The European Commission published the full Regulation and the FAQ for the EU Health Data Space.
As a reminder, 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 harmonized 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.
You can find the Regulation in all languages HERE
You can find the FAQ HERE
