DRAFT FOR REVIEW BY APPOINTED CLINICAL SAFETY OFFICER — MUST BE REVIEWED, AMENDED AND SIGNED BY A GMC/NMC/HCPC-REGISTERED CLINICIAN WITH FORMAL DCB0129 CLINICAL SAFETY OFFICER TRAINING BEFORE USE.
CSO02 — Clinical Safety Case Report (CSCR): Scribe-On-Site
Document reference: BRITI-CSCR-SCRIBE-001 Version: 0.9 (Draft for CSO review) Manufacturer: BritiAI Limited Subcontractor (in-scope): Votee AI (V-Note on-premises ambient capture and ASR) Applicable standard: DCB0129:2018 Status: Draft pending CSO sign-off
1. Executive Summary
Scribe-On-Site is an on-premises ambient clinical documentation tool deployed entirely within trust-owned infrastructure. It captures clinician–patient consultations via local microphones, transcribes the audio using the Votee AI V-Note automatic speech recognition (ASR) engine running on the trust’s hardware, and produces a structured draft note via the BritiAI Copilot summarisation layer. Every note must be reviewed, edited if required, and explicitly signed off by the responsible clinician before it enters the Electronic Health Record (EHR). No audio, transcript or note egresses the trust boundary.
This Clinical Safety Case Report sets out the intended use, environment, claims, hazards (with detailed entries in CSO07), and the basis on which BritiAI considers Scribe-On-Site safe for release subject to the controls described, pending Clinical Safety Officer sign-off and DCB0160 deployment assurance by each receiving trust.
2. Solution Description
Scribe-On-Site comprises:
- On-premises capture client. A trust-managed endpoint application that records consented audio in clinical settings.
- V-Note ASR (on-prem). Speech recognition optimised for UK clinical speech, with speaker diarisation, deployed as containerised workloads on trust infrastructure.
- BritiAI Copilot summarisation. Structures transcripts into clinical note templates (e.g. SOAP, problem-orientated, specialty-specific) using a clinical LLM hosted within the trust boundary.
- Clinician review UI. Side-by-side view of transcript, structured draft, and editable final note. Mandatory sign-off control before the note can be transmitted to the EHR.
- Audit and provenance store. Immutable record of audio capture metadata (not content, unless trust policy permits), edit history and sign-off event.
There is no cloud egress in the standard configuration. Where a trust opts into BritiAI’s optional aggregated quality telemetry (de-identified metrics only), this is explicitly enabled per deployment.
3. Intended Use
Scribe-On-Site is intended to assist registered clinicians in producing clinical documentation more efficiently. It generates draft notes for clinician review, edit and sign-off. It is not intended to:
- Produce final clinical documentation autonomously.
- Make or recommend diagnoses, treatments, prescriptions or referrals.
- Operate without an identified responsible clinician present.
- Record any patient or carer who has not provided consent in line with the deploying trust’s policy.
4. Intended Users
- Registered medical, nursing, AHP and dental clinicians authorised by the deploying trust to use the system.
- Trust-authorised administrative staff for configuration and audit (no clinical content authorship).
Users must complete the mandatory Scribe-On-Site training module prior to first use and an annual refresher thereafter.
5. Environment of Use
- UK NHS acute, community, primary care and mental health settings on trust-managed hardware.
- Consulting rooms, ward bays (with privacy safeguards), and clinic environments where consent for ambient capture has been obtained.
- Not intended for use in environments where reliable patient identification cannot be established (e.g. anonymous walk-in settings) without bespoke configuration.
6. Clinical Claims
BritiAI claims that Scribe-On-Site:
- Produces a draft structured clinical note from a captured consultation that, when reviewed and signed by the responsible clinician, can replace handwritten or dictated note-taking.
- Preserves audio and transcript provenance to support clinician verification.
- Operates entirely within the trust data boundary in its standard configuration.
Explicit non-claims
Scribe-On-Site does not claim to:
- Be a medical device or to provide diagnostic, therapeutic or triage output.
- Produce notes of guaranteed completeness or accuracy without clinician verification.
- Detect or interpret clinical findings independently.
- Substitute for clinician judgement, examination or documentation responsibility.
The responsible clinician retains full professional and legal accountability for the content of the signed note.
7. Risk Envelope
The principal hazard categories addressed in the Hazard Log (CSO07, hazards SCR-01 to SCR-10) are:
- Mis-transcription of clinically significant terms (drug names, doses, anatomical sides, negation).
- Omission of clinically significant information present in the consultation.
- Fabrication (“hallucination”) in the structured summary — content present in the draft note that was not present in the consultation.
- Unauthorised or non-consented recording of patients, carers or staff.
- Speaker mis-attribution (clinician statements attributed to patient or vice versa).
- Automation bias leading to under-scrutinised clinician sign-off.
- Inadvertent capture of third-party PII or safeguarding-relevant disclosures requiring separate process.
- Loss or unavailability of audio/transcript provenance affecting subsequent verification.
- Mis-routing of the signed note to the wrong patient record.
- Drift in ASR or summarisation behaviour following model update.
8. Risk Control Strategy
Controls applied across these hazards include, by hierarchy:
- Elimination by design. Restriction to draft-only output with mandatory clinician sign-off prior to EHR transmission. On-premises deployment eliminates a class of egress hazards.
- Reduction by design. Structured templating with explicit safety-critical fields (allergies, medications, plan) requiring active clinician confirmation; speaker diarisation with confidence scoring; numeric and drug-name confidence flagging.
- Protective measures. Side-by-side transcript and draft view; uncertainty highlighting; consent prompts and visible recording indicators; immutable audit trail; patient/record match confirmation step.
- Information for safety. Mandatory training; clear release notes per model version; documented known limitations.
Full mapping of controls to hazards is provided in CSO07.
9. Residual Risks Summary
After application of designed controls, the CSO is asked to confirm that the residual risk profile is:
- No residual hazard above Considerable severity / Low likelihood without explicit ALARP justification.
- No residual hazard in the unacceptable band.
- Specific attention drawn to: drug-name mis-transcription (residual risk amber, mitigated by clinician sign-off and on-screen highlighting of drug-name spans); automation bias (residual risk amber, mitigated by training, UI nudges and edit-distance monitoring); and consent-related hazards (residual risk amber, mitigated by trust policy alignment and pre-recording prompts).
These residual risks require CSO judgement and explicit acceptance.
10. Assumptions and Dependencies
- The deploying trust has a documented consent policy for ambient capture and trains staff to follow it.
- The trust EHR provides a stable interface for note submission with patient-record matching.
- Trust infrastructure meets the documented compute, storage and network requirements for V-Note and BritiAI Copilot.
- The trust CSO conducts a DCB0160 assessment reflecting local workflow.
11. Clinical Safety Verification
Verification activities completed prior to release include:
- Functional testing against the safety-critical requirements register.
- ASR evaluation on a curated UK-clinical speech evaluation set, with per-class accuracy reporting for drug names, doses, anatomical terms and negation.
- Summarisation evaluation including a fabrication probe set — synthetic and curated real consultations where ground-truth absence of certain content is known.
- Human factors review of the clinician sign-off flow.
- Penetration testing of the capture, storage and EHR submission interfaces.
Evidence is held in the BritiAI QMS and made available to deploying trust CSOs under NDA.
12. Post-Deployment Monitoring
In addition to the CSMS-wide monitoring (CSO01 §9), Scribe-On-Site specific monitors include:
- Distribution of ASR and summarisation confidence scores.
- Clinician edit distance between draft and signed note (aggregate, anonymised; not used for individual performance management).
- Rate of clinician-flagged fabrications or omissions.
- Rate of sign-offs occurring under the configurable “minimum review time” threshold.
- Audio-quality and microphone-failure indicators.
A safety review per deploying trust is conducted at three months post go-live and annually thereafter.
13. Change Control
Material changes that trigger re-assessment under this CSCR include: change to ASR model; change to summarisation model or prompt scaffolding; change to clinician sign-off flow; new clinical specialty template; change to trust integration interface. Minor parameter changes follow the abbreviated process described in CSO01 §8.
14. Statement of Conformance
Subject to CSO review and sign-off, BritiAI confirms that the clinical risk management activities undertaken for Scribe-On-Site have been performed in accordance with the principles and requirements of DCB0129:2018. The Hazard Log (CSO07), Clinical Risk Management Plan (held in the QMS), and this Clinical Safety Case Report together constitute the Clinical Safety Case for the release identified above.
Linked artefacts: CSO01 (CSMS), CSO07 (Hazard Log entries SCR-01 to SCR-10), CSO08 (DCB0160 engagement model), BRITI-CRMP-SCRIBE-001 (Clinical Risk Management Plan), BRITI-IFU-SCRIBE-001 (Instructions for Use), BRITI-TRAIN-SCRIBE-001 (Training pack).
Prepared by: BritiAI Quality and Clinical Safety function. To be reviewed, amended and signed by: Appointed Clinical Safety Officer.
CSO name: _________________________ Registration body and number: _________________________ Signature: _________________________ Date: _________________________