Study Design and Real World Data

The IGES Institute offers a study synopsis in order to agree on relevant aspects of the study. The study synopsis also serves as a basis for the BfArM consultation, another service provided by IGES. The BfArM consultation is highly recommended and takes place at an early stage of the process to identify potential obstacles in time. Finally, the IGES Institute also offers support in the preparation of the evaluation concept that has to be submitted to the BfArM.

The manufacturer of a digital health product that is to be listed as a DiGA can demonstrate the required positive care effect in two categories: The first option is to demonstrate a medical benefit, i.e., a measurable therapeutic effect on mortality, morbidity, or quality of life. The second option is to demonstrate a procedural and structural improvement benefit, which may be reflected, for example, in guideline-based care, improved adherence, or higher patient sovereignty. The fact that procedural effects are taken into account in the benefit assessment is a real milestone, as DiGAs can exploit their potential primarily as an element of a comprehensive care concept. 
The proof of these effects may only be provided by means of comparative studies. Single-arm observational studies are not permitted. Longer-term "real-world data", which can be easily collected and evaluated with digital applications, could enable a benefit analysis in actual health care practice. This "real-world evidence" can be taken into account in reimbursement negotiations in the course of outcome-based remuneration.

The manufacturer of a product that is to be listed as a DiPA must provide evidence of the nursing benefit by means of a quantitative comparative study. The manufacturer must submit the study results to the BfArM in the form of a study report written according to scientific standards.

This study report must show the benefit of the DiPA for the defined target group in an intraindividual comparison or in comparison to a control group without the use of the DiPA. Comparison with a comparable DiPA already listed in the DiPA Directory is also acceptable. Evidence of the nursing benefit of DiPA must be based on a validated measurement tool. The endpoints to be studied should be relevant to the intended target population, but may also be used as surrogate parameters as predictors of nursing benefit.