Wearable Technologies: Potential Benefits and Challenges in Clinical Decision-Making

What GAO Found Wearable devices (wearables) with health-related features have the potential to be used in clinical decision-making (see figure). Wearables can be either medical or wellness devices, and their features can be augmented by artificial intelligence (AI). Wearables use sensors to track vital signs and establish patient health baselines; alert users, caregivers, or clinicians of medical events or suggested lifestyle changes; and provide additional assessments of user data that can be sent to a clinician for interpretation. Clinicians could use such data as a source of information when diagnosing and treating patients. Examples of wearables that could be used in clinical decision-making Wearables increase the amount of information considered during clinical decision-making, which may allow for quicker diagnoses by clinicians, more personalized care plans, and improved patient compliance. Wearables may also benefit underserved populations by expanding remote patient monitoring. However, wearables vary in accuracy and reliability. AI has the potential to increase the capabilities of wearables by, for example, improving autonomous decision-making. However, the extent to which wearables will be able to make clinical decisions autonomously is unclear at this time. GAO identified challenges to using wearables for clinical decision-making, including challenges related to ensuring wearables benefit patients as intended, integrating wearables into clinical workflows, and navigating the health technology market. GAO developed three policy options that could help address the challenges and enhance the benefits of using wearables in clinical decision-making. The first is the status quo, whereby policymakers would continue with current efforts and activities in the field. The other two policy options identify possible new actions by policymakers, which may include legislative bodies, government agencies, standards-setting organizations, industry, and other groups. See below for details of the policy options and relevant opportunities and considerations. Policy Options Help Address Challenges with Use of Wearables in Clinical Decision-Making Continue the status quo (report page 24) Policymakers could continue ongoing digital health technology activities, and policymakers outside of government could continue voluntarily testing the use of wearables for clinical purposes. Opportunities Monitoring and assessing recent and ongoing activities related to digital health technologies, including wearables, may help address some of the challenges GAO identified. Such challenges include ensuring patient health benefits, integrating wearables into clinical workflows, and navigating the health technology market. Considerations Some of the challenges GAO identified may remain unaddressed by recent or ongoing activities, and some activities may worsen some challenges. Integration of wearables into clinical workflows (report page 26) Policymakers could refine the clinical workflows and technology infrastructure of medical facilities to support the integration of wearables into clinical decision-making. Opportunities Improving clinical workflow integration could help establish common practices for receiving, responding to, and protecting patient health data, which could protect privacy and improve patient outcomes. It could also help clarify clinician responsibilities surrounding the use of wearables data in clinical decision-making, which could ease liability concerns. Considerations Resource requirements for wearables integration could shift resources away from other priorities. Patients and clinicians may experience variable results according to the local implementation strategy. If administrators improve the integration of selected wearables, the use of wearables not selected may decline. Improvements to wearables performance (report page 27) Policymakers could incentivize manufacturers to improve the performance of wearables by building and maintaining a comprehensive public database of recommended wearables that have completed a selected, independent certification process. Clinicians and patients could then use the database to help find certified devices. Opportunities Testing and disclosure of wearables performance could help medical facility administrators, clinicians, and patients make more informed decisions about the benefits and risks of selecting specific wearables. Encouraging companies to maintain a certification may increase manufacturer testing of wearables’ effect on patient health and safety. Considerations Incentivizing participation in a certification process that is separate from the Food and Drug Administration’s review process may create confusion for wearables manufacturers, clinicians, and patients, with potential effects on patient safety. Research and development costs may rise significantly, hindering the market for new wearables and potentially advantaging larger, established manufacturers. Source: GAO. | GAO-26-107847 Why GAO Did This Study Because wearables may facilitate more timely and personalized patient care, manufacturers and medical association representatives have suggested increasing their integration into clinical decision-making. In addition, in 2025 leaders at the Department of Health and Human Services announced support for increasing the use of wearables in health care. GAO was asked to review the potential role of wearables in clinical decision-making. This report examines (1) the potential benefits and challenges of using wearables in clinical decision-making, (2) the potential benefits and challenges of using AI to augment the decision-making capabilities of such wearables, and (3) what policy options might help address challenges and enhance benefits associated with the use of wearables in clinical decision-making. To conduct this engagement, GAO reviewed scientific literature, federal agency guidance, and other documents; interviewed a wide range of stakeholders and agency representatives; and conducted site visits to laboratories, medical and research centers, and manufacturers to better understand these technologies. For more information, contact Sarah Harvey at HarveyS@gao.gov.

Wearable Technologies: Potential Benefits and Challenges in Clinical Decision-Making

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