Kevin Lancashire · October 2026

AI governance & regulation

ISO/IEC 42001 helps you govern AI. It does not show what public AI tells your customers.

An AI management system certificate documents your policies, risk controls and monitoring. It does not stop a public AI assistant from stating a wrong dose or leaving out a warning about your product.

The gap: The controls in Annex A apply to AI systems your organisation develops, provides or uses. Public assistants such as ChatGPT or Gemini answering your patients sit outside that scope. If you decide to monitor what they say about your products, the evidence has to come from outside in.

Two perspectives

Inside out and outside in

Inside out

ISO/IEC 42001

Governs the AI systems you develop, provide and use. Assessed in internal audits and by certification bodies.

Outside in

AI answer audit

Records what public AI assistants answer to patients and pharmacists, through the providers’ interfaces and by hand in the apps, and checks every statement against approved information your experts have confirmed.

What the evidence shows

Why the outside view matters

Three published studies on AI answers. Each has its own setting and limits, stated with the source.

01 · Accuracy

54 % matched the consensus

Share of an AI search chatbot’s answers to common questions about the 50 most prescribed drugs that matched scientific consensus.

Andrikyan et al., BMJ Quality & Safety, 2025 · Bing Copilot, 500 answers.

02 · Safety

5–13 % rated unsafe

Share of chatbot answers to 222 patient questions about medicines that were rated unsafe, depending on the model.

Draelos et al., 2025 · 888 answers, preprint, not peer-reviewed.

03 · Consistency

One run is not a finding

Answers to the same question vary between runs and over time; the study recommends treating results as a distribution and measuring repeatedly.

Schulte, Bleeker & Kaufmann, 2026 · Swiss data, preprint.

Conclusion

Necessary, not sufficient

ISO/IEC 42001 is a sound framework for the AI you run. What public AI says about your products cannot be inspected from the inside.

Start with a free snapshot

For OTC medicines and medical devices: five typical patient questions about one of your products, put to one AI system. Every answer is checked by hand against your approved information. You receive one page within 3 working days.

Request a free snapshot Or check AI answers yourself →