European Health Data Space
The European Health Data Space (EHDS) will be a key pillar of the strong European Health Union. and is the first common EU data space in a specific area to emerge from the European strategy for data.
In spring 2024, the European Parliament and the Council reached a political agreement on the Commission proposal for the EHDS.
The EHDS will:
- empower individuals to take control of their health data and facilitate the exchange of data for the delivery of healthcare across the EU (primary use of data)
- foster a genuine single market for electronic health record systems;
- provide a consistent, trustworthy, and efficient system for reusing health data for research, innovation, policy-making, and regulatory activities (secondary use of data)
Trust is a fundamental enabler for the success of the European Health Data Space. EHDS will provide a trustworthy setting for secure access to and processing a wide range of health data. It builds further on the:
- General Data Protection Regulation (GDPR)
- Data Governance Act
- Data Act
- Network and Information Systems Directive
As horizontal frameworks, they provide rules that apply to the health sector. However, the European Health Data Space will provide specific sectoral rules, considering the sensitivity of health data.
The EHDS will also include opt-out rules for:
- primary use, Member States can offer a complete opt-out from the infrastructures to be built under the EHDS;
- secondary use, the text includes rules on opting out that build a good balance between respecting patients’ wishes and ensuring that the right data is available to the right people for the public interest.
Building the European Health Data Space will require significant development work. The Commission supports these efforts by co-financing several projects.
More info, links, documents, and other details can be found here.
