The European Health Data Space (EHDS) has been published in the Official Journal of the EU. This is the final step prior to the regulation coming into effect. This will happen on March 26. The EHDS is another milestone in building a secure and efficient digital health ecosystem as part of the European data strategy.
The EHDS was adopted by the European Parliament last year. It is the first of the European sector- and domain-specific data spaces that the Commission wants to realize in its European data strategy. The EHDS is intended to provide a comprehensive framework for accessing and using digitally available health data in all member states. It should improve innovation and competitiveness in the healthcare sector for the benefit of all EU citizens.
Various phases
The EHDS regulation will apply in several phases after its entry into force, depending on the data types and use cases. The main milestone will take place in four years, on March 26, 2029, when data exchanges for the first group of priority categories (including patient summaries) under primary use will go live. At the same time, secondary use rules will become applicable to most data categories. Two years later, on March 26, 2031, the EHDS will be extended to additional data categories.
Over the next four years, the focus is on developing and adopting more than 20 implementing acts, as well as setting up the EHDS governing bodies, which are essential to the effective functioning of the system. It will work closely with member states, healthcare providers, researchers and industry stakeholders to ensure smooth and effective implementation.
Key benefits
The benefits of the EHDS highlighted by the European Commission are:
- Giving citizens more power and control over their personal health data and seamless access to their medical records across the EU, whenever and wherever they need healthcare (primary use)
- Strengthening re-use of health data in anonymized or pseudonymized form, for research, innovation, public health and policy-making, with safeguards fully aligned with EU data protection and cybersecurity standards (secondary use).
A third goal of the EHDS is a uniform legal framework for the development, marketing and use of electronic health records (EHRs). Currently, the level of digitization in healthcare varies quite a bit between EU member states. This makes it difficult to share health data across borders. EHRs and other patient records must meet the same requirements everywhere so that healthcare providers can better share health data about and for patients they treat.
Step forward
According to the EC, the EHDS represents a major step forward in strengthening the resilience of Europe's healthcare systems, ensuring that they can address the most pressing healthcare challenges, such as an aging population and staff shortages.
In this context, the EHDS supports the health sector in delivering high-quality, accessible and sustainable health care. By promoting more interconnected, patient-centered and data-driven health care, the EHDS will improve efficiency, reduce administrative burdens and support the long-term financial sustainability of health services.
Citizens will have the right to access and share their medical records, such as e-prescriptions, medical images or test results, securely across borders, ensuring more informed medical decisions and continuity of care.
At the same time, researchers, public health authorities and policymakers can use health data in a secure and privacy-protecting way to accelerate the development of new treatments, improve disease prevention and strengthen Europe's crisis preparedness.
Read more about the EHDS roadmap in this news release.
