Basic approaches to assessment of digital health products and services in the Russian Federation
V. V. Omelyanovskiy,
F. V. Gorkavenko,
V. A. Ryagina,
N. P. Rukavitsyna,
D. Yu. Morozov,
I. V. Sorokovikov,
V. V. Svetlov https://doi.org/10.17749/2070-4909/farmakoekonomika.2025.349
Abstract
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.
About the Authors
V. V. Omelyanovskiy
Center for Healthcare Quality Assessment and Control ; Russian Medical Academy of Continuing Professional Education
Russian Federation
Russian Federation
Vitaly V. Omelyanovskiy, Dr. Sci. Med., Prof.
WoS ResearcherID: P-6911-2018. Scopus Author ID: 6507287753
6/20 bldg 2 Pokrovsky Blvd, Moscow 109028
2 bldg 1 Barrikadnaya Str., Moscow 123995
F. V. Gorkavenko
Center for Healthcare Quality Assessment and Control ; Russian Medical Academy of Continuing Professional Education ; Sechenov University
Russian Federation
Russian Federation
Filipp V. Gorkavenko
Scopus Author ID: 57219030739
6/20 bldg 2 Pokrovsky Blvd, Moscow 109028
2 bldg 1 Barrikadnaya Str., Moscow 123995
8 bldg 2 Trubetskaya Str., Moscow 119048
V. A. Ryagina
Center for Healthcare Quality Assessment and Control
Russian Federation
Russian Federation
Veronika A. Ryagina
6/20 bldg 2 Pokrovsky Blvd, Moscow 109028
N. P. Rukavitsyna
Center for Healthcare Quality Assessment and Control ; Russian Medical Academy of Continuing Professional Education
Russian Federation
Russian Federation
Nadezhda P. Rukavitsyna, PhD, Assoc. Prof.
6/20 bldg 2 Pokrovsky Blvd, Moscow 109028
2 bldg 1 Barrikadnaya Str., Moscow 123995
D. Yu. Morozov
Center for Healthcare Quality Assessment and Control ; Russian Medical Academy of Continuing Professional Education
Russian Federation
Russian Federation
Dmitry Yu. Morozov
6/20 bldg 2 Pokrovsky Blvd, Moscow 109028
2 bldg 1 Barrikadnaya Str., Moscow 123995
I. V. Sorokovikov
Center for Healthcare Quality Assessment and Control ; Russian Medical Academy of Continuing Professional Education
Russian Federation
Russian Federation
Ivan V. Sorokovikov
6/20 bldg 2 Pokrovsky Blvd, Moscow 109028
2 bldg 1 Barrikadnaya Str., Moscow 123995
V. V. Svetlov
Association of International Pharmaceutical Manufacturers
Russian Federation
Russian Federation
Vasiliy V. Svetlov, MBA
15A Leninsky Ave., Moscow 119071
References
1. Omelyanovskiy V.V. (Ed.) Tracks of development and inclusion of medical technologies in clinical practice in the Russian Federation. Мoscow: Kachestvo zhizni; 2025: 54 pp. (in Russ.).
2. Rebrova O.Yu. Life cycle of decision support systems as medical technologies. Medical Doctor and IT. 2020; 1: 27–37 (in Russ.). https://doi.org/10.37690/1811-0193-2020-1-27-37.
3. Omelyanovskiy V.V., Avxentyeva M.V., Sura M.V., et al. Methodological recommendations for the evaluation of drug comparative clinical efficacy and safety. Мoscow: Center for Healthcare Quality Assessment and Control; 2016: 58 pp. (in Russ.).
4. Omelyanovskiy V.V., Avxentyeva M.V., Sura M.V., et al. Methodological recommendations for conducting a comparative clinical and economic evaluation of a medicinal product. Мoscow: Center for Healthcare Quality Assessment and Control; 2019: 44 pp. (in Russ.).
5. Omelyanovskiy V.V., Avxentyeva M.V. (Eds) Health technology assessment. Мoscow: Nauka; 2025: 389 pp. (in Russ.).
6. Vorobyev P.A. (Ed.) Clinical and economic analysis. 3rd ed. Мoscow: Nyudiamed; 2008: 778 pp. (in Russ.).
7. Rebrova O.Yu., Gusev A.V. Sample size calculation for clinical trials of medical decision support systems with binary outcome. Modern Technologies in Medicine. 2022; 14 (3): 6–14 (in Russ.). https://doi.org/10.17691/stm2022.14.3.01.
8. Ar’kova E.S., Luchinin E.A., Kornilova E.B., et al. Key recommendations for assessing medical devices: new in HTA. In: Proceedings of the Research Institute of Healthcare Organization and Medical Management: a collection of scientific papers. Мoscow: Research Institute of Healthcare Organization and Medical Management; 2021: 85–90 (in Russ.).
9. Fletcher R.H., Fletcher S.W., Wagner E.H. Clinical epidemiology: the essentials. Williams & Wilkins; 1996: 276 pp.
10. Guyatt G., Rennie D. Users' guides to the medical literature: a manual for evidence-based clinical practice. Amer Medical Assn; 2002: 672 pp.
11. Rebrova O.Yu. Statistical analysis of medical data. Using the Statistica software package. Мoscow: Media Sfera; 2006: 305 pp. (in Russ.).
Review
For citations:
Omelyanovskiy V.V., Gorkavenko F.V., Ryagina V.A., Rukavitsyna N.P., Morozov D.Yu., Sorokovikov I.V., Svetlov V.V. Basic approaches to assessment of digital health products and services in the Russian Federation. FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology. 2025;18(4):473-482. (In Russ.) https://doi.org/10.17749/2070-4909/farmakoekonomika.2025.349
Views:
62
JATS XML
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
Email this article 