The 3 Compliance Aspects For Passive Predictive Monitoring Device Success
By Anna Ronning and Hilde Viroux, PA Consulting
The healthcare and life science industry has been undergoing a digital transformation, and the global COVID-19 public health emergency has accelerated the development of at-home monitoring products. With this shift, at-home monitoring devices are focusing on a passive approach collecting data in the background. Understanding the regulatory compliance landscape is critical for getting these products on the market and in patients’ hands quickly. In this article, we define “passive at-home monitoring products” as non-invasive products that continuously monitor elements of health and collect the user’s data without the direct supervision of a healthcare professional. Organizations must take the following three key compliance aspects into consideration to ensure success.