Italy Enacts National AI Law Effective October 2025
Italy officially passes its first national artificial intelligence legislation, introducing complementary rules to the EU AI Act that take effect this October. The new framework specifically targets high-impact sectors like healthcare while delegating further rulemaking to the government.
Italy officially establishes its first national regulatory framework for artificial intelligence as the Italian Senate approves Bill No. 1146-B, now published as Law No. 132 of 2025. The new Italian AI Law takes effect on October 10, 2025, and contains 28 articles divided into six chapters that cover fundamental principles, national strategies, rights protection, and international cooperation. Rather than creating entirely new obligations, this legislation provides complementary provisions to the existing EU AI Act to address specific national contexts.
Unlike the EU's broad, risk-based approach, the Italian framework targets specific sectors of particular relevance, with healthcare standing out as a primary focus. Under the new rules, developers and healthcare providers explicitly cannot use AI systems to select or condition access to medical services. Additionally, the law mandates that medical professionals inform patients when AI technologies play a role in their care and requires continuous performance monitoring to minimize the risk of algorithmic errors.
The final version of the law incorporates amendments from the Chamber of Deputies that ease certain technical constraints and refine control mechanisms. These changes aim to strengthen alignment with the broader European framework while expanding democratic and social guarantees for Italian citizens. Despite this important legislative milestone, experts note that the framework still requires further delegated powers and secondary legislation from the government to fully fill in the operational details.