Chapter 05 · Validation & Evidence

Validation & Evidence as a reviewable surface.

Validation evidence proves fitness for a specific use context. Generic benchmark performance is not enough for healthcare workflows.

Focus: concept · data · model · evidenceRisk: confusing capability with readinessBridge: language · controls · records
Foundations traceConceptDataModelEvidenceHumanReviewAIsystemsource to workflow to evidence to review
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Validation & Evidence chapter.

Foundations

Validation evidence proves fitness for a specific use context. Generic benchmark performance is not enough for healthcare workflows.

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What this page maps.

operating content
Technical evidence

Technical evidence

Performance metrics, error analysis, robustness, calibration, subgroup checks, and reproducibility.

Workflow evidence

Workflow evidence

Usability, human review quality, adoption friction, false reassurance, alert fatigue, and operational failure modes.

Governance evidence

Governance evidence

Approval record, acceptance criteria, owner sign-off, limitations, monitoring, and review triggers.

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Governance questions.

review logic
Question

What decision or record does this validation & evidence surface influence, and who owns that decision?

Question

Which evidence is needed before routine use in Foundations, and where is it retained?

Question

What signal triggers review, restriction, escalation, or retirement?

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Evidence-ready minimum record.

iFeed use
Minimum record
OwnerNamed operational, clinical, technical, and governance owners.
UseClear intended use, user group, workflow point, and excluded use.
RiskRisk tier, rationale, residual risks, controls, and escalation route.
EvidenceSource claims, validation basis, limitations, approval decision, and review date.
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Source anchors and claim boundary.

official first

These anchors support the source layer for this page. iFeed interpretation remains separate from source facts and does not replace legal, regulatory, clinical, or product-specific advice.