Introduction. The article proposes a conceptual and methodological framework that interprets a healthcare facility (HCF) as an integrated cyber-physical system of clinical engineering, where buildings, structures, and engineering-medical/resource systems are considered through the lens of operational suitability throughout the entire life cycle.
Problem Statement. In Ukraine, there is no unified interagency regulatory framework for maintaining the operational suitability of the clinical environment aligned with European practice, which complicates ensuring the safety, reliability, and quality of medical processes.
Objective. To develop a methodology of “BIM / digital engineering → technical management → operational suitability” and to outline the composition and structure of the “Rules for ensuring and maintaining the operational suitability of clinical environment facilities in healthcare institutions” in the context of European integration.
Materials and Methods. Conceptual modelling of systems engineering, a review of international clinical engineering practices (Joseph Dyro et al.), analysis of current and draft state building codes and sanitary regulations, ISO 9000 procedures, approaches to digital operational engineering (CMMS / CAFM, BMS / BAS), and risk management.
Results. A system-structural model of the clinical environment (medical-engineering and resource sub-environments), a classification of operational characteristics, the organization of technical management, and the content of interagency “Rules” are proposed. Integration with the European synergistic strategy “Joint Action on Strengthening Health” and the UN Sustainable Development Goals is demonstrated.
Conclusions. The transition to formally established technical management and digital operational engineering is a necessary condition for the safe, energy-efficient, and controllable operation of healthcare facilities, as well as a key to harmonization with European and international clinical engineering practices.
