REGULATORY AND LEGAL FRAMEWORK FOR THE QUALITY OF MEDICAL SERVICES
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Keywords

law
regulatory framework
quality
medical services
healthcare facilities
healthcare

How to Cite

Pryimak, L. (2025). REGULATORY AND LEGAL FRAMEWORK FOR THE QUALITY OF MEDICAL SERVICES. Philosophy and Governance, (11(15). https://doi.org/10.70651/3041-248X/2025.11.03

Abstract

The healthcare reform in Ukraine, particularly amid current socio-economic and military challenges, necessitates the establishment of a comprehensive and effective regulatory and legal framework to guarantee the quality of medical services. Quality assurance is critical for increasing public trust, financial transparency, and the overall stability of the sector. Despite the significant number of legislative acts adopted, there is a clear need to systematically organize them and correlate them with the main quality assessment criteria. The study aims to analyze and classify the current regulatory and legal documents according to the key criteria for assessing the quality of medical services (Accessibility, Safety, and Effectiveness) and to define the organizational and legal measures that ensure healthcare facilities are prepared to operate in crisis conditions. This article presents a classification of regulatory and legal documents based on these criteria. Furthermore, measures to ensure the readiness of healthcare facilities to provide quality medical services to victims are defined. These measures include the temporary suspension of elective patient hospitalizations; the preparation of additional surgical teams; the provision of medical and social expert examination for adults and children using simplified and remote procedures; the organization of patient intake with signs of acute respiratory illness in separate areas with infection control compliance; and ensuring the full scope of emergency medical care provision. It is established that the organization of the healthcare system under this law is based on the principles of accessibility, quality, and effectiveness of medical services. Requirements for the organization of medical institutions, their material and technical support, and staffing policies are also defined. A comprehensive analysis has shown that the current regulatory framework provides the necessary basis for the functioning of the healthcare system on the principles of accessibility, quality, and efficiency. The systematization of documents according to quality criteria creates a clear tool for public administration, increasing the transparency of resource allocation and promoting the standardization of processes. Further efforts should be directed towards strengthening control over the practical implementation of these standards and their adaptation to dynamic challenges.

https://doi.org/10.70651/3041-248X/2025.11.03
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References

1. Zimenkovskyi, A. B. (2003). Systemnyi pidkhid do otsinky yakosti medychnoi dopomohy v period reformuvannia okhorony zdorov’ia v Ukraini [Systems approach to assessing the quality of medical care during the reform of healthcare in Ukraine]. Visnyk sotsialnoi hihiieny ta orhanizatsii okhorony zdorov’ia Ukrainy, (2), 42–45. (in Ukrainian)

2. Zakhidna, O. R., & Mydlyk, Yu. I. (2017). Medychna reforma v umovakh detsentralizatsii vlady v Ukraini [Healthcare reform in the context of decentralization of power in Ukraine]. Molodyi vchenyi, 11(51), 1155–1158. https://financial.lnu.edu.ua/wp-content/uploads/2015/11/278.pdf (in Ukrainian)

3. Nadiuk, Z. O., & Seniuk, Yu. I. (2020). Suchasna derzhavna polityka u sferi okhorony zdorov’ia: analiz reformuvannia systemy [Current state policy in the field of healthcare: Analysis of system reform]. Pravo ta derzhavne upravlinnia, (2), 211–220. https://doi.org/10.32840/pdu.2020.2.32 (in Ukrainian)

4. Barzylovych, A. D. (2021). Perspektyvy publichnoho upravlinnia rynku medychnykh posluh [Prospects for public management of the medical services market]. Publichne upravlinnia ta mytne administruvannia, 1(28), 5–10. https://doi.org/10.32836/2310-9653-2021-1.1 (in Ukrainian)

5. Ivanchov, P. V. (2021). Pravove rehuliuvannia transformatsii medychnoi systemy Ukrainy na rynkovykh zasadakh [Legal regulation of transformation of Ukrainian medical system on market basis]. Actual Problems in Economics, (235), 102–110. https://eco-science.net/wp-content/uploads/2021/09/1.21._topik_Ivanchov-P.V.-102-110.pdf

6. Shevchuk, R. (2023). Analiz normatyvno-pravovoho zabezpechennia u sferi okhorony zdorov’ia [Analysis of regulatory and legal security in the field of health care]. Scientific Works of Interregional Academy of Personnel Management. Political Sciences and Public Management, 1(67), 65–70. https://doi.org/10.32689/2523-4625-2023-1(67)-9 (in Ukrainian)

7. Lukovych, N. S. (2024). Zmist i sutnist medychnykh posluh v Ukraini v konteksti yevrointehratsii: administratyvno-pravovyi aspekt [The content and essence of medical services in Ukraine in the context of European integration: Administrative and legal aspects]. Dictum Factum, 1(15), 84–88. https://df.duit.in.ua/index.php/dictum/article/view/317 (in Ukrainian)

8. Volkova, Yu. (2024). Normatyvno-pravove zabezpechennia prav sub’iektiv pravovidnosyn u sferi nadannia medychnykh posluh [Regulatory and Legal Ensurement of The Rights of Subjects of Legal Relations in The Provision of Medical Services]. Pravnychyi chasopys of the Vasyl’ Stus Donetsk National University, (1), 23–31. https://doi.org/10.31558/2786-5835.2024.1.3 (in Ukrainian)

9. Goida, N., Moiseenko, R., Zhylka, N., Golubchikov, M., & Oktysiuk, Z. (2025). [Normatyvno-pravove zabezpechennia realizatsii derzhavnoi polityky v okhoroni zdorov’ia naselennia Ukrainy] Regulatory and Legal Support for the Implementation of State Policy in the Health Care of the Population of Ukraine. Family Medicine. European Practices, (2), 26–32. https://doi.org/10.30841/2786-720X.2.2025.331921 (in Ukrainian)

10. Dmitrenko, G. A., Semenets-Orlova, I. A., Mazur, Yu. V., & Dakal, A. V. (2025). Teoretyko-metodolohichni zasady rozbudovy normatyvno-pravovoho zabezpechennia derzhavnoho upravlinnia u sferi okhorony zdorov’ia [Theoretical and methodological principles of developing regulatory and legal support for public administration in the sphere of healthcare]. Public Management, 2(43), 50–58. https://doi.org/10.32689/2617-2224-2025-2(43)-6 (in Ukrainian)

11. European Parliament & Council of the European Union. (2011, March 9). Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (2011/24/EU). Official Journal of the European Union, L 88, 45–65. https://eur-lex.europa.eu/eli/dir/2011/24/oj

12. Verkhovna Rada of Ukraine. (1996, June 28). Constitution of Ukraine (Law No. 254к/96-ВР). https://zakon.rada.gov.ua/laws/show/254%D0%BA/96-%D0%B2%D1%80#Text

13. Verkhovna Rada of Ukraine. (1992, November 19). Fundamentals of the legislation of Ukraine on health care (Law No. 2801-XII). https://zakon.rada.gov.ua/laws/show/2801-12

14. Verkhovna Rada of Ukraine. (2022, September 6). On the public health system (Law No. 2573-IX). https://zakon.rada.gov.ua/laws/show/2573-20#Text

15. Verkhovna Rada of Ukraine. (1991, May 12). On protection of consumer rights (Law No. 1023-XII). https://zakon.rada.gov.ua/laws/show/1023-12

16. Verkhovna Rada of Ukraine. (2012, July 5). On emergency medical care (Law No. 5081-VI). https://zakon.rada.gov.ua/laws/show/5081-17#Text

17. Cabinet of Ministers of Ukraine. (2018, April 25). Some issues of the electronic healthcare system (Resolution No. 411). https://zakon.rada.gov.ua/laws/show/411-2018-%D0%BF

18. Ministry of Health of Ukraine. (2012, September 28). Procedure for monitoring the quality of medical care (Order No. 752). https://zakon.rada.gov.ua/laws/show/z1996-12

19. Verkhovna Rada of Ukraine. (2017, October 19). On state financial guarantees of medical services to the population (Law No. 2168-VIII). https://zakon.rada.gov.ua/laws/show/2168-19

20. Cabinet of Ministers of Ukraine. (2016, March 2). Approval of licensing conditions for conducting economic activities in medical practice (Resolution No. 285). https://zakon.rada.gov.ua/laws/show/285-2016-%D0%BF

21. Ministry of Health of Ukraine. (2013, September 9). Approval of the procedure for the application of assisted reproductive technologies in Ukraine (Order No. 787). https://zakon.rada.gov.ua/laws/show/z1697-13

22. Verkhovna Rada of Ukraine. (2015, March 2). On licensing of certain types of economic activities (Law No. 222-VIII). https://zakon.rada.gov.ua/go/222-19

23. Cabinet of Ministers of Ukraine. (2017, December 27). On the establishment of the National Health Service of Ukraine (Resolution No. 1101). https://zakon.rada.gov.ua/go/1101-2017-%D0%BF

24. Cabinet of Ministers of Ukraine. (2018, March 28). Approval of requirements for providers of medical services to the population with which chief managers of budgetary funds enter into contracts for medical services to the population (Resolution No. 391). https://zakon.rada.gov.ua/laws/show/391-2018-%D0%BF

25. Cabinet of Ministers of Ukraine. (2018, April 25). Contracts for medical services to the population under the medical guarantees program (Resolution No. 410). https://zakon.rada.gov.ua/laws/show/410-2018-%D0%BF

26. Ministry of Health of Ukraine. (2018, March 19). Approval of the procedure for selecting a doctor providing primary medical care and the form of declaration of selection of a doctor providing primary medical care (Order No. 503). https://zakon.rada.gov.ua/go/z0347-18

27. Verkhovna Rada of Ukraine. (2020, December 3). On rehabilitation in the healthcare sector (Law No. 1053-IX). https://zakon.rada.gov.ua/laws/show/1053-20

28. Ministry of Health of Ukraine. (2016, February 5). Organization of clinical-expert assessment of the quality of medical care and medical services (Order No. 69). https://zakon.rada.gov.ua/laws/show/z0285-16

29. Verkhovna Rada of Ukraine. (2020, September 30). On the safety and quality of donated blood and blood components (Law No. 931-IX). https://zakon.rada.gov.ua/laws/show/931-20#Text

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