Ambient clinical documentation assistant

Under reviewPilotDeveloping evidence

Undergoing in-depth clinical, technical and governance review.

Transcribes the clinician–patient conversation and drafts a structured clinical note for the clinician to review, edit and sign.

Plain-language summary

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Clinical context

Clinical problem: Automate documentation
Point of care: Back office
Nature of AI output: Generated text
Clinical specialty: General practice
Care setting: Hospital — outpatient
Patient population: Outpatient consultations across general medicine and specialist clinics.
Intended use: Transcribes the clinician–patient conversation and drafts a structured clinical note for the clinician to review, edit and sign.

Technology

Deployment

Regulatory & governance

EU AI Act risk tier: Limited risk
High-risk basis: Not applicable
Medical device: No
EU MDR class: Not a device
CE marking: Not required
FDA status: Not applicable
ISO 14971 risk class: Low
GDPR processing basis: Consent
GDPR DPIA: Completed
Data identifiability: Pseudonymised
Explainability method: None
Human oversight model: The clinician reviews, corrects and approves every generated note before it enters the record.

NICE evidence standards

Performance summary

Headline metric: Time saved
Value: 4.5
Subgroup performance assessed: No
Known bias signals: Transcription accuracy lower for non-native and accented speech; multilingual evaluation in progress.

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Studies and evaluations attached to this use case.

Prospective observational
Time saved: 4.5
Population: Outpatient consultations, minutes saved per encounter

Deploying organisation: [demo] Erasmus MC · Hospital / health system · Netherlands
AI vendor: [demo] Nabla · France
Product name: Nabla Copilot