Why the FDA’s new digital health guidance has physicians on edge
Industry Buzz
The current rule changes are intended to affect only low-risk software and devices designated as general wellness products. However, what qualifies as low-risk and a general wellness product is open to interpretation.
—David Cutler, MD
The FDA’s new guidance on general wellness products has sparked debate among experts about how much oversight is warranted.
Some argue that easing regulations on general wellness products poses risks, while others argue that the new guidance makes sense.
“Even with additional clarifying language, there has often been uncertainty about which products truly require FDA review and which do not. By more clearly delineating a category of low-risk ‘general wellness’ products, the new guidelines add clarity for both developers and consumers. That clarity can help reduce unnecessary regulatory burden while allowing genuinely low-risk products that promote healthy lifestyles to reach people more easily,” Thomas Kingsley, MD, Director of Applied Artificial Intelligence at UCLA Health, tells MDLinx.
But he notes that achieving balance with oversight is challenging.
“The wellness industry … has a well-documented problem with exaggerated claims and, at times, outright ‘snake oil.’ Some products offer no real benefit, and others may cause harm,” he says.
He continues: “In principle, greater oversight would be warranted, especially if it could be targeted, efficient, and scaled to the sheer volume of products entering the market. In practice, however, regulation is slow, expensive, and capacity-limited. Comprehensive oversight of every wellness product is not realistic, and attempting [this] could unintentionally stifle many trends that are genuinely beneficial.”
Some aspects of the new guidance make sense
Under the new guidance, the FDA considers general wellness products to be “low-risk” products that promote general health and wellness. These products include software, video games, exercise equipment, and audio recordings. []
These products do not include drugs, biologics, food, or cosmetics regulated by other FDA Centers or combination products.
Jorge Nieva, MD, a medical oncologist at USC Norris Cancer Hospital, says that easing regulations for general wellness products makes sense.
“These types of products are largely harmless, and if they do cause harm, they can still be subject to civil liability. I don’t know that having the FDA provide oversight does much for public health and safety except for increasing costs,” he tells MDLinx.
“I don’t see very much in the way of harm from health tech that falls within the parameters described in the guidance. There will still be oversight on technology that claims to impact diseases, performs analytics on body fluids, or [is] used to adjust medications,” Dr. Nieva adds.
Is easing guidance a risk?
However, those who value a high level of oversight may find the new guidance risky.
“A few examples may help illustrate the concerns of those who value government oversight. Software has been developed [that] gives faulty recommendations for insulin dosing. Devices have been recalled after multiple reports of failure, causing medical harm. Unregulated tanning beds are a known skin cancer risk. Home testing for infection can yield false-positive and false-negative results. Home blood pressure monitors require validation for accuracy. So, while the manufacturer, distributor, and sales agent will all claim accuracy and validity of software and devices, many see the value in having a third party without a financial conflict of interest providing oversight,” David Cutler, MD, a board-certified family medicine physician at Providence Saint John’s Health Center in Santa Monica, CA, tells MDLinx.
“The current rule changes are intended to affect only low-risk software and devices designated as general wellness products. However, what qualifies as low-risk and a general wellness product is open to interpretation,” Dr. Cutler adds.
Dr. Cutler continues: "The impact of these FDA regulatory changes will depend on both the frequency of adverse outcomes from software and devices [and on] the severity of these outcomes. It will be difficult to measure the frequency or severity of these outcomes if there is no one at the FDA monitoring these events.”
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