The Association of Scientific Medical Societies (AWMF) has assessed the opening of the Research Data Centre on Health (FDZ Gesundheit) at the Federal Institute for Drugs and Medical Devices (BfArM) as a decisive step forward in the use of patient data for medical research. The facility offers a central infrastructure for the secure provision and evaluation of health data and thus significantly supports the development of the European Health Data Space.

In the opinion of the AWMF, it is necessary to consistently digitize the existing data according to recognized interoperability standards such as FHIR. In addition, a step-by-step concept for the integration of data from the electronic patient record (ePA) and medical registers must be developed and an evaluation plan for the practical benefits and effects of the RDC Health must be drawn up. As an example, the AWMF cites the comparison of regional supply situations with the recommendations from quality-assured, digital guidelines. In this way, it can be checked what concrete influence the use of data has on treatment processes and results in care.

The professional societies see substantial scientific advantages in the new data infrastructure, especially for the analysis of the implementation of evidence-based guidelines in the real care situation. At the same time, the AWMF warns against an exaggerated interpretation of the billing data currently available in the FDZ Health, as they cannot provide a complete and undistorted picture of the state of health in the population due to their revenue-oriented collection.

For reliable statements on future health care, an expansion and standardization of data collection is necessary, among other things through the use of current WHO coding systems. Within the framework of the European Health Data Space, the ePA could play a central role, provided that it maps clinical patient data regardless of its billing relevance. The AWMF announced that it would actively support the BfArM both in the further development of the RDZ Health and in the harmonisation of national coding systems.

Editor: X-Press Journalistenbüro GbR

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