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Evaluating clinical AI before it touches patients

A 20-page report on how to judge a clinical AI tool before it reaches a patient.

PDF · 20 pages · Updated 30 September 2026

Who it is for
Physicians and health-system leaders who have to say yes or no to a clinical AI tool.
Format
PDF
Length
20 pages
Updated
30 September 2026
Topic
Evaluation

Three findings inside

  • 6%

    of 516 studies of AI for diagnostic imaging performed external validation.

    Kim et al., Korean Journal of Radiology, 2019

  • 87%

    of machine-learning prediction-model analyses were at high risk of bias.

    Andaur Navarro et al., BMJ, 2021

  • 0.63

    external AUROC for a widely used sepsis model, which missed 67% of patients who had sepsis.

    Wong et al., JAMA Internal Medicine, 2021

What is inside

  1. The gap between adoption and evidence
  2. What the number on the slide meansAUROC, positive predictive value, calibration, subgroups.
  3. Whose patients the evidence is about
  4. What FDA authorization actually establishes
  5. Europe: the clock was reset, not stopped
  6. Benchmarks, and the evidence hierarchy for language models
  7. The vendor demo, and the one-page checklist
  8. After go-live: evaluation becomes governance

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A 20-page report on how to judge a clinical AI tool before it reaches a patient.

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Questions

Is this clinical or regulatory advice?

No. It appraises published evidence and sources. Confirm anything that affects a patient or a purchase with your own governance team and counsel.

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Evaluating clinical AI before it touches patients

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