Clinical Safety Case | CliniSearch

System scope and positioning

Classification

Clinical decision support information system (non-deterministic, non-prescriptive). Supports clinicians; does not automate decisions.

Intended use

Surface current, cited national guidance with visible change status and thresholds. Reinforces local policy; never replaces it.

Exclusions

No diagnostic outputs, no automated prescribing, no autonomous actions. No copying of patient-identifiable data.

Hazards, mitigations, residual risk

Outdated guidance

Mitigated through update tracking, supersession flags, and visible timestamps on every recommendation.

Misinterpretation

Structured recommendations, decision-type tagging, and threshold extraction with units reduce ambiguity.

Inappropriate reliance

Explicit attribution, no deterministic outputs, and clear separation of national guidance vs local policy.

Safety case wording: “The system makes knowledge risk explicit, surfaces change, and requires clinical judgement for every action.”

Evidence pack

Hazard log alignment

Mapping to DCB0129 hazards (incorrect/outdated info)
Residual risk statements with rationale
Traceable mitigations linked to product features

Versioned artefacts

Date-specific guidance views
Version-locked exports for audits
Change logs for recommendations and thresholds

Operational controls

Update alerting with severity tagging
CSO review notes and approval timestamps
Supplier / Trust responsibilities split

Deployment and assurance steps

1. Context

Document local use-cases (e.g., ED triage, GP, pharmacy) and how guidance is consumed.

2. Hazard review

Agree mitigations, residual risk, and where local policy or training is required.

3. Evidence bundle

Attach versioning snapshots, change logs, and export exemplars for incident review and audit.

4. Governance

Capture CSO sign-off, change board approvals, and inclusion in PSIRF learning cycles.

Ready-to-drop-into DCB0129/0160 safety cases.