Analysis of the legal regulation of the healthcare digital transformation and the implementation of medical information systems in pharmaceutical services of the population

Abstract

In the context of active digital transformation of national healthcare, special attention is paid to the implementation of medical information systems, in particular in the activities of pharmacies. In this regard, the legal regulation of their functioning, unification of technical and functional requirements, as well as ensuring an appropriate level of protection of the personal and medical data are of particular importance.

Aim. To conduct a comprehensive analysis of the legal regulation of the digital transformation of the Ukrainian healthcare system and the introduction of medical information systems into pharmaceutical services to the population with the identification the stages of the legal support formation and problematic aspects of its further development.

Materials and methods. The materials for the study were the current normative legal acts of Ukraine that regulate the functioning of the electronic healthcare system and medical information systems placed in the official database of legislation, as well as documents of international organizations in the field of digital healthcare. To conduct the study, methods of analysis and synthesis were used in order to identify and generalize key legal provisions regarding the functioning of the electronic healthcare system and medical information systems. The historical approach made it possible to determine the sequence of the formation of the legal regulation and the main stages of the development of the electronic healthcare system. The systemic approach was applied to consider the electronic healthcare system as an integral digital healthcare infrastructure and determine the role of medical information systems in its structure. Grouping and classification methods were used to systematize regulatory legal acts according to certain criteria. The comparative legal method was used to identify consistency and gaps in the legal regulation. The content analysis was used to meaningfully process regulatory requirements for the architecture of the electronic healthcare system, the functioning of medical information systems, and the protection of personal data.

Results and discussion. As a result of the analysis of regulatory acts, it has been found that the development of the legal regulation of the electronic healthcare system is phased and includes four main stages: the formation of legal and informational bases; the formation of the state policy in the field of electronic healthcare; regulatory design of the architecture, the launch of a central database and the connection of medical information systems; the implementation and scaling of functional components of the electronic healthcare system, and improving the protection of personal data. It has been determined that the National Health Service plays a key institutional role in regulating the activities of medical information systems, and the introduction of technical requirements contributed to the standardization of work with electronic prescriptions and the integration of pharmacies into a single digital space. At the same time, the fragmentation of the legal regulation of medical information systems has been revealed, which determines the need for further unification of technical requirements and strengthening the information security.

Conclusions. The necessity of further improvement of the legal regulation of the activities of medical information systems in pharmacy institutions by unifying technical and functional requirements, introducing mechanisms for certification and software quality control, and strengthening information and cybersecurity standards has been substantiated.