Study Finds Most Wearable Devices Lack Independent Validation

Posted August 13, 2018

Popular wearable devices, such as watches that track metabolism or sleep patterns, represent a booming, new frontier in health technology. But according to a recent article published in the open-access journal Frontiers in Physiology, there is little data that shows how—or how well—these devices provide useful health-related information to wearers.

“A wide range of smart watches, bands, garments, and patches with embedded sensors, small portable devices, and mobile applications now exist to record and provide users with feedback on many different physical performance variables,” the authors wrote. “Among the technologies included in this review, more than half have not been validated through independent research. Only 5% of the technologies have been formally validated. Around 10% of technologies have been developed for and used in research.”

Validation is an important part of the device development process. Validation testing helps ensure that user needs are met and that the device consistently provides the intended benefit under real-world conditions.

For the study, researchers at Australia’s Queensland University of Technology and others evaluated the claims, validation methods, reliability, and commercial availability of nearly 100 wearable devices, which fell into six categories:

  • Devices for monitoring hydration status and metabolism
  • Devices, garments, and mobile applications for monitoring physical and psychological stress
  • Wearable devices that provide physical biofeedback (e.g., muscle stimulation, haptic feedback)
  • Devices that provide cognitive feedback and training
  • Devices and applications for monitoring and promoting sleep
  • Devices and applications for evaluating concussions

“Most of the health and performance technologies that we have reviewed have been developed based on real-world needs, yet only a small proportion has been proven effective through rigorous, independent validation,” the authors concluded. “Independent scientific validation provides the strongest level of support for technology. However, it is not always possible to attain higher standards of validation.”

The authors called for more information to be provided to consumers about whether the wearable device they’re considering falls into the category of “emerging” or “promising” technology as opposed to those that are “supported” or “well supported” by scientific evidence.

“Most of these technologies are not labeled as medical devices, yet they do convey explicit or implicit value statements about our standard of health,” according to the study’s authors. “There is a need to determine if and how using technology influences peoples' knowledge and attitude about their own health.”

The global market for wearable and fitness tracking devices is expected to reach $50 billion  by 2022, according to a report by Market Research Engine, representing a compound annual growth rate of about 15% since 2017.