Hospital.Help

Berlin – The Health Committee of the Bundestag today dealt with the Health Digital Agency Act (GDAG). Approval and criticism moved along the well-known positions – for example, the German Medical Association (BÄK) and the National Association of Statutory Health Insurance Funds criticized the proposed majority shareholding of the Federal Ministry of Health (BMG) in the future digital agency for health. IT industry representatives particularly rejected the planned expansion of the digital agency’s sovereign rights.

As the current chairwoman of the committee, Kirsten Kappert-Gonther (Greens), emphasized, despite the current political situation, there are “important projects” to discuss. The Bundestag will discuss how to deal with the knowledge gained.

A central agency with extensive rights is fundamentally to be welcomed, said Doris Pfeiffer, Chairwoman of the National Association of Statutory Health Insurance Funds. At the same time, she criticized it as “absurd” that the responsibility for financing the digital agency should lie with the statutory health insurance (GKV), while the decision-making authority should lie with the federal government or the BMG.

The BÄK made a similar statement in its statement. The proposed decision-making structure “doesn’t adequately reflect a development and implementation strategy that is broadly supported by all those affected.” Such a model does not promote the responsible introduction of further technical content.

In addition, the BÄK misses in the draft law “a clear commitment and its legal anchoring of mandatory testing and evaluation of applications before the nationwide rollout”. We expressly welcome further rights for the digital agency, combined with the possibility of enforcing them.

Sibylle Steiner, board member of the National Association of Statutory Health Insurance Physicians (KBV), supported this. More rights of intervention for gematik are urgently needed. Future roadmaps from the digital agency for the further development of the telematics infrastructure (TI) would have to focus more on the user perspective and everyday supply. Support is offered in defining binding standards for the user-friendliness of TI components, services and applications.

Industry associations bitkom and the Federal Association of Health IT (bvitg) rejected a stronger role for gematik and the digital agency for health. The planned expansion of the rights of intervention was “excessive,” said bitkom.

According to the draft law, the new digital agency is intended to implement the technical transformation in the healthcare system more effectively. According to the federal government’s draft law, there is a lack of central responsibility for controlling the complex interaction of regulations and specifications, the necessary control competencies and their implementation.

In order to achieve the transformation goals, the Society for Telematics (gematik) is to be expanded into a digital health agency and thus strengthened. The agency’s central task is to manage the development and provision of TI components and services. In the future, essential TI components and services will be able to be procured and provided by the digital agency through a tendering process.

In order to ensure the stability and functionality of the TI, the agency should involve “external stakeholders” earlier so that applications are available to users faster and in higher quality. The agency should also be given “sovereign” tasks. In addition to approval, this includes the certification process and the issuance of orders to avert threats to the functionality and safety of the TI. In particular, when it comes to averting danger, the digital agency is supposed to react to dangers and disruptions to the TI through its sovereign mandate.

The digital agency should also be given responsibility for setting usability standards for TI’s components, services and applications. It is intended to ensure that standards are adhered to and hurdles to use are eliminated. The digital agency is also intended to support self-governing institutions in the digitalization of care processes in the healthcare and nursing sectors. © aha/aerzteblatt.de