DMEA 2026: Health Ministry Pushes for More Data Use

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One year after the regulation on the European Health Data Space (EHDS), one of more than ten planned data spaces, came into force, the German government sees progress in the establishment of a European health data space – but also considerable need for action. According to DMEA moderator Barbara Bruzek (CompuGroup Medical), this puts them in a new phase.

Germany is strongly oriented towards European pioneers in its development. “The Nordic countries are the ones who have over 30 years of experience in data use – especially in secondary data use – have built up very good registers, very good systems,” said Nick Schneider, head of the “Fundamental Issues New Technologies and Data Use” division at the Federal Ministry of Health. The EHDS was largely modeled after Finland.

From the perspective of the Federal Institute for Drugs and Medical Devices (BfArM), the development has already begun. “The launch was successful. Nothing is perfect, but we are working on it,” said Karl Broich, President of the BfArM. At the same time, Broich pointed to the growing data base, which is expected to grow further thanks to medical registers and many other sources. “The FDZ now has the prescription data of 75 million statutory health insurance patients.”

More depth with ePA data

With data from electronic patient records, further data is to flow to the FDZ Health this year. Then “the depth that our Scandinavian colleagues have” will be added. The breadth already exists, as the pseudonymized billing data of all statutory insured persons are already regularly transmitted to the FDZ without the possibility of objection. The Society for Freedom Rights is currently suing against this. “We are starting with the medication list in the fall.” Addressing researchers, he said: “Come to us, submit your applications.”

Data protection: More is possible than is used

New EU guidelines – for example on broad consent – could expand the scope. Theresa Ahrens from Fraunhofer IESE said: “What has now been specified was actually always possible. But I think people perhaps just didn't dare to do it.” Bruzek had previously addressed precisely such “openings” that are necessary to bring the European approach to life. “We also need to create data access,” said Schneider. “Every entity that holds health data in electronic form is a data holder within the meaning of the EHDS,” and must therefore provide data.

The dynamics in AI research are high, but the transfer is stalling. “Several new AI papers are coming out every day, showing what hot shit this technology can do in pattern recognition for prevention, disease prediction, years in advance,” said Ahrens. Research is important, “but this research must then, of course, be transferred to the market with quality assurance.” In addition, there are structural deficits: “And especially for me as a woman on the panel, it is important to emphasize that women are often disadvantaged by AI products, but that this is often not tested in the approval process.”

Schneider emphasized the importance of real care data as a major advantage in Germany. This must lead to a rethink: “I believe in this change of mind from, we create evidence in 20-40 year old healthy, non-smoking men, to, we create products that are safe for the general population and that can perhaps also be applied as specifically as possible to a concrete user group.”

Medical Register Data and Genome Data

With the Medical Register Law, “a central office for medical registers will be established.” Clinical data are also to be made more accessible: “We have the Network University Medicine, which is now being spun off as a GmbH. This could be a service provider, as you said, to access the much deeper data, the clinical data in university hospitals, and make it available.” Another focus is on genome data, where he referred to the Genom.de project, among others.

To accelerate innovation, new formats are needed: “We need these, I'll call them frankly, trial spaces, to really speed up the transfer alongside research.” The interaction of laws is particularly important here. “In the health sector, we are at the interface of the General Data Protection Regulation, the Digital Markets Act, the EHDS Regulation, MDR (Ed.: Medical Device Regulation).” All of this must be taken into account.

From an industry perspective, speed is also required. “It is important that we not only talk about misuse, but also about what happens if we don't,” said Jens Dommel (EMEA Healthcare at AWS). The non-use of data also has consequences for care and research. In his view, the data should only be pseudonymized.

Data Protection Supervision “Proactive” but Fragmented

A focus of the discussion was also on the role of data protection supervision. “A few weeks ago, for the first time, we had a joint meeting with the BMG and the Data Protection Conference, i.e., with all data protection supervisory authorities at the state level. It is extremely important that we look at how we can bring together the existing structures. A central data protection authority would be extremely good in an ideal world in Germany, could facilitate many things, but could also hinder many things.”

Schneider also referred to the Federal Commissioner for Data Protection and Freedom of Information (BfDI). “We currently have an extremely proactive, data-use-friendly federal data protection authority.” At the same time, there are differences at the state level: “We see that we have state supervisory authorities that are very proactive, that also enable a lot of health data use, more than others.” These forces must be promoted and it must be examined whether regulation can ensure as little fragmentation as possible and thus faster processes. According to Schneider, however, there are very similar criticisms in France, which has a central data protection authority, as in Germany.

Data Protection Authorities Advocate for Data Subject Rights

His criticism of current coordination processes also became clear. However, this is his personal opinion, not the political one: “Then I have one contact person at one place, be it the federal authority or the state authority, with whom I negotiate it, who advises me.”

Schneider cited the ethics committees as a model for good centralization: “That means, one project at many locations, one ethics vote, the ethics vote is sufficient.” So far, the state data protection authorities have often been hesitant, as a supervisory authority is very reactive. Schneider advocated for more cooperation. Data protection is not a rigid system. “Data protection law is not binary, it is not 0 or 1, but it is a balancing of interests.”

Real-world Laboratories as Experimental Fields

A concrete approach is new regulatory experimental spaces. Schneider also referred to the Regulab of the BfDI, which aims to help statutory health insurance companies with legally compliant data use and the use of AI. Such formats are intended to enable innovation under controlled conditions. This should enable the legislator to make legal adjustments. According to Schneider, with the EHDS and the Health Data Use Act, “the script is written.” From Ahrens' perspective, data interoperability is particularly important for many things, “but on a technical, semantic, syntactic level, so that we can quickly get to the beautiful data we need for research,” said Ahrens.

(mack)