On 20 March 2025, the Senate approved Bill No. 1146 on artificial intelligence (“AI Bill”), originally presented by the Government on 20 May 2024, aimed at harmonizing Italian national legislation with the European Regulation 1689/2024 (“AI Act”).
Italy – Senate of the Republic – Bill No. 1146: “Provisions and Delegations to the Government on Artificial Intelligence”
20 marzo 2025
Numero
1146
The bill is structured into six chapters and was introduced by the Government with the goal of defining principles concerning the research, experimentation, development, adoption, and application of artificial intelligence (AI) systems, in accordance with the provisions of the AI Act.
These principles, listed in Chapter I, include respect for the fundamental rights protected by the Constitution and the European Union, fairness, reliability, safety, quality, appropriateness, proportionality in relation to the sector of use, human autonomy, harm prevention, intelligibility, transparency and explainability, equality among individuals, the protection of the democratic method, and full accessibility of AI systems to persons with disabilities (Art. 3). The use of AI systems must also respect freedom and pluralism of the media, freedom of expression, impartiality and fairness of information, as well as citizens’ privacy, with specific limitations on their use by minors (Art. 4). Furthermore, the bill sets out specific principles to promote economic development in the sector (Art. 5) and includes provisions regarding the use of AI for security and national defense purposes (Art. 6).
Given that the European Regulation 1689/2024 has a horizontal scope, the bill also provides, in Chapter II, specific sectoral provisions for the use of AI in healthcare (Art. 7), for the processing of personal data (Art. 9), in employment (Art. 11), in the practice of intellectual professions (Art. 13), by public administrations (Art. 14), in the justice sector (Art. 15), and for strengthening national cybersecurity (Art. 18).
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 not only of the use of AI in their care but also of the logic underlying algorithmic decision-making, ensuring a level of transparency and explainability aligned with informed consent standards
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, extending the scope of health innovation toward broader social justice goals.
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 stipulates that the national strategy for AI must be "prepared and updated by the Presidency of the Council of Ministers responsible for technological innovation and digital transition, in agreement with the National Authorities for Artificial Intelligence" (Art. 19), and that it shall promote collaboration between public administrations and private actors. Art. 20 designates the Agenzia per l’Italia Digitale (AgID – Agency for Digital Italy) and the Agenzia per la Cybersecurity Nazionale (ACN – Agency for National Cybersecurity) as the national authorities responsible for the implementation of national and European AI regulations.
Lastly, the bill delegates the Government to adopt, within twelve months from the entry into force of the law, legislative decrees to adapt national legislation to the AI Act, as well as to specify the rules for the unlawful development and use of AI systems (Art. 21).
Chapter IV amends copyright law, extending protection to works of human creativity “even when created with the aid of artificial intelligence tools, provided they are the result of the author's intellectual effort” (Art. 25).
The bill also amends certain provisions of the Criminal Code (Chapter V), including the introduction of Art. 612-quater to criminalize the dissemination of deepfakes that cause unjust harm to the depicted person (Art. 26).
The bill has been transmitted to the Chamber of Deputies.
The bill is available at the following link and in the download box.
Sergio Sulmicelli
Pubblicato il: Giovedì, 20 Marzo 2025 - Ultima modifica: Venerdì, 20 Giugno 2025
