Code Red: The FDA's Artificial Intelligence/Machine Learning Action Plan Poses Potential Risks for Medical Device Makers | Nutter McClennen & Fish LLP

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"The gathering and transmitting of personal data represents a major cyber threat to medical devices and must be extremely carefully thought through."
Q: The FDA’s stance on a regulatory framework for artificial intelligence and machine learning (AI/ML) software as a medical device is continuously evolving. Could you explain the history?
A: Artificial intelligence (AI) is “adaptive,” meaning that it continuously learns algorithms. For this reason, it is sometimes referred to as Machine Learning (ML). Newly designed medical devices that incorporate AI/ML by definition do not have a final “locked” design capable of a single FDA review. In April 2019, the FDA issued a white paper,

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