Technology assessment of digital health applications for reimbursement decisions

Background For most digital health applications (DiGA) only limited evidence of benefit is available. Currently available assessment frameworks do not cover all domains of a full health technology assessment (HTA). Additionally, technology-specific aspects are required for the evaluation of DiGA. This work aimed to analyze the available assessment frameworks and design an evaluation process for DiGA. Methods By a systematic literature search six assessment frameworks for DiGA were selected and analyzed. A hand search for strategies on DiGA of selected countries was conducted. Results Of the analyzed assessment frameworks four described study designs. One assessment framework proposed a risk classification of DiGA. Aspects of artificial intelligence were assessed by one assessment framework. The analyzed countries have differing strategies for reimbursement of DiGA. Conclusion Assessment frameworks for DiGA are very heterogeneous. There are efforts to find regulations for DiGA on a national level. When evaluating DiGA, a staged approach considering risk classes with subsequent evaluation of relevant HTA aspects is recommended.