The Opportunity and Obstacles for Smartwatches and Wearable Sensors
Abstract
In September 2017, the U.S. Food and Drug Administration (FDA) made a striking announcement. Transforming its current regulatory practice for approving and certifying medical devices-the FDA announced a bold new plan, the Digital Health Software Precertification (Precert) Program, to offer an entirely new regulatory model to assess smartphone apps, wearables, sensors, and software. This transformation and medicalization of the consumer health market present both opportunities and obstacles, by opening up large markets for health monitoring and diagnosis using inexpensive mass-market, off-the-shelf devices. It also raises challenges, both related to privacy and effective uses of the devices to promote health. The Fitbit and Apple Watch are examples.
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Many studies have focused on novel technologies, presenting prototypes, or investigating feasibility and acceptance of a wearable device in a specific setting.
“Many studies have focused on novel technologies, presenting prototypes, or investigating the feasibility and acceptance of a wearable device in a specific setting [3,27].”
From The impact of wearable technologies in health research: scoping review (2022) · cites this paper as [27]
These vital signs and device types seem to become the standard in wearable research.
“These vital signs and device types seem to become the standard in wearable research [3,27,31,224,225].”
From The impact of wearable technologies in health research: scoping review (2022) · cites this paper as [27]
Similar to other reviews, most devices were wrist-worn fitness trackers and accelerometers, and most were from Fitbit, measuring PA, HR, and sleep.
“Similar to other reviews, most devices were wrist-worn fitness trackers and accelerometers, and most of them are from the company Fitbit, measuring PA, HR, and sleep [3,27,31,224,225].”
From The impact of wearable technologies in health research: scoping review (2022) · cites this paper as [27]
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- Authors
- Foster, K. R., & Torous, J.
- Affiliations
- University of Pennsylvania (US)
- Harvard University (US)
- Venue
- IEEE Pulse
- Published
- 2019-01
- Volume
- 10
- Issue
- 1
- Pages
- 22-25
- ISSN
- 2154-2287 (ISSN-L)
- 2154-2317
- OpenAlex
- W2921475356
- Cited by
- 62
- References
- 5
- Citations by year
- 2026: 3 · 2025: 5 · 2024: 6 · 2023: 9 · 2022: 15 · 2021: 8 · 2020: 11 · 2019: 5
- FWCI
- 13.27
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- Locations
- IEEE Pulse (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Physical Sciences › Engineering › Biomedical Engineering › Non-Invasive Vital Sign Monitoring
- Physical Sciences › Engineering › Biomedical Engineering › Wireless Body Area Networks
- Keywords
- smartwatches, wearable sensors, FDA regulation, medical device regulation, consumer health technology, health monitoring, patient privacy, mobile health apps, Apple Watch, Fitbit
- MeSH terms
- Smartphone, Fitness Trackers, Health Promotion, Humans, United States, United States Food and Drug Administration, Mobile Applications
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