Background: With its digital health application (DiGA)-system, Germany is considered one of Europe's pioneers in the field of evidence-based digital health. Incorporating DiGA into standard medical care must be based on evidence-based success factors; however, a comprehensive overview of the evidence required of scientific studies for their approval is lacking. Objective: The study aims to, (1) identify specific requirements defined by the Federal Institute for Drugs and Medical Devices (German: Bundesinstitut für Arzneimittel- und Medizinprodukte; BfArM) to design adequate studies, proving a positive healthcare effect, and (2) to assess the evidence given for applications permanently listed in the DiGA directory. Methods: A multi-step approach was used: (1) identification of the evidence requirements for applications permanently listed in the DiGA directory, (2) identification of the evidence available supporting them. Results: All DiGA permanently listed in the DiGA directory (13 applications) are included in the formal analysis. Most DiGA addressed mental health (n = 7), and can be prescribed for one or two indications (n = 10). All permanently listed DiGA have demonstrated their positive healthcare effect through a medical benefit, and most of them provide evidence for one defined primary endpoint. All DiGA manufacturers conducted a randomized controlled trial. Discussion: It is striking that— although patient-relevant structural and procedural improvements show high potential for improving care, especially in terms of processes — all DiGA have provided a positive care effect via a medical benefit. Although BfArM accepts study designs with a lower level of evidence for the proof of a positive healthcare effect, all manufacturers conducted a study with a high level of evidence. Conclusion: The results of this analysis indicate that permanently listed DiGA meet higher standards than required by the guideline.
CITATION STYLE
Mäder, M., Timpel, P., Schönfelder, T., Militzer-Horstmann, C., Scheibe, S., Heinrich, R., & Häckl, D. (2023). Evidence requirements of permanently listed digital health applications (DiGA) and their implementation in the German DiGA directory: an analysis. BMC Health Services Research, 23(1). https://doi.org/10.1186/s12913-023-09287-w
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