GAO Assesses Wearables in Clinical Decision-Making, Offers Three Policy Options

The U.S. Government Accountability Office on August 6 released a technology assessment on how data from wearable devices, such as glucose monitors and smartwatches, could be used by clinicians to diagnose and treat patients, and on the role artificial intelligence might play, according to the report's GAO summary page. The report, GAO-26-107847, lays out three policy options.

GAO said it was asked to review the potential role of wearables in clinical decision-making. It noted that manufacturers and medical association representatives have suggested increasing that role, and that in 2025 leaders at the Department of Health and Human Services announced support for greater use of wearables in health care.

Benefits and limits

According to GAO, wearables can be either medical devices or wellness devices, and their features can be augmented by AI. They use sensors to track vital signs and set health baselines, alert users, caregivers or clinicians to medical events, and send assessments of user data to clinicians for interpretation.

GAO found that wearables increase the information available to clinicians, which may allow quicker diagnoses, more personalized care plans and better patient compliance, and may help underserved populations by expanding remote patient monitoring. "However, wearables vary in accuracy and reliability," the summary states.

On AI, GAO said the technology could increase wearables' capabilities, for example by improving autonomous decision-making, but that "the extent to which wearables will be able to make clinical decisions autonomously is unclear at this time." It identified challenges in ensuring wearables benefit patients as intended, integrating them into clinical workflows and navigating the health technology market.

Three options for policymakers

The first option is to continue the status quo, with current federal digital health activities and voluntary testing of wearables for clinical use by groups outside government continuing. GAO said monitoring those activities may address some challenges, but some may remain unaddressed and some activities may make certain challenges worse.

The second option is to refine the clinical workflows and technology infrastructure of medical facilities so wearables can be integrated into clinical decision-making. GAO said this could establish common practices for receiving, responding to and protecting patient data, and clarify clinicians' responsibilities, which could ease liability concerns. It could also shift resources from other priorities and produce variable results depending on local implementation.

The third option is for policymakers to encourage better device performance by building and maintaining a public database of recommended wearables that have completed a selected, independent certification process. GAO said testing and disclosure could help administrators, clinicians and patients make more informed choices. But it cautioned that a certification process separate from the Food and Drug Administration's review "may create confusion for wearables manufacturers, clinicians, and patients, with potential effects on patient safety," and that research and development costs could rise and favor larger, established manufacturers.

GAO said policymakers in the report include legislative bodies, government agencies, standards-setting organizations, industry and other groups. To prepare the assessment, it reviewed scientific literature and federal guidance, interviewed stakeholders and agency representatives, and visited laboratories, medical and research centers and manufacturers.