Mobile Medical Applications (MMA)

Publish Date:
April 21, 2015
Prithul Bom, MBA, RAC, Director, Medical Device and Diagnostic Development & Elizabeth Brooks, PhD, President, Decision Driver Analytics

Mobile communication devices, particularly smartphones, are radically changing the way we think and make decisions about our health care. Over the last decade, smartphones and applications have changed several important aspects of our lives, not just our entertainment options but also how we track personal finances, shop, travel and interact with friends and family. Health care technologies, such as mobile health tracking applications (mHealth apps) and activity monitors, have crept into our lives, and many of us routinely and actively engage with them. In fact, Jawbone, a manufacturer of popular wearable fitness trackers, proclaimed in a recent article that users spend more time with their Jawbone devices than on Facebook. Jawbone devices and other activity trackers represent just one category of devices that Wired magazine defines as lifestyle devices: “sensors worn perpetually to track personal and biological data that, over time, coalesce to create a portrait of health, habits and behavior.”i The use of lifestyle devices will continue to rise, which demands that all parties in the research community take notice. Regulated mobile medical applications (MMAs) are different than mHealth apps and other health care lifestyle devices. Because MMAs are regulated technologies, manufacturers must prove their technologies’ safety and efficacy to regulatory agencies. Their technologies are held to further regulatory standards, including regulatory labeling requirements governing any proclamations they make about their MMAs.