Draft Health Digital Agency Act: Gematik receives more responsibility

Gematik, which is currently responsible for the digitalization of the healthcare system, is to be expanded into a digital agency for healthcare. Health Minister Karl Lauterbach has already announced this several times, and now it is becoming concrete. 20 years after the first digitization efforts, the healthcare system is now to be truly digitized. The "central responsibility" for this is to lie with the "Digital Agency for Health". This is according to a draft bill for a Healthcare Digital Agency Act (Gesundheits-Digitalagentur-Gesetz, GDAG) published by heise online.

It is regularly criticized that no one is responsible for disruptions to health IT. With the reorganization, responsibility for the components and services related to the telematics infrastructure – which is intended for the secure exchange of health data – will in future lie with the Digital Agency for Health. Among other things, the digital agency will be able to set deadlines for providers of healthcare services and impose fines for violations. Gematik will also be able to visit providers and rectify IT faults itself. This should enable problems relating to the telematics infrastructure to be identified and resolved more quickly.

Manufacturers of software, such as practice management systems (PVS), are also subject to further obligations. At the request of doctors, they must do everything in their power to ensure that the PVS is changed as quickly and smoothly as possible. The National Association of Statutory Health Insurance Physicians had already published framework agreements for this purpose. Following the revision of the framework agreement, the previous PVS manufacturers will be obliged to help new PVS providers with the move. Lauterbach had already announced that some doctors will have to change their practice management system for the upcoming electronic patient file for all.

KIG for interoperability

A competence center for interoperability in the healthcare sector (KIG) is also to be set up within the digital agency to ensure that "information technology systems in the healthcare sector can not only communicate with each other technically, semantically and syntactically, but can also be used in practice", according to the draft. The task of the KIG is to "implement and orchestrate the interoperability process". The Digital Agency Health can also award contracts to obtain help.

Gematik is currently responsible for approving TI-related components and services and drawing up specifications, among other things. In the future, it will not only be able to sanction, but also decide who is allowed to develop and operate certain components and services of the telematics infrastructure. "In the past, it has been shown that the previous structure in the pure market model (approval model) has created a high degree of complexity due to many components, services and applications, which has a negative impact on operational stability and service quality," reads the draft. High availability could only be guaranteed by deviating from a pure market model.

Savings in the millions, with expenditure in the billions

For the National Association of Statutory Health Insurance Funds, "the centralized tendering of components and services by the Digital Agency Health" is expected to result in savings that cannot be quantified. However, "the elimination of the flat rate for the electronic doctor's letter and fax costs alone" could save around 4 million euros – a small sum compared to the billions invested in the digitization of the healthcare system to date.

Other points of the GDAG include involving all stakeholders at an earlier stage, for example, to increase the user-friendliness of the applications. It is also to be examined whether the electronic certificate of incapacity for work can also be stored in the electronic patient file. The Digital Agency for Health will then also take care of this. In addition, it will also prepare the connection to the European Health Data Space.

(mack)