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

Brinnae Bent,Jessilyn P Dunn

doi:10.2196/25137

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.

Highlights

Several big technology companies have released novel wearables with health functionalities, such as wearables capable of measuring blood oxygenation (SpO2)
In September 2020, Apple Inc released the Apple Watch 6, which is the first Apple wearable with SpO2 monitoring capabilities. This comes on the heels of the Fitbit software update in January 2020, which included SpO2 monitoring to existing wearables, and the August 2018 release of the Garmin Vivosmart 4, which is one of the earliest wearable consumer-targeted biometric monitoring technologies (BioMeTs) to monitor SpO2 at the wrist, with the reported intent of obtaining fitness measurements at high elevations
With the backdrop of the SARS-CoV-2 pandemic, wearables and other bodily connected sensors that are marketed as consumer-targeted wellness BioMeTs are, in practice, being used for health decision making [3,4,5,6]

Summary

Introduction

Several big technology companies have released novel wearables with health functionalities, such as wearables capable of measuring blood oxygenation (SpO2). Consumer-targeted BioMeTs that are intended for general wellness purposes [1] do not require medical device regulatory oversight. The majority of consumer-targeted BioMeT manufacturers do not publicly report on the performance of their sensor technologies.

Results

Conclusion