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European Health Data Space
- Stage
- In force, reached 5 Mar 2025
- In force
- In force since 25 Mar 2025 · CELEX 32025R0327
- Procedure
- Ordinary legislative procedure
- Rapporteurs
- Tomislav Sokol (EPP), Annalisa Tardino (PfE)
- Lead DG
- DG SANTE
- Commissioner
- Stella Kyriakides
- Last activity
- 31 Aug 2026
50 entries · record as of 14 Sept 2026
Where it stands
Latest: Public feedback open: European Health Data Space HealthData@EU requirements, 31 Aug 2026.
ShowHide the earlier record: 30 dates, 4 May 2022 to 9 Apr 2024
- 4 May 2022
- Adoption of legislative proposal by the Commission
- 6 May 2022
- Discussions within the Council or its preparatory bodies
- 30 May 2022
- Discussions within the Council or its preparatory bodies
- 6 Jun 2022
- Plenary sitting
- Referred to committee
- 23 Jun 2022
- Discussions within the Council or its preparatory bodies
- 14 Jul 2022
- Discussions within the Council or its preparatory bodies
- 12 Sept 2022
- Discussions within the Council or its preparatory bodies
- 27 Sept 2022
- Discussions within the Council or its preparatory bodies
- 28 Sept 2022
- Discussions within the Council or its preparatory bodies
- 20 Oct 2022
- Discussions within the Council or its preparatory bodies
- 2 Dec 2022
- Discussions within the Council or its preparatory bodies
- 7 Dec 2022
- Discussions within the Council or its preparatory bodies
- 8 Feb 2023
- Committee opinion tabled
- 10 Feb 2023
- Committee report tabled
- EP committee draft report
- 14 Feb 2023
- Committee opinion tabled
- 17 Feb 2023
- Discussions within the Council or its preparatory bodies
- 23 Feb 2023
- Discussions within the Council or its preparatory bodies
- 29 Mar 2023
- Committee amendments tabled
- Tabling of amendments in the EP committee responsible
- 5 Apr 2023
- Committee amendments tabled
- Tabling of amendments in the EP committee responsible
- 23 May 2023
- Committee opinion adopted
- 26 May 2023
- Discussions within the Council or its preparatory bodies
- 28 Nov 2023
- Committee report adopted
- 5 Dec 2023
- Tabled for plenary
- 6 Dec 2023
- Adoption of negotiating mandate by Coreper
- 7 Dec 2023
- Discussions within the Council or its preparatory bodies
- 12 Dec 2023
- Debate in plenary
- 13 Dec 2023
- EP decision on amendments to the legislative proposal
- Plenary vote
- Plenary sitting
- PLENARY_ACTIVITY']
- Plenary amended the proposal
- Referred back to committee for interinstitutional negotiations
- 12 Jan 2024
- Discussions within the Council or its preparatory bodies
- 22 Mar 2024
- Discussions within the Council or its preparatory bodies
- Endorsement of the provisional agreement by Coreper
- 9 Apr 2024
- Committee approved the provisional agreement
- 24 Apr 2024
- EP position at first reading
- Plenary amended the proposal
- Plenary vote
- 18 Jun 2024
- Discussions within the Council or its preparatory bodies
- 21 Jan 2025
- Approval of the EP's first reading position by the Council (adoption of the legislative act)
- 11 Feb 2025
- Signed
- 5 Mar 2025
- Published in the Official Journal
- 22 Jun 2026
- Commission plans implementing act under parent act
- 19 Jul 2026
- Commission plans implementing act under parent act
- 31 Aug 2026
- Public feedback open: European Health Data Space HealthData@EU requirements
16 people
Who is on it
The Parliament's rapporteurs, shadow rapporteurs and opinion rapporteurs currently on this file.
| Role | Name | Group | Country | Committee |
|---|---|---|---|---|
| Co-rapporteur | Tomislav Sokol | EPP | HR | ENVI |
| Co-rapporteur | Annalisa Tardino | PfE | IT | LIBE |
| Shadow rapporteur | Beata Kempa | ECR | PL | |
| Shadow rapporteur | Javier Zarzalejos | EPP | ES | |
| Shadow rapporteur | Joanna Kopcińska | ECR | PL | |
| Shadow rapporteur | Kateřina Konečná | The Left | CZ | |
| Shadow rapporteur | Konstantinos Arvanitis | The Left | EL | |
| Shadow rapporteur | Lucia Ďuriš Nicholsonová | Renew | SK | |
| Shadow rapporteur | Patrick Breyer | Greens/EFA | DE | |
| Shadow rapporteur | Petar Vitanov | S&D | BG | |
| Shadow rapporteur | Sara Cerdas | S&D | PT | |
| Shadow rapporteur | Susana Solís Pérez | Renew | ES | |
| Shadow rapporteur | Sylvia Limmer | PfE | DE | |
| Shadow rapporteur | Tilly Metz | Greens/EFA | LU | |
| Rapporteur for opinion | Andrey Kovatchev | EPP | BG | IMCO |
| Rapporteur for opinion | Cristian-Silviu BUŞOI | EPP | RO | ITRE |
11 acts
Delegated and implementing acts beneath it
By status: 10 planned, 1 adopted.
| Act | Kind | Status | Adoption |
|---|---|---|---|
| European Health Data Space HealthData@EU requirements | Implementing · Regulation | Planned | Q4 2026 |
| European Health Data Space – Data Quality and Utility Label | Implementing · Regulation | Planned | Q1 2027 |
| European Health Data Space – common specifications for the harmonised software components of EHR systems | Implementing · Regulation | Planned | Q4 2026 |
| European Health Data Space dataset descriptions | Implementing · Regulation | Planned | Q3 2026 |
| European Health Data Space MyHealth@EU requirements | Implementing · Regulation | Planned | Q2 2026 |
| European Health Data Space identification management | Implementing · Regulation | Planned | Q2 2026 |
| European Health Data Space Board operations | Implementing · Regulation | Adopted | Q1 2026 |
| European Health Data Space – common specifications for the European digital testing environment | Implementing · Regulation | Planned | Q1 2027 |
| European Health Data Space – European Electronic Health Exchange Format specifications | Implementing · Regulation | Planned | Q4 2026 |
| European Health Data Space - Requirements for Secure Processing Environments | Implementing · Regulation | Planned | Q1 2027 |
| Templates for health data access applications, health data requests, data permits and decisions on a data request | Implementing · Regulation | Planned | Q4 2026 |
Titles link to EUR-Lex where the act has been published.
20 documents
Documents
Newest first. Each opens at its source.
- Report · A9-0395/2023Parliament
- Proposal · COM(2022)0197Parliament
- Agenda · GEDA/A/(2024)001744Parliament
- Text adopted · OJ L 05.03.2025Commission
- Committee opinion · PE740.773Parliament
- Committee opinion · PE742.310Parliament
- Report · PE742.387Parliament
- Amendments · PE745.471Parliament
- Amendments · PE745.527Parliament
- Amendments · PE745.528Parliament
- Amendments · PE745.529Parliament
- Amendments · PE745.530Parliament
- Amendments · PE745.531Parliament
- Amendments · PE745.532Parliament
- Amendments · PE745.533Parliament
- Agenda · PE760.905Parliament
- Text adopted · Regulation 2025/0327Commission
- Text adopted · SP(2024)394Parliament
- Text adopted · T9-0331/2024Parliament
- Text adopted · T9-0462/2023Parliament
Summary
GeneratedThe European Health Data Space sets common rules for using health data for primary care (patient access and cross-border sharing) and secondary purposes (research, innovation, policy-making). It affects healthcare providers, national health authorities, researchers, and digital health tech companies. Signed in February 2025, the regulation is now in force.
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Sources: EP Legislative Observatory · EUR-Lex. Record as of 14 Sept 2026. Something wrong on this page? Report an error.
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