The EHDS - a framework for the ground rules and innovation
The clock is ticking for the implementation of the European Health Data Space. A discussion on the status quo, the role of AI in practice and research - and why doctors need to show foresight during the coming years.
The European Health Data Space (EHDS) came into force in March 2025. Are we on track?
Elena Fomin: A lot has happened. During the course of the past year and early this year, authorities in the Member States, relevant associations, and industry provided extensive feedback in a structured process on the drafts of the implementing acts that specify the requirements of the EHDS. At the same time, first guidelines were developed, containing precise specifications and recommendations on how the EHDS should be implemented. This goes to show: The EHDS is currently being truly implemented. But it also highlights the current challenges. Whereas the deadlines have been set politically, some of the technical and operational details still require finalizing.
A core promise of the EHDS is that patients can access and control their electronic health data EU-wide. How realistic is it that a German patient on holiday in Portugal can share his/her medical findings with a local doctor without problems?
Fomin: This scenario can be achieved. However, it will be the result of a process of consistent standardization and implementation lasting several years. The reason being, we have to distinguish between different levels of "doability". For the very first time, the EHDS creates a standardized European legal framework - that is the legal level. It determines primary categories and defines minimum data sets for exchange in its implementing acts - the content level. And it makes the use of interoperability standards obligatory - the technical level. The EHDS thus provides the basis. But all this still needs to be implemented. Technical standards need to be adopted in the practice and hospital information systems. Mechanisms and processes for controlled access and objection options to the use of data are required. The different levels in the digitization of the health systems in the Member States need to be aligned. Doctors will need to record the corresponding data and information in a structured manner.
Will the EHDS lead to even more bureaucracy in clinics and practices?
Fomin: Initially it will not lead to lessening bureaucracy. Doctors will have to accept changes in their daily routines, for example, new entry masks and workflows. Data will have to be entered in a more structured manner to ensure semantic interoperability. The question of who can view and change which data will come up more often as access to data becomes more transparent and controllable. Initially, this could possibly require more coordination between other service providers as more exchange of data will now be possible. This is where doctors' foresight is required. If we get it right, then the EHDS will reduce the burden in the long run. Once data have been recorded in a structured manner, they are open to multiple use, for example, referrals, doctor's letters or medication regimes. In the not too distant future, AI will significantly accelerate this effect by largely filing routine documentation, summaries of initial findings, or the filling in of forms, in an automated and structured manner. This is what we are working on at CGM.
Another core promise is the use of treatment data for research and policy-making. Are we already seeing more projects based on EU data?
Philipp Thiele: Based on the new regulation, the European Medicines Agency (EMA) has indirectly achieved its goal by establishing Real World Evidence as a complementary pillar to classical clinical research. What is particularly exciting is that the focus has now shifted significantly beyond traditional health services research - such as epidemiology or pharmacovigilance - towards AI research. AI-based approaches, in particular, realize their full potential when they take the context of both patients and treatment providers into account - with a low threshold and broad in scope. In these areas, we can observe a distinctive increase in European research projects.
CGM is committed to a European innovation center as part of the MARE project - a role model?
Thiele: MARE is a decentralized research infrastructure for service providers and the research-based industry at the European level - with real-world data from cross-sectoral sources and applications in healthcare research, healthcare management and artificial intelligence. Interdisciplinary teams in Paris, Berlin and Venice are involved here. In addition, a large research and innovation campus is being created in Venice for partners, universities, startups, and representatives of service providers. Overall, I would like to see significantly more genuine multi-country approaches, particularly in research projects within Europe.
Full implementation of the EHDS is not planned before 2031. Is there not a risk that technological advancements, such as AI, will overtake the regulation?
Fomin: Indeed, in 2031 we will be seeing AI systems of the generation after next, while parts of the EHDS are still in the implementation phase. At the same time, it is precisely this development which makes a European data space so necessary. The reason being, that high-performance, value-creating AI in the healthcare sector requires large volumes of high-quality, and above all legally compliant, usable data. The challenge lies in reconciling the technical possibilities with regulatory frameworks. We need a framework which follows clear, responsible rules AND enables innovation.
What is the EHDS?
The European Health Data Space (EHDS) creates an EU-wide infrastructure and legal framework for the joint use of health data. The EHDS came into force in March 2025. And the clock is ticking. By March 2027, Germany must have revised all relevant regulations to be EHDS-compliant. By 2029, E-prescriptions and patient files must be EHDS-compatible, images and laboratory data also by March 2031.
