NFDI4Health and EHDS

NFDI4Health and the European Health Data Space

The European Health Data Space (EHDS) is an initiative in Europe aimed at facilitating access to health data across national borders and enabling their exchange. In the long term, this is intended to promote health research, improve medical care, and strengthen patients' rights. The timeline is ambitious: the EHDS will launch on 1st January 2025 and is set to be implemented within four years.

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How is the EHDS implemented in Germany?

According to the legislation, the EHDS is intended to promote the linking and collaboration of various systems while complying with standard data protection regulations. An important step is the development of a metadata catalogue that will enable the cross-border use and exchange of health data. The Federal Institute for Drugs and Medical Devices (BfArM) is setting up the central infrastructure, known as the "German Node," coordinating "Health Data Access Body" (HDAB), which will serve as the point of contact for data access. In addition, decentralised nodes, the so-called "Decentralised Health Data Access Bodies" (dHDABs), will be established. These are primarily organisations that already possess existing infrastructures and extensive expertise, and they will manage and regulate the processes. They are also expected to provide a so-called SPE ("Secure Processing Environment") to enable secure analysis of sensitive data. Within the framework of the Coordination Group for Health Research Data Infrastructure (GFDI), which was initiated by the Medical Informatics Initiative (MII) and the Network of University Medicine (NUM), and in which NFDI4Health, the Federal Ministry of Health (BMG), the Federal Institute for Drugs and Medical Devices (BfArM), the Federal Ministry of Education and Research (BMBF) and Genom.DE are involved, the roles and responsibilities for the national implementation of the EHDS are currently being discussed.

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The Federal Institute for Drugs and Medical Devices (BfArM) plays the leading role in the establishment of the German Node / coordinating HDAB. As part of the EU4Health programme "Health Data Platform (HDP) for Germany" and other EU projects, it coordinates the development of this infrastructure. In doing so, the BfArM ensures that quality standards are met, the interoperability of systems is promoted, and research is supported through collaboration with national and international partners.

Latest news on NFDI4Health and EHDS

NFDI4Health beim Workshop zum Europäischen Gesundheitsdatenraum

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NFDI4Health at the Health-RI Conference in Utrecht

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