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Mobile Health, also known as mHealth, is defined as the use of wireless communication to support efficiency in public health and clinical practice (Yetisen et al., 2014). To facilitate mHealth, mobile applications (apps) have been developed, which can be executed either on a mobile platform or on a web-based software application that is tailored to a mobile platform but is executed on a server. Mobile medical apps are accessories to a regulated medical device or are software that transforms a mobile platform into a regulated medical device. These mobile devices may include, but are not limited to, mobile phones or smartphones, tablet computers, smartwatches, and point-of-care (POC) devices. As growth of mHealth continues, major areas for mHealth growth are:Preventive medicine and health promotion can be leveraged through education and awareness applications;Portable diagnostic devices that allow monitoring of human conditions in clinical settings or offsite locations;Applications for data management, training medical personnel, and mobile payments.Regulation of Medical DevicesThe United States Food and Drug Administration (FDA) oversees medical applications and assesses their potential misuse or malfunction in order to reduce these risks to the public. This growing risk factor prompted the FDA to introduce a guidance in 2011. In 2013, the FDA released its final guidance entitled "Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff". The guidance offers clear distinction between an unregulated "mobile application" and a "mobile medical
application" which are subject to overt FDA regulation. This guidance also focuses on apps that possess agreater risk to patients if they don't function as they intended.Medical Device or Mobile Application?The Food and Drug Administration (FDA) (2013) recognizes the extensive variety of actual and potential functions of mobile apps, the rapid pace of innovation in mobile apps, and the potential benefits and risks to public health represented by these apps. The FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms. Given the rapid expansion and broad applicability of mobile apps, the FDA is issuing this guidance document to clarify the subset of mobile apps to which the FDA intends to apply its authority. Many mobile apps are not medical devices, meaning such mobile apps do not meet the definition of a device by the Federal Food, Drug, and Cosmetic Act (FD&C Act); therefore, the FDA does not regulate them. Some mobile apps may meet the definition of a medical device but because they pose a lower riskto the public, the FDA intends to exercise enforcement discretion over these devices (meaning it will not enforce requirements under the FD&C Act). One example is a mobile app that makes a light emitting diode (LED) operate. If the manufacturer intends the system to illuminate objects generally (i.e., without