At an October healthcare AI conference at Philadelphia-based University of Pennsylvania, a moderator asked HHS Acting Chief AI Officer Micky Tripathi, PhD, about the regulatory process for technologies like the AI feature in Epic’s MyChart.
“There isn’t really a federal approval process it would have to go through,” Dr. Tripathi said, according to the Penn Leonard Davis Institute of Health Economics’ Oct. 22 coverage of the event. “It doesn’t qualify as a medical device by FDA definitions. … And within electronic health record software, there’s no requirement that it go through some kind of approval process.”
The moderator, institute adjunct senior fellow Dan Gorenstein, cited a New York Times story relaying how the technology “troubles some experts who worry that doctors may not be vigilant enough to catch potentially dangerous errors in medically significant messages drafted by AI” and a small Lancet study that found that if left unedited the messages posed a risk of severe harm 7.1% of the time.
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