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Aipedia: Pharmacists and pharmacies

AI governance for pharmacy owners and superintendents

Pharmacy owners and superintendents must carry out due diligence, risk-assess, govern, train and monitor any AI used in their pharmacies, and the GPhC says inspectors can examine this. The same records help show insurers that AI risk is managed.

In short

The GPhC position statement of April 2026 sets out duties for pharmacy owners and superintendent pharmacists under the Standards for registered pharmacies: due diligence on the safety and suitability of AI tools, governance including risk assessment, data security and information governance, staff training and routine monitoring as part of quality and risk management. Compliance can be examined on inspection. Owners must also hold indemnity for the services they provide. Written governance records are the main evidence for both the regulator and an insurer, and they help defend claims where AI was involved.

Where AI sits in a pharmacy business

AI may be in the PMR, the dispensing robot, the accuracy-checking camera, the online questionnaire, the patient app, the consultation-room scribe or the chatbot a pharmacist uses on their own phone. Some of these the owner chose deliberately; others arrived in a software update. Governance starts with knowing what is in use.

The GPhC statement gives these duties to superintendent pharmacists as well as owners. In a multi-site business, AI decisions are often made centrally by operations or IT teams, but the professional duties in the GPhC statement still need someone with pharmacy authority to own them.

The duties in the GPhC statement

DutyWhat it looks like in practice
Due diligenceChecking a tool's intended use, safety, suitability and, where relevant, medical device status before adopting it
Risk assessmentA written assessment of what could go wrong and the controls for each tool
Data security and information governanceA DPIA where needed, supplier agreements, rules on patient data in AI tools
Staff trainingTraining on each tool, its limits and when not to rely on it
Routine monitoringReviewing errors, near misses and outputs as part of quality and risk management

These come from the GPhC position statement, which links them to the Standards for registered pharmacies. The statement also notes that the MHRA regulates AI that is a medical device, which is relevant to due diligence. Individual pharmacists in the business remain personally accountable for their own decisions, so owner governance supports their judgement rather than replacing it.

How inspectors may test them

The GPhC says owners' compliance can be examined on inspection. An inspector may reasonably ask which AI tools are in use, how they were chosen, what the risk assessment says, how staff were trained, how patient data is protected and what monitoring has found. A pharmacy that cannot answer these questions may struggle to show it meets the standards, even if no harm has occurred. Online pharmacies should also expect questions under the GPhC distance guidance about questionnaire-only prescribing and independent verification.

What can go wrong

Illustrative scenario: a small pharmacy chain adds a patient chatbot and an AI scribe within a few months, each set up by a different manager. There is no list of tools, no risk assessment and no training record. A patient complains that the chatbot gave unsafe advice. The inspector, the insurer and the patient's solicitor all ask the same question: what did the owner do to make sure the tool was safe? There is no written answer.

Documenting AI governance for insurers

Owners must hold indemnity reflecting the services they provide, according to the GPhC. Insurers may ask about new services and technology at renewal, and a governance file makes those answers easy and accurate. It also helps if a claim arises, because it shows what the pharmacy did before the incident. A useful file contains:

See AI use and your PI insurance: what to document, dispensing robots and accuracy checks, patient-facing chatbots, the GPhC AI position statement and the pharmacy AI hub.

How Apex helps

Apex arranges indemnity for pharmacy owners. A broker reviews how your AI tools and governance are presented to insurers and how your policy treats claims involving them.

Sources

Frequently asked

Does the GPhC approve AI tools for pharmacies?

No. The GPhC does not regulate AI tools; the MHRA regulates AI that is a medical device. The GPhC places the duty on owners and superintendents to carry out due diligence, risk-assess, train staff and monitor tools.

Can a GPhC inspector ask about our AI tools?

Yes. The position statement says compliance with the owner and superintendent duties on AI can be examined on inspection under the Standards for registered pharmacies. Be ready to show your tool list, risk assessments, training and monitoring.

How often should we review our AI tools?

The GPhC statement asks for routine monitoring as part of quality and risk management but sets no fixed interval. A sensible approach is to review each tool after any update or incident and at least as often as your other clinical governance reviews, recording what you found.

Do we need to tell our insurer about AI tools?

It is sensible to disclose material changes in how you deliver services, such as automation, online prescribing algorithms or patient chatbots. The GPhC requires owners' indemnity to reflect the services provided, and clear disclosure reduces the chance of a dispute later.

Check your PI covers how you use AI

Tell us about your firm and the work you do. A broker will review how your current PI treats AI-assisted work, or arrange new cover. No fee for a quote. Or call 0117 325 0027.

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Apex Insurance Brokers Limited is authorised and regulated by the Financial Conduct Authority. Registered in England and Wales, company number 07014570. This page is general information about how AI is used in the profession and how insurance may respond. It is not legal, regulatory or insurance advice on your circumstances, and it does not guarantee that cover will be available or on what terms.