Compliance System as an Element of Strategic Management of Healthcare Institutions

Posted on by adminLeave a comment

Prof. O. Serdiuk, assoc. prof. N. Prosolenko, assoc. prof. I. Parfonova, assoc. prof. V. Krupenia, assoc. prof. H. Holovanova

Institute of Postgraduate Education Kharkiv National Medical University, The Department of Social Medicine, Organisation and Management in Healthcare

The article examines the essence of compliance management as an element of strategic management of healthcare institutions in the context of increasing regulatory requirements, digitalization and increased risks. It is substantiated that compliance is transformed from a control tool into a comprehensive management system aimed at ensuring that the organization’s activities comply with legislative, professional and ethical standards.

The main scientific approaches to the interpretation of compliance management are analyzed, in particular normative, risk-oriented, strategic and value-based, which allows us to determine its multidimensional nature. The key components of compliance in healthcare are identified: normative, clinical, digital and ethical.

It is proven that the integration of compliance into the strategic management system contributes to improving the quality of medical services, reducing risks and building trust on the part of patients and stakeholders. A model of compliance management integration is proposed, which includes strategic, organizational, process, digital and cultural levels.

The main implementation problems are identified, in particular, resource constraints, staff shortages and insufficient digital maturity. Modern trends in compliance development are outlined, including digitalization, integration with risk management and patient orientation. Practical recommendations are provided for the implementation of compliance systems in healthcare institutions.

Key words: compliance management, strategic management, healthcare, risk management, digitalization, healthcare institutions

https://doi.org/10.15407/internalmed2026.01.092

Download.PDF (ukr)

Cite:

Сердюк, О.І. Система комплаєнсу як елемент стратегічного управління закладами охорони здоров’я / О.І. Сердюк, Н.В. Просоленко, І.І. Парфьонова, В.І. Крупеня, Г.Є. Голованова // Східноєвропейський журнал внутрішньої та сімейної медицини. — 2026. — № 1. — С. 92-99. doi: 10.15407/internalmed2026.01.092

Serdiuk O, Prosolenko N, Parfonova I, Krupenia V, Holovanova H. Systema komplaiensu yak element stratehichnoho upravlinnia zakladamy okhorony zdorovia [Compliance system as an element of strategic management of healthcare institutions]. Shidnoevr. z. vnutr. simejnoi med. 2026;1:92-99. Ukrainian. doi: 10.15407/internalmed2026.01.092

References:

  1. Alqahtani FS, Alshammari AM, Alenezi MM. Impact of governance, risk management and compliance on healthcare systems: a systematic review. Healthcare. 2025;13(5):412-425.

  2. Barbaria S, Jemai A, Ceylan Hİ, Muntean RI, Dergaa I, Boussi Rahmouni H, et al. Advancing Compliance with HIPAA and GDPR in Healthcare: A Blockchain-Based Strategy for Secure Data Exchange in Clinical Research Involving Private Health Information. Healthcare. 2025;13(20):2594. https://doi.org/10.3390/healthcare13202594

  3. Song X, Li J. Strategizing data compliance in intelligent healthcare systems. Front Public Health. 2025;13:142516.

  4. Tsague MS, Mbapah LT, Teuwafeu DG, Jabbossung FE, Etaka ST, Ngunjoh NF, et al. Compliance with infection prevention and control standard precautions and associated factors among healthcare workers in four health facilities in Fako division, Cameroon. BMC Health Serv Res. 2025;25(1):596. https://doi.org/10.1186/s12913-025-12594-z

  5. Rodeck D. The Future of Healthcare HR: Workforce & Compliance Trends for 2025 [Internet]. ADP Spark; 2025 [cited 2026 May 15]. Available from: https://www.adp.com/spark/articles/2025/03/the-future-of-healthcare-hr-workforce-compliance-trends-for-2025.aspx

  6. Senbato FR, Wolde D, Belina M, et al. Compliance with infection prevention and control standard precautions and factors associated with noncompliance among healthcare workers working in public hospitals in Addis Ababa, Ethiopia. Antimicrob Resist Infect Control. 2024;13:32. https://doi.org/10.1186/s13756-024-01381-w

  7. Deloitte Insights. Compliance in healthcare: trends, challenges and opportunities [Internet]. Deloitte; 2024 [cited 2026 May 15]. Available from: https://www2.deloitte.com

  8. European Commission. EU4Health Programme: compliance and governance in healthcare [Internet]. Brussels: European Commission; 2021 [cited 2026 May 15]. Available from: https://health.ec.europa.eu/funding/eu4health-programme-2021-2027-vision-healthier-european-union_en

  9. EY. Risk and compliance in healthcare organizations [Internet]. EY Consumer Health Survey; 2023 [cited 2026 May 15]. Available from: https://www.ey.com/en_gl/insights/health/ey-consumer-health-survey-2023

  10. International Organization for Standardization. ISO 31000:2018 Risk management — Guidelines. Geneva: ISO; 2018.

  11. International Organization for Standardization. ISO 37301:2021 Compliance management systems — Requirements with guidance for use. Geneva: ISO; 2021.

  12. OECD. Health at a Glance 2023: OECD Indicators. Paris: OECD Publishing; 2023.

  13. Oskrochi Y, Patel V. Digital health technology compliance and risk management frameworks. J Med Internet Res. 2025;27:e58214. https://doi.org/10.2196/80076

  14. Porter ME. Competitive strategy: techniques for analyzing industries and competitors. New York: Free Press; 2008.

  15. PwC. Moving faster: Reinventing compliance to speed up, not trip up [Internet]. PwC Ukraine Survey; 2025 [cited 2026 May 15]. Available from: https://www.pwc.com/ua/en/survey/2025/compliance-2025.html

  16. Risk management and compliance in healthcare project delivery: lessons from West Africa [Internet]. ResearchGate; 2025 [cited 2026 May 15]. Available from: https://www.researchgate.net/publication/397100602

  17. Transparency International. Corruption risks in healthcare systems [Internet]. Transparency International; 2022 [cited 2026 May 15]. Available from: https://www.transparency.org

  18. Gilson L, Agyepong I. Strengthening health system leadership for better governance: What does it take? [Internet]. ResearchGate; 2018 [cited 2026 May 15]. Available from: https://www.researchgate.net/publication/326388915

  19. Zaiarnyi O. Cyber risk management in healthcare organizations: modern challenges. Baltic J Econ Stud. 2025;11(2):85-93. https://doi.org/10.30525/2256-0742/2025-11-1-95-103