Abstract
The European Health Data Space (EHDS) is one of the European Union’s most ambitious initiatives to improve the access, exchange, and reuse of electronic health data across Member States. By addressing longstanding challenges such as fragmented healthcare systems, limited interoperability, and barriers to data sharing, the EHDS seeks to enhance healthcare delivery while enabling the responsible use of health data for research, innovation, public health, and evidence-based policymaking. This article provides an accessible overview of the EHDS by examining its objectives, the key actors involved in its implementation, the journey of electronic health data through its primary and secondary uses, and the governance arrangements, safeguards, and operational mechanisms that support its functioning. Rather than focusing solely on the legal provisions of the Regulation, the article adopts an operational perspective to explain how the EHDS works in practice and how its various components interact to create a trusted and interoperable European health data ecosystem. By presenting the EHDS as an interconnected ecosystem, the article aims to provide readers with a clear understanding of one of the European Union’s most significant digital health initiatives and how it is intended to transform the use of health data across the Union.
Key Takeaways
- The European Health Data Space (EHDS) creates a common framework for sharing and reusing electronic health data across the European Union.
- It enables individuals to access and control their electronic health data while supporting healthcare professionals in delivering safe and continuous care, including across national borders.
- The EHDS also allows health data to be reused for research, innovation, public health, and policymaking under strict legal and governance safeguards.
- A network of actors, digital infrastructures, and governance bodies work together to ensure that health data is exchanged securely, responsibly, and transparently.
- Understanding how these components interact is essential to understanding how the EHDS is intended to improve healthcare and strengthen Europe’s digital health ecosystem.
Acknowledgments:
The author would like to thank Theodoros Karathanasis and Shadée Pinto, Research Fellows at the Chair Responsible AI (Legal), Ine van Zeeland, Postdoctoral Researcher at imec-SMIT, Vrije Universiteit Brussel, Anastasiya Kiseleva, Researcher at CY Cergy Paris Université, and Laura Centeno Casado, Doctoral Researcher at CSIC, for their careful reading of the manuscript and their valuable comments. Any remaining errors are the author’s own.
To cite this article: To cite this article: P. Raj, Understanding the European Health Data Space: Actors, Data Flows and Governance Mechanisms, AI Regulation Papers, 26-07-01, AI-Regulation.com, July 7, 2026.
These statements are attributable only to the author, and their publication here does not necessarily reflect the view of the other members of the AI-Regulation Chair or any partner organizations
This work has been partially supported by MIAI @ Grenoble Alpes, (ANR-19-P3IA-0003) and by the Interdisciplinary Project on Privacy (IPoP) of the Cybersecurity PEPR (ANR 22-PECY-0002 IPOP).
