The U.S. FDA, in its draft guidance on mHealth APPs, summarizes two categories of potentially risky APPs: those that turn a mobile platform into a medical device. In many cases, this is done through an appendage or sensor, such as an APP that turns a mobile device into a stethoscope through sensors, or an APP that measures blood glucose and electrocardiograms and presents the results on a smartphone; the other category is one that controls the use, functionality, modes, and energy sources of an existing medical device. This includes APPs that control the function of medical accessories, such as insulin delivery through an insulin pump. It also includes APPs that display data from bedside monitors and images from PACS (Picture Archiving and Communication System) servers. Both types of APPs need to be regulated because they may create new risks by connecting to or controlling medical devices that are already regulated.
Mobile healthcare is a global trend, and one that is already taking off in China, with healthcare IT companies increasing by 78 percent in 2010, and 41 percent of those companies developing smartphone apps. In this context, domestic authorities should take proactive measures to regulate mHealth APPs to prevent possible market disruptions and healthcare risks in the future.