The Current Regulatory Framework as Applied to InTouch Health’s Telemedicine Solution
Mobile health and telemedicine products (including software associated with these technologies) have for many years been regulated as medical devices by the U.S. Food and Drug Administration (FDA). More recently, the FDA has begun developing a regulatory framework specific to mobile health and telemedicine technologies. Through this work, the FDA has clarified—and expanded-how these technologies are regulated. This white paper summarizes the current FDA framework for mobile health and telemedicine products and how it applies to InTouch Health’s Telemedicine Solution.
FDA regulation of medical devices depends on the risk associated with the product. Class I devices are associated with low risk and, therefore, involve the least burdensome regulatory oversight. Class II and III devices involve increasingly greater regulatory requirements as devices that fall within these categories are associated with moderate or high risk. Mobile health and telemedicine devices fall into each of these classifications, and devices involved in active patient monitoring fall within Class II or III.
The InTouch Health Telemedicine Solution is a range of mobile, robotic telecommunications devices that enable transmission and storage of real‐time audio/video and other patient data as well as active patient monitoring. It has been cleared by FDA as a Class II medical device.