Wearable Wellness Devices
There is sufficient evidence that the usage of consumer wearable wellness devices is associated with improved social outcomes.
Impact Assessment
The findings below synthesize the results of the studies on wearable wellness devices across three domains of measurement:
- Healthcare Cost, Utilization & Value: More evidence is needed. No included studies reported healthcare cost, utilization, or economic outcomes associated with the use of consumer wearable wellness devices.
- Health: More evidence is needed on the health impact of consumer wearable wellness devices. A randomized controlled trial with a limited sample size showed indicative improvements in cardiovascular fitness. More robust studies are required to examine the impacts of the use of these devices on a broad range of clinical measures.
- Social: There is sufficient evidence for the impact of wearable device usage on social outcomes. Studies including randomized clinical trials and observational studies suggest potential benefits for physical activity, sleep quality, mental wellbeing, and stress reduction. Additionally, positive impacts were more pronounced when combining wearable use with personalized feedback or behavioral support programming. The current evidence base could be supported by more longitudinal studies to assess the long-term impact of wearable wellness device usage and device impact on psychological wellbeing where results are mixed.
Background of the Need / Need Impact on Health
Physical inactivity and chronic stress are among the most prevalent modifiable health risks facing adults in the United States (U.S.) today. Nearly one in four adults in the U.S. do not meet federal physical activity guidelines, and inadequate physical activity is associated with $192 billion in annual healthcare costs, representing 12.6% of total national health care spending[1]. Physical inactivity is linked to increased risk of cardiovascular disease, type 2 diabetes, cancer, hypertension, stroke, and premature death, contributing to an estimated one in ten premature deaths nationally[2]. Hispanic, non-Hispanic Black, and adults with lower-incomes have significantly higher rates of inactivity than other Americans[3].
Stress, anxiety, and depression place an equally significant burden on population health. In 2022, approximately one in five adults in the U.S. experienced symptoms of anxiety (18.2%) or depression (21.4%) in the previous two weeks, with prevalence significantly higher among younger adults, women, and those with lower incomes and education levels[4]. Depression prevalence has increased steadily from 2013 to 2023 across all age groups, with nearly 88% of adults with depression reporting difficulty with work, home, or social activities as a result[5]. Each year, serious mental illness costs the US economy $193.2 billion in lost earnings, while depression and anxiety disorders together result in a loss of $1 trillion from the global economy due to lost productivity[2].
For payers and providers, the burden is significant. Physical inactivity, chronic stress, anxiety, and depression drive healthcare utilization across primary care, behavioral health, and specialty settings, and disproportionately affect historically underserved populations and people with lower incomes. Scalable, consumer-facing tools that support self-monitoring and behavior change, including wearable wellness devices, represent a growing area of interest for health promotion and chronic disease prevention across insured populations[6]. For vulnerable populations and people with lower incomes, structural factors such as safe and accessible places for physical activity and time and labor demands of work may have more influence over physical activity behaviors than personal attributes like motivation and capability.
Background on the Intervention
Consumer wearable wellness devices, including Oura Ring and smartwatches such as Apple Watch, Fitbit, and Garmin, have become mainstream health technology in the U.S. As of 2023, nearly one in three Americans used a wearable device to monitor health metrics such as heart rate, daily activity, sleep, fall detection, temperature, Vo2 max, noise exposure and blood pressure. Approximately one in five adults regularly wears a smartwatch or fitness tracker[7]. The U.S. wearables market was valued at $18.6 billion in 2024 and is projected to grow at 11.4% annually through 2032, driven by rising consumer demand for personalized health monitoring and preventive care[8]. Several smartwatch fitness trackers have the ability to send data to electronic health records (EHRs) presenting new opportunities for clinical applications but also new risks[9]. There is an emerging field of wearables designed to leverage real-time tracking with artificial intelligence to support personalized medicine.
This EA focuses on wearables designed for fitness and/or wellbeing that do not require a prescription to obtain, however, some of these devices do have Food and Drug Administration (FDA) approval and are also able to serve as medical devices. In addition, this EA focuses solely on watches, rings and bracelets and excludes the less common patches, glasses and clothes.
Consumer wellness wearables are not generally currently covered by traditional Medicare or Medicaid, as the Centers for Medicare and Medicaid Services (CMS) classifies them as general health and fitness devices, rather than medically necessary equipment[10]. While the devices are not covered, some Medicaid agencies do reimburse for clinician review of digital device data and consultation. For example, North Carolina reimburses for Remote Patient Monitoring which “enables providers to collect and analyze information such as vital signs (blood pressure, heart rate, weight, and blood oxygen levels) in order to make treatment recommendations”[11]. Some Medicaid Managed Care Organizations offer lower cost devices like fitbits as value added benefits. Medicare provides limited coverage for some Remote Patient Monitoring clinical activities including patient education and device set up, device supply and treatment management for patients with acute or chronic conditions requiring monitoring with internet-connected devices that have been approved by the FDA for clinical purposes [12]. Between 2019 and 2022 there was a tenfold increase in the number of remote patient monitoring services covered by Medicare (both original Medicare and Medicare Advantage)[13]. In addition, Medicare Advantage plans may offer limited coverage for wearable devices in some cases, and fitness trackers may be eligible for reimbursement through flexible spending accounts (FSAs) or health savings accounts (HSAs), but only with a Letter of Medical Necessity documenting that the device will be used to treat a specific diagnosed condition[14]. The Center for Medicare and Medicaid Innovation also launched the Advancing Chronic Care with Effective Scalable Solutions (ACCESS) Model which combines an outcomes-based payment model linked to condition-specific clinical measures (such as blood pressure, hemoglobin A1c, lipids, weight or Patient Reported Outcome Measures) with “technology supported care services” such as telehealth visits, wearable devices, and apps that coach on lifestyle changes. Applications for this ten year model will be accepted on a rolling basis beginning in spring 2026. The first awardees will launch in January of 2027. Additionally, some employers offer wearables as part of workplace wellness programs, and lifestyle spending accounts (LSAs) increasingly cover devices such as Fitbit, Apple Watch, and Garmin[15].
Data privacy, device accuracy, and equitable access remain key implementation considerations, with wearable adoption consistently higher among adults who are younger, have a higher income, and have a higher education level. In December 2024, the U.S. Equal Employment Opportunity Commission published new guidance addressing how federal nondiscrimination laws, including the Americans with Disabilities Act, apply to employer use of wearable devices in workplace wellness programs, reflecting growing regulatory attention to privacy[16].
Additional Research and Tools