Think in three gates (pass all three, or don’t ship)
Governance map (what to produce, and who owns it)
1) Define the exact use case (scope statement)
2) Create a data flow diagram (minimum viable)
3) DPIA + lawful basis (IG lead)
4) Transparency materials (patient-facing)
5) Clinical Safety case (DCB0160 adopter duties)
6) Supplier assurance (DCB0129 + evidence pack)
7) DTAC baseline (procurement/IT)
8) Security posture (minimum questions)
9) Interoperability plan (avoid ‘copy/paste drift’)
10) Training + competency sign-off (ops owner)
11) Pilot metrics (measurement before rollout)
12) Exit plan (if it fails, you still look professional)
Clinician operating rules (the non-negotiables)
Rule 1 — Human sign-off is mandatory
Rule 2 — Don’t add data you didn’t verify
Rule 3 — Use ‘source-aware’ phrasing
Rule 4 — Know your identifier policy
Rule 5 — Escalate documentation safety events
Rule 6 — Don’t create ‘note bloat’
Rule 7 — Separate admin assistance from decisions
Rule 8 — Audit yourself weekly during pilots
If your governance is unclear, pause
References
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Write one paragraph: where it will be used (setting), what it will generate (notes/letters/summaries), what it will NOT do (no autonomous clinical decisions), and the clinician sign-off rule (human remains accountable).
Return to this sectionMap: audio capture → transcription → LLM summarisation → storage → EPR entry. Include where processing occurs, where logs live, who can access them, and retention windows.
Return to this sectionRun a DPIA aligned to your organisation’s IG process. Specify: identifiers used, minimisation strategy, retention, and controls for secondary use (analytics/model improvement).
Return to this sectionCreate a 1-page notice: what the tool does, what data it processes, whether audio is stored, how to opt out, and where to direct questions/complaints.
Return to this sectionNominate a Clinical Safety Officer (CSO) for the deployment. Maintain a hazard log focused on documentation risks: omission, hallucinated detail, misattribution, wrong patient context, and copy-forward errors.
Return to this sectionRequest the supplier’s clinical risk management evidence (developer side) and how it interfaces with your DCB0160 adopter responsibilities.
Return to this sectionEnsure the supplier can evidence DTAC’s core areas (clinical safety, data protection, technical security, interoperability, usability/accessibility). Don’t accept ‘we’re working on it’ for production use.
Return to this sectionClarify encryption at rest/in transit, access controls, audit logs, incident response timelines, and subcontractors. Align to your organisation’s cyber/security requirements.
Return to this sectionDecide how outputs enter the record: direct integration vs structured template vs manual paste. Define a ‘single source of truth’ rule to avoid multiple competing versions of notes.
Return to this sectionMandatory micro-training: how to correct outputs, how to avoid introducing identifiers if policy forbids, and how to document tool usage (where required).
Return to this sectionPick 5 measures: time saved, clinician satisfaction, documentation error rate (spot checks), patient experience (opt-out rate), and ‘near miss’ reporting rate.
Return to this sectionDefine how you turn it off safely: access revocation, data deletion/return, comms to staff, and a closure note for governance records.
Return to this sectionTreat every output as a draft. You review, correct, and sign. No exceptions.
Return to this sectionIf the tool invents a detail, delete it. If it misses a detail, add it yourself from your own history/exam documentation.
Return to this sectionWhere relevant, phrase uncertain items as patient-reported vs clinician-observed to reduce misattribution in the record.
Return to this sectionFollow your local policy on entering patient identifiers and whether audio is stored. If unsure: do not include identifiable details.
Return to this sectionIf the tool creates a risky note, report it through your organisation’s incident route (and log it for the pilot).
Return to this sectionShorter and accurate beats longer and risky. Trim boilerplate aggressively.
Return to this sectionUse for drafting/formatting. Decisions remain grounded in your clinical judgement and local guidance.
Return to this sectionSpot-check a sample of notes (self or buddy system). Track common failure modes and feed back to the governance owner.
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Portfolios and governance · Article 8 of 12