Health Data Act: Consumer advocates find new projects “highly risky”
On the occasion of the first hearing on the Health Data Utilization Act (GDNG), the Federal Association of Consumer Centers (vzbv) also published a statement calling for improvements to the GNDG. From the point of view of the vzbv, the data in the current draft bill for consumers is “not adequately protected”.
Although there are many advantages for the insured when using the data, consumers still have to be able to rely on confidential and responsible handling of the particularly sensitive data, says Thomas Moormann, Head of the Health and Care Team at vzbv. With the current draft of the GNDG, “all imaginable actors for almost any purpose” could process data. However, access to health data must be reserved exclusively “for purposes of use oriented towards the common good”.
The National Association of Statutory Health Insurance Physicians (KBV) sees it similarly: “Everything should be avoided that could jeopardize the special relationship of trust in the doctor-patient relationship,” says Sibylle Steiner, KBV board member. She firmly rejects the idea that health insurance companies evaluate patient data and use them to care for the insured. That is the job of the medical profession. The Association of Substitute Funds (vdek) sees things differently. CEO Ulrike Elsner is in favor of health insurance companies having more powers to inform insured persons about preventive care offers.
New regulation for health insurance companies “highly risky”
The vzbv criticizes the corresponding new regulations for the health and nursing care insurance funds and describes them as “highly risky”. These may evaluate data on the individual health protection of the insured. The network data protection expertise had previously criticized this in its report on the GNDG. Accordingly, it is planned that the health insurance companies may also “address individually” their insured persons for the early detection of diseases “data-supported evaluations for the individual health protection of their insured persons” and to improve care – contradiction is possible.
The Federal Joint Committee (G-BA), the highest body of medical self-government, also criticizes (PDF) the planned innovation. In his opinion, the information provided by the health insurance companies, for example about the risk of cancer, could lead to unnecessary uncertainty. The German Medical Association takes a similar view. “However, data originating from the billing context (…) does not reflect the morbidity of the insured person in such a way that valid statements on the early detection of rare diseases or cancer risks (…)” are possible. According to the statement, other associations such as the joint general association are also of the opinion that the “data sovereignty of patients and their informational self-determination should be the top priority and starting point for all decisions”.
Health insurance companies could discriminate
According to Moormann, “extended data access” conflicts with the role of health insurance companies. With the GDNG draft, they would have better opportunities “to filter out particularly costly patients from the data sets in order to persuade them to switch health insurance companies. It is also questionable whether the health insurance companies can reliably assess the individual health risks of their insured persons. Therefore, the vzbv calls for the individual address requires the express consent of the insured person (opt-in).
Simple objection options required
For the transmission of data from the electronic patient file (ePA) to the research data center (FDZ), the vzbv requires simple objection options. This must be “possible in text form in a simple and barrier-free manner”. Likewise, risks in data transmission should not be concealed. A transmission of the data from the electronic patient file to the research data center (FDZ) should therefore not take place before clarification has been given and not before a reasonable objection period has expired.
The Federal Association of Health IT (bvitg) fears technical challenges in the “implementation of a reliable and automated pseudonymisable data transmission”, since the electronic patient file is currently mainly filled with documents. In its statement, the bvitg therefore recommends taking a look at structured data in the technical implementation. This is also in the spirit of the Association of Substitute Funds.
In the opinion of the vzbv, the data at the FDZ should also be stored in encrypted form, which is currently not the case. It is also “not ideal that both the central data access and coordination office and the FDZ are located at the Federal Institute for Drugs and Medical Devices (BfArM). According to the vzbv, the data should only be made available anonymously, in pseudonymised form, due to the risk of re-identification but only in exceptional cases.
Conflicts of interest possible with access to data
The technology and method platform for networked medical research (TMF) supports “the planned expansion of a decentralized health data infrastructure with a central data usage and coordination office” and the associated simpler availability of health data. According to the vzbv, however, this could lead to conflicts of interest. The data access and coordination office located at the BfArM should be “transformed into an independent institution as soon as possible”.
The TMF sees an opportunity to streamline administrative data protection processes in a planned linking of data from the research data center and the clinical cancer register. The Federal Data Protection Act is also to be amended for this purpose. According to this, companies and research institutions should only be subject to a single data protection supervisory authority in the future.
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