3 Tips For Designing At-Home Monitoring Devices That Deliver Actionable Information
By Anna (Ronning) Cohen and Hilde Viroux, PA Consulting
We’re all seeing it in real time: Healthcare is increasingly shifting from clinical settings to our homes. The COVID-19 pandemic has accelerated the development of at-home monitoring products and many are collecting data in the background without requiring specific user action. This acceleration is not likely to slow down post-pandemic. In this article, we define “passive at-home monitoring tools” as non-invasive products that continuously monitor elements of health and collect the user’s data without the direct supervision of a healthcare professional. Take, for example, smart devices such as the Apple Watch or a biosensor patch neither requires operation from the user to collect data, so we consider them to be passive at-home monitoring tools.
[author: Daniel Meckley]
Today’s wearable devices the ones that monitor the number of steps we take, our heart rate, and our sleep habits (to mention only a few) walk the line between personal accessories and true medical devices. To clarify the differences the FDA has issued several guidance documents including “General Wellness: Policy for Low Risk Devices” and “Policy for Device Software Functions and Mobile Medical Applications.”
Just recently, the FDA granted permission to market Nightware, a new device intended to treat sleep disturbance related to nightmares in adults with post-traumatic stress disorder or other nightmare disorders.
Nightware is a digital therapeutic device that uses an Apple Watch and an iPhone configured and logged into a software application along with the Nightware server. The Apple Watch sensors monitor body movement and heart rate during sleep, and these data are sent to the Nightware server which use a proprietary algorithm to create a