What is the EHDS Regulation about
Unlocking the future of health data in Europe
The European Health Data Space (EHDS) is a cornerstone of the European Health Union and the first common EU data space dedicated to a specific sector as part of the European strategy for data.
The EHDS Regulation aims to establish a common framework for the use and exchange of electronic health data across the EU. It enhances individuals’ access to and control over their personal electronic health data, while also enabling certain data to be reused for public interest, policy support, and scientific research purposes. It fosters a health-specific data environment that supports a single market for digital health services and products. Additionally, the regulation establishes a harmonised legal and technical framework for electronic health record (EHR) systems, fostering interoperability, innovation, and the smooth functioning of the internal market.
The EHDS will:
- empower individuals to access, control and share their electronic health data across borders for the healthcare delivery (primary use of data);
- enable the secure and trustworthy reuse health data for research, innovation, policy-making, and regulatory activities (secondary use of data);
- foster a single market for electronic health record (EHR) systems, supporting both primary and secondary use.
By doing so, the EHDS will enable the EU to benefit from the full potential offered by a safe and secure exchange, use and reuse of health data to benefit patients, health professionals, researchers, regulators, and innovators. The EHDS regulation was discussed in a series of webinars.
What is the timeline for the implementation of the EHDS Regulation?
On 5th March 2025, the European Health Data Space Regulation was officially published in the Official Journal of the European Union. It enters into force on 26 March 2025, marking the beginning of the transition phase towards application.
When a regulation is published, what happens next?
However, this does not mean that the regulation will immediately apply. Instead, it is the beginning of a process that will unfold over time.
When a regulation is published, it typically establishes the main principles and objectives. However, to make these principles operational, additional implementing acts are needed. These implementing acts provide more detailed rules and specifications that help to put the regulation into practice.
The EHDS Regulation, first proposed by the European Commission in March 2022, underwent extensive negotiations before being adopted by the European Parliament and the Council. Now, its implementation will be gradual and structured to ensure a smooth transition.
Key milestones towards full implementation
- March 2025: The EHDS Regulation enters into force, marking the beginning of the transition period.
- March 2027: Deadline for the Commission to adopt several key implementing acts, providing detailed rules for the regulation operationalisation
Excerpt from the official page. The original is authoritative. Continue reading at European Commission ↗