The main objectives of the Act are to
- make decentralised health data easier to find and to reduce bureaucratic barriers for data users
- leverage existing structures, especially in genomic medicine and facilitate the exchange of health data
- make the claims data of the statutory health insurance funds available at the Research Data Centre Health to a wider user community
- facilitate the linking of health data
- simplify coordination procedures with data protection authorities while strengthening the protection of health data
- provide comprehensive and representative electronic health records for research
- enable statutory health and long-term care insurers to make better use of their own data to improve care.
Juliane Fluck, spokesperson of NFDI4Health and representative of the NFDI, participated in an expert hearing of the Bundestag Committee for Education, Research and Technology Assessment and submitted a statement on the draft GDNG together with the Coordination Group Health Data Infrastructures. Overall, the regulations for improving access to medical data for research are highly appreciated. Major needs of the NFDI4Health community are covered by the draft as, for instance, the planned expansion of a decentralized health data infrastructure and the intention to improve the findability of health data. In particular, with respect to the latter aspect, NFDI4Health already established the German Central Health Study Hub with a standardized metadata catalog which is well suited for this purpose.
The GDNG draft also addresses the introduction of a research pseudonym/identifier for record linkage which has been urgently requested by NFDI4Health since its start. Although a research identifier is desperately needed in Germany, the plan to only use such an identifier to enable record linkage of health insurance data from the Research Data Centre (FDZ) and cancer registry data is far from sufficient. It would be desirable, instead, that a unique identifier is introduced allowing for record linkage of different health data sources including health data that have been primarily collected for research purposes, such as observational studies.
We therefore strongly recommend a very timely development of a concept for record linkage of health data in Germany where relevant scientific stakeholders, such as NFDI4Health, should be involved in this process. Please consider that NFDI4Health has already worked on a White Paper "Improving record linkage for health research in Germany” with broad participation of various stakeholder groups pointing out the requirements for record linkage in Germany and illustrating the broad spectrum of potential applications for the good of public health. Finally, the goal of legal uniformity in transnational health research projects must urgently be further pursued, which is why Section 5 GDNG (like the predecessor provision of § 287a SGB V) must regulate not only data protection supervision, but also the uniform application of § 27 BDSG.