So, what is the right balance for regulating general wellness apps and devices whose data are increasingly making their way into the exam room?
Too much regulation can stymie innovation of tools that help promote health lifestyles by tracking steps, sleep or the like.
But too little could potentially negatively affect patients.
“Digital health technologies hold extraordinary potential to encourage prevention, improve diagnosis and personalize disease management. Realizing this potential requires not only innovation but also public confidence in the evidence,” wrote AMA CEO John Whyte, MD, MPH, in a Viewpoint essay that was recently published in JAMA.
Individuals with depression or anxiety may use an app that addresses emotional well-being. Those concerned about arrhythmia or cardiovascular disease may use a wearable device promoted as optimizing heart health. Women’s reproductive decisions may be impacted by cycle-tracking tools they use.
“If software can meaningfully influence health decisions, even indirectly, then the standards supporting those claims should be transparent, understandable and proportionate to the potential benefit and harm. Otherwise, a familiar pattern could be repeated: a rapidly expanding industry, enthusiastic consumers and a regulatory gap that becomes fully apparent only after harm has occurred,” Dr. Whyte explained.
In the article, “The Need to Avoid a Regulatory Gray Zone in Digital Wellness,” Dr. Whyte wrote that not every wellness technology needs to be regulated in the same way the Food and Drug Administration (FDA) approaches medical devices. But he argued that as the technology begins to influence health decisions, evidence validating a device or app’s performance needs to evolve accordingly and he offered suggestions on how that can happen.
Where regulation stands now
The FDA is taking a hands-off regulatory approach for products that fall under the general wellness category.
Guidance the agency adopted in January advises that apps encouraging exercise, supporting sleep or tracking general well-being may fall outside the more stringent medical device oversight if they don’t claim to diagnose, treat, cure, mitigate or prevent disease.
But Dr. Whyte’s essay explores whether this is the best approach, asking: “Does it inadvertently create the type of regulatory gray zone that has characterized some health-related industries?”
He noted that consumers that are basing some health decisions on these devices and apps aren’t likely to make the same distinction in standards that FDA regulators do.
“Continuous streams of physiological and biometric data, from heart rate patterns to sleep metrics to cardiorespiratory fitness estimates, can create an impression of clinical precision. In some circumstances, such information may appropriately prompt medical evaluation. In others, it may generate unnecessary anxiety, false reassurance or inappropriate utilizations. Algorithms trained on underrepresented populations may also perform unevenly across demographic groups, raising concerns about bias and reliability,” Dr. Whyte wrote.
The situation is similar to the one created in the dietary-supplement industry after the Dietary Supplement Health and Education Act of 1994 allowed manufactures to begin making structure-and-function claims— such as improving memory or promoting prostate health—without having to show clinical efficacy through the same standards that drugs are held to. Regulations require disclaimers for the claims, but studies have suggested that consumers still may infer a degree of validation that doesn’t exist.
A new path forward
Dr. Whyte called for a more constructive path forward for wellness apps and devices. Regulatory transparency, evidence generation and targeted oversight could be a better approach, he wrote. The FDA should consider a regulatory framework that distinguishes between wellness technologies based not only on stated claims, but also on practical function.
“Technologies intended primarily to support health behaviors may warrant continued enforcement distraction. However, products that generate individualized physiological insights, provide algorithmic assessments or influence decisions regarding health care utilization should be held to greater expectations regarding validation and transparency,” he wrote.
The FDA could explore:
- Graduated evidentiary standards, including independent performance validation.
- Standardized disclosure of supporting evidence.
- Enhanced post-market monitoring for products that are widely adopted.
- Clear labeling to help consumers understand if a product is supported primarily by consumer experience, observational data, performance validation studies or clinical trials.
But it is not just on the FDA’s shoulders.
“Professional societies, health systems, payers, employers, consumer organizations, technology developers and policymakers all have roles in promoting evidence generation as well as communicating evidentiary standards,” Dr. Whyte wrote. “Greater transparency and disclosure could encourage developers to pursue stronger validation while preserving opportunities for innovation and competition.”
A recent study from the AMA and Medscape, “AMA Multi-Country Study on Consumer Wearable Data in Clinical Practice,” explored how physicians in six countries are using wearables, concluding “the path forward requires a coordinated effort to build credibility through evidence, develop interpretive capability through education and peer learning, reduce implementation friction through workflow and structural support and activate patient demand.”
From AI implementation to digital health adoption and EHR usability, the AMA is fighting to make technology work for physicians, ensuring that it is an asset to doctors. That includes the AMA Center for Digital Health and AI, which works to ensure physicians help shape how AI is developed, implemented and regulated across the healthcare system, with patient safety and physician-led care remaining at the center of those efforts.