A Comparative Overview of Digital Health Applications between Belgium and Germany

Abstract The increasing use of mobile digital technologies in our daily life is also affecting the healthcare sector. Digital health applications have the potential to improve disease monitoring and management, avoid hospitalizations, and more. A main task for the health care system is to create a framework that facilitates the identification of safe and effective apps for health care professionals and patients to generate the most health benefit as well as guide payer coverage decisions. Currently some European countries have already developed a national framework for market access approval, nevertheless only Belgium and Germany have additionally created a reimbursement system. The aim of this investigation is to compare the two different approaches of Belgium and Germany, based on the framework itself, the access requirements, and the experience so far. The overall approach seems to be similar, but scrutinizing the details, there are several significant differences. The evaluation procedure in Belgium consists of a 3-level validation pyramid while in Germany there is a normal procedure as well as a DiGA-Fast- Track. Only applications in stage 3 are reimbursable in Belgium whereas in Germany applications from provisional and permanent listing are reimbursable. The comparative overview shows that the two forerunners, Belgium, and Germany, use similar but not identical approaches, with partly relevant differences such as the evaluation procedure reimbursement and the formulation of the target group. The current situation (status 11.04.22) shows that the focus of the app indications differs between both countries. Furthermore, not a single app is listed in Belgium and Germany at the same time. From our perspective it should be a goal for manufacturers of CE marked medical devices to achieve reimbursement in as many member states as possible.