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?:abstract
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Recently, companies including Apple, Fitbit, and Garmin released new wearable blood oxygenation (SpO2) measurement technologies While the release of these technologies has great potential for generating health-related information, it is important to acknowledge repercussions of consumer-targeted biometric monitoring technologies (consumer BioMeTs) that in practice are often used for medical decision-making BioMeTs are connected digital medicine products that process data captured by mobile sensors using algorithms to generate measures of behavioral and/or physiological function These BioMeTs span both general wellness products and medical devices, and consumer BioMeTs intended for general wellness are not required to undergo a standardized and transparent evaluation process to ensure their quality and accuracy A combination of the product functionality, marketing, and the circumstances of the global SARS-CoV-2 pandemic have inevitably led to the use of consumer BioMeTs that report health-related measurements to drive medical decision-making We urge consumer BioMeT manufacturers to go beyond the bare minimum requirements described in FDA guidance when releasing information on wellness BioMeTs, and we also explore new methods and incentive systems that may result in a clearer public understanding of consumer BioMeT performance and intended use
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