August 6, 2025

The Governance Vacuum in Medical Device AI: Toward an Equitable and Accountable Framework

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Policy analysis addresses governance failures in medical device AI, suggesting frameworks for enforceable equity and accountability.

Governance in medical AI currently suffers from structural failures rooted in a lack of equity-centered design.
Existing regulatory frameworks fall short in providing enforceable standards related to fairness and safety.
The proposed lifecycle-oriented governance framework aims to translate ethical principles into actionable standards.
Embedding enforceable equity can align innovation with accountability, enhancing trustworthiness in medical AI.

Ganguly et al. (2025) studied this question.

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