Ледовских Юлия Анатольевна – к.м.н., начальник отдела методического обеспечения стандартизации
Хохловский пер., д. 10/5, Москва 109028
Yulia А. Ledovskikh – MD, PhD, Head of Department of Methodological Support of Standardization
10/5 Khokhlovskiy Aly, Moscow 109028
Тишкина Светлана Николаевна – заместитель начальника отдела методического обеспечения стандартизации
Хохловский пер., д. 10/5, Москва 109028
Svetlana N. Tishkina – Deputy Head of Department of Methodological Support of Standardization
10/5 Khokhlovskiy Aly, Moscow 109028
Пирова Гунель Ифтихаровна – главный специалист отдела методического обеспечения стандартизации
Хохловский пер., д. 10/5, Москва 109028
Gunel I. Pirova – Chief Expert, Department of Methodological Support of Standardization
10/5 Khokhlovskiy Aly, Moscow 109028
Семакова Евгения Васильевна – заместитель начальника отдела методического обеспечения стандартизации
Хохловский пер., д. 10/5, Москва 109028
Evgenia V. Semakova – Deputy Head of Department of Methodological Support of Standardization
10/5 Khokhlovskiy Aly, Moscow 109028
Омельяновский Виталий Владимирович – д.м.н., профессор, генеральный директор; руководитель Центра финансов здравоохранения; заведующий кафедрой организации здравоохранения и общественного здоровья с курсом оценки технологий здравоохранения; главный научный сотрудник отдела экономических исследований в здравоохранении
Хохловский пер., д. 10/5, Москва 109028
Настасьинский пер., д. 3, стр. 2, Москва 127006
ул. Баррикадная, д. 2, стр. 1, Москва 123995
ул. Воронцово поле, д. 12, стр. 1, Москва 105064
WoS ResearcherID: P-6911-2018; Scopus Author ID: 6507287753
Vitaliy V. Omelyanovskiy – Dr. Med. Sc., Professor, Director General; Head of Center for Healthcare Finance; Chief of Chair of Healthcare Organization and Public Health with a Course in Health Technology Assessment; Chief Researcher, Department of Economic Research in Healthcare
10/5 Khokhlovskiy Aly, Moscow 109028
3/2 Nastasyinskiy Aly, Moscow 127006
2/1 bldg 1 Barrikadnaya Str., Moscow 123242
12 bldg 1 Vorontsovo Pole Str., Moscow 105064
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.
The authors declare that there are no conflicts of interest present.