Experts question need for more regulatory scrutiny of digital wellness devices
Two recent papers published in JAMA have highlighted the potential need for additional regulatory scrutiny for low-risk digital health technologies used by consumers.
Gregory Curfman, executive editor of JAMA, said that the US Food and Drug Administration (FDA) in tandem with the Federal Trade Commission create a “meaningful but limited framework” for general wellness devices like wearables and mobile apps. However, as these devices become more complex, there may be a need for additional regulatory requirements, such as for devices that leverage artificial intelligence.
“Future regulation will likely focus on the boundary between wellness functions and disease diagnosis or treatment. As that boundary becomes less distinct, regulators will need a carefully calibrated approach,” Curfman said.
However, low-risk software products are not medical devices under current law, Curfman added, and the agency needs to follow federal law when regulating products that promote general wellness.
“Regulation should be applied when necessary and withheld when it is not. As digital health tools become increasingly embedded in daily life, stringent regulatory policies should be reserved for circumstances in which they are clearly needed to protect public welfare,” he said.
A regulatory gray zone?
John Whyte, chief executive officer and executive vice president of the American Medical Association, said employing the same kind of regulatory review reserved for medical devices to digital wellness technologies for consumers could stifle innovation. The question is “not whether these technologies should exist but how consumers can distinguish among products supported by markedly different levels of evidence,” he wrote.
FDA’s hands-off approach to general wellness technologies is reflective of the agency’s risk-based approach to oversight, Whyte said, but may have created a “regulatory gray zone” as consumers are increasingly using these digital tools to make health-related decisions.
“Consumers rarely parse these distinctions as regulators do,” Whyte explained. “Instead, the presence of health metrics, insights, and personalized dashboards can convey an impression of medical validation. Many users reasonably assume that products generating health insights have been rigorously evaluated. In some cases, however, the evidentiary standards supporting wellness technologies remain limited.”
Whyte cited several examples of wellness technologies that consumers with real health problems may use, including apps that assist in emotional well-being used by consumers with depression and anxiety, cycle-tracking tools for reproductive health, and wearable devices promoting heart health used by consumers concerned about cardiovascular disease.
“Although the language may be framed in wellness terms that adhere to current regulatory guidance, the practical implications may extend into areas traditionally associated with medical care,” he said.
The result is that consumers may use information from health technologies “as a form of health guidance,” and continuous data may give the impression of clinical precision. “The challenge is ensuring that consumers understand the strength of evidence supporting the information they receive and often act on,” Whyte said.
Whyte said FDA should consider a “more explicit framework” for these technologies that incorporates practical function in addition to stated claims. “Technologies intended primarily to support healthy behaviors may warrant continued enforcement discretion. 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 said.
This could take the form of “graduated evidentiary standards” where performance is independently validated, products are more clearly labeled, there is standardized disclosure of supporting evidence, and a broader postmarket monitoring setting for popular products. Policymakers may also need to grant FDA greater oversight to accomplish these tasks, Whyte noted.
“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,” Whyte said. “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.”
