Looser FDA rules for wearables may add to provider burdens

A look into the FDA's stance on certain wearables

In an update to its General Wellness guidance, published in January, the FDA stated that general wellness products are not subject to the regulatory requirements for devices under the Federal Food, Drug, and Cosmetic Act.

The guidance divides general wellness products into two categories:

• Products that do not reference disease or medical conditions.
• Products that claim they help reduce the risk of certain chronic diseases or assist people in better managing these diseases by promoting healthy lifestyles.

The two categories include tools that support healthy behaviors, like a good diet, physical fitness and stress management; however, they may or may not claim that these behaviors could help people manage chronic conditions, like diabetes.

FDA further noted that it would consider certain products that use non-invasive sensing to provide physiologic parameters to be general wellness products when such outputs are intended solely for wellness uses. The agency highlighted other instances where these non-invasive sensing products would be considered general wellness products, including when they do not involve an intervention or technology that may pose a risk to the safety of users and do not include values that mimic clinical ones.

"The FDA's recent update to the General Wellness guidance is meant to provide clarity for the growing market of wearable devices and apps that output physiologic parameters for wellness purposes," an FDA spokesperson told Virtual Healthcare.

The guidance was issued in 2019 to clarify the FDA's interpretation of a provision in the 21st Century Cures Act. The provision exempted certain software functions from the definition of a medical device, including software functions designed for maintaining or encouraging a healthy lifestyle.

"The update provides additional guidance and examples on how to apply these factors to products that output physiologic parameters for general wellness uses," the spokesperson said.

The spokesperson added that they have observed "immediate, high engagement" among stakeholders, who have welcomed clearer boundaries between general wellness products and clinical-grade tools.

What it means for providers

For healthcare providers and patients, the FDA's decision to limit the regulation of wearables could result in tools that provide low-quality or inaccurate data.

According to Brett Atwater, MD, Inova's Electrophysiology section chief and Inova Schar Heart and Vascular's Atrial Fibrillation D'Aniello Chair, providers must be wary of data being brought in by patients using consumer-grade wearables.

"If the current high-quality systems are replaced by lower quality, then that may mean that our cardiologists and electrophysiologists and others in the market end up relying on unreliable data to make clinical decisions, which is something we need to try to avoid," he said.

The FDA has underscored its commitment to patient safety, noting that it will continue to actively monitor general wellness products through adverse event reporting, consumer complaints, market surveillance and real-world data.

"If a general wellness product shows evidence of inaccurate readings, misleading claims, or potential patient harm, the FDA can and will act," the spokesperson said. "That includes safety communications, product removals, recalls, or enforcement action when warranted."

Despite these reassurances, Atwater noted that inaccurate wearables data could impact patient perception. For instance, if a wearable correctly diagnoses a patient with hypertension, it could result in early intervention and treatment. But if the wearable is incorrect, it could result in high anxiety and unnecessary medical appointments that drive up healthcare costs. In other cases, inaccurate readings could result in a condition being undertreated.

"One of the issues we face is the psychological dilemma that is common, which is something called a primacy fallacy, which is the first piece of information is generally believed, even if subsequent information that's more accurate becomes available to a patient," Atwater said. "So if a wearable device tells them they have a condition, they're very likely to continue to believe that, even if better equipment tells them they actually don't have that problem. Likewise, if a wearable device that may be unreliable tells them they don't have a condition, it can be very difficult to convince them that they do, even with better testing in the future."

Research has shown that wearable device utilization is associated with pathologic symptom monitoring and excessive preoccupation with symptoms. So, providers need to be ready to manage patient concerns.

One strategy to address these concerns is to ensure patients can double-check their wellness product's readings with an FDA-approved device to assess the accuracy, Atwater said.

In addition to touting its commitment to monitoring the space, the FDA appears to be relying on physicians' discretion in supporting real-world wearables use.

In a January Fox Business interview, FDA Commissioner Marty Makary, M.D., was asked about accuracy concerns. He responded, "Let's let the market decide, let's let doctors choose from a competitive marketplace which ones they'd recommend for their patients."

Atwater noted that wearables currently in the market were subject to FDA approval, and he expects them to continue to meet FDA criteria as they scale. This could make sifting through the available options a little easier for providers who may be asked by patients to recommend devices.

Still, despite potential upticks in patient concerns and inaccurate data, Atwater sees a rise in wellness-focused healthcare wearables as a boon for patients.

"These types of devices, I think, are designed to lead to a healthier lifestyle, to help prevent disease in the future, although they can't explicitly say that they will be able to prevent disease," he said. "But in general, if you're moving more and you're eating less and you're managing obesity or stress or anxiety or some other things, that's a good thing. It makes people live longer and have a healthier and happier life in general. So, I think that's the role for these devices."

Anuja Vaidya has covered the healthcare industry since 2012. She currently covers the virtual healthcare landscape, including telehealth, remote patient monitoring and digital therapeutics.