Health IT Analytics June 7, 2019
AMIA is encouraging the FDA to refine its AI and machine learning regulatory framework across several areas, including bias and cybersecurity.
AMIA is encouraging FDA to modify its regulatory framework for Artificial Intelligence (AI)/Machine Learning (ML)-based software as a medical device (SaMD), particularly in areas of potential bias and cybersecurity risks.
In April 2019, FDA announced that it would develop a framework for regulating AI products that self-update based on new data. Although FDA has authorized other AI products, these products typically use “locked” algorithms that don’t continually adapt or learn each time the algorithm is used.
In response to FDA’s request for feedback, AMIA offered comments on the draft framework, and outlined areas that may need to be...
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