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A Brave New World: Regulatory Flexibility Key To AI Development, Stakeholders Say

About 130 stakeholders representing a broad spectrum of the health-care industry are asking the US FDA to consider taking a soft touch in any future guidance document addressing artificial intelligence and machine learning devices in order to keep up with developments in the field. Drug lobbyists have also asked the agency to develop guidance that reaches across centers to avoid future conflicts.

AI

An overwhelming number of medical stakeholders have given their two cents to US regulators about how artificial intelligence and machine learning products should be regulated. A common theme across the board is they want more clarity and agreement on key terms, as well as a soft regulatory touch when it comes to AI/ML software updates when compared to requirements for traditional medical devices.

In April, the US Food and Drug Administration published a discussion paper on how it's thinking about regulating AI/ML products....

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