Mobile Medical Apps
USA: FDA – Mobile apps are software programs that run on smartphones and other mobile communication devices. They can also be accessories that attach to a smartphone or other mobile communication devices, or a combination of accessories and software. Mobile medical apps are medical devices that are mobile apps, meet the definition of a medical device, and are an accessory to a regulated medical device or transform a mobile platform into a regulated medical device (source: FDA website – Device Software Functions Including Mobile Medical Applications).
Consumers can use both mobile medical apps and mobile apps to manage their own health and wellness, such as to monitor their caloric intake for healthy weight maintenance. For example, the National Institutes of Health’s LactMed app provides nursing mothers with information about the effects of medicines on breast milk and nursing infants (source: FDA website – Device Software Functions Including Mobile Medical Applications).
Other apps aim to help health care professionals improve and facilitate patient care. The Radiation Emergency Medical Management (REMM) app gives health care providers guidance on diagnosing and treating radiation injuries. Some mobile medical apps can diagnose cancer or heart rhythm abnormalities, or function as the “central command” for a glucose meter used by an insulin-dependent diabetic patient (source: FDA website – Device Software Functions Including Mobile Medical Applications).
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