An ambient AI scribe drafts a referral letter after a consultation. A clinician checks and sends it. The supplier’s next release adds a feature that recommends which patients to refer. The interface looks much the same, but the new function changes what the software is intended to do and what the clinical team needs to assess before switching it on.
On 29 July 2026, the MHRA published guidance on when ambient voice technology (AVT) qualifies as a medical device in Great Britain. NHS England published version 3 of its deployment guidance the same day. The MHRA explains how existing device law applies in England, Scotland and Wales. NHS England sets out how providers in England can assess, deploy and monitor an ambient scribe in their own care setting. MHRA ambient voice technology guidance, NHS England version 3.
Check exactly what you are buying
Under the MHRA guidance, products intended solely to transcribe or summarise clinical conversations, draft letters, or suggest clinical codes for a clinician to review generally fall outside medical device regulation. A product intended to inform diagnosis, treatment or prevention, or to take an automated clinical action such as placing an order without clinician review, falls within the device framework. The manufacturer’s intended purpose, claims and the way the product works matter. An invented diagnosis in a draft note is a safety issue. A feature designed to suggest a diagnosis raises a device qualification question. Ask the supplier to state which version, features and integrations its regulatory assessment covers. Revisit the assessment when an update changes the product’s intended purpose. MHRA qualification and classification guidance.
For procurement, use the current Digital Technology Assessment Criteria (DTAC) form and obtain the supplier’s supporting evidence for the version you will deploy. DTAC covers clinical safety, data protection, technical security, interoperability, and usability and accessibility. The NHS England AVT Supplier Registry is a source of supplier evidence. Your team still needs to decide whether the product is safe in your workflow. Where the clinical safety standards apply, the supplier’s DCB0129 documentation describes product hazards and controls. The deploying organisation’s DCB0160 work addresses risks in local use. Assign a Clinical Safety Officer and document those risks in a local hazard log and safety case. A safe draft in the supplier’s demonstration can still go into the wrong patient’s record if the local integration handles patient switching poorly. DTAC guidance, NHS England digital clinical safety assurance.
Agree who monitors performance, investigates defects, notifies sites of updates and can pause the system. Put those responsibilities in the contract, alongside access to version and incident records, supplier indemnity and a route for recovery if a product failure contributes to harm. NHS Resolution says its existing schemes cover eligible clinical negligence claims involving NHS care delivered with AI, subject to the usual scheme terms. A product defect can also raise questions about the manufacturer’s liability. The patient’s care and any later contractual recovery from the supplier are separate matters. NHS Resolution guidance on AI, scheme cover and liability.
Give patients a practical choice
Complete a Data Protection Impact Assessment before using patient data in a live pilot. Map where audio, transcripts and drafts go, who can access them, how long each is retained and when it is deleted. NHS England’s information governance guidance for individual care explains that implied consent can satisfy the common law duty of confidentiality where appropriate. Identify the separate UK GDPR lawful basis and condition for processing health data. The organisation’s privacy notice should describe the use, and staff should tell people before activating the scribe. If a patient objects, take notes using the usual method. The national data opt-out is a separate mechanism and does not apply to individual care. Research and model training need a separate assessment. NHS England information governance guidance, Guidance for clinical staff.
Use the pilot to find errors that matter
Before starting a pilot, engage the integrated care board and regional team for assurance. NHS England describes pilots or proofs of concept as time limited, up to four months, and subject to compliance. Agree what would justify wider use and what would trigger a pause. A team could, for example, stop the affected integration after a single wrong-patient filing while investigating the cause. Measure review and correction time as well as time saved, and look for errors with clinical consequences. Try consultations with background noise, different accents, speech impairments, interpreters or multiple speakers where those uses are supported. Check whether a draft drops an allergy, reverses a negative finding, attributes a relative’s history to the patient, or omits an agreed follow-up. Repeat targeted checks after changes to the model, template or record integration. NHS England ambient scribing deployment guidance.
Set up the workflow so a practitioner can check and correct every note, code or letter before it enters the record or is sent. Make it clear how staff can fall back to ordinary documentation when the system is down or the draft is unreliable. After launch, track clinically significant corrections, near misses and differences in error patterns across settings and patient groups. Give a named person authority to act when an agreed threshold is crossed. NHS England guidance on clinical review, NHS Resolution guidance on monitoring and audit trails.
What happens when an error gets through?
Suppose a referral letter sent from an approved scribe omits a known serious drug allergy. The clinician or team should correct the record, contact the receiving service promptly and check whether anyone acted on the incorrect letter. Log the incident through the local patient safety process and alert the Clinical Safety Officer and supplier. Preserve the relevant version, template and audit trail through approved channels so the team can see whether the problem was an omission in the draft, a review failure or an integration error. In England, local incident systems can feed into the Learn from Patient Safety Events service. Follow the organisation’s candour procedure and check whether the event meets the threshold for a notifiable safety incident. If a medical device may be involved, follow the local device reporting procedure and report the suspected problem to the MHRA via Yellow Card. Manufacturers have their own vigilance duties. A recurring omission is a reason to review the affected workflow and consider pausing it. NHS England LFPSE, CQC guidance on notifiable safety incidents, MHRA reporting for software, apps and AI.
For wording to explain a scribe in a consultation and examples of documenting the conversation, see iatroX’s guide to AI scribe transparency.
Frequently asked questions
Does an AI scribe need to be a medical device in Great Britain? It depends on its intended purpose and functionality. Drafting notes for review and recommending a clinical action are different uses under the MHRA’s July 2026 guidance.
Can a patient object to using the scribe? Yes. Tell the patient about the scribe before using it and explain the choice. If the patient objects, use the usual way of taking notes and follow your organisation’s policy.