Lauterbach's race to catch up continues: Gematik becomes digital agency of BMG
The cabinet has passed the Health Digital Agency Act and other laws to give the healthcare system a complete overhaul.
(Image: sdecoret/Shutterstock.com)
The Federal Ministry of Health wants a "complete overhaul" of the healthcare system. This includes a number of different laws, four of which were passed today – including the Act to Strengthen Public Health, the Emergency Reform and the Health Digital Agency Act. The latter is intended to accelerate the digitalization of the healthcare system, but had previously come in for a lot of criticism.
In addition, the Competence Center for Interoperability in Healthcare (KIG), which is based at the digital agency, is to ensure "that applications are interoperable". This should make it easier to switch practice management systems. If costs are incurred because systems are not interoperable, doctors should not have to pay for them.
The Health Agency Act plans to expand Gematik with more powers. "The new digital agency should enable digital infrastructure such as practice software, electronic patient files or digital hospital files to function reliably and quickly through its powers of intervention and supervision," said Health Minister Karl Lauterbach. So far, Gematik has mainly drawn up specifications, but has not been able to ensure that these are adhered to.
Gematik should also be allowed to certify and issue "orders to avert danger within the TI". In the future, Gematik, as a digital agency, is to request information from providers in the event of faults and take the necessary measures, if necessary, at the provider's premises. Providers will have to bear the costs themselves. There will also be penalties and fines for those who do not adhere to Gematik's guidelines.
Criticism of the Digital Agency Act
The German Health IT Association (bvitg) and the digital association Bitkom believe that the law goes "too far in many places". It interferes "deeply" with free competition, as has already been criticized in the past. They fear that the law will have "serious consequences for those players in the healthcare system who make a significant contribution to maintaining and improving medical care with their IT systems". Excessive regulation does not create innovation.
"A central institution to operate a telematics infrastructure (TI) and to ensure interoperability is sensible and necessary," said bvitg Managing Director Melanie Wendling. However, in her opinion, the question arises: "Where does the regulatory responsibility of the central institution begin and, above all, where should it end?" asked Wendling. The draft law would not only distort competition. The bvitg Managing Director explained that market-based players would also be prevented from developing optimal solutions and added value for users through creativity.
According to Bitkom CEO Bernhard Rohleder, the increasing complexity of the healthcare sector requires a "modern digital agency for healthcare that sets standards and monitors compliance with them. What we don't need, however, is a Gematik that develops certain applications itself or puts them out to tender. Digital solutions must be created and developed through competition".
Awarding contracts and developing products
Further criticism of the Health Digital Agency Act comes from the health insurance funds, as Gematik "can itself award contracts for the development and operation of TI components and services", said Doris Pfeiffer, Chairwoman of the Board of the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband). At the same time, Gematik can continue to approve products. "The new digital agency is then itself a market participant with its own products and at the same time should approve the products of its competitors from the industry - an obvious conflict of interest. The possibility of operating the TI's own components and services can and should therefore only apply to central products that are available or necessary once in the system," criticizes Pfeiffer.
Costs not considered
In addition, the higher costs have not yet been considered in the draft law. According to Pfeiffer, 93 percent of the costs must continue to be "borne by the contributors to statutory health insurance. And the Federal Ministry of Health, with its 51 percent shareholding and simple majority decision in the shareholders' meeting, will ultimately be able to decide on these funds in future too," said Pfeiffer.
The law thus joins a "large number of recent legislative plans that place a one-sided burden on SHI contributors". If the statutory health insurance funds continue to bear the costs, the GKV demands that the decisions of Gematik's shareholders' meeting must "at least" be made in agreement with the GKV.
(mack)
