With its cabinet decision on the Act on Data and Digital Innovation in Healthcare (GeDIG), the German government has taken a new step towards the digitalisation of healthcare. The Act aims to develop the electronic health record (elektronische Patiënten Akte or ePA) into the central platform for healthcare, strengthen digital communication channels and simplify bureaucratic processes. At the same time, the draft bill has provoked mixed reactions among health insurers, doctors and other stakeholders. This is particularly the case with regard to access to health data and the future role of health insurers.
The German Minister for Health, Nina Warken, described the draft bill as a key building block for an interconnected healthcare system. “The future of our healthcare system is digital and interconnected,” she stated following the cabinet’s decision. In future, health data must be able to be used “more widely, securely and responsibly.”
Catching up
Three years ago, Germany’s then Minister of Health, Karl Lauterbach, decided that efforts needed to be made to catch up in the field of digital healthcare. At the time, an ambitious plan, complete with an equally ambitious timeline, was presented. At the start of this year, those plans were supplemented with a catch-up strategy regarding the use of AI tools and applications within the healthcare sector.
Central to the recently approved GeDIG Act is the further development of the ePA. In future, health insurers are to be given greater scope to expand their applications with additional functions. Provisions include prevention advice, reminders for preventive check-ups, AI-supported processing of medical findings and personalised patient information leaflets. Furthermore, a full-text search function is to be available in the ePA from the start of 2027. A digital vaccination record is also planned for mid-2027.
The GKV-Spitzenverband expressly supports this development. “The electronic patient record must not be viewed as a digital document repository,” emphasised board member Dr Martin Krasney. Rather, it must develop into the central platform for networked and patient-centred care.
The AOK-Bundesverband also views the planned expansions positively in principle. Chair of the Executive Board Dr Carola Reimann is particularly pleased with the extensive possibilities for data-driven identification of individual health risks and with the planned ‘real-world labs’, in which innovative applications, including artificial intelligence, can be tested under real-world conditions.
The Kassenärztliche Bundesvereinigung (KBV), by contrast, takes a considerably more critical stance. The KBV regards the expanded access rights for health insurers as a fundamental paradigm shift. “The draft still represents a dangerous paradigm shift, which we resolutely reject,” stated KBV board members Andreas Gassen, Stephan Hofmeister and Sibylle Steiner. According to the medical associations, medical information belongs within the treatment context between patient and doctor or psychotherapist, and not within the sphere of responsibility of health insurers. Furthermore, the KBV is critical of the fact that, in future, health insurers could also analyse data from wellness applications, with the consent of the insured.
Digital primary care without faxes or paper
Another focus of the GeDIG concerns the digitisation of primary care. Electronic referrals are to be introduced in stages by September 2029 at the latest and integrated directly into the ePA. In future, insured persons must be able to access the healthcare system via their health insurer’s ePA app, their GP practice or by calling 116117.
At the same time, communication between healthcare providers must be conducted entirely digitally. Fax machines and paper-based communication must be replaced by the secure communication services KIM and TI-M. The GKV-Spitzenverband regards this as a key prerequisite for the planned digital primary care system. The AOK also takes a generally positive view of digital access to healthcare via the ePA. At the same time, however, it is calling for a legal obligation on doctors’ practices to make sufficient appointment slots available for a central appointment register. Furthermore, it sees a considerable need for coordination regarding the planned digital needs assessment.
The KBV, on the other hand, criticises the planned implementation via numerous different ePA apps from health insurers. According to estimates by the doctors’ organisation, up to 90 different applications could be created. This carries the risk of confusing structures and unnecessarily competes with the already established 116117 service.
Savings, research and Gematik
The German Ministry of Health anticipates annual savings of around 445 million euros. However, this calculation has been met with scepticism. According to the KBV, it remains unclear how this figure was arrived at. In medical practices, new digital applications would initially entail mainly extra work and costs before they actually led to a reduction in the administrative burden.
The AOK is also critical of certain provisions. In particular, the proposed extension of direct billing to services provided on a ‘service-based’ basis could unnecessarily complicate existing billing structures and incur additional costs. On this point, there is, for once, agreement between health insurers and healthcare providers, who are calling for this provision to be scrapped.
Deutsche Hochschulmedizin, by contrast, views the general objective of the Act positively. From its perspective, the GeDIG creates important conditions for modern, data-driven healthcare and for the use of health data in medical research. At the same time, it calls for the abolition of bureaucratic duplication of regulations and greater consideration of the requirements of scientific institutions.
Prof. Jens Scholz, Chairman of the Board of the Association of University Hospitals in Germany, describes the Act as an “urgently needed milestone”, but calls for further progress in the areas of interoperability, reducing bureaucracy and integrating data from different sources.
Greater responsibility
Another point of discussion concerns the future role of Gematik. According to the draft bill, the organisation must in future be able to procure digital services and applications directly in order to reduce the complexity of the telematics infrastructure. The background to this is recurring disruptions and the large number of technically similar applications from different providers. Whilst the GKV-Spitzenverband, the Innungskrankenkassen and the AOK support the objective of a more stable telematics infrastructure, they warn against an excessive expansion of powers. They are calling for transparent governance structures and a clear division of roles between the parties involved.
Despite its fundamental criticism, the KBV also recognises some improvements in the draft bill. For the first time, digital applications would take into account not only interoperability but also requirements relating to quality and user-friendliness. Furthermore, in future, manufacturers of practice management systems should be obliged to support medical practices in switching to other software solutions, to make data available free of charge and to provide timely information about system updates.
Finally, the occupational health insurers emphasise that digital health applications must meet strict requirements regarding evidence and security in future. “Anything that has not been proven to be beneficial must not be financed from insurance premiums.”
