Brussels, 15 March 2024
The Commission welcomes the political agreement reached today between the European Parliament and the Council of the EU on the European Health Data Space (EHDS) – one of the central building blocks of a strong European Health Union. The rules proposed by the Commission in May 2022 have two main aims:
- To put citizens at the centre of healthcare, giving them full control over their data to obtain better healthcare across the EU;
- To open up data for research and public health uses.
The agreement reached by the co-legislators establishes clear rules for the use of health data for better healthcare delivery, research, innovation, and policymaking. The new rules will harness the potential offered by the safe and secure exchange, use, and re-use of health data, while ensuring full compliance with the EU’s high data protection standards.
Under the new rules, citizens will have immediate and easy access to their digital health data wherever they are in the EU. Health professionals will be able to access the medical records of a patient when required for treatment in a different Member State, allowing for evidence-based decision making, in full compliance with EU data protection rules. The EHDS also creates a strong legal framework for the re-use of health data for research, innovation, and public health purposes. The data will help develop life-saving treatments and personalised medicines, but also improve crisis preparedness, under strict data security and access conditions, and respecting fundamental rights.
Next steps
The European Parliament and the Council will now formally adopt the new Regulation. It will then become applicable in different stages according to use case and data type.
For More Information
Proposal for a Regulation to set up the European Health Data Space
Quotes
The European Health Data Space is a game changing moment for health in Europe and for the care our citizens receive. It will enable patients to share health data, such as their medical history, test results, or prescriptions with hospitals and medical practitioners within and across Member States, as they wish. At the same time, it will unleash the potential of health data for the development of innovative and lifesaving treatments and devices, as well as for better health policy-making, all with strong data protection and security safeguards. Our Health Union is built on cooperation, and the European Health Data Space will be one of the strongest and most emblematic examples of what we can achieve when we come together.