Mobile health apps are being designed to promote fitness and track beneficial health metrics aiding healthy living. With the wearable market expanding, the Mobile industry estimates about 500 million smartphone users worldwide will be using a health care application by the end of 2015, and by 2018, 50% of smartphone and tablet users will use mobile health applications to track healthy habits. (Source: research2gudience report).
Health apps are making significant progress along with the industry tide and it would not be an over statement to say that such health-related apps are being embraced rapidly and are extending to a new genre of apps called Mobile Medical Apps (MMAs).
MMAs are mobile apps encapsulating medical devices that meet the definition of a medical device defined by the Food and Drug Administration (FDA). MMAs could also be an accessory to a regulated medical device. This “genre” of apps usually aids health care professionals and facilitates patient care. For example, the Radiation Emergency Medical Management (REMM) app from NIH gives health care providers guidance on diagnosing and treating radiation injuries. Some Mobile Medical Apps are in trial phases to diagnose heart rhythm abnormalities, or function as the “front-end” to a glucose meter or CGM (continuous glucose monitoring) device used by a diabetic patient.
The FDA offers a wide range of guidelines for MMAs and, in some cases, the FDA also regulates them. The FDA adopts a tailored risk-based approach on the small subset of mobile apps that meet the regulatory definition of a “device” and are intended to be used as an accessory to a regulated medical device. Mobile apps span a wide range of health functions, and many carry minimal risk; those that can pose a greater risk to patients will require FDA review. The following link lists some examples of MMAs that FDA regulates: Examples of MMAs the FDA Regulates. It is to be noted that the FDA's Mobile Medical App policy does not apply to mobile apps that function as an electronic health record (EHR) system or personal health record system. Currently in-market MMAs are considered extensions to data capture and retrieval systems.
Lots of progress is being made in this area, and MMAs are pivoting themselves to a new idea called “Telemedicine” which is combining medical apps with some form of entertainment. For example, on the App stores, I found musical ‘whistle’ apps that provide numbers to gauge lung health; or using special software operated through Microsoft Kinect (motion-sensing device), physical therapists prescribe games to assist patients with rehabilitation exercises and monitor progress by analyzing motion data captured by the device.
The growth in this area is super fast, and all the future indications postulate apps in combination with mobile devices will move from an information retrieval system to an extension of a doctor’s hands and eyes, helping physicians become nearly omnipresent. In a matter of time, going to the doctor could be as simple as standing in front of motion or gesture capture device at home where the doctor shows up on time and does a physical using a motion capturing device. An added benefit? No need to browse through those outdated fashion magazines while waiting.
Post Date: 11/21/2014