Clinical safety standards for an AI scribe

DCB0129, what the supplier owes you

DCB0129 is a clinical risk management standard issued by NHS England and the Department of Health and Social Care, and it applies to the manufacturer of a health IT system rather than to you. It requires the supplier to assess and manage clinical risk across the product's lifecycle.

Four artefacts come out of it. A clinical risk management plan, a hazard log, a clinical safety case report, and evidence of a named and currently registered Clinical Safety Officer. Ask for all four by name. A supplier that offers a certificate instead has misunderstood the standard, because there is no certificate.

Two details separate a real submission from a performance. The hazard log has to be live rather than a document written once for procurement, and the clinical safety case report has to be updated for every material release. A product shipping AI changes monthly against a safety case dated eighteen months ago is not compliant in any meaningful sense.

DCB0160, what you owe

DCB0160 is the same discipline applied by the organisation deploying and using the system in a live clinical environment. The supplier cannot do it for you, because it is about your patients, your pathways and your staff.

It produces a local clinical safety case, a local hazard log and a monitoring framework, and NHS England's ambient scribing guidance pairs it with a data protection impact assessment. The hazards are specific to you. A scribe in a memory clinic carries different risks from the same scribe in a fracture clinic, and the standard exists to make you write that down.

The monitoring framework is the part most often skipped and the part that matters after go-live. Ongoing audits of clinical documentation, reviews of incident reports and reviews of system performance, done on a schedule rather than when something goes wrong.

The Clinical Safety Officer is a person, not a role on a form

Both standards require a named Clinical Safety Officer. On your side that has to be a qualified healthcare professional, currently registered, with training in clinical safety and clinical risk management. It is not the practice manager, the IG lead or the person with capacity this quarter.

In general practice and at PCN level this is the requirement that most often delays a deployment, because the obvious candidate is a partner who has no clinical safety training and no time to get it. Start it early, because the training is the long pole.

The Clinical Safety Officer signs the safety case. That signature is a clinical judgement about whether the risks are acceptable in your setting, which is why it cannot be delegated to the supplier or to a template.

The hazards an ambient scribe actually presents

A hazard log written from a template will list data loss and system unavailability and miss the ones specific to this category. The useful ones come from the published evidence rather than from imagination.

A fabricated finding in a section nobody spoke aloud, because simulated-encounter research puts scribe error highest on the physical examination. A negation flipped, where no chest pain becomes chest pain. A number transcribed wrong in a specialty where numbers are the record. A draft signed without being read, which is the most likely failure and the least dramatic. A consultation captured after a patient declined.

Our review of what the hallucination studies actually found is a reasonable starting point for the log, and the mitigations mostly come back to the same control, which is that a clinician reads and approves before anything is saved.

A pilot does not defer any of it

NHS England's guidance states that running a pilot or proof of concept does not exempt a supplier from compliance, and that pilots may continue only if they are time-limited, up to four months, and are not used to bypass compliance.

So the safety case, the hazard log, the data protection impact assessment and the Clinical Safety Officer all sit before the first patient rather than after a successful trial. A four month evaluation with a supplier who has no DCB0129 is a non-compliant deployment that happens to have an end date.

Design the evaluation so it answers the commercial question at the same time. Our guide to running a scribe pilot sets out the acceptance criteria worth agreeing before it starts.

What to ask, and what a good answer looks like

Ask for the clinical safety case report and the hazard log as documents, not as an assurance that they exist. Ask when the safety case was last updated and against which release. Ask for the Clinical Safety Officer's name and registration.

Then ask the question that separates suppliers who have done this from suppliers who have bought it. Which hazards in your log are specific to ambient capture rather than to software generally. A supplier who can talk about negation errors and unspoken examination findings has read their own log.

The wider procurement set is in what to ask a scribe vendor, and the NHS picture in full is in AI scribes in the NHS.

Where wai sits

wai is built so a clinician makes every clinical decision. It drafts the note, the letters and the coding for review, shows its working so a reviewer checks reasoning rather than trusting output, and holds every patient-affecting action for approval.

That design is not a compliance posture, it is what makes the sign-off a real check rather than a reflex, which is the control every hazard in this category ultimately relies on.

Ask us for the safety case and the hazard log before the demo. If a supplier will not hand those over early, including us, that tells you where they are in the process. Clinicians still decide what enters the record.

Frequently asked questions