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

J Diabetes Sci Technol. 2022 Sep 3:19322968221121660. doi: 10.1177/19322968221121660. Online ahead of print.

Abstract

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.

Keywords: Germany; clinical trials; digital health; evidence; reimbursement; value-based healthcare.