2002, FDA, Medicaid and Public Health - Health Care Compliance Brief

FDA Oversight of AI Software Developed by Health Care Providers

Health Law Advisor

AUGUST 10, 2023

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. It’s important to understand that FDA regulation isn’t punitive in the sense that it’s only intended to apply to bad people.

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FDA Oversight of AI Software Developed by Health Care Providers

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