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Background: This study correlates the up-to-date ethical, functional and legal evaluations related to the management and governance of artificial intelligence (AI) under European Union (EU) law, particularly impacting the health data sector and medical standards as provided by the Artificial Intelligence Act within the Regulation adopted by the European Council in May 2024. The initial proposal for the management and governance of the AI sector was submitted in April 2021. Three years later, on 13 March 2024, the European Union Artificial Intelligence Act (EU AIA) was adopted by the European Parliament. Subsequently, on 21 May 2024, the Council adopted an innovative legislative framework that harmonises the standards and rules for AI regulation. This framework is set to take effect in May 2026, with the central objective of stimulating and motivating a fair, safe, legal single market that respects the principles of ethics and the fundamental rights of the human person. Methods: The current legal analysis focuses on the European Union’s new institutional governance involving a multistage approach to managing health data, ethical artificial intelligence, generative artificial intelligence and classification of types of AI by considering the degree of risk (e.g. artificial intelligence systems with limited risk and systems with high risk) and medical devices. It outlines the legal framework for AI regulation and governance in the EU by focusing on compliance with the previously adopted legislation in the Medical Devices Regulation (2017) and the In-Vitro Diagnostic Regulation (2017). The paper also examines the application of the newly adopted EU Artificial Intelligence Act in relation to national justice systems, previous EU regulations on medical devices and personal data protection regulation, and its correlation with the European Court of Human Rights jurisprudence. This opens up complex discussions related to judicial reform and access to justice. For this purpose, as a research objective, the legal analysis includes an innovative perspective following an integrative discussion on the latest legal reforms and regulations of the AI sector in Eastern Europe launched in 2024 with a special focus on the latest developments in the EU Candidate Countries namely Ukraine and the Republic of Moldova. Results and conclusions: The present research facilitates the exploration of the real benefits of managing innovative AI systems for medical data, research, and development, as well as within the medical technology industry.
Anca Parmena Olimid (Mon,) studied this question.