Security Regulation of the Digital Transformation of the Healthcare System in the European Union
Year: 2024
Type: article
Abstract: The article examines the specific features of regulating the security of the digital transformation process of the healthcare system in the European Union and identifies areas for applying European regulatory and legal experience in Ukraine. The relevance of the study is determined by the active digitalization of the healthcare sector, the growing cyber threats to healthcare digital infrastructure, and the need to adapt national legislation to EU law in the context of Ukraine’s European integration. The security of digital transformation is considered as a comprehensive category encompassing the security of medical devices and diagnostic devices, cybersecurity of medical information systems, and the protection of data, digital infrastructure, personnel, suppliers, and recovery processes. A political and legal analysis of key European Union legal acts was conducted, including Regulations (EU) 2017/745 (MDR), 2017/746 (IVDR), 2019/881 (Cybersecurity Act), Directive (EU) 2022/2555 (NIS2), and Regulation (EU) 2024/2847 (Cyber Resilience Act). The main security mechanisms were identified, including risk-based classification, strengthened requirements for clinical and technical evidence, traceability of medical devices, post-market surveillance, cybersecurity certification, cyber risk management, incident reporting, and ensuring the cyber resilience of digital products throughout their life cycle. The complementary nature of the analyzed regulatory acts, which together form an integrated system for regulating the security of digital healthcare, has been established. It is substantiated that the adaptation of European requirements in Ukraine should be carried out through substantive convergence of legislation rather than mechanical copying of legal provisions. Priority areas include strengthening the institutional capacity of state regulators, expanding the network of accredited conformity assessment bodies and testing laboratories, training qualified personnel, digitalizing regulatory procedures, and introducing a proportionate risk-based approach. It is demonstrated that, under martial law, uninterrupted access to medical devices, critical diagnostics, and secure digital services constitutes an essential component of Ukraine’s national security.
Author: Dmytrenko, Ihor
Institution: Zhytomyr Polytechnic State University
Language: English
Subfield: Law
Field: Social Sciences
Domain: Social Sciences
Open Access status: green
OpenAlex ID: W7204613019