Principles of medical care standards development based on clinical guidelines

Objective: to review legislative and regulatory legal acts and other documents and consider the changing requirements for the development of medical care standards and the current standard form, to determine the key principles and methodology for the development of medical care standards based on clinical guidelines.

Material and methods. The article reviews the provisions of the Federal Law of November 21, 2011, No. 323-FZ “On fundamentals of health care in the Russian Federation”, which establishes the requirements for the development of medical care standards. A review of the procedure for the development of standards (Orders of the Ministry of Health of the Russian Federation (MH RF) of February 8, 2018, No. 53n and of February 22, 2022, No. 103n) was conducted. The form of the medical care standard was considered based on the example of the medical care standards approved in 2021–2022. A review of methodological materials regulating the development of medical care standards based on clinical guidelines was performed.

Results. The procedure for developing medical care standards was first regulated in 2018. The participants of the process (MH RF departments, MH RF chief external specialists, Center for Expertise and Quality Control of Medical Care), their functions, and the stages and terms of development are regulated. The methodology for the development of medical care standards based on clinical guidelines involves the formation of standardized modules of medical care and a mathematical model.

Conclusion. Currently, the process of developing medical care standards based on clinical guidelines is regulated and the methodology is defined. However, there are still issues that require additional regulation, such as the standard form, the methodology of medical and economic evaluation.

1. Federal Law of 21.11.2011 No. 323-FZ “On the basics of public health protection in the Russian Federation”. Available at: http://www.consultant.ru/document/cons_doc_LAW_121895/ (in Russ.) (accessed 10.11.2022).

2. Naigovzina N.B., Filatov V.B., Borozdina O.A., Nikolaeva N.A. Standardization in healthcare. Overcoming contradictions of legislation, practice, ideas. Мoscow: GEOTAR-Media; 2015: 208 pp. (in Russ.).

3. Kovaleva M.Y., Sukhorukikh O.A. Clinical guidelines. History of creation and development in the Russian Federation and abroad. Remedium. 2019; 1–2: 6–14 (in Russ.). https://doi.org/10.21518/1561-5936-2019-1-2-6-14.

4. Ledovskikh Yu.A., Semakova E.V., Avksent’eva M.V. The state guarantees program of free medical care: approaches to standardize the costs of medical care. FARMAKOEKONOMIKA. Sovremennaya farmakoekonomika i farmakoepidemiologiya / FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology. 2017; 10 (4): 53–60 (in Russ.). https://doi.org/10.17749/2070-4909.2017.10.4.053-060.

5. Starodubov V.I., Efremova T.A., Korobov N.V., Loshakov L.A. The medical care standards in health care system of Russia: condition and prospects. Zdravookhraneniye Rossiyskoy Federatsii. 2015; 59 (4): 4–9 (in Russ.).

6. Order of the Ministry of Health of the RF of 13.10.2017 No. 804n “On approval of the nomenclature of medical services”. Available at: http://www.consultant.ru/document/cons_doc_LAW_282466/ (in Russ.) (accessed 10.11.2022).

7. Federal Law of 29.07.2017 No. 242-FZ “On amendments to certain legislative acts of the Russian Federation on the use of information technologies in the field of health protection”. Available at: http://www.consultant.ru/document/cons_doc_LAW_221184/ (in Russ.) (accessed 10.11.2022).

8. Order of the Ministry of Health of the RF of 08.02.2018 No. 53n “On approval of the procedure for developing standards of medical care”. Available at: http://www.consultant.ru/document/cons_doc_LAW_299614/ (in Russ.) (accessed 10.11.2022).

9. Order of the Ministry of Health of the RF of 28.06.2019 No. 472n “On amendments to the procedure for developing standards of medical care, approved by Order of the Ministry of Health of the Russian Federation of February 8, 2018 No. 53n”. Available at: http://www.consultant.ru/document/cons_doc_LAW_333473/ (in Russ.) (accessed 10.11.2022).

10. Order of the Ministry of Health of the RF of 22.02.2022 No. 103n “On approval of the procedure for developing standards of medical care”. Available at: http://www.consultant.ru/document/cons_doc_LAW_418539/ (in Russ.) (accessed 10.11.2022).

11. Decree of the Government of the RF of 31.12.2018 No. 3053-r “On approval of the list of medical devices implanted into the human body when providing medical care under the program of state guarantees of free medical care to citizens, as well as the list of medical devices dispensed by prescription for medical devices when providing a set of social services”. Available at: http://www.consultant.ru/document/cons_doc_LAW_315495/ (in Russ.) (accessed 10.11.2022).

12. Resolution of the Government of the RF of 22.06.2019 No. 797 “On approval of the rules for procurement, storage, transportation and clinical use of donated blood and its components and on invalidation of certain acts of the Government of the Russian Federation”. Available at: http://www.consultant.ru/document/cons_doc_LAW_328029/ (in Russ.) (accessed 10.11.2022).

13. Methodological recommendations for the development of draft standards of medical care (new edition). FSBI "Center for Healthcare Quality Assessment and Control" of the Ministry of Health of the RF. 2022. Available at: https://rosmedex.ru/standarts (in Russ.) (accessed 10.11.2022).

14. Ledovskikh Y.A., Semakova E.V., Omelyanovskiy V.V. Methodology for the development of diagnosis related groups based on clinical guidelines using standardized modules of healthcare. Medical Technologies. Assessment and Choice. 2019; 3: 8–15 (in Russ.).