01

Check against the underlying fact

A treatment or dosing statement needs to reconcile with the relevant patient context, lab values, labelling and approved source material. Fluency does not establish that a claim is clinically correct.

02

The checker needs its own controls

A system that evaluates other AI outputs should also keep evidence of its own checks, protect sensitive information and resist manipulation. Its verdict needs to be reviewable, not taken on faith.

03

Follow the lifecycle of the decision

Pharmacovigilance and electronic-record disciplines already value traceability. The FDA and EMA's 2026 good-AI-practice principles point in the same direction, while remaining principles rather than new binding rules.

Basis

EU Good Pharmacovigilance Practices · 21 CFR Part 11 · ALCOA+ · FDA/EMA Guiding Principles of Good AI Practice in Drug Development (January 2026)