On September 23, 2025, the Parliament approved Law No. 132, titled “Provisions and Delegations to the Government on Artificial Intelligence”, which had been introduced by the Government on May 20, 2024, and aims to regulate the development and use of artificial intelligence (AI) within the Italian legal system.
Italy – Law No. 1146/2025: Provisions and Delegations to the Government on Artificial Intelligence
23 settembre 2025
Numero
132
The law, which is divided into six chapters, introduces several principles and rules concerning the research, experimentation, development, adoption, and application of AI systems and models. Its goal is to promote a responsible, transparent, and fair use of AI within a human-centered framework that allows the country to benefit from the opportunities offered by AI. In this regard, the law ensures oversight of the economic risks and impacts of AI on fundamental rights, and it must be interpreted and applied in accordance with Regulation (EU) 2024/1689.
Chapter I defines the general principles to be respected in the development and use of AI, including respect for fundamental rights protected by the Constitution and the European Union, fairness, reliability, safety, quality, appropriateness, proportionality with respect to the sector of use, human autonomy, harm prevention, transparency, explainability, equality, sustainability, cybersecurity, protection of the democratic process, and full accessibility of AI systems to persons with disabilities (Article 3).
The use of AI systems must also respect freedom and pluralism of the media, freedom of expression, impartiality and integrity of information, as well as citizens’ privacy, ensuring the lawful, fair, and transparent processing of personal data in accordance with EU law. The law further provides that information and communications related to data processing must be conveyed in clear and simple language, to ensure that users are aware of potential risks and can exercise their right to object to authorized data processing (Article 4).
Regarding minors’ access to AI technologies, the law establishes that parental consent is required for children under 14, while minors aged 14 to 18 may give their own consent to personal data processing, provided the information is easily accessible and understandable (Article 4). The bill also lays out specific principles to promote economic development in the AI sector (Article 5) and provisions concerning the use of AI for security and national defense purposes (Article 6).
Chapter II of Law No. 132 includes specific sectoral provisions for the use of AI in healthcare (Articles 7 and 10), personal data processing (Article 9), employment (Articles 11 and 12), intellectual professions (Article 13), public administration (Article 14), the judicial system (Article 15), and national cybersecurity (Article 18). The law also grants the Government the power to adopt, within twelve months of its entry into force, a comprehensive regulatory framework on the use of data, algorithms, and mathematical methods for AI training, without imposing additional obligations on sectors already covered by Regulation (EU) 2024/1689.
In exercising this delegation, the Government must identify the cases requiring a legal framework for the use of data, algorithms, and mathematical methods for AI training, provide for remedies (compensatory or injunctive) and a sanctions system, and assign jurisdiction over related disputes to the specialized business courts (Article 16). Furthermore, Chapter II amends Article 9 of the Code of Civil Procedure, establishing that cases concerning the functioning of AI systems fall under the exclusive jurisdiction of the courts (Article 17).
Specifically with regard to the use of AI in the healthcare sector, Article 7 affirms that AI must serve as a support tool for prevention, diagnosis, and treatment, without ever replacing the autonomous decision-making of medical professionals. The patient remains central: individuals must be informed of the use of AI in their care.
Importantly, the Article prohibits the use of AI systems in ways that could discriminate or condition access to healthcare services. It also promotes the development of AI technologies that enhance autonomy, accessibility, and inclusion for persons with disabilities.
The provision further emphasizes the need for technical reliability, mandating regular updates and verification of both systems and data to reduce risks and enhance patient safety. In this way, Article 7 seeks to strike a balance between technological innovation and the protection of human dignity, equality, and trust in the clinical context.
In addition, Art. 8 establishes certain rules for scientific research and experimentation aimed at developing AI systems for medical purposes (prevention, diagnosis, treatment), drug development, health and healthcare safety, as well as the study of human physiology, biomechanics, and biology, Specifically, it provides that data processing for such purposes by public and non-profit private entities, scientific hospitalization and treatment institutes, and private entities operating in the healthcare sector within the context of research projects involving the institutions must be declared of significant public interest. As such, the secondary use of personal data, including sensitive data, is always permitted provided that the data lacks directly identifiable elements and that data subjects are adequately informed, including by means of a general notice published online. Such data processing must be approved by the relevant ethics committees and communicated to the Data Protection Authority.
Chapter III provides that the national AI strategy shall be drafted and updated by the Presidency of the Council of Ministers, specifically by the office responsible for technological innovation and digital transition, in cooperation with the National Authorities for Artificial Intelligence, and in line with international humanitarian law. The strategy aims to foster collaboration between public administrations and private entities (Article 19). Article 20 designates the Agency for Digital Italy (AgID) and the National Cybersecurity Agency (ACN) as the national authorities responsible for implementing national and EU AI regulations.
The law also provides specific funding for the experimental use of AI systems in services offered by the Ministry of Foreign Affairs and International Cooperation (Article 21), investments in AI, cybersecurity, and quantum computing (Article 23), and support measures for youth and sports regarding AI skills and use (Article 22). Finally, the Government is delegated to adopt, within twelve months, legislative decrees to align national legislation with the AI Act and to specify the rules on the unlawful creation and use of AI systems (Article 24).
Chapter IV amends copyright law, extending protection to works of human creativity “even when created with the aid of artificial intelligence tools, provided they result from the author’s intellectual effort”, and introduces a new Article 70-septies in Law No. 633 of April 22, 1941 (Article 25).
Chapter V amends certain provisions of the Criminal Code, including the introduction of Article 612-quater, which penalizes the distribution of deepfakes that cause unjust harm to the person depicted (Article 26).
Chapter VI contains the financial and final provisions.
The law is available at the following link and in the download box.
Marta Fasan - Sergio Sulmicelli
Pubblicato il: Martedì, 23 Settembre 2025 - Ultima modifica: Mercoledì, 05 Novembre 2025
