European Union: Regulation (EU) 2025/327 establishing a European Health Data Space (EHDS) including rules for portability and sharing of health data
Progress
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Timeline of events
European Health Data Space Regulation (2025/327) including provisions on third-country participation enters into force
On 26 March 2035, Article 75(5) of the European Health Data Space (EHDS) Regulation (2025/327) enters into force. Third countries or international organisations may become authorised participants in HealthData@EU if they comply with the Regulation's…
SourceEuropean Health Data Space Regulation (2025/327) including provisions on expanded data categories and EHR system requirements enters into force
On 26 March 2031, specific provisions of the European Health Data Space (EHDS) Regulation (2025/327) become applicable. In particular, the priority categories of personal electronic health data referred to in Article 14(1)(d), (e) and (f) will be su…
SourceEuropean 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…
SourceEuropean Health Data Space Regulation (2025/327) enters into force
On 26 March 2027, specific provisions of the European Health Data Space (EHDS) Regulation (2025/327) come into force. These include the adoption of common specifications for EHR systems, which will set requirements for interoperability, security and…
SourceEuropean Health Data Space (EHDS) Regulation (2025/327) enters into force with grace period
On 25 March 2025, the European Health Data Space (EHDS) Regulation (2025/327) entered into force with a grace period. The Regulation facilitates access to electronic health data for primary use in healthcare and secondary use for research, policy ma…
SourceCouncil of the European Union adopted Regulation on European Health Data Space (EHDS)
On 21 January 2025, the Regulation on the European Health Data Space (EHDS) was adopted by the Council of the European Union. The Regulation establishes an opt-out mechanism, enabling individuals to decide whether their health data, including patien…
SourcePassed Regulation establishing a European Health Data Space (EHDS) by European Parliament
On 24 April 2024, the Regulation on the European Health Data Space (EHDS) was passed by the European Parliament. The Regulation introduces an opt-out mechanism, granting individuals the right to decide whether their health data, such as patient summ…
SourceAdopted Council and Parliament Agreement on Regulation establishing a European Health Data Space (EHDS) including rules for portability and sharing of health data
On 15 March 2024, the Council of the EU and the European Parliament reached a provisional agreement on the Regulation on the European Health Data Space (EHDS). Firstly, the agreement introduces an opt-out mechanism, granting individuals the right to…
SourceAdopted European Parliament position on Regulation establishing a European Health Data Space (EHDS) including rules for portability and sharing of health data
On 13 December 2023, the European Parliament adopted its position on the Regulation on the European Health Data Space (EHDS). The Regulation would allow both patients and healthcare professionals to access patients' data, such as patient summaries, …
SourceAdopted Council general approach on European Health Data Space (EHDS) including rules for portability and sharing of health data
On 6 December 2023, the Council of the European Union (EU) adopted its general approach on the European Health Data Space (EHDS), including rules for portability and sharing of health data. The EHDS aims to facilitate the exchange and access to heal…
SourceAdopted LIBE and ENVI position on Regulation establishing a European Health Data Space (EHDS) including rules for portability and sharing of health data
On 28 November 2023, the European Parliament's Committee on Environment, Public Health and Food Safety (ENVI) and the Committee on Civil Liberties, Justice and Home Affairs (LIBE) adopted their position on the Regulation on the European Health Dat…
SourcePublished proposal for a Regulation on the European Health Data Space (EHDS) including rules for portability and sharing of health data
On 3 May 2022, the European Commission published a proposal for a Regulation on the European Health Data Space (EHDS), with the main objective to ensure that individuals in the European Union have more control over their electronic health data and h…
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