Abstract
Wearable sensor technology could have an important role for clinical research and in delivering health care. Accordingly, such technology should undergo rigorous evaluation prior to market launch, and its performance should be supported by evidence-based marketing claims. Many studies have been published attempting to validate wrist-worn photoplethysmography (PPG)-based heart rate monitoring devices, but their contrasting results question the utility of this technology. The reason why many validations did not provide conclusive evidence of the validity of wrist-worn PPG-based heart rate monitoring devices is mostly methodological. The validation strategy should consider the nature of data provided by both the investigational and reference devices. There should be uniformity in the statistical approach to the analyses employed in these validation studies. The investigators should test the technology in the population of interest and in a setting appropriate for intended use. Device industries and the scientific community require robust standards for the validation of new wearable sensor technology.
Highlights
In the past 5 years, there has been a huge proliferation of wrist-worn heart rate monitors, often embedded in smart-bands and smartwatches, which can generate a vast amount of data on lifestyle, physiology, and disease providing exciting opportunities for future health applications
Wearable sensor technology could have an important role for clinical research and in delivering health care [1]
Wearable heart rate monitors could enable therapeutic monitoring such as medication titration. Such monitors should undergo rigorous evaluation prior to market launch, and their performance should be supported by evidence-based marketing claims [1]
Summary
In the past 5 years, there has been a huge proliferation of wrist-worn heart rate monitors, often embedded in smart-bands and smartwatches, which can generate a vast amount of data on lifestyle, physiology, and disease providing exciting opportunities for future health applications. The lack of stringent regulations for the release of nonmedical heart rate monitoring devices should not justify the lack of standard requirements for validating this technology. We give an overview of clinical applications exploiting wearable heart rate monitors.
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