Italy Adopts Artificial Intelligence Law

The global race to regulate Artificial Intelligence is accelerating, and Italy has just cemented its position as a proactive leader. With AI technologies rapidly reshaping industries and daily life, the critical question for businesses and innovators alike becomes: how do we harness AI's potential responsibly within a clear legal framework? Italy’s new Artificial Intelligence Law, signed on September 23, 2025, and entering into force on October 10, 2025, offers crucial clarity, setting a precedent for national-level AI governance.

This law is not merely a standalone directive; it acts as a strategic complement to the broader European Union’s Artificial Intelligence Act (EU AI Act). For any entity operating within or interacting with the Italian market, understanding this dual regulatory landscape is paramount. It ensures that while adhering to EU-wide standards, specific national nuances are also addressed, creating a robust, multi-layered approach to AI governance.

Navigating Italy's Specific AI Mandates

While the EU AI Act provides a foundational framework, the Italian AI Law introduces sector-specific provisions that demand immediate attention.

Empowering Healthcare Innovation Responsibly

One significant area of impact is healthcare and scientific research. The law permits the secondary use of depersonalized data, including special categories of data, for public interest and non-profit scientific research. This is aimed at developing AI systems for disease prevention, diagnosis, and treatment, without requiring renewed data subject consent. However, strict transparency obligations apply: data controllers must publish a privacy notice on their website, and processing activities must be communicated to the Italian data protection authority (Garante). This careful balance fosters innovation while safeguarding individual privacy.

AI in the Workplace: Employee Rights and Training

For employers, the Italian AI Law introduces clear directives regarding AI tools. Companies must inform workers about the use of AI systems and ensure appropriate training for their employees. This provision underscores the importance of transparency and preparedness in integrating AI into daily work operations, fostering an informed and capable workforce.

Protecting Younger Generations in the AI Era

Recognizing the unique vulnerabilities of minors, the law establishes age-based consent requirements for AI technology access and data processing. Parental consent is mandatory for children under 14, while minors between 14 and 18 can provide consent, provided the information is presented in an easily accessible and comprehensible manner. This ensures that AI interactions with young users are age-appropriate and ethically managed.

Creative AI and Copyright: A New Frontier

The Italian AI Law also steps into the evolving world of intellectual property. It affirms that works created "with the aid of AI tools" can be copyrighted, provided they are the result of the author's intellectual work. Furthermore, text and data mining of lawfully accessed works for AI model training, including generative AI, is explicitly permitted, subject to the owner’s opt-out rights. This provides a clearer legal footing for creators and AI developers navigating complex copyright issues.

Understanding the Regulatory Ecosystem and Future Direction

Designated Authorities for Oversight

To ensure effective implementation and oversight, the law designates two key competent authorities: the Agency for Digital Italy (AgID) as the notifying authority, and the National Cybersecurity Agency (ACN) as the market surveillance and enforcement authority. Understanding the roles of these bodies is crucial for compliance and engagement.

Evolving Landscape: What's Next?

The Italian government has been delegated to adopt further measures within 12 months. These will aim to align the national framework with the EU AI Act, define comprehensive rules on data and algorithm use for AI training, set rules for AI in policing, and update civil and criminal penalties. Notably, earlier draft proposals, such as a strict localization requirement for public sector AI servers and specific labeling for AI-generated news, were removed from the final text. Instead, a preference for Italian data centers for strategic public sector data is recommended, and general EU AI Act transparency requirements apply to AI-generated content. This signifies a flexible, adaptive approach to AI governance.

Italy’s AI Law represents a significant stride in creating a balanced and forward-thinking regulatory environment for Artificial Intelligence. For businesses, developers, and public sector bodies, proactive engagement with these new mandates is not just about compliance—it's about leveraging AI innovation responsibly and ethically. Ignoring these developments could lead to significant operational and legal hurdles. Instead, view this as an opportunity to reinforce trust and ensure sustainable AI integration.

Navigating the intricacies of national and EU-level AI regulations can be complex. We encourage you to seek expert guidance to ensure your strategies are aligned with these pivotal legal advancements. Understanding the nuances of the Italian AI Law today will position your organization effectively for the AI-driven future.