Episode 26 of AI Ethics with Fexingo dives into the growing use of AI systems that recommend medical treatments—like sepsis management or cancer therapy—without the rigorous clinical trials normally required for drugs or devices. Lucas and Luna examine the case of Epic Systems' Sepsis Model, which was deployed in hundreds of hospitals before a 2021 JAMA study showed it failed to detect sepsis in over two-thirds of cases. They also discuss the FDA's evolving regulatory framework for AI as a Medical Device (SaMD), the tension between rapid deployment and patient safety, and what the recent 2024 FDA guidance on 'predetermined change control plans' really means. The hosts ask: should an algorithm that influences your chemotherapy regimen be held to the same standard as a new pill?

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