Evidence standards of permanently listed digital health applications in Germany

Background

Since the introduction of the German DiGA system in 2020, Germany has been considered a pioneer in evidence-based digital health. DiGA are low-risk medical devices (class I and IIa) that can be prescribed and reimbursed by statutory health insurance. Market access requires evidence of a positive healthcare effect, demonstrated through quantitative comparative studies. Six years after implementation, however, the number of permanently listed DiGA remains limited, and the inclusion of new applications appears to have slowed. Concerns are increasingly raised that evidentiary requirements may be too demanding and reduce the attractiveness of the pathway for manufacturers. This study assesses the evidence requirements fulfilled by DiGA to achieve permanent listing.

Methods

We analysed all permanently listed DiGA in the directory of the Bundesinstitut für Arzneimittel und Medizinprodukte, focusing on study design, endpoints, and demonstrated effects.

Results

A total of 50 DiGA (status: April 2026) were included, most addressing mental health (n = 26). All demonstrated a positive healthcare effect based on one or more randomized controlled trials. Most provided evidence for a clearly defined primary endpoint alongside secondary outcomes. Nearly all pivotal studies were conducted in Germany.

Conclusions

All permanently listed DiGA demonstrated positive effects based on high-level evidence from randomized controlled trials. Although lower levels of evidence are accepted by regulation, manufacturers consistently implemented rigorous study designs. These findings suggest that permanently listed DiGA meet higher evidentiary standards than formally required.

Key messages

• All permanently listed DiGA rely on RCT evidence, exceeding regulatory requirements and indicating high evidentiary standards in German digital health.

• High evidentiary standards ensure robust, trustworthy DiGA and support evidence-based digital health integration into routine care and population health improvement.