Basic approaches to assessment of digital health products and services in the Russian Federation

Objective: To analyze the applicability of approaches conventionally used to assess the clinical and economic effectiveness of pharmaceuticals to that of digital health products and services (DHPS). Material and methods. In this study, DHPS was considered to be an umbrella concept that encompasses various health technologies such as mobile health apps and services, including those based on artificial intelligence. Approaches to drug assessment were reviewed based on regulatory documents, methodological guidelines, and monographs on drugs assessment. Results. The examined approaches to assessing the effectiveness and safety of pharmaceuticals can be applied to DHPS, having no fundamental limitations. Specific characteristics of DHPS that influence the choice of their assessment approaches were identified and described. A draft dossier for DHPS was proposed, with its composition aligned with the goals and objectives of the assessment task. Conclusion. Future research should address the development of methodological guidelines for assessing DHPS based on the approaches used for drug assessment.