The contents of the law on artificial intelligence and future challenges.
The final approval
On September 17, 2025, the Senate, with 77 votes in favor, 55 against and 2 abstentions, definitively approved the law on artificial intelligence (hereinafter, the “Law”).
Italy thus becomes the first EU country to integrate the rules set out in the AI Act with national legislation on artificial intelligence. The aim of the national legislator is to further strengthen the level of protection from risks connected with the use of artificial intelligence in certain areas and sectors.
The structure of the Law
The Law is composed of 28 articles divided into six titles.
Title I, programmatic in nature, establishes the principles to be respected and the purposes that artificial intelligence should pursue.
Title II lays down specific provisions regarding the use of artificial intelligence systems in certain sectors such as the healthcare sector, scientific research, the world of employment, intellectual professions, public administration and the administration of justice.
Title III sets out the procedures for drafting and updating the national strategy for artificial intelligence, which must foster public-private collaborations and promote research and training.
Title IV is dedicated to copyright protection and Title V to criminal protection.
Finally, Title VI contains the financial and final provisions.
The competent authorities
With the approval of the Law, the Agency for Digital Italy (AgID) and the National Cybersecurity Agency (ACN) have been officially designated as the national competent authorities in the field of artificial intelligence.
AgID, as the notifying authority, will define the procedures and exercise the functions and tasks relating to notification, assessment, accreditation and monitoring of the entities appointed to verify the compliance of high-risk artificial intelligence systems.
Meanwhile, ACN, as the supervisory authority, will be responsible for monitoring artificial intelligence systems, with inspection and sanctioning powers.
Both authorities will also contribute to the definition and updating of the national strategy for artificial intelligence in agreement with the Department for Digital Transformation.
In addition, within the Presidency of the Council, the following are established:
The main innovations sector by sector
Healthcare and research. Art. 8 of the Law authorizes the secondary use of personal data (including special categories) for research purposes, provided they are free of identifying elements and without prejudice to the obligation to inform the data subject. The use of artificial intelligence in healthcare will be allowed as support for prevention, diagnosis, care and treatment processes, on condition that the final decision remains with the doctor.
Employment. A ministerial observatory on artificial intelligence is established to monitor risks and opportunities of artificial intelligence in the employment context. Any automated assessment of workers’ performance without the possibility of contestation is prohibited, while employers are required to inform and train staff on the use of technological tools.
Intellectual professions. Art. 13 of the Law limits the use of artificial intelligence systems in intellectual professions to instrumental and support activities for professional work, with prevalence of the intellectual work being performed. In addition, professionals are required to inform the client about the artificial intelligence systems used, with clear, simple and exhaustive language.
Justice. Art. 15 of the Law prohibits the use of artificial intelligence systems for the adoption of judicial decisions in an automated way; however, they may be used for analysis and support in the drafting of documents, without prejudice to the responsibility of magistrates.
How the criminal code changes
Title V introduces certain amendments to the criminal code. In particular, the Law introduces a new type of offence and a new common aggravating circumstance.
The new offence, which is included in Art. 612-quater c.p., punishes the dissemination of falsified content, capable of misleading (so-called deep fakes), through artificial intelligence systems.
On the other hand, the Law establishes an articulated system of aggravating circumstances, the core of which is the introduction of a common aggravating circumstance in Art. 61, no. 11-decies c.p., which provides for an increased penalty where the use of an artificial intelligence system constitutes a treacherous means to facilitate the offence, hinder the defence or aggravate its consequences.
Implementation of the Law
For the entry into force of the Law, it remains only to await promulgation by the President of the Republic and its publication in the Official Gazette, from which the 15 days of vacatio legis will begin.
In any case, once the Law has entered into force, it will be up to the Government to complete the framework through the adoption, within twelve months, of one or more legislative decrees. These will regulate aspects of particular importance, including:
The unresolved issues
Some critical issues highlighted during the parliamentary process remain in the text of the Law definitively approved by the Senate.
In particular, in its detailed opinion C(2024)7814, the Commission had “rejected” the first draft of the Law for three main reasons:
The challenge is now
The final approval of the Law represents an important milestone for Italy, which takes the lead among other European countries with regard to artificial intelligence. But the real challenge begins now with the implementation of the legislation.
The success of the Law will in fact largely depend on the quality of the legislative decrees that the Government will have to adopt within the next year; a crucial test to translate the programmatic objectives into operational rules that can adequately balance the needs of operators, technological progress and the protection of fundamental rights and freedoms.
