Italy Regulates Artificial Intelligence: An Anthropocentric Law for Security, Healthcare, and Economic Development

The Official Journal of the Italian Republic published on 25 September 2025 the Law no. 132 of 23 September 2025, containing "Provisions and delegations to the Government regarding artificial intelligence." This new legislation establishes the fundamental principles for research, testing, development, adoption, and application of artificial intelligence (AI) systems and models.

Guiding Principles and European Conformity

The primary objective of the law is to promote a correct, transparent and responsible use of AI, in an anthropocentric dimension, aiming to seize the opportunities offered by technology while ensuring vigilance regarding economic and social risks and the impact on fundamental rights. The provisions are interpreted and applied in accordance with Regulation (EU) 2024/1689.

Among the general principles that must guide the development and use of AI for general purposes, respect for fundamental rights, transparency, proportionality, safety, protection of personal data, accuracy, non-discrimination, gender equality, and sustainability stand out. It is essential that development and application take place in compliance with theautonomy and human decision-making power, ensuring human surveillance and intervention. Furthermore, the law establishes that the cybersecurity be an essential precondition throughout the lifecycle of AI systems and models, adopting a proportionate and risk-based approach.

The law also pays specific attention to people with disabilities, guaranteeing them full access to AI systems and related functions on an equal and non-discriminatory basis, in line with the UN Convention on the Rights of Persons with Disabilities.

New Governance and National Strategy

To ensure the application of the legislation, the law designates theAgency for Digital Italy (AgID) and theNational Cybersecurity Agency (NCA) as National Authorities for Artificial Intelligence.

The responsibilities are divided as follows:

  1. AgID It is responsible for promoting AI innovation and development, defining procedures for the notification, evaluation, accreditation, and monitoring of entities responsible for verifying system compliance. AgID and ACN also jointly manage testing spaces for regulatory-compliant systems. Furthermore, AgID is designated as the Notifying Authority.
  2. ACN It is responsible for oversight, including inspections and sanctions, relating to the cybersecurity and general security of AI systems. ACN is designated as the market supervisory authority and single point of contact with the European institutions.

The law also establishes the National Strategy for Artificial Intelligence, prepared and updated at least every two years by the Presidency of the Council of Ministers in agreement with the national authorities.

AI in the Economic, Labor and Public Administration Sectors

In the economic sphere, the state and public authorities are promoting AI to improve human-machine interaction, increase productivity, and support the national productive fabric (SMEs and microenterprises). An innovative, fair, and competitive AI market is being fostered, facilitating access to high-quality data for businesses and the scientific community.

A specific provision (Art. 5, paragraph 1, letter d) addresses the platforms of e-procurement public to favor solutions that guarantee the localization and processing of strategic data at data center places in the national territory, with procedures of disaster recovery And business continuity also implemented in Italy.

For the world of workThe use of AI must be safe, reliable, transparent, and must not conflict with human dignity or violate privacy. Employers are required to inform workers about the use of automated decision-making or monitoring systems. A dedicated body has been established at the Ministry of Labor. Observatory with the task of defining a strategy, monitoring the impact on the market and promoting training.

In the public administrations, AI is used to increase the efficiency and quality of services, but its use is limited to a instrumental and support function for the regulatory activity, leaving the person solely responsible for decisions. Similarly, in thejudicial activity, any decision on the interpretation of the law, on the evaluation of facts and evidence, and on the adoption of measures is always reserved to the magistrate.

Innovation in Healthcare and Research

AI is seen as an enabling factor for improving the healthcare system, contributing to prevention, diagnosis, and treatment, while ensuring that access to services is not conditioned by discriminatory criteria. Data subjects have the right to be informed about the use of these technologies.

In the health sector, the National Agency for Regional Health Services (AGENAS) is responsible for establishing a artificial intelligence platform to support care purposes, especially in community care. This platform will provide non-binding suggestions to healthcare professionals and physicians in clinical practice.

For scientific research, the processing of data (including personal and sensitive data) for the creation of AI systems in healthcare are declared significant public interestThe secondary use of personal data (without directly identifying elements) for research and experimentation is authorized, even without further consent, except in cases where identifying the data subject is necessary to protect the data subject's health.

Legal Protection: Criminal Sanctions and Copyright

Chapter V of the law introduces amendments to the Criminal Code to address the risks arising from the illicit use of AI.

  1. Common Aggravating Circumstances: The use of AI systems is now a common aggravating factor if it constitutes an insidious means, hinders defense (public or private), or aggravates the consequences of the crime (Art. 61 cp, n. 11-decies).
  2. Illegal Dissemination of Deepfakes: A new crime (Article 612-quater of the Criminal Code) has been introduced, punishing anyone who disseminates, without consent, images, videos, or voices that have been falsified or altered by AI, capable of misleading people about their authenticity, thus causing unjustified harm.
  3. Increase in Penalties: The penalties are aggravated for the crimes of attacks against citizens' political rights (Art. 294 of the Criminal Code), stock market manipulation (Art. 2637 of the Civil Code), and market manipulation (Art. 185 of the Consolidated Law on Finance), if committed through the use of artificial intelligence systems.

As for the copyrightThe law specifies that creative works of human ingenuity are protected, even if created with the aid of AI tools, provided they constitute the author's intellectual work. Reproduction or text and data mining (TDM) from legitimately accessible works for the purpose of training AI models is permitted in accordance with Articles 70-ter and 70-quater of the Copyright Act.

Delegations and Funding for the Future

The Government has been empowered to adopt legislative decrees within twelve months. These decrees will align national legislation with Regulation (EU) 2024/1689 and specify the rules for cases of unlawful creation and use of AI systems, addressing criminal and civil liability.

Finally, to support industrial development, an overall investment of up to one billion euros to support, through equity And quasi-equity, innovative small and medium-sized enterprises (SMEs) and high-potential companies operating in the fields of AI, cybersecurity, quantum technologies and telecommunications (such as 5G and Web 3). These investments will be made using the resources of the Support Fund for venture capital.

Content by the Lawyer. Gianmaria Pesce

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