Announcement
In future, the Research Data Center (FDZ) at the Federal Institute of Medicines and Medical Devices (BfArM) will cooperate with the central office for data access and coordination of the technology and methodological platform for online medical research (TMF), which is also located there. Electronic health record data may also be included. But there are still many unanswered questions, as the Federal Data Protection Commissioner (BfDI) recently said in an interview with Deutschlandfunk.
Consumer protection organizations are critical of the agreement of the FDZ and TFM with the pharmaceutical authority BfArM. Due to possible conflicts of interest, the TMF should be transformed into an independent institution, they asked. Currently, there are still no criteria on who can use FDZ data outside of research oriented towards the common good. The TMF should review and then approve requests for data usage. Interested parties are not required to accept the procedure, but can oppose it (opt-out). The original plans of the then Federal Minister of Health Jens Spahn stipulated that private research should not have the right to request access to anonymous data.
However, with the private sector accounting for around 90% of pharmaceutical research activity, it was feared that the data collected would go largely unused. Union parties are therefore now emphatically (PDF) for the right to appeal. In future, health insurance companies will also be able to request the use of the data, for example to improve the quality of care.
The research data center (FDZ) and the technology and methodology platform for online medical research (TFM) are located at the Federal Institute for Medicines and Medical Devices (BfArM). The focus of the planned cooperation is the improvement of cancer research. For this purpose, the data from the FDZ and the data from the clinical cancer registry must be individually linked via an event-based search index. The aim is to significantly increase data quality through data fusion: while the pseudonymized billing data of health insurance companies stored in the FDZ shows patient journeys through different areas of care and for different clinical pictures over time , data from clinical cancer registries enable insights into cancer care.
The data stored in the ePA electronic health record should also be made available to research institutions in pseudonymised form. Only in January 2023 were the court proceedings on data retention at the FDZ suspended because the concept of final protection was still missing. The Society for the Rights of Liberty GFF is thus trying to prevent the planned “mass archiving” of health data. It is expected to continue into late 2023, the GFF announced online.
Can the TMF assume the function of gatekeeper?
Kathrin Vogler, spokeswoman for health policy of the left-wing party in the Bundestag, believes that “the whole construction” is worthy of criticism: In terms of data protection, the criticized high risk of re-identification remains because data is not constantly anonymised. It is questionable whether the TMF can perform the “guardian function” in the interests of those affected. For example, individual patient data needs to be protected from abuse, although legal, data protection and ethical concerns related to the Health Data Use Act and the European Health Data Area (EHDS) have not yet been eliminated .
Encouragement from government parties and the Union
Announcement
The planned central access via the BfArM, on the other hand, is unreservedly supported by the health politicians of the traffic light coalition and the Union. “The approach of pooling expertise to be able to handle more access requests and maintain a high level of protection is not wrong,” says Matthias Mieves, deputy spokesperson for health policy of the SPD parliamentary group. Kelber had called for improvements: suitable measures would also be implemented.
Great importance was attached to data security and the prevention of conflicts of interest. The federal data protection authority stressed online that no public statement on the law on the use of health data will be made before the government’s decision. However, a spokesperson stressed that a separate application procedure had been agreed so that the BfArM does not check its own applications. In the current activity report of the Federal Data Protection Commissioner (PDF) there is nothing about it yet.
Green health policymaker Maria Klein-Schmeink sees no problems and points out the advantages: “The diverse data collected in the context of healthcare has great potential for today’s patients and, in the context of research, all the more for patients: within tomorrow.”
Even liberals do not oppose the project: Andrew Ullmann, health policy spokesman of the FDP parliamentary group, is critical of the creation of a new institution, as requested by consumer protection groups: “That would mean one more obstacle and more bureaucracy . ”
The CDU health politician Erwin Rüddel also regards the plan to locate the technology and methodological platform for online medical research (TMF) and the FDZ Gesundheit at the Federal Institute for Medicines and Medical Devices (BfArM) as “unproblematic”. According to him, “consistent requirements for good data handling” are more important than discussing who performs these tasks.”
Leaner structures for data protection are needed
Rüddel therefore pushes for leaner structures in data protection supervision, the responsibilities for which are currently still shared between 18 federal and state data protection authorities: “Why not orient ourselves here on the structure of the ethics commissions or special prosecutors’ offices, which concentrate competencies and can they make decisions that are binding on everyone?”
Indeed, the draft amendment to the Federal Data Protection Act for Transnational Research Projects stipulates that companies and research projects only have to submit to and cooperate with a single data protection supervisory authority. The data protection authority of the company with the highest turnover in the previous year is responsible.
(mac)
