On September 17th, the Italian Senate gave final approval to the Artificial Intelligence Bill (link only available in Italian), marking the beginning of a national regulatory framework following the introduction of the European AI Act (Regulation EU 2024/1689). This legislation empowers the Government to adopt implementing decrees in the coming months, setting national rules and standards for AI use across various strategic sectors.
Key Updates
- Data Protection and Privacy: Strengthened safeguards for personal information, aligned with the GDPR.
- Minors and Informed Consent: Stricter criteria for transparency and accountability.
- Healthcare and Research: Regulations for AI applications in diagnostics, treatment, and clinical trials.
- Employment and Public Administration: Guidelines for ethical and safe use of new technologies.
- Sanctions and Liability: Definition of control measures and oversight mechanisms.
The introduction of specific AI legislation will directly affect those working in clinical research and the life sciences sector:
- Diagnosis and Treatment: AI algorithms supporting professionals in interpreting images, tests, and medical records. The law mandates full transparency regarding the AI tools employed, alongside strict requirements to ensure continuous medical oversight in clinical decision-making. It firmly establishes that the physician’s role remains central and non-negotiable: AI systems must function purely as supportive aids, with all clinical decisions ultimately under the professional judgment and responsibility of healthcare providers.
- Clinical Trials: Use of AI systems for patient recruitment, predictive analysis of endpoints, remote monitoring, and processing of large data sets. The legislation may impact the design of clinical trial protocols and impose stricter requirements for informed consent.
Public Health and Prevention: AI applications in epidemiological management, personalized medicine, and screening programs. The law aims to strike a balance between opportunities and risks, with particular emphasis on data security and the protection of citizens' rights. - Disability and Inclusion: Promotion of AI-based solutions to improve healthcare accessibility and support for individuals with specific needs.
- Ethical Principles: Non-discrimination is a cornerstone. Algorithms must be designed and validated to prevent biases that could lead to inequalities in diagnosis, treatment, or care pathways.
For companies, research centers, and Contract Research Organizations (CROs), the new law represents both a compliance challenge and a strategic opportunity: a clear regulatory framework can strengthen the trust of patients, regulatory authorities, and stakeholders, facilitating the safe and sustainable adoption of innovative solutions.
At PRINEOS, we believe this new law is a crucial step towards the future of digital healthcare and clinical research in Italy. We continuously monitor regulatory developments to support our clients in their projects.