European Union: Adopted Council general approach on European Health Data Space (EHDS) including rules for portability and sharing of health data

On 6 December 2023, the Council of the European Union (EU) adopted its general approach on the European Health Data Space (EHDS), including rules for portability and sharing of health data. The EHDS aims to facilitate the exchange and access to health data at the EU level, improve individuals' access to their electronic health data and enable the re-use of data for research and innovation. Furthermore, the proposed regulation aims to create a health-specific data environment that favours a single market for digital health services and products. In addition, the EHDS aims to standardise cross-border access to health data to facilitate the collection of prescriptions and access to patient information across Member States. Under the Council approach, the rules regarding access to electronic health data and the applicability of the General Data Protection Regulation (GDPR) are clarified, and the option of opting out of the system is established. The next steps include negotiations with the European Parliament to reach a provisional agreement on the proposed Act creating the European Health Data Space (EHDS).