What are the special features of DiGA clinical investigations?

Digital health applications (DiGA) are innovative medical devices that are tested using the BfArM's fast-track procedure. The clinical investigations for DiGA have special features, such as

Regulatory and qualitative requirements:

• The clinical investigation is conducted to provide evidence of a positive healthcare effect.
• The methodological requirements from the current versions of the fast-track procedure must be carefully implemented.
• Often, no data are yet available that allow a prediction of an effect or an effect size.
• The BfArM places very high demands on study design, methodological characteristics to ensure validity and on the conduct of the study.

Digital endpoints:

DiGA often utilise endpoints captured via apps or sensors, which requires specific considerations and measurements.

Real-time data:

DiGA enable real-time data collection and usage data, allowing for special analyses.

Type of patients:

Regardless of patient age and gender, DiGA beneficiaries are people who are digital-savvy and therefore also increasingly enable the use of digital elements in a clinical investigation.

Combination of technology and therapy:

Treatment and / or diagnosis is carried out via digital elements outside of clinical facilities and therefore also enables data to be collected via this route.

Country-specific:

The clinical investigation must be conducted in Germany on patients with statutory health insurance, unless it can be demonstrated that the healthcare data of another country is comparable to that of Germany.

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