European Health Data Space (EHDS)

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 harmonised 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 healthcare delivery (primary use of data), enable the secure and trustworthy reuse of health data for research, innovation, policy-making, and regulatory activities (secondary use of data), and foster a single market for electronic health record (EHR) systems. On 5th March 2025, the European Health Data Space Regulation was officially published in the Official Journal of the European Union and enters into force on 26 March 2025. Key milestones: March 2027 for implementing acts, March 2029 for first group of priority categories (Patient Summaries, ePrescriptions/eDispensations), and March 2031 for the second group (medical images, lab results, hospital discharge reports). This regulation will significantly impact AI health applications by creating standardised health data formats and interoperability requirements across all EU member states.