EveryAILaw.comDoes 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 — For prevention, diagnosis, care, and therapeutic choice, the decision remains with medical professionals (Art. 7(5))
- Patient notification — Data subjects have the right to be informed that AI technologies are being used (Art. 7, comma 3). The Act grants a right to be informed of AI use; it does not require disclosure of decision logic or of expected benefits
- Support role only — Healthcare AI systems constitute support in prevention, diagnosis, care, and therapeutic choice (Art. 7(5))
- Reliability and updating — Healthcare AI systems and the data they use must be reliable, periodically verified, and updated to minimize errors and improve patient safety (Art. 7(6))
Healthcare AI — Human Oversight
Article 7 treats healthcare AI as support in prevention, diagnosis, care, and therapeutic choice while reserving the clinical decision to medical professionals. It separately gives the interested person a right to be informed of AI use and requires healthcare AI systems and their data to be reliable, periodically verified, and updated.
Penalties qualification: This entry does not assign a provision-specific penalty to the Article 7 requirements. Applicable oversight and sanctions depend on the competent authority and the relevant national and EU framework.
Institutional context (not a private requirement): Article 10 inserts Article 12-bis into Decree-Law 179/2012. It assigns AGENAS the design, implementation, operation, and ownership of a national healthcare AI platform. The platform supplies non-binding suggestions to healthcare professionals and doctors and access support to users. These are statutory functions of AGENAS and the platform, not requirements imposed on the private deployers described in the Article 7 provision above.
Requirements
| Requirement | Details |
|---|---|
| Physician authority | For prevention, diagnosis, care, and therapeutic choice, the decision remains with medical professionals (Art. 7(5)) |
| Patient notification | Data subjects have the right to be informed that AI technologies are being used (Art. 7, comma 3). The Act grants a right to be informed of AI use; it does not require disclosure of decision logic or of expected benefits |
| Support role only | Healthcare AI systems constitute support in prevention, diagnosis, care, and therapeutic choice (Art. 7(5)) |
| Reliability and updating | Healthcare AI systems and the data they use must be reliable, periodically verified, and updated to minimize errors and improve patient safety (Art. 7(6)) |
Sources: Law No. 132/2025, official Gazette act Law No. 132/2025, Normattiva consolidated act Squire Patton Boggs — Italian Law No. 132/2025 (first EU national AI law) Cleary IP Tech Insights — Italy adopts first national AI law in Europe Pharma Phorum — What US healthcare companies need to know about Italy's AI law Law No. 132/2025 — full text (PDF, Procura Generale Perugia / giustizia.it)