The German Fast Track Toward Reimbursement of Digital Health Applications: Opportunities and Challenges for Manufacturers, Healthcare Providers, and People With Diabetes.

Background: Digital health applications (DiGA) supporting the management of diabetes are among the most commonly available digital health technologies. However, transparent quality assurance of DiGA and clinical proof of a positive healthcare effect is often missing, which creates skepticism of some stakeholders regarding the usage and reimbursement of these applications.
Methods: This article reviews the recently established fast-track integration of DiGA in the German reimbursement market, with emphasis on the current impact for manufacturers, healthcare providers, and people with diabetes. The German DiGA fast track is contextualised with corresponding initiatives in Europe.
Results: The option of a provisional prescription and reimbursement of DiGA while proving a positive healthcare effect in parallel may expedite the adoption of DiGA in Germany and beyond. However, hurdles for a permanent prescription and reimbursement of DiGA are high and only one of 12 that have achieved this status specifically addresses people with diabetes.
Conclusion: The DiGA fast track needs to be further enhanced to cope with remaining skepticism and contribute even more to a value-based diabetes care.
Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: F.S. and T.A.D. are full-time employees of Profil Institut für Stoffwechselforschung GmbH. L.H. is a shareholder of Profil Institut für Stoffwechselforschung GmbH. F.S. is a member of the EIT Health Supervisory Board. J.-M.B. and N.G. are full-time employees of the EIT Health e.V. and the EIT Health Colocation Center Germany–Switzerland, respectively. F.S., T.A.-D., C.S., J.S., M.J., and D.M.-W. are part of the EIT Health-funded RealWorld4Clinic consortium.