Presentation (CTI)

OBJECTIVES: The Digital Healthcare Act introduced digital healthcare applications (DiGAs) as part of healthcare provided to patients, subject to successful Federal Institute for Drugs and Medical Devices (BfArM) assessment leading to either a provisional or permanent (final) listing of the application in the DiGA Directory. Our study aimed to examine whether the evidence of positive healthcare effect (medical benefit and / or patient-relevant improvement of structure and processes), which led to provisional listing of the DiGA, was confirmed after submission of additional clinical data from the planned study.
METHODS: The analysis included all 69 DiGAs published on the BfArM's website between 27 May 2020 and 29 February 2025 and assessed the clinical evidence submitted to support the positive healthcare effect, as well as the change in the DiGA listing and the rationale behind it.
RESULTS: Twelve out of the 69 currently reimbursed DiGAs received direct permanent listing, while the remaining 57 DiGAs received provisional listing. In 19 of them, additional clinical data are still expected. Among the remaining 38 assessments, the provisional listing was later successfully changed to permanent in 74% of cases, due to proven positive healthcare effect based on data from the completed comparative study, while the DiGA was removed from the DiGA Directory in 26% of the cases. The removal was a result of the manufacturer’s own request for withdrawal (4 DiGAs), lack of completion of the planned study within the test period (1 DiGA) or lack of sufficient positive healthcare effect after reviewing the evidence (6 DiGAs).
CONCLUSIONS: Provisional listing allows faster patients' access to healthcare, while further clinical data are collected. A submission of clinical data from a comparative study that proves the claimed positive healthcare effect is crucial for a change to permanent listing.