FDA: AI-powered medical devices ‘simply providing information’ are not subject to regulation
The U.S. Food and Drug Administration (FDA) made a big policy announcement during a recent TV segment on Fox Business.
In an interview between network host Stuart Varney and FDA Commissioner Martin Makary, MD, the latter revealed that the agency will not require developers of consumer wearables, even those that generate health data, to be subject to regulation.
More specifically, this would be any medical device that provides general health information, such as a calorie calculator or sleep monitor, that isn’t purporting to be diagnosing a condition or producing what Makary called “medical grade” data.
"We want to let companies know, with very clear guidance, that if their device or software is simply providing information, they can do that without FDA regulation," Makary told the outlet during a Varney & Co. segment.
As an example of what would still be subject to FDA regulation, Makary mentioned things like blood pressure readers, which are providing data to users and providers alike. Ostensibly, if the data is being used for clinical purposes, companies will be required to follow FDA guidelines.
But there’s a lot of wiggle room in between. According to Makary, the regulatory line will be based largely on what companies claim their products do—meaning, even those that provide more detailed information on patient health may not be subject to the agency’s approval and oversight, so long as they don’t make claims about the clinical viability of the data.
In making the announcement, the FDA is attempting to balance the need for data to fuel what Makary called an “AI revolution” while also ensuring healthcare devices aren’t a metaphorical Wild West, where patients make important medical decisions based on what a consumer wearable app tells them.
“We don’t want people changing their medicines based on something that’s just a screening tool or an estimate of a physiologic parameter,” Makary clarified.
He said the agency was attempting to give the industry “clear guidance,” noting that “markets like predictability" from regulators.
Accuracy and reliability determined by market forces
This announcement on Fox Business, made on Jan. 6, coincided with official guidance the FDA released specifically about large language models that is of a similar vein.
According to Makary, this hands-off approach on consumer-focused AI in healthcare would include tools such as ChatGPT and Google Gemini, which are frequently used by Americans to answer medical questions. As long as those systems are not purporting to replace doctors, and are providing advice and general information as opposed to a serious clinical action plan, it sounds as if the agency will not intervene.
He was asked directly by Varney if the FDA is attempting to ensure that medical data produced by apps and wearables is accurate—and the answer appears to be context dependent.
“If they’re not making claims that they are medical grade, let’s let the market decide, let’s let doctors choose from a competitive marketplace which [devices and products] they recommend for their patients,” Makary said.
That answer seemed to mean that, even if a wearable isn’t producing clinically viable data, the device can be used for patient care regardless of whether it's rubber stamped by the FDA. In defense of this, Makary noted that many AI-powered devices are improving over time as a result of people using them.
“If something is simply providing information like ChatGPT or Google, we’re not going to outrun that lion,” he added.
“We have to promote these products and, at the same time, just guard against major safety concerns.”
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.