What are the special features of DiGA clinical investigations?

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

1. digital endpoints:

- DiGAs often use digital endpoints such as apps or sensors, which requires specific considerations and measurements.

2. real-time data:

- DiGA enables real-time data acquisition and usage data, which makes special evaluations possible.

3. type of patient:

- Regardless of the age and gender of the patients, DiGA users are people who are digitally savvy and therefore also increasingly enable the use of digital elements in a clinical trial.

4. combination of technology and therapy:

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

5. 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.

 6. regulation and qualitative requirements:

- The clinical investigation is carried out to prove the positive effect of the treatment.

- The methodological requirements from the current versions of the fast-track procedure must be carefully implemented.

- There is often no data available yet that allows a prediction of an effect or an effect size.

- The BfArM places very high demands on the study design, methodological features to ensure validity and the conduct of the study.