In 2019, the German government established a new evaluation procedure for digital health applications (DiGAs) to facilitate their reimbursement by statutory health insurance. The procedure involves the assessment of a DiGA’s “positive healthcare effect”, which is defined as a medical benefit and/or “a patient-relevant improvement of structure and processes”. If the available clinical evidence is insufficient to prove the manufacturer’s claim on the positive healthcare effect, but the claim seems plausible, the DiGA is provisionally reimbursed, and further clinical evidence within twelve months must be generated. DiGAs eligible for provisional or permanent reimbursement are publicly listed in the DiGA directory.

In contrast to the usual pathways for reimbursement of healthcare technologies which involve IQWiG as the national HTA agency and the G-BA (Federal Joint Committee) as the decision-making body, the DiGA procedure is currently carried out by the national competent authority (BfArM) and thus outside the joint self-government. Furthermore, legal evidence requirements for DiGAs are comparatively low.

This work analyzed the suitability of clinical studies that intended to prove a DiGA’s medical benefit. For this purpose, the key elements for clinical studies published in the DiGA directory and clinical trial registries were extracted and compared with the usual evidence requirements in the reimbursement context.

As of October 2020, 20 DiGAs have successfully undergone the application procedure. Fourteen DiGAs (70%) were provisionally accepted. A randomized controlled study (RCT) design was chosen for all clinical studies to be conducted for further evidence generation. However, in four cases (28%), it is questionable whether the clinical study is suitable to demonstrate a medical benefit mainly due to the choice or operationalization of the primary endpoint (n=2), the timing of the endpoint survey (n=2) and/or the choice of the control intervention (n=1).

Even though all currently ongoing or planned clinical studies with DiGAs are RCTs, not all of them are adequate to demonstrate a medical benefit according to the usual evidence requirements.