Italy’s Comprehensive New AI Law

The Italian Law No. 132/2025 on rules applicable to AI systems and models (‘Italian AI Law’) took effect October 10, 2025. It aims to integrate and implement the broader European AI regulatory framework (EU AI Act) by establishing the responsibilities for AI governance and supervision in Italy, with specific provisions for core sectors as follows:

• Healthcare: AI may be used for prevention, diagnosis and treatment, but the final decision always remains with doctors. Patients must be informed about the use of AI.
• Research and clinical studies: Universities, IRCCS (Scientific Institutes for Research, Hospitalization and Healthcare) and other research bodies are encouraged to use AI in clinical research, including through the secondary use of anonymised personal data, in compliance with privacy laws (i.e., Article 8(2) of the Italian AI Law). Specifically, the Italian AI Law establishes conditions for reusing health data — once anonymized or pseudonymized — to support the development of AI systems in healthcare. This provision unlocks access to a wealth of information that is crucial for medical and scientific innovation, while respecting the principles of personal data protection.
• Intellectual Property (IP) and copyright: The Italian AI Law protects the copyright of works created with the aid of AI, provided they are the result of human intellectual work. It also introduces rules for the reproduction and extraction of data using AI.
• Criminal law: New criminal offences target the unlawful dissemination of AI-generated or altered content. Under The Italian AI Law, it is a crime to cause unfair damage to a person by transferring, publishing, or otherwise disseminating images, videos, or audio recordings that have been falsified or altered using artificial intelligence systems, without the individual’s consent. This also includes AI-generated or altered content that is likely to mislead others as to its authenticity.
• Employment law: AI may be used to improve working conditions, protect the physical and mental integrity of employees and increase the quality of work performance and productivity, while protecting the employees' dignity and privacy. Informing employees and customers about the use of AI is mandatory. The Italian AI Law establishes a National Observatory to monitor the impact of AI on the labour market and promote training.
• Knowledge-based professions: AI can only be used as an auxiliary and supporting tool, and does not replace the intellectual work of professionals, who must inform their clients about the use of such systems.
• Public administration: AI may be used to increase the efficiency of services, reduce the time required to complete procedures and increase the quality and quantity of services provided, but decisions remain a human responsibility.
• Judicial services: AI may support the administrative and logistical management of the courts, but any interpretative or applicative decisions, factual assessments and the adoption of measures are reserved to the judge.
• Security and defence: The use of AI in national security, cybersecurity, and defence activities is excluded from the scope of the law but must still respect fundamental rights.

The Italian AI Law also identifies the roles of national authorities, as well as initiatives aimed to promote the responsible use of AI:

• National authorities: The Italian AI Law confirms the following as the Italian national authorities for artificial intelligence:
  • Agency for the Digitalization of Italy (AgID), responsible for promoting innovation and development in artificial intelligence.
    • AgID also defines the procedures and performs the functions and tasks relating to the notification, assessment, accreditation and monitoring of the entities responsible for ensuring AI systems comply with national andEuropean Union legislation;
  • National Cybersecurity Authority (ACN), responsible for supervising, inspecting and sanctioning the use of artificial intelligence systems, in accordance with national and European Union legislation.
    • ACN is also responsible for the promotion and development of artificial intelligence in relation to cybersecurity profiles.
  • In addition, the Italian AI Law confirmed the jurisdiction of the Data Protection Authority and of the Communications Regulatory Authority (AGCOM), in their capacity as Digital Services Coordinator under the EU Digital Services Act (DSA).

• Investments and promotion: Planned investments of up to €1 billion aim to support companies innovating in the fields of AI, cybersecurity and quantum computing. The funding will also promote collaborative research, STEM training and access to AI technologies for young people and people with disabilities, including in sports.

If you have any questions, please contact one of the authors.