Italian law is moving towards simplification, especially in the health sector
The Italian law on artificial intelligence, Law No. 132 of 23 September 2025, 'Provisions and Delegations to the Government on Artificial Intelligence', was published in the Official Gazette on 25 September 2025 and will enter into force on 10 October. It naturally moves within the framework outlined by the European legislator with the so-called Ai Act, makes the choices entrusted to the national legislator, also introduces some novelties and, in reaffirming certain principles, clarifies some important issues.
It is certainly not an easy task, today, to regulate a technology whose power we glimpse, without yet being fully aware of it, not least because it is still in full evolution. The questions for the legislator are therefore many.
On the one hand, we must seize the opportunities offered by artificial intelligence (think of the increased efficiency in the examination of radiological images in healthcare or in the management of risk profiles in banking and insurance) and, on the other hand, minimise the risks. Often we focus on the risks, as the European legislator has done, but encouraging the spread of reliable Ia is at least as important. This requires economic investment, but also from a legal point of view much can be done: first of all, simplify the applicable regulations. Simplification is invoked by all, but little practised. An opening, not yet a simplification, is in the provisions of law Ia on scientific health research. Much still needs to be done in this area to strengthen the competitiveness of the country's system.
Turning to the law, the national legislator was first and foremost called upon by the European Regulation to express itself on two major issues.
The first, that of the governance of Ia. The National Artificial Intelligence Strategy will be the responsibility of the Presidency of the Council, as well as the Coordination Committee on Artificial Intelligence Authorities that will be set up. The National Authorities for Artificial Intelligence will be the National Cybersecurity Agency and the Digital Italy Agency, without prejudice to the specific competences of the Bank of Italy, Consob and Ivass. Coordination will also be required with the already existing Authorities, from the Garante per la protezione dei dati personali to the Autorità Garante per le garanzie nelle comunicazioni.
