Introduction of the European Health Data Space

On 5 March 2025, the European Union officially adopted Regulation (EU) 2025/327, which established the European Health Data Space (EHDS). It is the first data space implemented under the broader EU Data Strategy, demonstrating the EU’s commitment to digital transformation in public services. To transform the way electronic health data is accessed and used across Member States, the new framework builds on the lessons of the COVID-19 pandemic and forms a central pillar of the European Health Union.

To enhance innovation and competitiveness within the healthcare sector, the regulation introduces a dual-use model for health data: primary use, which involves direct patient care, and secondary use, which covers scientific research, policymaking, regulatory oversight, and public health planning. To support this, the EHDS provides a common set of standards, governance rules, and interoperable digital infrastructure, including the “MyHealth@EU” platform for cross-border health data exchange.

To promote the application of the EU 2025/327 Regulation, the European Health Data Space Board will be set up, which will be co-chaired by a Member State and the European Commission. The board will include national authorities responsible for health data, as well as observers and stakeholders, such as patient organizations and researchers.

Given the scale and complexity of EHDS, the implementation will occur in phases. A key milestone is set for March 2027, by which point essential categories of electronic health records (such as prescriptions, lab results, and patient summaries) must be accessible across EU borders. By 2029, the EHDS will expand to enable wider secondary uses of health data, including research. To support this rollout, over 20 implementing acts will be adopted to detail technical and governance structures developed in close cooperation between EU institutions, Member States and relevant stakeholders. This step-by-step approach of the EHDS will reshape healthcare, and as a result, is expected to position Europe as a global leader in the responsible and innovative use of health data.