Profile of evidence-bundle-spec scoped to pre-market and post-deployment bias / equity-coverage evidence for clinical AI/ML devices. Names the OMB SPD 15 + Section 1557 protected-class taxonomy, Fitzpatrick + sub-cohort dimensions, performance + equity metrics, and decision-document conventions. Healthcare-readiness scaffolding, not certification.
fda equity bias ai-safety healthtech clinical-ai ai-governance evidence-bundle kinetic-gain-protocol-suite hti-1 section-1557
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Updated
May 29, 2026