From mid-2025, in addition to billing data, other data on people with statutory health insurance will be automatically transmitted to the Health Research Data Centre. This was made possible by laws, notably the Health Data Use Act, which aimed, among other things, to better link health data and make more data from statutory health insurance companies more quickly available for research. The Federal Health Ministry has now published an “Ordinance for more detailed regulation of procedures under the Act for better use of health data”. The central association of statutory health insurance companies has a special role. Among other things, it compiles data transmitted by nursing and health insurance companies (…) into insurance-related data sets.
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The implementing regulation, which has also been adapted to the rules of the European Health Data Space, also regulates that health insurance companies must continue to regularly transmit data from insured persons to a health research data center in addition to billing data: “Furthermore, the new process of rolling out quarterly data distribution by health insurance companies has been adopted in the draft,” the draft said. Its aim is to create a unique research data room in Germany.
For example, in addition to data from several hundred medical registers, data from the electronic patient file in FDZ Health must also be collected and made available as secondary data. draft Planned research closely related to data center health regulation has not yet been published.
Pseudonymization process for electronic drug lists
A newly established “Pseudonymization Working Group” aims to define reliable pseudonymization processes for documents and data sets in patient files, which is the responsibility of the organization; The working group on pseudonymisation should include, among others, representatives of the Society for Telematics, the umbrella body of statutory health insurance companies, the National Association of Statutory Health Insurance Practitioners and patient representatives. The working group should define reliable pseudonymization procedures for documents and data sets in patient files; The organization is the responsibility of Zematic; By January 31, 2025, the Pseudonymization Working Group must define a reliable pseudonymization process for the electronic medication list that accompanies the new electronic patient file.
According to the draft, the FDZ examines health research applications and ensures that “no data has been provided that constitute a total objection (…)” and “data of an insured person who has filed a partial objection (. ..) is not available for the purposes for which further processing was objected to.
Regular checking of state of the art
According to BMG, before the data from the EPA reaches the FDZ Gesundheit, it is split into two parts. The health insurance number is sent in encrypted form to the Trust Office of the Robert Koch Institute and is used as a research pseudonym to specify other data. Pseudonymized data goes to FDZ Health. “The pseudonymization process should be regularly checked to ensure a state-of-the-art level of compliance,” it says. It remains to be seen whether the current safety concept of the FDZ Gesundheit, which is based on the Federal Institute for Drugs and Medical Devices based, enough. In early 2023, the lawsuit against the transfer of pseudonymous billing data was halted, but the process is expected to continue soon.
If there is new data then it must be matched. One goal is to implement approximately 300 research proposals by 2026. The draft also states that fees will be charged “for the provision of data in a secure virtual environment of a research data centre”. However, significant cuts are planned for institutions such as, among others, the Federal Joint Committee on Quality and Efficiency in Health Care and the Institute for Quality Assurance and Transparency in Health Care, the Federal Medical Association and the German Hospital Association.
(Mac)
