The Regulation on the European Health Data Space (EHDS) has been published in the Official Journal of the EU. 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 EHDS will provide a comprehensive framework for the access to and use of electronic health data across Member States. It will enhance innovation and competitiveness in the health sector for the benefit of all EU citizens.
The EHDS benefits are:
- empowering citizens, giving them better control over their personal health data and enabling seamless access to their medical records across the EU, whenever and wherever they need healthcare (primary use).
- strengthening the re-use of health data in anonymised or pseudonymised form, for research, innovation, public health, and policymaking, with safeguards fully in line with EU data protection and cybersecurity standards (secondary use).
EHDS is a game changer for healthcare in Europe
The EHDS represents a major leap forward in strengthening the resilience of Europe’s health systems, ensuring they can tackle today’s most pressing challenges such as an aging population and workforce shortages.
The EHDS supports the health sector to provide high-quality, accessible, and sustainable healthcare. By fostering a more interconnected, patient-centred, and data-driven healthcare system, the EHDS will enhance efficiency, reduce administrative burdens, and support the long-term financial sustainability of health services.
Citizens will have the right to access and share their health records, such as e-prescriptions, medical images, or test results securely across borders, ensuring better-informed medical decisions and continuity of care.
At the same time, researchers, public health authorities, and policymakers will be able to leverage health data in a secure and privacy-preserving way to accelerate the development of new treatments, improve disease prevention, and strengthen Europe’s crisis preparedness.
Next steps
The EHDS Regulation will enter into force on 26 March 2025 and will become applicable in different phases according to data types and use cases.
The most significant milestone will happen in four years time, on 26 March 2029, when data exchanges for the first group of priority categories (including patient summaries) under primary use will go live. At the same time, the rules on secondary use will begin to apply to most data categories. Two years later, on 26 March 2031, the EHDS will expand to additional data categories.
Over the next four years, the focus will be on developing and adopting more than twenty Implementing Acts, as well as establishing the EHDS governance bodies, which will be essential for the effective functioning of the system. The Commission will work closely with Member States, healthcare providers, researchers, and industry stakeholders to ensure a smooth and effective implementation.
Source: European Commission | Public Health (https://tinyurl.com/4af9v82a)