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)
By doing so, the EHDS will enable the EU to fully benefit from the potential offered by a safe and secure exchange, use and reuse of health data to benefit patients, researchers, innovators, and regulators.
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 projects such as:
- the HealthData@EU pilot project;
- the Xt-EHR Joint Action, providing direct grants to Member States;
- building on existing infrastructures.
The proposal for the EHDS was accompanied by a Communication from the Commission. It resulted from a process that included an impact assessment and an open public consultation.
More information
- Press release
- Questions and Answers
- Factsheet
- Proposal for a regulation - The European Health Data Space
- Communication from the Commission
- Impact Assessment
- Study supporting the impact assessment of policy options for an EU initiative on a European health data space
- Public Consultation
- Assessment of the EU Member States’ rules on health data in the light of GDPR
- Study on health data, digital health and artificial intelligence in healthcare
- Study on an infrastructure and data ecosystem supporting the impact assessment of the European Health Data Space
- Smart Health Videos
