AI Regulation ReferenceDoes Law on Artificial Intelligence require Human Oversight?
Italy • enforcing
Yes — 1 provision
Requirements at a glance
This regulation imposes 4 specific requirements for Human Oversight across 1 provision:
- Physician authority — AI systems cannot replace human clinical judgment or make fully automated clinical decisions; physicians retain ultimate decision-making authority
- Patient notification — Patients must be informed of AI use, its benefits, and the logic of AI-assisted decision-making before and during care
- Support role only — AI may support prevention, diagnosis, and treatment but must be positioned as a decision-support tool, not a decision-maker
- AGENAS platform — National Agency for Regional Health Services (AGENAS) develops a national AI platform to assist medical staff; outputs are non-binding suggestions
Healthcare AI — Human Oversight #
Italy is the first EU member state to legislate sector-specific AI rules beyond the EU AI Act. For healthcare AI, the law establishes a hard prohibition on AI making autonomous clinical decisions — physicians retain ultimate authority regardless of AI recommendation quality. Any healthcare organisation deploying diagnostic or treatment AI in Italy must build physician-override workflows into every clinical AI deployment.
Requirements
| Requirement | Details |
|---|---|
| Physician authority | AI systems cannot replace human clinical judgment or make fully automated clinical decisions; physicians retain ultimate decision-making authority |
| Patient notification | Patients must be informed of AI use, its benefits, and the logic of AI-assisted decision-making before and during care |
| Support role only | AI may support prevention, diagnosis, and treatment but must be positioned as a decision-support tool, not a decision-maker |
| AGENAS platform | National Agency for Regional Health Services (AGENAS) develops a national AI platform to assist medical staff; outputs are non-binding suggestions |