Research with Routine Healthcare Data: Germany Aims to Catch Up Quickly

First overviews from a research-related special evaluation of the #smarthealthsystems study by the Bertelsmann Foundation were presented by study leader Dr. Thomas Kostera. According to this, Germany was at the bottom of the league in terms of secondary data use at the time of the study. However, with the legislative adjustments made and pending, as well as the preparatory work of the MII, there are now good conditions to catch up with the leaders.

Israel is one of the few countries where structured data from everyday care are already available nationally for research purposes. In a keynote speech, Esti Shelly, the head of digitization at the Israeli Ministry of Health, reported on the digital transformation of healthcare in Israel. A central success factor is the ability to generate care innovations from the data available on the "Eitan" platform in international standards within an open e-health ecosystem.

With the presentation of the draft Patient Data Protection Act, the discussion on the trusted framework for future use of routine data for medical research in Germany is gaining momentum. Dr. med. Markus Leyck Dieken, managing director of gematik, emphasized the intention to cooperate closely with the Medical Informatics Initiative to maintain a high pace within the digital catch-up race. For this purpose, the gematik CEO presented the further roadmap for an already in 2023 research-compatible electronic patient record:

In a panel discussion moderated by Ärzteblatt editor Rebecca Beerheide, the societal acceptance of research data donation was the focus. Prof. Hans-Ulrich Prokosch (Friedrich-Alexander University Erlangen-Nuremberg) from the National Steering Committee of the MII warned against too restrictive access to medical information contained in the EPR: "The possibility of using anonymized data via the planned research data center for social data is not suitable for all research questions. We urgently need to link this with consent-based research projects that use pseudonymized data, for example, to track the long-term effects of diseases and therapies within the framework of long-term studies." The Medical Informatics Initiative has already established a sustainable, internationally fully compatible research data infrastructure for this purpose, which can serve as a one-stop gateway for validated and complete clinical care data through a national access and patient portal.

For CDU/CSU research politician Stephan Albani MdB, the MII is an important backbone of digitalization in the German healthcare system. The next step is to initiate comparable investments in the breadth of the healthcare landscape. Transparency is crucial for further acceptance. The health policy spokeswoman for the B90/Greens faction, Maria Klein-Schmeink MdB, supported the desire of the MII participants to quickly achieve a nationwide uniform legal practice for obtaining patient consent. However, engaging in a serious societal debate about future research data usage is also important. All stakeholders, but especially patient organizations, must be involved in this.

According to Prokosch, the MII already creates an effective and trustworthy legal framework that can serve as a blueprint: "In the MII, we have shown that our processes and data structures for data integration are suitable. Data usage is solely based on informed consent; data is only aggregated in anonymized or pseudonymized form. Usage requests are strictly reviewed by a 'Use & Access Committee' for compliance with all technical and organizational data protection requirements and must always be approved by an independent ethics committee." The crucial next step is for data protection authorities to reach an agreement on the draft of a nationally uniform consent form submitted by the MII. According to representative surveys, people's willingness to donate data is high. "It must also be possible in Germany for us to ask people in a legally secure manner whether they would like to support medical research with their treatment data," Prokosch concluded.