Learning from Experience: FDA’s Treatment of Machine Learning


Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, authored an article in MobiHealthNews, titled “Learning from Experience: FDA’s Treatment of Machine Learning.”

Following is an excerpt:

There seems to be a modern day gold rush as companies explore how to use machine learning in clinical decision support software. Unfortunately for libertarians, FDA will regulate some of that software because of its risk profile. While the 21st Century Cures Act that passed last December exempted certain CDS from regulation and indeed FDA intends to exempt even more, FDA will continue to regulate high risk CDS. The question is: how will FDA regulate high risk CDS when the software involves machine learning?

Some might assume that machine learning in healthcare is so new, we have no idea how FDA will react. But that’s simply not the case. FDA has decades of experience regulating machine learning and, fortunately, that gives us some useful clues as to how FDA will respond to the expanded uses of that technology.