The Legal Framework of Artificial Intelligence in the European Union: Regulation, Liability, and Sectoral Challenges.

Abstract

This paper provides a systematic analysis of the emerging legal profiles in the artificial intelligence ecosystem, structured along three interdependent conceptual axes. Firstly, it examines the multi-level regulatory framework taking shape in the European Union. The EU Regulation 2024/1689 is critically explored in its risk-based approach, with particular attention to the categories of high-risk AI systems. The synergies and tensions with the legal framework governing data circulation in the Union are analyzed, with a profound influence in terms of compliance on data-driven technologies. This includes the EU Regulation 2016/679, which directly addresses crucial issues such as automated decisions and profiling; the EU Regulation 2022/868 on data altruism mechanisms and the reuse of public data; the EU Regulation 2023/2854, which introduces rules related to accessing data generated, among others, by IoT and industrial devices, as well as the EU Regulation 2025/327. Secondly, the complex issue of AI liability is evaluated, in the dual dimension of and safety. Particular attention will be paid to the now dismissed EU regulatory proposals. A specific focus will deal with the possible applicability of the product liability discipline. Finally, several sectoral criticalities are identified through case studies in healthcare and transport domains, evaluating for each the difficult balance between potential benefits and risks from algorithmic biases and systemic discrimination. The methodology combines dogmatic analysis, legal comparison, and concrete case studies, contributing to the debate on harmonization between technological innovation, protection of fundamental rights and sustainable legal governance models in the AI era.