Scientific Approaches and Contemporary Transformations in Public Healthcare Regulation Driven by Digitalization

Digital transformation in healthcare acts not merely as a technological update but as a pivotal factor in redefining the state's role as an architect of secure digital ecosystems. Amidst military challenges and pandemic threats in Ukraine, establishing a resilient regulatory design becomes a critical prerequisite for ensuring national security and protecting patient rights. The purpose of the article is to systematize contemporary scientific approaches to state healthcare regulation under digitalization and to identify strategic policy shifts in regulatory practice relevant to the national economy. The research aims to expose gaps between the rapid technical implementation of digital tools and their normative support. The work is based on a systemic-structural analysis of digitalization processes as a complex interaction of institutional and technological factors. The concept of "government as a platform" is applied, necessitating a fundamental transition from overseeing individual entities to governing through the architecture of rules and information flows. The main hypothesis posits that effective digital transformation requires a shift towards risk-oriented and service-oriented oversight based on evidence. It is assumed that in the Ukrainian context, the technical progress of the electronic healthcare system outpaces the state's institutional readiness to regulate emerging technologies, particularly artificial intelligence. The methodological framework comprises a systematic review of 24 relevant scientific sources from 2020–2026 and content analysis of regulatory acts. Comparative institutional analysis was utilized to contrast European Union standards with Ukrainian practices, alongside matrix methods for constructing strategic shift maps.During the research, theoretical approaches to smart regulation, platform governance, risk-orientation, data governance, and evidence-informed policy were summarized. Strategic shifts were identified in the domains of data management, interoperability, telemedicine, artificial intelligence, and cyber resilience. A comparative assessment of international frameworks from the WHO, OECD, and EU against national experience was conducted, revealing critical regulatory gaps. Proposals were formulated for transitioning from static administrative control to dynamic lifecycle monitoring of digital products. The author's "Shift-to-implementation" algorithm and a conceptual model for regulatory design in Ukraine's eHealth system were developed. The impact of martial law on accelerating digitalization was evaluated through the lens of the "war shift" concept. The theoretical significance lies in expanding scientific understanding regarding the evolution of regulatory paradigms in medicine driven by technological innovation. The necessity of integrated application of "privacy-by-design" principles and evidence-based feedback loops in industry management was proven. The practical value is defined by the applicability of the proposed "Gap-Risk-Response" matrix for prioritizing government reforms during the European integration process. The results can be utilized by public authorities when harmonizing national legislation with the requirements of the European Health Data Space. The scientific novelty consists of a comprehensive study of strategic policy shifts and the justification of validation mechanisms for algorithmic solutions as medical devices. The transition to risk-based supervision is substantiated as a key condition for ensuring digital infrastructure stability during wartime. Research limitations are related to high data volatility during the war period and limited access to complete private sector statistics. Type of article – theoretical.