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A Distinct Approach to Clinical GenAI Oversight

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  • Thiers, Fabio A.

    (Convergen AI)

  • Lucy, Kimberly

Abstract

Policymakers are determined to regulate clinical Generative AI (GenAI) solutions, but progress has been hampered by the commingling with regulatory approaches originally designed for Narrow AI (NarAI). This article clarifies this matter by describing the distinctive function and risk profile of GenAI models in healthcare settings. It elaborates why regulatory frameworks crafted for NarAI oversight are not adequate for GenAI because of their distinct nature. A first principle analysis is then used to delineate the pivotal role that healthcare organizations will need to take in GenAI oversight. Finally, it describes a distinct approach to clinical GenAI regulation that combines centralized benchmarking of GenAI models with the ISO/IEC 42001 certification of AI Management Systems (AIMS) implemented in healthcare organizations.

Suggested Citation

  • Thiers, Fabio A. & Lucy, Kimberly, 2024. "A Distinct Approach to Clinical GenAI Oversight," OSF Preprints vm6zy, Center for Open Science.
    • Handle: RePEc:osf:osfxxx:vm6zy
    DOI: 10.31219/osf.io/vm6zy
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    1. Yukun Zhou & Mark A. Chia & Siegfried K. Wagner & Murat S. Ayhan & Dominic J. Williamson & Robbert R. Struyven & Timing Liu & Moucheng Xu & Mateo G. Lozano & Peter Woodward-Court & Yuka Kihara & Andre, 2023. "A foundation model for generalizable disease detection from retinal images," Nature, Nature, vol. 622(7981), pages 156-163, October.
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