Cited by 10Mobile Health and mHealth ApplicationsNon-Invasive Vital Sign MonitoringHealthcare Regulation

Wearables in the SARS-CoV-2 Pandemic: What Are They Good for?

Open access
Bent, Brinnae, Dunn, Jessilyn P·2020·JMIR mHealth and uHealth

Published version of a preprint

Abstract

Recently, companies such as Apple Inc, Fitbit Inc, and Garmin Ltd have released new wearable blood oxygenation measurement technologies. Although the release of these technologies has great potential for generating health-related information, it is important to acknowledge the repercussions of consumer-targeted biometric monitoring technologies (BioMeTs), which in practice, are often used for medical decision making. BioMeTs are bodily connected digital medicine products that process data captured by mobile sensors that use algorithms to generate measures of behavioral and physiological function. These BioMeTs span both general wellness products and medical devices, and consumer-targeted BioMeTs intended for general wellness purposes are not required to undergo a standardized and transparent evaluation process for ensuring their quality and accuracy. The combination of product functionality, marketing, and the circumstances of the global SARS-CoV-2 pandemic have inevitably led to the use of consumer-targeted BioMeTs for reporting health-related measurements to drive medical decision making. In this viewpoint, we urge consumer-targeted BioMeT manufacturers to go beyond the bare minimum requirements described in US Food and Drug Administration guidance when releasing information on wellness BioMeTs. We also explore new methods and incentive systems that may result in a clearer public understanding of the performance and intended use of consumer-targeted BioMeTs.

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Authors
Bent, B., & Dunn, J. P.
Affiliations
Duke University (US)
Corresponding author
Dunn, Jessilyn P
Venue
JMIR mHealth and uHealth
Published
2020-12-22
Volume
8
Issue
12
Pages
e25137
ISSN
2291-5222 (ISSN-L)
OpenAlex
W3112020795
Cited by
10
References
3
Citations by year
2024: 2 · 2023: 1 · 2022: 3 · 2021: 4
FWCI
2.09
Type
journal article
Language
en
Open access
Licence
cc-by
Locations
  • JMIR mhealth and uhealth (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • 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
  • Health Sciences › Health Professions › Health Information Management › Healthcare Regulation
Keywords
wearable devices, COVID-19 pandemic, consumer health technology, biometric monitoring, clinical decision-making, FDA guidance, wellness products, incentive mechanisms
MeSH terms
Fitness Trackers, Wearable Electronic Devices, COVID-19, Humans, Pandemics

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