Challenges Underlined by Opportunity for a Validated Consumer Wearable Database

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Kevin Uchimura

There has been a burgeoning conversation around consumer wearables about whether such hobby-enthusiast devices need to be validated. After all, different devices measure with different accuracy, which makes the use of collected data to inform clinical decision-making problematic. Rather than clutter the market with some devices doing X and others doing Y, would it be more sustainable if there could be one device that could do it all, or at least be tested for and uphold the accuracy needed to help clinicians and their patients make informed decisions?

Developing an interactive database of clinically-validated wearable biosensors—and the validation process itself—holds many challenges. In response, the Center for Sustainable Health launched Project HoneyBee in 2014 and has been engaged in ongoing, scientifically rigorous clinical trials that test the utility of consumer wearable biosensors. From this, the Center has developed a database prototype. Though still in beta, those clinicians who have interacted with the database are enthusiastic.

Kevin Uchimura, lead engineer on the project, is working closely with the HoneyBee team to improve visual displays and user interface. “We’re currently focused on providing the database as a resource to clinician collaborators,” says Uchimura. “They have been employing it as part of their clinical trials. The device information could aid the investigator in choosing the most appropriate device for the particular condition they are examining.”

As the database moves through different iterations, complications common in the digital health field have arisen. Device interoperability options are often amended, and the wearable biosensor hardware is also quickly evolving, which means that keeping tabs on how devices in the database are evolving is very challenging. The newest devices and platforms hitting the market, along with any modified or attaining FDA approval are all details Uchimura and his team must track. Using sites like MDDI or MDT to provide credible reference indicators are helpful.

The underlying motivation—and innovation—is that this effort presents an entirely new use-value to the consumer wearable biosensor market. It proposes to acknowledge and meld together daily lifestyle choices with medical choices for improved health and wellness. Debra Corley, a Graduate Research Assistant involved in the Observational Clinical Trials validating the database’s consumer wearables says, “Biosensors that offer long-term monitoring provide a wealth of assessment data for both clinicians and the wearers of the device. Valuable assessment data lost in shortened face-to-face provider visits could possibly be more efficiently captured remotely with these devices. I am very excited to see how these methods of data collection will provide new insights for patient assessment.”

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