Advancing Healthcare Through The European Health Data Space
Key Developments & Implications of the European Health Data Space
What is the European Health Data Space?
The European Health Data Space (EHDS) is a health-specific ecosystem designed to manage the growing volume of health data across Europe. It includes a set of rules, common standards, digital infrastructures, and a robust governance framework. The EHDS has two fundamental objectives:
Primary Use – Empowering individuals by granting them greater digital access to and control over their personal health data at both national and EU-wide levels.
Secondary Use – Facilitating the secure and trustworthy reuse of health data for purposes such as scientific research, innovation, policy-making, and regulatory activities.
As part of the European Health Union, the EHDS aims to create a unified digital infrastructure for health data across EU member states, ensuring improved access to electronic health records (EHR), medical devices, and artificial intelligence (AI) systems. The regulation also builds upon existing frameworks such as the General Data Protection Regulation (GDPR) and the Data Governance Act, ensuring compliance and data protection.
The Legislative Journey of the EHDS
The journey to establishing the EHDS has been marked by significant legislative milestones. The European Commission proposed the EHDS regulation on May 3, 2022. By December 2023, the Council of the European Union reached a consensus on the regulation’s mandate. In March 2024, the European Parliament and the Council achieved a provisional agreement, and on April 24, 2024, the regulation was approved. The formal adoption by the Council occurred on January 21, 2025, and the regulation is expected to enter into force on March 26, 2025.
However, the implementation of the EHDS will be gradual. Key milestones include the European Commission adopting detailed implementing acts by March 2027, with full operationalization of key aspects, such as patient summaries and ePrescriptions, expected by March 2029.
Read more about EHDS here: https://resource.ddregpharma.com/blogs/key-developments-implications-of-the-european-health-data-space/
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DDReg Pharma
With the right blend of experience, relationships, skill, innovation, and in-depth expertise in pharmaceutical regulatory affairs consulting, we bring top-quality global regulatory consulting to our clients.
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