Over the last few years, health-related mobile applications (apps) have become widely used by consumers for weight control, disease-related monitoring, smoking cessation, and other purposes. However, healthcare practitioners, including physicians, may use these types of apps for higher-level medical activities—for example, performing electrocardiograms (EKGs) or measuring blood glucose levels—in the process of diagnosis and treatment in a clinical setting. According to a 2015 survey of 500 healthcare professionals by Research Now, only 16 percent used mobile applications with their patients, but 46 percent planned to in the next five years. In addition, 86 percent of healthcare practitioners believed that apps would increase their knowledge of their patient’s conditions, with 46 percent claiming the apps would improve their relationships with their patients. Surveys have also shown that physicians believe there is value in connecting apps with electronic health records to share patient data. While the majority of physicians agree that there is great potential for new technologies to improve healthcare via apps, without any oversight there are obvious potential risks to patients. This has garnered a federal-level response by both the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC).
In February 2015, the FDA issued final guidance on the regulation of mobile medical apps. The FDA defines a mobile medical app as a software application that can be executed on a mobile platform, or a web-based software application that is tailored to a mobile platform but is executed on a server. The FDA’s definition of a “mobile platform,” is a handheld, off-the-shelf, commercial computing platform, with or without wireless connectivity, or a software application that is web-based and executed on a server but tailored to a mobile platform. iPhones, iPads, and other personal mobile devices fall under this definition.
According to the FDA, the targeted mobile medical apps are either “intended to be used as an accessory to a regulated medical device” or “intended to transform a mobile platform into a regulated medical device.” Apps can be considered “medical devices” and subject to FDA regulation if they are “intended for use in the diagnosis or the cure, mitigation, treatment of prevention of disease, or to affect the structure or any function of the body.” Specifically, appendix E of the guidance document provides an overview of compliance obligations applicable to medical devices, including mobile medical apps. Pertinent requirements include: establishing registration and medical device listing, premarket submission for approval or clearance, quality system regulation, product labeling, and adverse-event reporting.