Health Law Daily Wrap Up, GENERAL HEALTH CARE NEWS—GAO REPORTS: Wearables could improve clinical decision-making but face accuracy, workflow, and market barriers, (Aug 7, 2026)

By Jordan Sonderegger

According to the GAO, wearable devices with health-related features could improve clinical decision-making through quicker diagnoses and more personalized care. Still, they vary in accuracy and reliability and face challenges that GAO says three policy options could help address.

The Government Accountability Office (GAO) found that wearable devices—whether FDA-reviewed medical devices or wellness devices the agency does not review—have the potential to be used in clinical decision-making by tracking vital signs, alerting users or clinicians to medical events, and supplying data a clinician can interpret, with AI potentially expanding their capabilities over time. GAO identified benefits, including more information for clinicians, quicker diagnoses, and improved patient compliance, alongside challenges in ensuring wearables benefit patients, integrating them into clinical workflows, and navigating the health technology market. GAO developed three policy options to address those challenges: continuing the status quo, improving workflow integration, and incentivizing performance improvements through an independent certification database. GAO provided a draft to HHS and the Department of Veterans Affairs (VA) for technical comments. (GAO Report, No. GAO-26-107847 (Aug. 3, 2026)).

Background. Wearables are devices worn externally on the body or clothing, containing sensors and performing at least one health-related function, that are available or expected to reach the market within five years. Whether a wearable is a medical or wellness device depends on its intended use: FDA reviews medical devices, intended for clinical purposes such as diagnosis or treatment, for safety and effectiveness, while wellness devices, intended only to promote general wellness, are not reviewed. The global market for wearable devices was nearly $87 billion in 2025 and is projected to reach $240 billion by 2032, according to a market research report. GAO based the assessment on a literature review, 27 stakeholder interviews, and site visits conducted between September 2024 and August 2026.

Current capabilities. Most clinicians and manufacturers GAO interviewed described current wearables as tools that may flag issues or prompt referral, not as replacements for clinician diagnosis; a clinician may treat a watch-based single-lead electrocardiogram (ECG) reading as a preliminary sign of atrial fibrillation, then confirm it with a standard 12-lead ECG. No fully autonomous wearables are marketed for clinical decision-making. Some devices operate with limited independence—a continuous glucose monitor paired with an insulin pump can adjust dosing within a clinician-set range—but stakeholders do not consider them fully autonomous, and those who viewed full autonomy as possible estimated it is at least five years, and potentially several decades, away.

Potential benefits. GAO reported that continuously updated wearable data could enable quicker diagnoses and more personalized care, giving a better picture of a patient's condition than sporadic office visits. Pairing wearables with AI could reduce false alarms by comparing readings to a patient's own baseline rather than to demographic averages, and less obtrusive devices, such as a cardiac patch in place of a Holter monitor, may improve compliance by reducing stigma and discomfort. Underserved and rural populations could benefit from expanded remote patient monitoring; GAO cited a program in which data from a pulmonary wearable patch informed risk-assessment outreach, and patients experienced 65 percent fewer hospitalizations in the program's first year.

Challenges to patient benefit, safety. GAO found that wearables may not always benefit patients and, in some cases, may put safety at risk. Wellness device manufacturers are not required to publicly disclose testing methods or results, leaving clinicians unable to assess a device's suitability for clinical use. Both medical and wellness devices are subject to limited postmarket monitoring. GAO noted the risk of model drift, in which an AI model becomes less accurate as real-world patterns change, and pointed to a 2026 recall of glucose monitor sensors following reports of 860 serious injuries and 7 deaths tied to incorrect readings. Data privacy and security are further concerns: wellness devices are not subject to the cybersecurity requirements that the FDA enforces for medical devices, users often must consent to data being shared with or sold to third parties, and GAO cited a breach involving 61 million fitness tracker records.

Workflow, market challenges. Wearables are not integrated into most medical facilities' technology infrastructure or workflows, GAO found, and the data can add to clinician cognitive overload when a device lacks effective alerts. Clinicians and manufacturers also described liability uncertainty – such as whether a clinician could face malpractice exposure after a wearable flags an irregular heartbeat that is never confirmed – which has kept some products off the market. In the market itself, representatives of an association of more than 600 medical device manufacturers called coverage uncertainty "monumental"; because Medicare decisions can be slow and costly even after FDA review, some manufacturers may develop wellness devices instead, and both medical and wellness manufacturers may decline to build wearables for uncommon diseases.

Policy options. GAO identified three policy options, which it did not rank or present as exhaustive. Continuing the status quo would have policymakers monitor recent activities such as CMS's 2025 Health Technology Ecosystem and its ACCESS Model, giving programs time to work but leaving some challenges unaddressed. Improving workflow integration would prompt medical facilities to refine their infrastructure and workflows, thereby standardizing data handling and easing liability concerns. Still, it could require significant resources and yield variable results across facilities. Incentivizing performance improvements would have national medical associations encourage manufacturers to join an independent certification process that feeds a public database of recommended devices, which could improve testing and disclosure but could also create confusion alongside the FDA's review and raise costs in ways that favor larger manufacturers.

Agency comments. GAO provided a draft to HHS and VA for technical comments and incorporated those comments as appropriate.

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