Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was a featured guest for the Yale Certificate Program on Medical Software and Medical AI.

In this video, Brad discusses topics including:

  • What types of medical software are regulated as medical devices?
  • The controversy on the recent FDA Clinical Decision Support (CDS) Guidance.
  • Web searches as CDS?
  • The line between CDS and Medical Devices.
  • Provider-generated AI tools.
  • FDA and software tools used outside medical practices (e.g. insurance companies)
  • Bias and evaluation of results on subpopulations as emerging regulatory issues.

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