Regulation on the European Health Data Space published!
The Regulation is an important milestone in the EU’s efforts to build a secure and efficient digital health ecosystem as part of the European data strategy.
The European Health Data Space (EHDS) Regulation has been published in the Official Journal of the EU, marking a significant step toward creating a secure and efficient digital health ecosystem within the European data strategy.
The EHDS will establish a framework for accessing and using electronic health data across EU Member States, promoting innovation and competitiveness in healthcare. Key benefits include:
- Empowering Citizens: Offering better control over personal health data and easy access to medical records across the EU (primary use).
- Strengthening Data Re-use: Allowing anonymized or pseudonymized health data to be used for research, innovation, public health, and policymaking, while ensuring compliance with EU data protection and cybersecurity standards (secondary use).
The EHDS aims to enhance the resilience of Europe's healthcare systems to address challenges like an aging population and workforce shortages. It will support high-quality, accessible, and sustainable healthcare, reduce administrative burdens, and help ensure long-term financial sustainability.
Citizens will have the right to securely access and share health records, like e-prescriptions and test results, across borders. This will improve medical decisions and continuity of care. Researchers, public health authorities, and policymakers will also be able to use health data securely for new treatments, disease prevention, and better crisis preparedness.
The EHDS Regulation will take effect on 26 March 2025, with implementation occurring in phases based on data types and use cases. By 26 March 2029, data exchanges for priority categories will begin, and rules for secondary use will apply to most data categories. By 26 March 2031, the EHDS will expand to more data categories. Over the next four years, focus will be on creating implementing acts and establishing governance bodies for smooth implementation, with collaboration from Member States, healthcare providers, and industry stakeholders.