OBJECTIVES: Since December 2019, the Digital Healthcare Act enables healthcare providers to prescribe digital health applications (DiGA) that are reimbursed by the statutory health insurance (SHI) in Germany. To be reimbursed, DiGA need to pass an assessment of the Federal Office for Drugs and Medical Devices (BfArM) for a listing in a directory of reimbursable DiGA. In an application for provisional or final listing, manufacturers are required to provide evidence based on a study proving or indicating at least one positive healthcare effect. This research aimed at aggregating evidence provided by the manufacturers.

METHODS: All DiGA in the directory accessible until June 26^th, 2022 were screened and analyzed regarding their timepoint and type of listing (provisional vs. final vs. deleted), indication, claimed positive healthcare effects as well as evidence that was generated (e.g., study type, study outcomes, study population, and study period).

RESULTS: Overall, N=33 DiGA were publicly available in the directory. Thereof, n=12 were listed finally, n=19 provisionally, and n=2 were deleted. Of N=14 main studies provided for final listing, n=13 were designed as randomized controlled trial (RCT), while n=1 retrospective data analysis was conducted. Of N=25 pilot studies conducted to provide evidence for provisional listing, the majority was considered patient-individual pre-post comparisons (n=18). Population sizes varied between 20 and 797 patients in the pilot studies and between 56 and 1,013 patients in the main studies. The follow-up period of the main studies spanned between 3 and 12 months with most studies having a follow-up of 6 months (n=9).

CONCLUSIONS: Even though it is no mandatory requirement for final listing in the DiGA directory, most of the manufacturers provide evidence generated in RCTs to demonstrate positive healthcare effects. The successful completion of these studies is fundamental for a final listing in the directory and, accordingly, reimbursement by the SHI.