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Berlin – The law to accelerate the digitalization of the healthcare system (DigiG) and the Law on the Use of Health Data (GDNG) offer great potential. To be able to use this in research and care, a lot of development work still needs to be done and the regulations need to be further refined. This was the talk at the Capital Congress this week (HSK) in Berlin there is a widespread consensus.
The electronic patient record (ePA) will be introduced in the two model regions Franconia and Hamburg for a month before its full implementation in early 2024, explained Susanne Ozegowski, head of the department for digitization and innovation at the Federal Ministry of Health. (BMG): “As long as no bugs or other issues arise in the first four weeks, we want to start rolling out nationwide afterwards.”
She expects very little resistance from policyholders – debates about data protection 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 ambulatory care division at Techniker Krankenkasse (TK), was previously very satisfied with the objection rates so far. TK has already started writing to its policyholders and previously expected a rejection rate of 15 to 20 percent. In fact, so far there have only been minimal rejection numbers. “People are much more culturally advanced than we sometimes assume,” he emphasized.
The ePA will be the backbone of the new data infrastructure in the healthcare system. The broader vision behind this is to be able to better utilize the possibilities of technological progress in healthcare in the future – especially artificial intelligence (AI).
“A digital ecosystem will emerge that will ensure the right things are handled in the right place at the right time,” Cardinal emphasized. This will be essential to maintain supply, taking into account the shortage of qualified workers and demographic changes. DigiG and GDNG have already created a foundation for this.
AI-based applications in particular could create new added value. In a few years, it will be possible to use previous anamnesis and preliminary diagnoses to quickly generate recommendations for doctors that will provide relief in their daily work. Much more personalized and individualized medicine will also be possible.
However, it is necessary to ensure that digital processes actually lead to increased efficiency, warns Rudolf Dueck, Chief Information Officer (CIO) at the University Hospital Schleswig-Holstein (UKSH). If only analogue processes are digitally remapped in parallel, this will not be the case.
Furthermore, it is necessary to work more with structured and well-organized data than before, otherwise there is a risk that APEs will turn into data warehouses. Medical information objects (MIO) are the solution here, but their development is progressing very slowly.
Especially in highly specialized areas such as oncology, AI-based support programs will often become indispensable in the future, explained Julia Wagle, Chief Medical Officer at Roche Germany. Today, cutting-edge medicine is only conceivable through digitalization. Given the explosion of knowledge in oncology in recent years, doctors would need decision-making assistance to keep up with things.
It is also very important for research that existing data are well curated, emphasized Ralf Heyder, head of coordination at the University Medicine Network (ON ONE). This requires specialized platforms on which data can be gathered and processed.
The research data center currently under construction (FDZ) at the Federal Institute of Drugs and Medical Devices (BfArM) will have a large inventory of general healthcare data due to EHR data flow, while other databases would often contain very specific data from small populations.
“What is still missing at the moment is the connection of the FDZ data with data from other sources,” explained Heyder. An appropriate infrastructure must be built for this. “In many cases, this is no longer possible when university hospitals compete with each other,” he warned. Given the need for well-preserved data, more cooperation between university hospitals will be necessary in the future than before.
Also with data from the German Research Practice Networks Initiative (DESAM ForNet) There are no plans yet for any integration with ePA’s routine data collection, explained Leonor Heinz, head of the initiative’s coordination office.
Anne-Sophie Geier, Managing Director of the leading association for digital healthcare (SVDGV).
The quantity limit for telemedicine treatments has been lifted, but this is not yet noticeable in the service provided. However, billing methods are still very complex, which discourages many doctors. Telemedicine billing should therefore be equated to other services.
Furthermore, ways would have to be found to connect pure telemedicine providers to the telematics (IT) infrastructure in order to enable data transfer to the ePA or the issuing of electronic prescriptions.
Digital health applications (DiGA) must also be updated, expanding their areas of application to risk class IIb of medical devices in the future – at least theoretically. In practice, this is difficult to implement for the vast majority of suppliers.
To be included on the list, manufacturers would have to present sophisticated studies in which only medical parameters were allowed and not, as in the lower risk classes, evidence of added value in care.
“The investments in this area are so high that first you have to see who can afford it,” Geier explained. She does not know of any German manufacturer that is planning to launch a DiGA of this risk class on the market.
But she suspects this could be the case for French companies in the future. The French government has explicitly stipulated application areas such as telemonitoring in its legislation.
French companies will probably soon develop such applications with which they can also reach the German market, Geier explained: “And this also makes a lot of sense, especially for patients with chronic diseases.” © lau/aerzteblatt.de