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The AI Validation Gap: Decision Support Tools Are Outrunning Their Own Evidence
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Fusion42 · 16 August 2026 · Fusion42 review
AI decision support tools in clinical trials are being deployed faster than regulatory validation frameworks, particularly FDA guidance, have been finalised, creating a gap in oversight for adaptive AI models in critical healthcare decision contexts.
This Wire brief sits within Fusion42's coverage of Digital Health.
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You face a sharp rise in regulatory risk as AI tools outpace FDA validation frameworks. Pin down validation strategies now to avoid operational disruptions in clinical trial software deployment.
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1 source · 16 Aug 2026
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