Description

Council 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 patient summaries, electronic prescriptions, medical images, and laboratory results, can be accessed by healthcare professionals. Patients may also restrict access to sensitive information, with exceptions for emergency situations where access is necessary to protect vital interests. The Regulation includes provisions for stricter governance of sensitive data, such as genetic information, in secondary use cases like research. Member States are permitted to designate trusted data holders to facilitate secure and efficient access to health data while minimising administrative burdens. Additionally, the Regulation mandates the disclosure of clinically significant findings to patients or healthcare professionals.

Original source

Scope

Policy Area
Data governance
Policy Instrument
Data protection regulation
Regulated Economic Activity
cross-cutting
Implementation Level
supranational
Government Branch
legislature
Government Body
parliament

Complete timeline of this policy change

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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…