European Health Data Space (EHDS)

The European Health Data Space (EHDS) is a health-specific data-sharing regulation that establishes clear rules, common standards, and a governance framework to ensure the effective use of electronic health data for both healthcare delivery (‘primary use’) and health research and policy-making (‘secondary use’). The EHDS legislative proposal was adopted by the European Commission in May 2022 as part of the EU’s broader “Strategy for Data” to allow the free flow of electronic health data across the EU. The EHDS, formally published in the Official Journal of the European Union on March 5, 2025, entered into force on March 26, 2025. However, the application of its provisions is scheduled to commence later, starting on March 26, 2027.

The EHDS will be enforced by ​​the digital health authorities and health data access bodies at the national level regarding the access and transmission of electronic health data for primary and secondary use, respectively. Any breaches, violations, or non-compliance with the obligations under the EHDS will be subject to substantial penalties as provided for under the GDPR and other applicable EU data laws.

Natural persons will gain extensive control over their electronic health data, with the rights to access, share, and manage it across the EU countries while also being able to opt out of their data being used for secondary purposes. This standardized approach aims to ensure innovation in the health sector while improving healthcare outcomes for natural persons and establishing the EU as a global leader in digital health governance. For a detailed understanding of EHDS, refer to our white paper.