Foundations

Voice & tone

Copy in a clinical interface is a safety surface. It is read by someone interrupted, tired, at distance, and about to make a decision — and it is the layer where the software either respects the limits of what it can know, or quietly exceeds them.

Stable · v1.0 IEC 62366-1 Framework · ISO 9241-11

Overview

Most of this system constrains what an interface looks like. This page constrains what it is allowed to say — which turns out to matter more, because a component rendered perfectly can still assert a diagnosis the device is not cleared to make.

This page is the clinical register

Everything below assumes a trained reader who can tell when the screen is wrong. Where the reader is the patient — no training, no supervision, nobody to ask — that assumption fails, and precision starts reading as reassurance while correct hedging reads as evasion. That is a second register, not a simplified version of this one. See Lay & patient-facing design.

Every rule here already existed, scattered across Alert Banner, Dialog, Button, Status chip, Select and Confidence disclosure. This page is where they live now; those pages defer to it.

Specific

Name the finding, the territory and the measurement. Specificity is what makes a statement checkable, and checkable is what makes it trustworthy.

Bounded

Never claim more than the software can know. It detects patterns; the clinician diagnoses. No wording may blur that line.

Calm

Urgency is carried by priority level and colour. Words carry information. No capitals, no exclamation marks, no adjectives doing an alarm's job.

The claim ladder

The single most important table in this system. What AcuteLine may say about a finding, and what it may never say — regardless of how confident the model is.

PermittedMeansProhibitedWhy
"…pattern detected" The model matched a pattern in this signal "diagnosed", "has a STEMI" A diagnosis is a clinician's act, integrating history and examination the software never saw.
"consistent with…" Compatible with, not established "confirms", "indicates" Compatibility is not confirmation.
"…cannot be excluded" The finding remains possible "probable", "likely" Bare likelihood words invite reliance without a number. Give the number instead.
"no … detected" The model did not match a pattern "normal", "clear", "ruled out", "negative for" Absence of detection is not absence of disease, and "normal" is a clinician's summary judgement of a whole patient.
"interpretation limited by…" Input conditions constrain what can be said Silence, or a lower confidence score See Confidence disclosure — withhold rather than extrapolate.
"review", "confirm", "consider" Directs attention "administer", "give", "start", any dose or agent Decision support does not prescribe. Refer to local protocol; never name therapy.
The line this protects

AcuteLine's regulatory position is that it is decision support: it flags patterns for clinician review and never diagnoses or treats. That position is asserted in the technical file and it is enacted, or broken, in the microcopy. A single alert reading "AcuteLine has diagnosed a heart attack" contradicts the file more effectively than any architecture diagram supports it.

Governed strings

A small set of exact wordings that exist as risk controls. They are not shortened for space, not moved to a tooltip, not shown only on first use, and not freely translated — a translated version is reviewed for equivalent meaning and recorded alongside the source.

StringAppearsMitigates
"A negative result does not exclude ACS. Continue clinical assessment." Every negative or no-finding result False reassurance; premature discharge
"No confidence score is reported for this recording." Any input outside validated scope Confident output on an input the model cannot assess
"Your assessment is recorded against model vn and used for post-market performance monitoring." The override control Undisclosed use of clinician data; unconsidered agreement
"Emergency access active — this session is being audited." Break-glass sessions, persistently Forgetting an audited session is open
"Change from baseline cannot be assessed." No prior study on file Unknown chronicity read as acute, or vice versa

Microcopy by component

WhereShapeExample
Alert titleFinding — territory. ≤ 60 characters, no full stop STEMI pattern detected — anterior leads V2–V4
Alert descriptionMeasurement. One imperative referring to local protocol ST elevation 3.1 mm. Confirm ECG and activate local chest-pain pathway.
ButtonVerb + object. 2–4 words, sentence case, no full stop Activate pathway · Discard draft report
Dialog titleA question naming the object Discard this draft report?
Dialog bodyWhat happens, to whom, and what is not affected …will be permanently lost. The original ECG is unaffected.
Status chipA state, 1–2 words, never an instruction Awaiting serial
Select placeholder"Select a …"Select a reason
Field errorWhat is wrong, then what to do. No blame MRN must be 9 digits — 7 entered. Check the wristband and re-enter.
Empty stateThe state, plus evidence the system is alive No cases awaiting review. Last analysis 14:47. Monitoring 4 sources.

Never blame the reader

Use error, not user error

This system uses the term use error precisely because such errors usually arise from a mismatch between the interface, the task and the environment — not from a deficient user. Copy follows the same logic: it describes the state, never the person's failing. "You entered an invalid MRN" locates the fault in the clinician. "MRN must be 9 digits — 7 entered" locates it in the data and says what to do.

Mechanics

Tone under pressure

Tone is not decoration here. A clinician's emotional response to the interface is part of satisfaction, and wording that raises stress in a resuscitation has a measurable cost.

Do
STEMI pattern detected — anterior leads V2–V4
ST elevation 3.1 mm. Confirm ECG and activate local chest-pain pathway.

Bounded claim, specific measurement, one action, no adjectives. The urgency is in the colour, not the words.

Don't
URGENT! AcuteLine has found a serious heart attack!
Sorry — you must act immediately. Give aspirin now.

Claims a diagnosis, leads with the product, shouts, apologises, blames, and prescribes therapy the device is not cleared to recommend.

Translation

Outcomes of use

What this contributes to, in the terms of Usability & context of use.

Do's and don'ts

Do
No acute ischaemic pattern detected
A negative result does not exclude ACS. Continue clinical assessment.

Bounded claim plus the governed caveat. The software says what it did, not what is true of the patient.

Don't
ECG normal

“Normal” is a clinician's summary judgement of a whole patient, asserted here by a pattern matcher on one recording.

Do
MRN must be 9 digits — 7 entered. Check the wristband and re-enter.

States the rule, the actual, and the recovery. Nobody is blamed and the next step is obvious.

Don't
You entered an invalid MRN.

Locates the fault in the clinician, names no rule, and offers no way forward.

Clinical safety notes

Risk controls carried by this foundation

Trace these in your risk file (ISO 14971) and usability engineering file (IEC 62366-1). Copy is a design control; changing a governed string is a design change.

NotJustAnyMed.Tech Design System · Voice & tone · v1.0 · draft for review
Reference applications named in this system are fictional; all copy shown is illustrative and has not been reviewed by a clinician.