LAS VEGAS, January 9, 2024 — The Food and Drug Administration significantly loosened regulations Tuesday for a range of wellness products and clinical decision support software, a move intended to spur innovation in digital health. It’s a shift that’s already sparking debate, particularly around how closely we should regulate the data coming from our wrists and phones.
The FDA’s new guidance aims to clarify the line between wellness features and medical devices, potentially opening the door to more sophisticated health tracking tools.
Wellness Trackers Get a Wider Latitude
The agency released two final guidance documents, one addressing wellness devices and the other focusing on clinical decision support software. The wellness guidance clarifies what the FDA considers a “wellness device,” offering more flexibility for wearables that track metrics like heart rate, blood pressure, and blood glucose—as long as they’re marketed solely for wellness purposes.
For example, a wrist-worn wearable that tracks sleep, pulse rate, and blood pressure would be considered a general wellness product, provided the blood pressure readings are validated. However, a wearable using microneedle technology to estimate blood glucose would not qualify as low-risk. The FDA warned consumers in 2024 against using smartwatches or rings claiming to measure blood sugar without piercing the skin.
“In the past, the FDA has permitted some measurements like pulse rate and O2 saturation in some wellness products, but not others,” FDA Commissioner Marty Makary said at the Consumer Electronics Showcase. “It didn’t always make a lot of sense from the outside.”
A Reversal on Whoop?
This new guidance appears to walk back a warning letter the FDA sent to wearable company Whoop last year regarding its blood pressure feature, which the agency had said was inherently tied to medical diagnosis. A spokesperson for Whoop applauded the guidance, stating it clarifies the company can provide wellness insights when designed for non-medical use and should “help resolve long-standing uncertainty about the boundary between providing wellness insights and medical diagnosis and treatment.”
Tom Hale, CEO of Oura, a maker of a wearable ring working on a blood pressure feature, also welcomed the changes, writing on LinkedIn that “modern regulation that recognizes the difference between early awareness and medical diagnosis is critical.”
Software That Supports, Not Replaces, Doctors
The second guidance document outlines significant changes to how the FDA regulates clinical decision support tools. The key shift: software that provides a single medical recommendation can now be exempt from regulation, unlike previous guidance that would have classified it as a medical device.
Consider software that predicts a patient’s risk of future cardiovascular events based on factors like weight, smoking status, blood pressure, and lab tests. Under the new guidance, this would be exempt from FDA enforcement. However, if the same software predicted risk within 24 hours or used genomic data, it would be regulated as a medical device.
Similarly, software summarizing radiologists’ findings using generative artificial intelligence would be exempt if it analyzes a radiologist’s report to generate a summary with recommendations. But if the software directly analyzed the image to create the report, it would still be subject to FDA regulation.
The FDA emphasized that device makers must provide clinicians with information about the basis of the software’s suggestions. Software used for critical, time-sensitive tasks will still be considered a device, requiring a description of the underlying algorithm, validation, and necessary input information.
The pair of guidance documents offer a glimpse into the Trump administration’s approach to AI, which has favored deregulation. The Department of Health and Human Services requested feedback from the healthcare industry in December on how to accelerate AI adoption. Both guidance documents were published Tuesday without a public comment period, a recent practice for major policy changes.
