As leaders in precision medicine, clinical trial design, and regulatory science, we have seen firsthand the promise and pitfalls of new medical technologies. From our distinct vantage points — directing a precision medicine institute, leading the global trials that result in new drug approvals, and shaping health policy informed by past experience at the Food and Drug Administration — we have arrived at a shared, urgent conviction: For artificial intelligence to truly transform patient care, it must first be held to the same standard of evidence as the medicines it promises to enhance.

The excitement around AI is palpable. The promise is that these tools will help physicians diagnose disease earlier, personalize treatment selection, and predict patient outcomes with unprecedented accuracy

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