Research with data from e-patient records: "Easily a decade away"

The European Health Data Space (EHDS) is the first of several European data spaces. While in 2020 there was talk of nine data spaces as part of the European data strategy, the total is set to be 14 – new ones include the "Green Deal Data Space", the "Energy Data Space", and the "Skills Data Space". They are intended to, among other things, train European AI models and improve healthcare. However, while expectations are high, experts point to a decades-long implementation process and considerable hurdles. Data protectionists are alarmed.

Prof. Martin Gersch, holder of a chair at Freie Universität (FU) Berlin, described the EHDS as a long-overdue step: "10 to 15 years too late, but at least we have recognized that we have slept through something." The USA and China have already shown how valuable data is. However, the market has led to this value being privatized and monopolized "in the hands of individual players." Examples include ChatGPT and DeepSeek.

For Gersch, European regulation is a rare case where politics becomes an innovation driver. The EHDS will be "a real door-opener [...] especially for the entrenched German structures," said Gersch. He referred to examples where data is already being used to advance research, such as the "Caring S" project. Data from various sources, such as robotics, smartphones, and care documentation, can be made available.

Objection to the Protection of Intellectual Property

Support also came from the industry. Maro Bader, head of Digital Transformation and Political Affairs in Healthcare at the pharmaceutical company Roche, spoke of a novelty, as the industry is obliged to become part of a networked and publicly regulated health data infrastructure. He also welcomed the fact that the EHDS gives companies the opportunity to "grant objection rights in case of a risk to intellectual property." The national data access point can then deny the applicant access to this data.

According to Dr. Verena Benz, Head of Pharma Digital at Bitkom, the urgency has not yet reached all companies: "Some think, 'oh, it will be a while before this affects me.' And others think it's not yet time to participate." Sebastian C. Semmler, managing director of TMF e. V., also dampened expectations of a quick implementation. While the EHDS offers a great opportunity, the actual work lies with the federal states. Many questions remain open.

"Everywhere where it gets complicated in the European Health Data Space," said Semmler, attempts are made to shift responsibility. While he described the electronic patient record (ePA) as a milestone, the use of data from the electronic patient record (ePA) for research is still a long way off. For example, it is unclear how data from different sectors can be combined over longer periods. "We are easily a decade away from that." There is keen interest in the Medical Register Act, "to actually create the prerequisites for us in Germany to be able to link the data that we certainly have, and to use it ourselves within this legal framework."

This was also confirmed by a speaker from the Federal Ministry of Health, Dr. Nilofar Badra-Azar. "This is a very tough timeline that we have to adhere to," she said, referring to the deadline of 2029. According to Badra-Azar, most data categories, such as prescription data, must be connected to the EHDS by then. However, the plan is to build on existing structures: "So we will not reinvent the wheel, but we will reuse and further develop what we have built here in Germany."

(mack)