Ministry of Health provides insight into planned register law

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At this year's Registry Days in Berlin, experts discussed the work of medical registries and the planned registry law, which is considered an important building block for a networked health data ecosystem. At the event organized by the Technology and Methods Platform for Networked Medical Research (TMF), Markus Algermissen, Head of Division 31 for Medical and Professional Law at the Federal Ministry of Health (BMG), presented further details on the Registry Act.

Record linkage

In future, it will not only be possible to request register data for research purposes via the Health Research Data Center, but also to link it with data from the electronic patient record, for example. "Important: Data will not be released at the RDC, but researchers will be given access to the data in secure, virtual processing rooms. Depending on the data, data is transmitted to the applicants in anonymized and aggregated or pseudonymized form," writes the BMG in a FAQ.

Record linkage should make it possible to individually link different health data. This is the only way to answer scientific questions; with anonymized data, for example, it is not possible to evaluate longitudinal studies. The National Research Data Infrastructure for Personal Health Data NFDI4Health presented a white paper on improving record linkage and called for a standardized identification number. This should also enable connection to the European Health Data Space.

Funding still unclear

According to Dr. Mélodie Bernaux from the European Commission, the broader use of data associated with the EHDS could also strengthen the financial basis of the registers. One of the main problems is the question of long-term financing of the registries and the extent to which this is provided by the state, health insurance funds or industry, which could lead to dependencies for the latter two to a large extent.

All registers are to be linked via a research identification number, a pseudonymized insured person number. At the end of 2023, the Conference of Independent Federal and State Data Protection Supervisory Authorities (DSK) advised against using standardized numbers such as the health insurance number (KVNR) for the register numbers, which could facilitate profiling, for example.

"We have to be courageous"

The registers should be allowed to collect the KVNR and store it in the trust center, explains Algermissen. "This would then be an introduction to the continuation of a later research code in order to [...] make the data silos linkable. [...] In the meantime, we are all a bit further along in our thinking and also more courageous, so I would say that [the] research code is clearly the goal". The Register Act is intended to be an important building block for this – provided it no longer says "Register Act ante portas", but "habemus draft bill".

The project is based on laws such as the Health Data Utilization Act (GDNG) and the Research Data Act. These are closely linked to the Register Act and, according to the plans, will ensure that the data silos are linked and used, with storage being decentralized.

Registers for better care

Medical registers are used for quality assurance in care, for example for cancer patients. The data can be used for research purposes, whereby a distinction is made between anonymized and pseudonymized data. The latter generally require the consent of the person concerned. There are plans to set up a central office for medical registries (ZMR), which will be responsible for organizing, advising and making decisions for the approximately 400 existing registries, among other things.

"The planned data processing with an objection solution and the facilitation of linking registry data with other data sources will enable registries to be understood as a research platform in the future, with which registry-based intervention studies as well as the performance monitoring and safety of decision-support systems and other medical devices and drugs can be rethought," said TMF Chairman Prof. Dr. Rainer Röhrig.

With the law, the Federal Ministry of Health wants to enable more interoperability, but also improve consent management, taking into account personal rights in the use of data for research and care. To this end, an objection solution is planned, which should be explained transparently. The ZMR should provide information on this and support the registers.

Concerns about even more bureaucracy

Doctors fear that the ZMR will lead to more bureaucracy. According to Prof. Dr. med. Bertil Bouillon, Director of the Clinic for Orthopaedics, Trauma Surgery and Sports Traumatology at the Cologne-Merheim Clinic, there is great concern about a huge, centralized bureaucratic administration. For the trauma registry, which was started with "five enthusiasts" "and is now backed by a highly professional organization with the Academy of Trauma Surgery", it was important to have a close exchange with those who are driving the content of the registry "and those who are responsible for the security of the data and then also have to put together the advisory boards", explains Bouillon. Achieving this under a ZMR is a challenge.

No money for a monster

"We are not planning a monster," Algermissen replied to the fears. "And what is perhaps even better for you to hear is that we have no money for a monster. Then perhaps you will believe me even more". The central office is intended to create transparency and prevent data from being collected twice and, according to the expert opinion, involve the specialist community. "We are of course looking at how we can involve the community as much as possible". The autonomy of the registers is important, "they should [...] not be captured in any way". Organizationally, we need to think about how consent management can be integrated.

Transparency and justification important

According to Christine Mundlos from the Alliance of Chronic Rare Diseases (Axis), it is important to "communicate particularly well" if a declaration of consent for data release is to be made "particularly simple". It must be clear why this is being done and why patients do not need to worry about their data. After all, patients with rare diseases in particular are even more "afraid that I could experience discrimination in some form or other or that my child could experience it", explained Mundlos. In addition, the data collection should also be meaningful and related to the disease being researched.

She would also like to know on what basis genetic data would be processed. According to Mundlos, it is important that it is clear on what basis the genetic data is processed. To this end, the conference of independent data protection supervisory authorities recently decided that "research using the body's own substances, such as blood, hair or saliva, obtained without the knowledge of the person concerned" must remain prohibited.

Algermissen agreed that it was important to inform those affected accordingly when the system switches to opt-out. In addition, informed consent is always required when processing genetic data. He also referred to the Genetic Diagnostics Act, which came into force in 2020 and regulates the conditions under which genetic analyses and genetic data may be used in Germany. As far as genetic data is concerned, the Register Act "does not want to go back behind the previous level of protection".

Opt-in, opt-out or no-opt?

When asked where the Register Act falls between "no-opt", as with the FDZ Gesundheit, "opt-out", as with the ePA, and "opt-in", Algermissen replied that the previous "informed consent" caused many problems and was not applicable to certain registers. With the Register Act, a "simple consent solution" is planned for registers that have undergone a qualification process. This would mean that patients would have to read through and sign less information. In addition, data should be able to be "reused for certain purposes within the framework of a link with other registers and then also used with the linked data upon request". Details on this will soon be provided in the draft law, but it is not yet known exactly when.

The plan is to process data from patient records, clinical studies, information from public health registers, biobanks, genetic data or wellness data for public interest purposes as part of secondary data use. "The data could be used, for example, to find treatments for rare diseases where small data sets and fragmentation are currently preventing progress in treatment," writes the TMF in a press release on the Registry Days.

(mack)