reading position; Parliament and the Council then negotiate a common text (trilogues) which both must approve before it is published as law.

Who is working on it

Lead committee
LIBE — Civil Liberties, Justice and Home Affairs
Rapporteurs
Tomislav SOKOL PPEMEP #197806 ID
Shadow rapporteurs
MEP #197641 S&DSusana SOLÍS PÉREZ RenewTilly METZ Verts/ALEMEP #197530 ECRMEP #197483 IDKateřina KONEČNÁ The LeftJavier ZARZALEJOS PPEMEP #197844 S&DMEP #197766 RenewMEP #197431 Verts/ALEMEP #197519 ECRKonstantinos ARVANITIS The Left
For opinion
BUDG — Budgets

The rapporteur drafts and negotiates the text for the lead committee; each other political group names a shadow rapporteur to follow the file.

The text, version by version

Adopted by Parliament · latest Adopted text TA9-0331/2024 24 April 2024 ✦ Parliament's position at first reading on the proposed regulation on the European Health Data Space, amending Directive 2011/24/EU and Regulation (EU) 2024/2847.⇄ what changed Adopted by Parliament Adopted text TA9-0462/2023 13 December 2023 ✦ Parliament's amended version of the proposed regulation on the European Health Data Space sets up rules for access to and control of electronic health data for healthcare (primary use) and for research, innovation, policy-making and regulatory purposes (secondary use).⇄ what changed Tabled for plenary Report A9-0395/2023 5 December 2023 ✦ Parliament's amended version of the Commission proposal for a regulation on the European Health Data Space sets up rules for access to and exchange of electronic health data for healthcare (primary use) and for research, innovation, policy-making and other purposes (secondary use).

Committee opinions: Draft opinion (IMCO),Draft opinion (ITRE),Opinion (IMCO),Opinion (ITRE)

Newest version first. Open a version to read it in full. “What changed” shows the differences paragraph by paragraph; ✦ lines are AI-written from the texts themselves.

Timeline

  1. Outcome
  2. 5 March 2025 Published in the Official Journal

    The act is now EU law.

  3. 11 February 2025 Signed by the Presidents of Parliament and the Council

    The last step before the act is published in the Official Journal.

  4. Plenary stage
  5. 24 April 2024 Plenary vote
    Sitting of 24 April 2024 📄 Adopted text TA9-0331/2024📄 Report A9-0395/2023
    Adopted Adopted by a large majority
    For 445 Against 142 Abstained 39

    Final vote on the provisional agreement at 13:53 · 71% of votes cast in favour · every MEP’s position →

  6. Negotiations with the Council
  7. 9 April 2024 Committee approved the deal reached with the Council

    The provisional agreement from the trilogues goes to the whole Parliament for a vote.

    📄 CJ43-AG-760905
  8. 13 December 2023 Parliament opened negotiations with the Council

    After its vote Parliament sent the file back to committee, so that its negotiators can seek a compromise text with the Council (in “trilogues”).

  9. Plenary stage
  10. 13 December 2023 Plenary vote
    Sitting of 13 December 2023 📄 Adopted text TA9-0462/2023📄 Council / Commission text C9-0167/2022📄 Report A9-0395/2023
  11. 12 December 2023 Debated in plenary

    MEPs debated the text in the chamber ahead of the vote.

    Sitting of 12 December 2023 📄 Council / Commission text C9-0167/2022📄 Report A9-0395/2023
  12. 5 December 2023 Report tabled for plenary

    This is the text all MEPs vote on. Political groups can still table amendments to it.

    📄 Report A9-0395/2023
  13. Committee stage
  14. 28 November 2023 Committee vote: report adopted

    LIBE (Civil Liberties, Justice and Home Affairs) voted on the amendments and adopted the report that goes to plenary.

  15. 23 May 2023 IMCO (Internal Market and Consumer Protection) adopted its opinion

    The opinion is attached to the report for the lead committee to consider.

    📄 Opinion (IMCO)
  16. 23 May 2023 ITRE (Industry, Research and Energy) adopted its opinion

    The opinion is attached to the report for the lead committee to consider.

    📄 Opinion (ITRE)
  17. 29 March – 5 April 2023 Amendments tabled in committee (4 batches)

    Members of the committee proposed changes to the draft.

    📄 CJ43-AM-745530📄 CJ43-AM-745531📄 CJ43-AM-745532📄 CJ43-AM-745533
  18. 14 February 2023 Draft opinion from ITRE (Industry, Research and Energy)

    An associated committee gives its view to the lead committee.

    📄 Draft opinion (ITRE)
  19. 10 February 2023 Draft report published

    The rapporteur’s first text. Members can table amendments before the committee votes.

    📄 CJ43-PR-742387
  20. 8 February 2023 Draft opinion from IMCO (Internal Market and Consumer Protection)

    An associated committee gives its view to the lead committee.

    📄 Draft opinion (IMCO)
  21. 6 June 2022 Referred to the LIBE (Civil Liberties, Justice and Home Affairs) committee

    The lead committee prepares the report; BUDG (Budgets) gives an opinion.