Much implementation work still needed on digital laws

Much implementation work still needed on digital laws



Berlin – The law to accelerate the digitization of the healthcare system (DigiG) and the Health Data Use Act (GDNG) offer great potential. However, in order to be able to use this in research and care, a lot of development work still needs to be done and regulatory measures need to be tightened up again. There was widespread agreement on this at the Capital Congress (HSK) in Berlin this week.

For example, the electronic patient record (ePA) will be introduced for one month in the two model regions of Franconia and Hamburg before its complete rollout at the beginning of 2024, explained Susanne Ozegowski, head of the Digitization and Innovation Department at the Federal Ministry of Health (BMG): “If no bugs or other problems arise in the first four weeks, we want to start the nationwide rollout after that.”

She expects very little resistance from the insured – in any case, the data protection debates no longer have the same resonance in society as they did a few years ago. “These are very theoretical discussions that we are having here,” she said.

Daniel Cardinal, head of the Innovation and Outpatient Care division at Techniker Krankenkasse (TK), had previously expressed his satisfaction with the rejection rates to date. TK had already begun writing to its insured members and had previously expected a rejection rate of 15 to 20 percent. In fact, however, there had only been minimal rejection rates so far. “People are much more advanced culturally than we sometimes assume,” he emphasized.

The ePA will be the linchpin of the new data infrastructure in the healthcare system. The bigger vision behind it is to be able to better utilize the possibilities of technological progress in future healthcare – especially artificial intelligence (AI).

“A digital ecosystem will emerge that ensures that the right things are dealt with at the right time in the right place,” Cardinal stressed. This will be essential to maintaining care in view of the shortage of skilled workers and demographic change. DigiG and GDNG have already laid the foundation for this.

AI-based applications in particular could create new added value. In just a few years, it will be possible to generate faster recommendations for action for doctors through preliminary anamnesis and pre-diagnoses, which will make their everyday work easier. Much more personalized and individualized medicine will also be possible.

However, it is important to ensure that digital processes really do lead to an increase in efficiency, warned Rudolf Dueck, Chief Information Officer (CIO) of the University Hospital Schleswig-Holstein (UKSH). If analogue processes are simply reproduced digitally in parallel, this is not the case.

In addition, it is necessary to work more with structured and well-curated data than before, otherwise there is a risk that the ePAs will become data dumps. Medical information objects (MIO) are the solution here, but their development is progressing too slowly.

Especially in highly specialized areas such as oncology, AI-based support programs will often become indispensable in the future, explained Julia Wagle, Medical Director of Roche Germany. Today, top-class medicine is only possible through digitalization. Given the explosion of knowledge in oncology in recent years, doctors will need decision-making aids to keep track of things.

It is also very important for research that the existing data is well curated, emphasized Ralf Heyder, head of the coordination office of the University Medicine Network (NUM). This requires specialized platforms on which data can be brought together and processed.

The Research Data Center (FDZ) currently being set up at the Federal Institute for Drugs and Medical Devices (BfArM) will have a large stock of general healthcare data thanks to the data flow from the ePA, whereas other databases often contain very specific data from small populations.

“What we are currently lacking is the linking of FDZ data with data from other sources,” explained Heyder. For this, an appropriate infrastructure must be set up. “In many cases, this is no longer possible in competition between university hospitals,” he warned. Given the need for well-maintained data, more cooperation between university hospitals will be needed in the future than before.

Even with the data from the Initiative of German Research Practice Networks (DESAM-ForNet), there are no plans yet to link it with the routine data collection of the ePA, explained the head of the initiative’s coordination office, Leonor Heinz.

Anne-Sophie Geier, Managing Director of the German Association for Digital Health Care (SVDGV), also stressed that further innovations brought about by DigiG and GDNG are still awaiting their effect on healthcare.

Although the volume limit for telemedical treatments has been lifted, this has not yet had an impact on care. However, the billing procedures are still too complex, which puts many doctors off. Billing for telemedicine must therefore be treated the same as other services.

In addition, ways would have to be found to connect pure telemedicine providers to the telematics infrastructure (TI) in order to enable data transfer to the ePA or the issuing of e-prescriptions.

Digital health applications (DiGA) are also to be upgraded by expanding their areas of application to include risk class IIb of medical devices in the future – at least in theory. In practice, this is difficult for the vast majority of providers to implement.

In order to be listed, manufacturers would have to submit sophisticated studies in which only medical endpoints are permitted and not, as in the lower risk classes, proof of added value.

“The investments are so high in this area that you first have to see who can afford it,” explained Geier. She does not know of any German manufacturer that is currently planning to bring a DiGA of this risk class onto the market.

However, she suspects that this could be the case for French companies in the future. The French government has explicitly defined areas of application such as telemonitoring in its legislation.

French companies are expected to soon develop such applications with which they could then target the German market, explained Geier: “And that makes a lot of sense, especially for patients with chronic diseases.” © lau/

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