Italy’s new law on Artificial Intelligence: reasons why the UK should be aware

Italy has made history by being the first EU member state to enact a comprehensive national artificial intelligence law, which received final parliamentary approval on September 17, 2025. This new legislation builds upon Italy’s “National AI Strategy” from 2020, emphasizing the need for an ethical regulatory framework to promote transparency, accountability, and reliability in AI systems and to instill trust and engagement among citizens in a thriving AI landscape.

The primary goal of this law is to establish human-centered guardrails around the deployment of AI while fostering innovation across various sectors of the economy. Its provisions include requirements for human oversight and traceability in AI-assisted decision-making, particularly in crucial areas such as healthcare. Medical professionals are mandated to retain decision-making authority over prevention, diagnosis, treatment, and therapeutic choices, ensuring that AI remains a supportive tool rather than a substitute for human judgment. Patients must also be informed when AI technologies are utilized in their medical care.

Furthermore, the law introduces guidelines for the access of minors to AI technology, stipulating that children under 14 can only engage with AI under parental consent. It also addresses the issue of unlawful dissemination of AI-generated or manipulated content, such as deepfakes, by establishing criminal penalties to deter malicious use of AI, with potential prison sentences ranging from one to five years.

In terms of governance and enforcement, the law designates the Agency for Digital Italy (AgID) and the National Cybersecurity Agency (ACN) as the regulatory bodies responsible for overseeing compliance. Additionally, the Department for Digital Transformation has been tasked with steering Italy’s national AI strategy. To support companies engaged in AI, cybersecurity, quantum technologies, and telecommunications, the government has earmarked up to €1 billion in investment.

The legislation also touches upon copyright issues related to AI works. It clarifies that creations assisted by AI are eligible for copyright protection if they involve genuine human intellectual effort, aligning with existing EU copyright principles. Notably, the law permits text-and-data mining (TDM) for AI applications, subject to specific conditions outlined in the EU Directive on copyright in the Digital Single Market. However, there are potential implications for AI companies operating in the EU due to ongoing discussions at the EU Parliament regarding the tightening of TDM copyright exceptions to regulate AI training models more rigorously.

Italy’s proactive stance on AI regulation has broader implications for the UK and other countries in the EU. While the UK has historically advocated for a flexible approach to AI innovation, Italy’s new law underscores the growing momentum towards national regulatory frameworks in the absence of EU-wide consensus. The UK may face increasing pressure to align its AI regulations with EU standards to minimize friction across borders, particularly concerning criminal sanctions and protection for minors. The delay in the UK’s decision-making could result in the country adopting one of the emerging approaches from its EU counterparts.

In conclusion, Italy’s groundbreaking artificial intelligence law sets a significant precedent for EU member states as they navigate the complexities of regulating AI technologies. As companies operating in the EU prepare to comply with evolving regulations, adopting a harmonized approach that integrates core principles of the EU AI Act and national regulations will be essential to mitigate potential enforcement risks and ensure compliance with the diverse regulatory landscape in the region.