Italy Leads Europe with New AI Legislation

Italy Enacts Comprehensive Artificial Intelligence Law, Effective October 2025

Italy has taken a pioneering step in artificial intelligence (AI) regulation by adopting its first comprehensive national AI law, officially published as Law No. 132 of 2025. The legislation was approved by the Italian Senate on September 17, 2025, signed into law on September 23, and will come into force on October 10, 2025. This law positions Italy as the first European Union (EU) member state to enact a detailed national regulatory framework addressing AI, complementing the broader EU Artificial Intelligence Act (AI Act) set to govern AI across the continent.

Key Features of Italy's AI Law

The Italian AI Law incorporates 28 articles divided into six chapters, establishing a wide-ranging framework that covers general AI principles, sector-specific rules, governance, and enforcement mechanisms.

• Complementing the EU AI Act: The law is designed to align with and supplement the EU AI Act (Regulation EU 2024/1689), reflecting Italy’s commitment to harmonize its national rules with European standards while addressing specific national contexts and regulatory needs.

• Designation of Competent Authorities: Two key agencies are tasked with oversight:

  • The Agency for Digital Italy (AgID) serves as the notifying authority, responsible for notification procedures, assessment, accreditation, and monitoring of AI systems and notified bodies.
  • The National Cybersecurity Agency (ACN) acts as the market surveillance authority, overseeing compliance, enforcement, and supervision in the AI market.

• National AI Strategy: The law introduces a national AI strategy updated biennially by the Interministerial Committee for Digital Transition, supported by the Department for Digital Transformation under the Presidency of the Council of Ministers. This strategy will guide policymaking and regulatory evolution for AI in Italy.

• Sector-Specific Provisions:

  • In healthcare and scientific research, AI can be used as a support tool but cannot replace human decision-making. AI cannot be used to discriminate or determine access to treatment, ensuring the primacy of human responsibility and ethical oversight. Public and private non-profit research is recognized as being of significant public interest, allowing the processing of personal data without consent, under strict ethical committee approval and notification to the Italian Data Protection Authority (Garante).
  • The labor and justice sectors are also explicitly regulated, emphasizing accountability for AI “deployers” and linking AI oversight with existing data protection measures (such as Data Protection Impact Assessments and privacy by design).
  • Additional provisions apply to sectors including education, government services, and sports, reflecting a broad scope aimed at safeguarding democratic and social rights.

• Accountability and Transparency: The law strengthens organizational controls and prioritizes transparency, including the right for individuals to be informed when AI tools affect them, especially in critical areas like healthcare.

Context and Implications

Italy's AI law marks a significant milestone in AI governance within the EU. While the EU AI Act establishes a continent-wide legal framework, Italy’s national law caters to specific domestic concerns, addressing gaps and clarifying obligations delegated to member states under the EU regulation. This dual regulatory environment means businesses and public entities in Italy will need to navigate overlapping rules, with some provisions of the EU AI Act already in effect and others becoming operational in 2026.

The law’s introduction signals Italy’s ambition to lead in responsible AI development and deployment, balancing innovation with ethical considerations and citizen protections. It reflects careful incorporation of feedback from the Italian Data Protection Authority (Garante) and the European Commission, which called for greater consistency with the EU AI Act and a more open stance towards AI use.

For companies and public bodies operating in Italy, the legislation introduces new compliance requirements related to AI system notification, risk management, and monitoring by designated authorities. The focus on sectors like healthcare and labor underscores the government’s intent to ensure AI’s role supports human-centered decision-making and protects fundamental rights.

Challenges and Next Steps

While the Italian law lays foundational rules, many operational details and sector-specific guidelines require further development. Authorities will need to issue implementing regulations and guidance to clarify compliance processes, especially regarding the interaction with EU-level rules.

Public and private operators must prepare for a transitional phase marked by regulatory uncertainty as they adapt to the combined Italian and EU AI frameworks. This includes aligning internal governance, enhancing transparency measures, and engaging with the newly designated oversight bodies.

Visual Representations

Images related to this topic could include:

• The official logo of the Agency for Digital Italy (AgID) and the National Cybersecurity Agency (ACN), highlighting the authorities responsible for AI oversight.
• Photographs of the Italian Senate during the September 2025 session approving the law.
• Infographics illustrating the scope of the law’s sectoral applications (healthcare, labor, justice).
• Visuals of AI technology use in healthcare or government services in Italy to contextualize the law’s impact.

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Italy’s adoption of Law No. 132/2025 on artificial intelligence sets a precedent for national AI governance in Europe, emphasizing ethical AI deployment, transparency, and alignment with EU regulations, with implementation starting from October 2025.