GeDIG: An Important Step Towards Data-Driven Medicine of the Future
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The TMF – Technology, Methods, and Infrastructure for Networked Medical Research (TMF e.V.) welcomes the objectives of the cabinet draft on the Act on Data and Digital Innovation in Healthcare (GeDIG) as an important step towards data-driven medicine of the future. Of particular note are the improved resilience of the telematics infrastructure and the improved availability of data across different systems envisaged by the draft bill.
The German Federal Cabinet today adopted the draft of the Act on Data and Digital Innovation in Healthcare (GeDIG). The aim of the legislation, introduced by the Federal Ministry of Health, is to make greater use of the opportunities offered by digitalisation in healthcare for insured persons and healthcare providers, and to further improve the use of health data for research, innovation and healthcare delivery. The TMF welcomes the further development of the Health Data Utilization Act (GDNG) envisaged in the draft legislation but calls for further improvements during the parliamentary process.
TMF Chair Prof. Dr Rainer Röhrig of RWTH Aachen University Hospital comments: “The GDNG already offers clear advantages over the EHDS Regulation, including consent-free data use by healthcare institutions, thereby minimizing bias; the absence of restrictions to specific technical instruments, such as a standardized secure processing environment; and streamlined procedures that are largely exempt from authorization requirements.”
By contrast, the consent requirements involving data protection supervisory authorities provided for under the GDNG have so far proved impractical in practice. Sebastian C. Semler, Executive Director of the TMF, comments: “Sections 5 and 24 of the GDNG represent a missed opportunity to establish genuinely enabling legal provisions. In particular, we would welcome harmonised rules and faster procedures for research projects involving multiple participating institutions in order to accelerate healthcare services research. If developed further in a consistent manner, the GDNG could provide a highly suitable, research-friendly complement to the European legal framework for the EHDS.”
As a necessary further development of a unified, cross-sectoral research identifier, a comprehensive, end-to-end conceptual framework should be developed with the involvement of data holders and the scientific community.
“The legislation should also apply to data derived from so-called residual samples. Residual samples are data carriers just like medical records. The data contained in the samples should be treated legally in the same way as medical records, enabling research to advance significantly through a minor legal adjustment,” Röhrig adds.
From TMF’s perspective, a provision is still lacking that would waive the requirement for additional regulatory approval for the processing of health insurance data where valid, informed consent has been obtained. Such a clarification would eliminate legal uncertainty, reduce bureaucracy, and accelerate access to data for research.
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About TMF e.V.
TMF – Technology, Methods, and Infrastructure for Networked Medical Research (TMF e.V.) stands for research, collaboration and digitalization in medicine. It is the umbrella organization for collaborative medical research in Germany, bringing together leading researchers to exchange knowledge, jointly develop ideas and concepts, and shape the future of medical research in the digital age.
