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August 6, 2025

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

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Authors

DGDebmalya GangulyEJEdward JonesLRLinekie Redd

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Overview

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

Key Points

  • 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.

Cite This Study

Ganguly et al. (2025) studied this question.

synapsesocial.com/papers/689a0fa0e6551bb0af8d16f9https://doi.org/10.31235/osf.io/unq6y_v2
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