eHealth: Gematik reorganization promises stable infrastructure, experts doubt
The Health Digital Agency Act is intended to ensure stable digitalization of the healthcare system. Why those involved are skeptical.
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Gematik is to be expanded to become the "Digital Agency for Health" and assume central responsibility for digitalization. With the health digital agency as the center of power, politicians are hoping for faster digitalization of the healthcare system. According to the draft bill for the Healthcare Digital Agency Act, Gematik will have penalties, fines and sanctions as well as other bodies at its disposal to enforce this. A competence center for interoperability in healthcare (KIG) is also to be set up within the digital agency and more.
Hope for a stable infrastructure
The National Association of Statutory Health Insurance Physicians recognizes "quite positive approaches" in the draft, such as the fact that the restructuring of Gematik will ensure stability of the telematics infrastructure- the healthcare network. It is also correct that the future digital agency will "replace the printout of the electronic certificate of incapacity for work (eAU) with an electronic procedure". However, "what role the medical and psychotherapeutic self-administration will play" must be critically questioned. They would know best which digital processes would really make everyday practice easier. According to a reader survey conducted by Ärztezeitung, many doctors do not believe that the new digital agency will be able to solve the TI problems in the long term.
No improvement through new certification bodies
Erich Gehlen from the practice management system manufacturer Duria eG is sharply critical. In his opinion, politicians have lost touch with reality and the current situation in practices. The quality of practice management systems would not improve as a result of further certification rounds with new certification bodies; this seems "far-fetched" to him. He suspects that politicians have not yet made the effort to understand a PVS change.
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His practice management system is one of the few that was rated positively by users in a survey conducted by the Central Institute for Statutory Health Insurance Physicians. Gehlen knows what doctors want. "Developing new guidelines 'from above' on the qualitative and quantitative framework" is only of very limited help. He fears that the market will now be largely eliminated. "It is important that it [Gematik] no longer develops digital applications itself in future – as it did recently with the e-prescription –, but leaves this to the market," emphasizes TK boss Jens Baas in a press release from Techniker.
Procurement processes do not guarantee high availability
"Component approvals in a competitive market have existed for a long time in many other areas such as PoS terminals (point-of-sale) or ATMs, but also for railroads, medical products and air traffic. Regulatory authorities are taking their responsibilities seriously and defining specifications and approval procedures that must be adhered to," says cyber security expert Manuel Atug. "It is a fallacy that the high availability required in the healthcare sector can be achieved by dissolving the pure market model in favor of more procurement processes. What exists in the healthcare sector and is to be made worse with the GDAG is contrary to previous experience," says Atug.
For Christof Gessner, medical IT specialist at HL7 Germany, the question is "how Gematik can, should and will implement the extension of the tasks in Section 311 (1) No. 8 to promote interoperability and implement the interoperability process in accordance with Section 385, including the awarding of contracts, in particular for the provision of corresponding specification and certification services". As a medical IT specialist, he has been involved in national and international standardization projects for many years. There, 'specifications' are developed in cooperation with various stakeholders and then adopted by consensus and developed further over the years. "This includes regular meetings and, above all, compliance with the rules of the respective standardization organization (SDO)," explains Gessner
Hurdle for standardization work
"The draft law mentions the 'awarding of contracts' in the context of the 'provision of services'. It would be quite a challenge to reconcile the above-mentioned approach with this. For me, the draft therefore represents more of a hurdle for open, transparent standardization work than it would be a help, and would also explicitly name such cooperation in SDOs as worthy of support," summarizes Gessner. An example of such cooperative work can be found, for example, in the international patient short file – in contrast to German work on the "patient short file" and the connection of the electronic patient file to the EU.
(mack)