FDZ Gesundheit: Working group for reliable pseudonymization planned
As much data as possible from the healthcare sector is to be transferred to the Health Research Data Center. A further ordinance is to regulate the details.
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From mid-2025, in addition to the billing data, further data from those with statutory health insurance is to be automatically transmitted to the Health Research Data Center. This was made possible by legislation, in particular the Health Data Utilization Act, which is intended, among other things, to improve the linking of health data and make more data from statutory health insurance funds available for research more quickly. The Federal Ministry of Health has now published an "Ordinance on the more detailed regulation of procedures under the Act on the Improved Use of Health Data". The National Association of Statutory Health Insurance Funds has a special role to play here. Among other things, it merges the data "transmitted by the nursing care and health insurance funds [...] into insurance-related data records".
The implementation regulation, which has also been adapted to the regulations for the European Health Data Space, also stipulates that health insurance funds must continue to regularly transmit data on insured persons to the Health Research Data Center in addition to billing data: "In addition, the new procedure of rolling quarterly data delivery by the health insurance funds is adopted in the draft," the draft states. This is intended to create a unique research data space in Germany.
In addition to data from several hundred medical registers, for example, data from the electronic patient file is also to be collected at the FDZ Gesundheit and made available as secondary data. The draft is closely linked to a planned Research Data Center Health Regulation, which has not yet been published.
Pseudonymization procedure for electronic medication list
A newly established "Pseudonymization Working Group" is to define reliable pseudonymization procedures for documents and data records in patient files; Gematik is responsible for the organization. The Pseudonymization Working Group is to consist of representatives from the German Telematics Society, the National Association of Statutory Health Insurance Funds, the National Association of Statutory Health Insurance Physicians and patient representatives, among others. The working group is to define reliable pseudonymization procedures for documents and data records in patient files, with Gematik responsible for the organization. By 31 January 2025, the Pseudonymization Working Group is to define a reliable pseudonymization procedure for the electronic medication list that will come with the new electronic patient file.
According to the draft, the FDZ Gesundheit examines the research applications and ensures that "no data is provided that is covered by a total objection [...]" and "data of an insured person who has lodged a partial objection [...] is not provided for purposes for which further processing has been objected to".
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Regular review of the state of the art
Before the data from the ePA reaches the FDZ Gesundheit, it is split into two parts according to the BMG. The health insurance number is sent in encrypted form to the trust center at the Robert Koch Institute and is used as a research pseudonym for assignment to other data. The pseudonymized data is sent to the FDZ Gesundheit. "The pseudonymization procedure must be regularly checked for compliance with the state of the art," it says. It remains to be seen whether the current security concept of the FDZ Gesundheit, which is based at the Federal Institute for Drugs and Medical Devices, is sufficient. At the beginning of 2023, a lawsuit against the disclosure of pseudonymized billing data was put on hold, but the proceedings are likely to continue soon.
If new data is available, it must be matched. One goal is to have implemented around 300 research applications by 2026. The draft also states that "fees will be charged for the provision of data in a secure virtual environment of the Research Data Center". However, significant reductions are planned for the Joint Federal Committee and institutes such as the Institute for Quality and Efficiency in Healthcare and the Institute for Quality Assurance and Transparency in Healthcare, the German Medical Association and the German Hospital Federation, among others.
(mack)
