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可穿戴设备在 SARS-CoV-2 大流行期间的应用:它们有什么作用?

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

机构信息

Department of Biomedical Engineering, Duke University, Durham, NC, United States.

Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, United States.

出版信息

JMIR Mhealth Uhealth. 2020 Dec 22;8(12):e25137. 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.

摘要

最近,苹果公司、Fitbit 公司和佳明公司等企业发布了新的可穿戴血氧测量技术。虽然这些技术的发布有很大潜力可以产生与健康相关的信息,但我们也必须认识到消费者导向的生物计量监测技术(BioMeTs)所带来的影响。在实践中,这些技术通常被用于医疗决策。BioMeTs 是一种与身体连接的数字医疗产品,它处理由移动传感器捕捉的数据,这些传感器使用算法生成行为和生理功能的测量值。这些 BioMeTs 涵盖了一般健康产品和医疗设备,而面向一般健康目的的消费者导向的 BioMeTs 则不需要经过标准化和透明的评估过程,以确保其质量和准确性。产品功能、营销以及全球 SARS-CoV-2 大流行的环境,不可避免地导致了消费者导向的 BioMeTs 被用于报告与健康相关的测量值,以推动医疗决策。在本观点文章中,我们敦促消费者导向的 BioMeT 制造商在发布有关健康 BioMeTs 的信息时,超越美国食品和药物管理局指南中描述的最低要求。我们还探讨了可能导致公众更清楚地了解消费者导向的 BioMeTs 的性能和预期用途的新方法和激励制度。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c5a6/7758082/58d1abd9cf63/mhealth_v8i12e25137_fig1.jpg

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