TRUST

Clinical Safety

Make measurement quality, critical-result handling, alert escalation, human review and failure visibility explicit in connected-care workflows.

Owner: Clinical Product Governance
Scope: Clinical-facing workflows and safety-relevant handoffs
Status: Published control statement

01 / CONTROL

Control model

Data quality

Source, subject, time, unit, quality flags and correction status travel with clinical data.

Escalation

Critical/urgent rules create accountable review and escalation paths where configured.

Human oversight

Decision-support output is presented with context and does not silently replace professional judgement.

Failure visibility

Missing data, stale device state, delivery failure and unacknowledged work remain visible to operators.

02 / BOUNDARY

Responsibility boundary

Trusted Care supports configured workflows; clinical judgement, diagnosis, emergency response and provider protocols remain with qualified care organizations.

03 / ESCALATION

Evidence and escalation

Clinical-safety concerns require the provider’s operational/clinical escalation path; security or service defects should also use their dedicated reporting channels.

SAFETY CONTROL

Clinical safety starts with intended use and failure behavior

The platform should make clear which functions inform a professional, which merely transport data, and which actions require human confirmation. A missing message, stale value or unavailable dependency must fail visibly.

Intended use

Define the operational/clinical role of each alert, workflow or AI-assisted signal; do not imply diagnosis when the function is informational.

Human confirmation

Actions with clinical consequence remain attributable to an authorized professional unless a separately validated automation is explicitly supported.

Data quality

Surface stale, missing, duplicate or low-quality measurements and preserve source context rather than silently normalizing uncertainty away.

Fail visible

Timeouts, delivery failure and unavailable dependencies create a recoverable state/escalation path instead of a false success state.

SAFETY LOOP

Detect, review, act and learn

Safety controls continue after go-live through incident evidence and controlled change.

Detect signalReceive measurement/order/result/alert with source and quality context.

Evaluate ruleApply configured policy/threshold with versioned context.

Human reviewPresent enough evidence for the authorized reviewer to understand the trigger.

Act or escalateRecord action, deferral, override or escalation with timestamp/responsible role.

Confirm handoffDo not assume downstream receipt; expose delivery/acknowledgement state where required.

Review incidentsUse correlated evidence to investigate failure and feed controlled policy/product change.