In order to unleash the full potential of health data, the European Commission is presenting a regulation to set up the European Health Data Space. This proposal
- supports individuals to take control of their own health data
- supports the use of health data for better healthcare delivery, better research, innovation and policy making and
- enables the EU to make full use of the potential offered by a safe and secure exchange, use and reuse of health data
The European Health Data Space is a health specific ecosystem comprised of rules, common standards and practices, infrastructures and a governance framework that aims at
- empowering individuals through increased digital access to and control of their electronic personal health data, at national level and EU-wide, and support to their free movement, as well as fostering a genuine single market for electronic health record systems, relevant medical devices and high risk AI systems (primary use of data)
- providing a consistent, trustworthy and efficient set-up for the use of 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. The European Health Data Space will provide a trustworthy setting for secure access to and processing of a wide range of health data. It builds further on the General Data Protection Regulation (GDPR), proposed Data Governance Act, draft Data Act and Network and Information Systems Directive.
As horizontal frameworks, they provide rules that also apply to the health sector. However, more specific rules are developed in the European Health Data Space Regulation, taken into account the sensitivity of health data.
The proposal for the European Health Data Regulation is accompanied by a Communication from the Commission. It is the result of a process that included an impact assessment and an open public consultation.
- Press release
- Questions and Answers
- 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