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<p>Large language models (LLMs) show considerable promise for clinical decision support (CDS) but none is currently authorized by the Food and Drug Administration (FDA) as a CDS device. We evaluated whether two popular LLMs could be induced to provide device-like CDS output. We found that LLM output readily produced device-like decision support across a range of scenarios, suggesting a need for regulation if LLMs are formally deployed for clinical use.</p>

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Unregulated large language models produce medical device-like output

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年3月7日

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  • Gary E. Weissman,
  • Toni Mankowitz,
  • Genevieve P. Kanter

摘要

Large language models (LLMs) show considerable promise for clinical decision support (CDS) but none is currently authorized by the Food and Drug Administration (FDA) as a CDS device. We evaluated whether two popular LLMs could be induced to provide device-like CDS output. We found that LLM output readily produced device-like decision support across a range of scenarios, suggesting a need for regulation if LLMs are formally deployed for clinical use.