TMF: Consent-based Data Donation in the Patient Data Protection Act Milestone for German Health Services Research

Sebastian C. Semler, Managing Director of the TMF - Technology and Methods Platform for Networked Medical Research, explains: "Compared to the original draft, today's cabinet decision contains significant improvements: In principle, patients can now provide all record contents directly for research projects. The requirement for informed consent for individual data donation additionally builds trust among patients, which researchers rely on."

The federal government is pushing ahead with the proposed bill and the introduction of research data donation. It aims to implement the originally intended introduction of a research-compatible electronic patient record by January 1, 2023, instead of the initially targeted year 2025. It is gratifying that research associations, as already in the development of the record contents, will now also be involved in specifying the data interface on a statutory basis. This ensures that research data donation can indeed be optimally utilized to identify new causal disease associations, develop tailored treatment strategies, and train AI applications on quality-assured learning data sets.

The TMF also supports the envisaged mandatory introduction of international terminology standards in Germany: "As the current National Release Center of SNOMED CT in Germany, we welcome the statutory introduction of the terminology in general health care. This will also open up new opportunities for data-driven health services research in our country. These days, the importance of structured and institutionally standardized data collection and analysis across institutions is becoming increasingly evident. However, we would like to see a clearer legal framework for the role of the future National Competence Center for Medical Terminologies, especially regarding the close involvement of the research community. The legislative process certainly offers opportunities for improvement in this regard. This also applies to the necessary creation of further transparency and information offerings for patients," explains Semler.

Last Friday, following the Bundestag, the Bundesrat also ensured significant facilitation of cross-site medical research in Germany as part of the legislative process to combat the coronavirus pandemic by introducing a new § 287a into the SGB V. In the future, federal data protection law will apply to cross-state health and healthcare research projects. In addition, a lead supervisory authority will be designated.

The TMF - Technology and Methods Platform for Networked Medical Research (TMF) is Germany's umbrella organization for medical networked research. Launched on May 1, 1999, at the initiative of the Federal Ministry of Education and Research, the TMF has been bringing together researchers from different disciplines to develop concepts, infrastructures, and methods for research. Organized as a non-profit association, the TMF makes these solutions freely and publicly available. In particular, large consortia and flagship projects such as the Medical Informatics Initiative are supported by the TMF both in terms of content and organizationally through sponsorship of accompanying structures. By pooling resources, the TMF makes an important contribution to efficient top medical research in Germany.

In February of this year, the TMF submitted a comprehensive statement on the draft of a Patient Data Protection Act and participated in the association hearing of the Federal Ministry of Health.

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