TMF Statement on the Draft Health Data Utilization Act - GDNG
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On August 14, the TMF—Technology and Methods Platform for Networked Medical Research—participated in the hearing on the draft of a law for the improved use of health data (Health Data Use Act—GDNG) at the Federal Ministry of Health and presented its statement on the draft.
The GDNG is intended to make health data accessible for research purposes. The law's core is to make it easier to use health data for public welfare purposes. Among other things, a decentralized health data infrastructure with a central data access and coordination point for using health data is being established for this purpose.
Sebastian C. Semler, the TMF’s Managing Director: "We welcome the GDNG draft, which can be a significant step towards better use of health data in medical research to benefit patients in Germany. Better data availability, tighter supervisory procedures, the first steps towards secure data linkage of distributed data sets in the German healthcare system, and, in particular, strengthening service providers' own research are important approaches. Timely preparation for the European Health Data Space also seems sensible."
The TMF supports the planned expansion of a decentralized health data infrastructure, which is already intended to create connectivity to the future health data infrastructure in the European Health Data Space. This will significantly improve the availability of health data in the healthcare system in the future. Strengthening patient health data protection will also increase acceptance of the secondary use of health data. The TMF also welcomes the provisioned linking of data from the research data center and the clinical cancer registries, as well as the introduction of a research pseudonym/identifier. The TMF welcomes the intention to streamline administrative processes and reduce bureaucracy with the envisioned principle of lead responsibility in data protection supervision. Further regulations are necessary for consent-based research to standardize the official supervisory processes.
The TMF welcomes the GDNG establishing a central data access and coordination office to support and advise data users on accessing health data. "When establishing corresponding infrastructures, such as the data access and coordination center envisioned in the law, attention should be paid less to official establishment and more to scientific proximity and service orientation. A scientific concept for this infrastructure is urgently required in advance, in which experience from the medical informatics initiative or the NAKO health study in particular should be incorporated at an early stage," emphasizes Semler.
The statement is based on discussions within the "Health Data Infrastructure Coordination Group," which was organized by the Medical Informatics Initiative (MII) and the Network of University Medicine (NUM). Various initiatives and organizations from medical research and health data infrastructure support it.
The statement is available for download here.
Press Contact
Sophie Haderer
Phone: +49 30 2200 24732
E-mail: presse@tmf-ev.de
Twitter: @tmf_eV
Further Information
About the TMF
The TMF – Technology and Methods Platform for Networked Medical Research e.V. stands for research, networking and digitisation in medicine. It is the umbrella organisation for collaborative medical research in Germany, within which leading researchers exchange knowledge, jointly develop ideas and concepts, and thus shape the future of medical research in the digital age. In 2019, TMF launched the Register Days in cooperation with the German Network for Health Services Research (DNVF).
