Acceptable Use

This document is the working reference for what features sit inside the registered intended purpose of the Cogent Clinic Class I medical device and what features sit outside that scope. The boundary, in summary: features that operate on text the clinician has authored are in scope; features that would generate clinical reasoning of the device's own are out of scope and would require a reclassification of the device.

Cogent Clinic is a Class I medical device under UK MDR 2002 (registered with the MHRA). The Class I classification is defended by the architectural commitment that the device contributes no clinical reasoning of its own. The body of this document applies that commitment, feature by feature.

Safely in scope (document operations, not clinical reasoning)

Core drafting

• Structured document drafting per document type
• Template variants within each document type
• Tone adjustment (more formal, plain-language, clinical)
• Length adjustment (shorter, expand, tighten a section)
• Audience adjustment (GP, patient, medico-legal)

Document transformation

• Summarisation
• Restructuring (e.g., reformat as SOAP, five-areas)
• Extraction to structured form (e.g., pull risk information into structured summary)
• Cross-document synthesis (drafting across multiple session notes: progress update, supervision summary, discharge summary)

Editorial and writing support

• Clarity check (is this letter clear for intended reader)
• Tone check
• Grammar and style polish
• Jargon translation (clinical → plain English for patient; plain → clinical for report)
• Consistency checking across long documents (tense, person, terminology)
• Source-grounding check: comparing a finished draft against the material the clinician supplied and flagging any statement without support in it, for the clinician to confirm or strike. The check compares text against text and offers no view on clinical correctness; it exists so nothing invented slips into a record unnoticed

Retrieval and search

• Search within notes
• Cross-session retrieval
• Timeline extraction

Input methods

• Typed input
• Pasted de-identified text
• Voice memo dictation (post-session, not ambient recording)
• PDF input (carefully, with tokenisation applied)

Structured output

• AI-model tool-use for schema-enforced output in structured documents (risk assessment templates, formulation frameworks, report sections)

Deferred: outside the registered Class I scope

These features would push the device past the Rule 11 boundary into Class IIa territory under UK MDR 2002, requiring an Approved Body conformity assessment, an updated technical file, and a new Declaration of Conformity. They are not part of the registered Class I device.

• "Ask a clinical question about these notes": clinical decision support
• Risk assessment reasoning ("is this person at risk?")
• Diagnostic suggestions
• Treatment recommendations
• Predictions or prognostics
• Flagging concerning content (e.g., automatic suicidality flagging)
• Psychometric interpretation (clinical interpretation of PHQ-9, GAD-7, etc.)
• Screening or assessment scoring with clinical conclusions

Document operations on sensitive material (in scope, with explicit framing)

The following features sit inside the registered Class I scope because they operate on text the clinician has authored or content the clinician has supplied, even where the underlying material is clinically sensitive:

• Reflective thinking prompts scoped to one client's plan and recent drafts.
• Cross-session synthesis for supervision briefs and treatment summaries, drafted from the clinician's own session notes.
• Deterministic psychometric scoring: computing the headline score, band, and subscale totals from the values the clinician enters, recorded against the folder and carried into report drafts without any clinical interpretation.
• Assessment note drafting including the risk section, drafted from the clinician's own input.

Decision rules

• If the feature generates clinical reasoning about a specific patient, it is outside the registered Class I scope.
• If the feature transforms text the clinician has written into a different form, it is inside the registered Class I scope.
• Disclaimers do not change regulatory classification; feature design does.
• When uncertain, the architectural test is the one in the manufacturer's classification rationale, which asks whether the device contributes any clinical reasoning of its own or only reorganises content the clinician has authored.

Reference

The full discussion of the document-operation vs clinical-reasoning distinction is held in the manufacturer's classification rationale within the technical documentation file, and is available to procurement reviewers under NDA.