Health Digital Agency Act: dispute over Gematik's dual role

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In future, Gematik, as an agency of the Federal Ministry of Health, is to promote the acceleration of the healthcare system and enable the trouble-free operation of the telematics infrastructure and be able to crack down on this. In the past, Gematik lacked room for maneuver. However, there is considerable criticism of the draft law –, for example regarding Gematik's dual role. The financing of Gematik, or the future "Digital Agency Health", is also controversial; the costs are to be borne by the health insurance companies and therefore the insured.

The law is intended to strengthen Gematik's ability to act by developing it into a digital health agency. At a hearing in the Bundestag, experts were asked how exactly this is to happen and what new tasks and process responsibilities the agency is to take on in future.

Insured parties must finance digital agency

Dr. Doris Pfeiffer from the National Association of Statutory Health Insurance Funds criticized the funding of the Digital Agency for Health. Since the last legislative period, the lion's share of funding for the digitalization of the healthcare system has come from the statutory health insurance funds.

"The National Association of Statutory Health Insurance Funds has to finance Gematik's budget," said Pfeiffer. Nevertheless, the decision-making authority lies with the Federal Ministry of Health. From the point of view of contributors, it is "unacceptable that we have no opportunity to influence the financing of this company or to increase the financial provision here". In her view, the financial responsibility borne by the insured does not match the decision-making responsibility. In addition, certain requirements should also be set centrally.

Criticism of Gematik's dual role

Melanie Wendling from the Federal Association of Health IT (Bvitg) also sees Gematik's diplomacy at risk, as it acts as a certifier on the one hand and can also develop applications itself or award contracts for them on the other. This is an impermissible intervention in the market. This gives Gematik a dual role, which is unacceptable to the Bvitg.

Dr. Verena Benz from Bitkom also criticized Gematik's role and considered the extended powers of the digital agency to be "excessive". The providers themselves have an interest in preventing and eliminating disruptions to the telematics infrastructure, but excessive intervention, even without further notice from Gematik, would hinder rather than promote the elimination of disruptions.

Other parties, such as Gabriele Overwiening, President of the Pharmacists' Association, also criticized the planned dual role of the Digital Agency for Health. Together with the Federal Ministry of Health, it would become a shareholder and legislator, but would also be responsible for supervising the shareholders and thus be able to distribute fines, for example.

GPs demand unlimited ePA access

When asked by Sebastian Mieves, eHealth spokesperson for the SPD, whether doctors should have access to the electronic patient file for longer than 90 days in future, Nicola Buhlinger-Göpfarth from the GP association answered with a clear yes. "Practices already have permanent access to treatment data. "Permanent access would therefore also be logical from a GP's point of view with regard to the management and coordination of a long-term doctor-patient relationship, which currently only exists in the GP sector," explained Buhlinger-Göpfarth. In this way, it would be possible to respond quickly to urgent requests and share information with other parties involved in patient care – such as laboratories, pharmacies or doctors.

ePA registration too complicated

The KIM and TIM services would be helpful for exchanging documents between the various facilities if the technology worked reliably. When asked whether there was still a need for regulation regarding registration for the electronic patient file with the health insurance company, Klaus Rupp, who was invited as an expert by Techniker Krankenkasse, said that it was too complicated. Many insured persons would therefore not complete the registration process.

"If you compare this with the banking sector, you can see that you have other options. And we are now dealing with the health idea and access to ePA, which involves considerably more effort," says Rupp. In his opinion, a balance should therefore be struck between data protection requirements and usability. To achieve this, it must also be possible to reset the PIN for the ID card not only by going to the citizen service. It is already planned that the PIN can also be reset online.

Statutory health insurance companies: Assignment of insurance numbers required

When asked to explain why it is not yet mandatory for privately insured persons to be allocated a health insurance number (KVNR), Anke Schlieker from the PKV association explained that KVNRs have to be generated in a complex process. The health insurance number is the prerequisite for applications such as digital identity and therefore also for electronic patient files, e-prescriptions and other applications. "You also need this number for other purposes, such as for all the implant registers, cancer registers and so on. [...]. This number has to be generated in a complex, individual process. And we need the active participation of the insured persons. They have to submit an application, especially so that the data protection consents for the use of personal data are available. The companies are very active in this regard."

In addition, there are only a few who respond. "For two years [...] mailings have been sent out [...] and to date only ten percent of those insured with private health insurance have been provided with a KVNR". This is a "very time-consuming, very bureaucratic and very expensive process". In addition, not all policyholders can be reached. Especially "the groups that really need it, i.e. the vulnerable groups, the chronically ill, the elderly, those in need of care. We generally don't reach the foreign-language policyholders."

The PKV association has therefore been calling for "a legal regulation for years so that the PKV companies can create the KVNR for every insured person without consent and on a mandatory basis". Then the number would be available when it is really needed in the event of treatment, and then the opt-out EPA and the e-prescription would also become established in private health insurance," says Schlieker. There have always been discussions with the BMG, but concrete implementation proposals have not yet been taken up.

(mack)