Digital Health & Medical Devices
Where does your product concept fit within the universe of potentially regulated "Digital Health" technologies?
The creators of a “collaborative emerging industries knowledge resource portal” named nuviun® describe Digital Health as “…an umbrella term for all healthcare-related applications, technologies and delivery systems that result from the confluence of medicine, genomics and the technologies that comprise the digital space.”
If you visit this nuviun weblink, you will be able to scroll down to view an active, clickable version of the image on the left that will allow you to explore all of the sub-specialties that are associated with Digital Health, including Telemedicine, eHealth, mHealth, EMR/EHR, Personal Genomics, Health IT, Big Data and other related terms that have emerged over the past several years of this digital revolution.
The site above provides a rich compilation of links to the latest articles and blog contributors associated with each Digital Health subset.
Another good source of current information and linkage to other individuals interested in this field is through Paul Sonnier’s LinkedIn Digital Health Group, where you can also review his frequent Digital Health Updates.
How do you determine whether or not your envisioned product will fall under the regulatory jurisdiction of the U.S. Food and Drug Administration (FDA) and/or U.S Federal Communications Commission (FCC)?
The convergence of technologies enabling "wearable" electronic sensors and wireless communication of data have generated an amazing array of products and services that are positioned along the following continuum:
Fitness & Wellness Tracking ↔ Chronic Disease Management
According to the U.S. FDA, device developers routinely inquire about the likely regulatory classification of devices whose position along this continuum may not be clear.
In an attempt to provide clarification, the FDA released in July 2016 a final guidance document representing their “current thinking” about a category of products they would not consider to be under their jurisdiction. This document is entitled General Wellness: Policy for Low Risk Devices.
As always, the FDA cites "intended use" of a device as its guide for classification, and this policy emphasizes that Low Risk Devices are in two categories:
1) Those that do not make references to diseases or medical conditions
2) Those with disease-related wellness claims should only contain references where it is well understood that healthy lifestyle choices may reduce the risk or impact of a chronic disease or medical condition
NOTE: The FDA intends to focus its regulatory oversight on a subset of mobile medical apps that present a greater risk to patients if they do not work as intended.
Within this guidance document, the FDA provides examples of product applications they believe would, and other examples they believe would not, be regulated under these “Low Risk Device” provisions.
If it remains unclear whether or not your product may be regulated, or within which risk category it may reside, you should visit Wireless Devices & Mobile Medical Apps