Фармакоэкономика (Apr 2023)
Principles of medical care standards development based on clinical guidelines
Abstract
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.
Keywords
