Italy’s Artificial Intelligence Act and Global AI Governance: The EU Model’s Practice and Prospects

Abstract

The Italian Artificial Intelligence Act, enacted on September 17, 2025, represents the first comprehensive national implementation of the European Union’s AI Act. This study examines the Italian legislation through the theoretical lens of multi-level governance, analyzing its dual function as both a “bridging legislation” that translates EU framework into domestic practice and a site of significant regulatory innovation. Through detailed textual analysis and case studies, particularly in healthcare AI, this research investigates how Italy has navigated the complex interplay between supranational standardization and national specificity. The findings reveal that Italy has not merely passively transposed the EU AI Act but has actively engaged in “normative localization,” refining the risk-based approach with distinctive national characteristics—such as stringent safeguards for cultural heritage and tailored provisions for small and medium enterprises. The study further explores Italy’s creation of a coordinated regulatory architecture involving multiple existing authorities and its development of a multi-layered enforcement regime that innovatively combines administrative, civil, and criminal liabilities. The Italian approach demonstrates a sophisticated balancing of legal certainty through clear prohibitions and regulatory flexibility through adaptive tools like regulatory sandboxes. This analysis contributes to theoretical understanding of implementation dynamics in multi-level governance systems and offers practical insights for other jurisdictions developing AI governance frameworks. The Italian experience suggests that effective AI governance requires both principled foundation and contextual adaptation, providing valuable lessons for global AI governance amid ongoing technological evolution and regulatory competition.