Digital Policy Alert logo

European Union: European Health Data Space Regulation (2025/327) including provisions on primary and secondary use of electronic health data enters into force

Policy overview

Description

European Health Data Space Regulation (2025/327) including provisions on primary and secondary use of electronic health data enters into force

On 26 March 2031, specific provisions of the European Health Data Space (EHDS) Regulation (2025/327) come into force. Specifically, Articles 3 to 15, Article 23(2) to (6), Articles 25, 26, 27, 47, 48, and 49 of the EHDS Regulation will apply to prio…

Scope

Policy Area
Data governance
Policy Instrument
Data protection regulation
Regulated Economic Activity
cross-cutting
Implementation Level
supranational
Government Branch
executive
Government Body
central government

Complete timeline of this policy change

Hide details
2022-05-03
under deliberation

On 3 May 2022, the European Commission published a proposal for a Regulation on the European Health…

2023-11-28
under deliberation

On 28 November 2023, the European Parliament's Committee on Environment, Public Health and Food Sa…

2023-12-06
under deliberation

On 6 December 2023, the Council of the European Union (EU) adopted its general approach on the Euro…

2023-12-13
under deliberation

On 13 December 2023, the European Parliament adopted its position on the Regulation on the European…

2024-03-15
under deliberation

On 15 March 2024, the Council of the EU and the European Parliament reached a provisional agreement…

2024-04-24
under deliberation

On 24 April 2024, the Regulation on the European Health Data Space (EHDS) was passed by the Europea…

2025-01-21
adopted

On 21 January 2025, the Regulation on the European Health Data Space (EHDS) was adopted by the Coun…

2025-03-25
in grace period

On 25 March 2025, the European Health Data Space (EHDS) Regulation (2025/327) entered into force wi…

2027-03-26
in force

On 26 March 2027, specific provisions of the European Health Data Space (EHDS) Regulation (2025/327…

2029-03-26
in force

On 26 March 2031, specific provisions of the European Health Data Space (EHDS) Regulation (2025/327…

2031-03-26
in force

On 26 March 2031, specific provisions of the European Health Data Space (EHDS) Regulation (2025/327…

2035-03-26
in force

On 26 March 2035, Article 75(5) of the European Health Data Space (EHDS) Regulation (2025/327) ente…