Viewpoint Defines 'Refined Exclusion' in Medical AI and Proposes Safety Governance Framework

A viewpoint defines 'refined exclusion' — when medical AI performs well overall but fails in underrepresented groups — and proposes lifecycle decision gates (proceed, enrich, restrict, pause) to shift focus from average performance to demonstrable safety for all populations.

• Refined exclusion links hidden stratification and dataset shift to unequal safety, not just fairness metrics.
• Decision gates span intended use, subgroup learnability, data provenance, validation, procurement, local deployment, monitoring, updates, and patient feedback.
• Governance intensity should be proportionate to clinical risk and evidentiary uncertainty, not a one-size-fits-all checklist.

Automated summary

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