Experiences of digital health care applications (DIGA) manufacturers with the BfArM Fast-Track procedure

Since October 2020, the first digital health applications (DiGA) have been listed with the Federal Institute for Drugs and Medical Devices (BfArM) and can be prescribed by physicians and psychotherapists in the statutory health insurance system. In this article, four of the first BfArM-listed DiGA manufacturers report on their experiences with the BfArM Fast-Track procedure for DiGA, which enables listing from the time of application in just three months. Regarding the DiGA Fast-Track procedure and the cooperation with the BfArM, overall positive experiences are reported. However, applicants need to consider some points before and during the application process as well as after the positive decision. Before submitting the application, it is advisable to conduct audits to ensure that all requirements are met. BfArM consultations should be used, especially to clarify questions regarding proof of positive supply effect. Manufacturers should be prepared for numerous queries and follow-up requests from BfArM and be able to respond quickly. In the case of ambiguities, direct contact should be made with the BfArM. Manufacturers should note that sales of their product will not automatically follow a positive decision, as the medical profession still needs to be informed more fundamentally about DiGA and the path from the prescription to the activation of DiGA is currently still cumbersome. Manufacturers should also be prepared for continued interaction with BfArM after listing. Overall, manufacturers are recommended to cooperate early, proactively, openly, and closely with the BfArM because they themselves are liable for the information they provide in the application and the BfArM does not check all of it in detail.