In 2024 there should be not only the electronic prescription, but also the electronic patient file (ePA) for everyone, the opt-out ePA. If you don’t want it, you have to disagree. Federal Health Minister Karl Lauterbach conceded in the Digital Committee that “one could have to pay a lot for any data protection errors” – “legitimate data protection concerns (are) like gold”. Those responsible would therefore work on the necessary safety precautions. He is convinced that there will be a solution that will convince the security experts. The Federal Ministry of Health (BMG) takes the concerns very seriously, but the ePA should also be used.
Many people would underestimate the risk of “sudden serious illness”. With the planned ePA for everyone, they also want to take those who think they are healthier than they actually are. The ePA as a core element of the digitization strategy is intended to improve patient care – they should be “masters of the data” for the first time. He himself could sing a song about missing preliminary findings and double examinations. That will change.
“No sensitive diagnoses”
In the case of particularly sensitive diagnoses such as HIV disease or suicidal tendencies, doctors should in future ask patients whether they really want to save such information in their patient files. Fine-grained authorization management also makes it possible for doctors to sometimes only receive read rights from patients if patients give the appropriate permission. A feared possible disclosure of the ePA data to law enforcement authorities is ruled out. The right of objection to the ePA for insured persons will also be retained in the future – this is also not possible in any other way for reasons of data protection. With the participatory process that started in autumn 2022, the aim is also to work out which data should go into the electronic patient file first and who should fill it in.
Health Data Use Act
According to Lauterbach, the upcoming Health Data Utilization Act should make it possible to merge existing health insurance data, registry data, genome data or data from studies such as Germany’s largest medical cohort study NAKO. According to Lauterbach, thanks to the changes in the law, pharmaceutical companies can “finally” also carry out longitudinal studies in Germany. In order to get the data, the companies have to fill out research applications. The purpose of the research should be the focus of the allocation rights for the data, not who completed the research application.
As already mentioned when presenting the digital strategy, any unauthorized access to health data should be logged. However, the accesses could not be ruled out. So far, research pseudonyms have been discussed, but they have been heavily criticized by data protection officials because the data allow conclusions to be drawn about the patients. Security researchers therefore want to obtain a right to object to the pseudonymised transfer of all billing data to the research data center for those with statutory health insurance. In the future, Lauterbach wants to work out with experts exactly how the data should be protected. Details on how data protection and research can be reconciled were not given.
Conversion of the gematics
According to Lauterbach, the restructuring of Gematik GmbH, which is responsible for the digitization of the healthcare system, was done by mutual agreement. This is the only way to accelerate the digitization of the healthcare system. Although Gematik will be subject to the BMG – which previously owned 51 percent of the shares – the statutory health insurance companies would continue to assume a significant part of the financing. According to Lauterbach, the proportion was 93 percent.
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The statements of the Federal Minister of Health are surprising because, for example Doris Pfeiffer, Chairwoman of the Board of Directors of the National Association of Statutory Health Insurance Funds, had recently expressed a different opinion: “We do not believe that it makes sense to separate central players such as doctors, hospitals, pharmacies and health insurance companies from the sponsorship of this central institution for the further development of the digitization of the health care system within the framework of the nationalization of Gematik rule out”. She also assumes that Gematik, as a state institution, will also be financed by the state.
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