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by Mike Miliard, HealthcareIT News (OCTOBER 17, 2019)
The U.S. Food and Drug Administration unveiled a new set of draft recommendations on clinical decision support software recently, and in its guidance, the agency said it's taking a risk-based approach to categorization of these various CDS tools, many of them powered by artificial intelligence, that it hopes will be an "appropriate regulatory framework that take into account the realities of how technology advances play a crucial role in the efficient development of digital health technologies."
Given the vast proliferation of AI and machine learning software across healthcare, and the speed at which it's evolving, that certainly won't be the last word from the FDA, or other regulatory agencies, on the subject.
A truly global framework
Indeed, said Robert Havasy, managing director of the Personal Connected Health Alliance, when he looks across the U.S. and around the world he sees the beginnings of a "truly global framework emerging, with common principles among the U.S., Europe and other places," for the safe and effective deployment of AI in healthcare.
Havasy was speaking at the HIMSS Connected Health Conference during a roundtable discussion about developing approaches to AI regulation and design.
"We're assessing risk with a global system," said Havasy. "There are some common principles, one of which seems to be that the risk is presumed to be lower when there are competent individuals who can make their own decisions and understand how a system works."
As Dr. Art Papier, a dermatologist at the University of Rochester and founder and CEO of the AI company VisualDx explained, even if an AI algorithm says a mole is 99.9% benign, if the patient says the mole has recently changed, it's getting removed.
Healthcare is nowhere near the point where "these algorithms are reliable enough to trust" without skilled human intervention, he said.
An explainable process
At VisualDx, said Papier, "we are very process oriented. As we read the FDA guidance we're seeing that the FDA really wants to make sure that your process is explainable, and you know running your tests and having the data to support the work."
It's critical, he said, for AI developers to be "explaining what you're doing as best you can and surfacing that - so your users don't have a sense that it's just a big black box."
VisualDx is an award-winning diagnostic clinical decision support system that has become the standard electronic resource at more than half of U.S. medical schools and more than 1,500 hospitals and institutions nationwide. VisualDx combines clinical search with the world's best medical image library, plus medical knowledge from experts to help with diagnosis, treatment, self-education, and patient communication. Expanding to provide diagnostic decision support across General Medicine, the new VisualDx brings increased speed and accuracy to the art of diagnosis. Learn more at www.visualdx.com.