Like the planned European Health Data Space (EHDS), the initiative represents a paradigm shift for research with health data. Using health data for the benefit of patients can significantly improve healthcare. The prerequisite for this is a clear definition of which health data may be used by whom and how. It is equally important that the underlying data is sufficient, of high quality and structured. This is the basic prerequisite for more precise diagnoses, new individualized examination and treatment methods as well as targeted prevention offers to become a reality. The Health Data Utilization Act aims to achieve this concrete added value for patients, service providers and payers.
In particular, the VDGH sees a great opportunity in the possibility of linking and processing pseudonymized health data via the Health Research Data Centre (FDZ). Earmarked access to pseudonymized health data for the industrial healthcare sector will enable new medical products, medicines, examination and treatment methods, aids and remedies as well as digital health and care applications, including artificial intelligence applications in the healthcare sector. Together with the continuation of the model project for comprehensive diagnostics and therapy identification using genome sequencing, the research location in Germany will be strengthened. With the opt-out procedure for the release of data from the electronic patient file (ePA) and the establishment of an access and coordination office, the course is being set to ensure that sufficient structured data will be available for the permitted purposes of the RDC in the future. Fast and unbureaucratic access to pseudonymized data is crucial in order to remain competitive with other countries in medical research.
The VDGH also sees the planned simplification of data protection supervision as a positive step in the right direction, particularly for transnational health research projects. This further development is an important step towards more innovation in the healthcare sector. In the following, the VDGH comments on individual legal provisions of the GDNG. Corresponding articles and paragraphs are underlined below and specific proposed amendments are highlighted in bold or crossed out accordingly.
