mHealth and FDA Guidance

As the market for mobile health applications continues to grow, developers look to the FDA for guidance on what will be regulated and how.

"The FDA intends to apply its regulatory oversight to only those mobile apps that are medical devices and whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended."

Mobile health, or mHealth, refers to the use of smartphones, tablets, and other mobile and wireless devices in both public health and health care. One of the most commonly understood forms of mHealth includes software applications, most commonly called "apps," which are designed to provide a health-related service for the user. The apps are sometimes called mHealth apps, medical apps, mobile medical apps, or similar permutations. Consumers may use mHealth apps to monitor their own health; doctors or other health care providers similarly can use the apps to engage patients in the tracking of their health.

For consumers, the apps may allow for a greater personal control in health management, from tracking exercise to scheduling doctor appointments. For physicians and other care providers, apps can assist in day-to-day medical care, as well as allow for health-related tasks in remote areas without access to traditional health care infrastructure.

Both the relative newness of the mHealth market and the influx of applications pose challenges to the federal agencies responsible for regulating health-related products. This is particularly true for the Food and Drug Administration (FDA). Part of the FDA’s mission is to protect the public by making sure drugs, medical devices, and other health-related products are both safe and effective. To continue this mission in the mHealth sphere, the agency must ensure that certain mobile health apps—specifically those considered to be medical devices—are demonstratively safe and that the apps do as the companies who make them claim.

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expected growth in new apps each year for the foreseeable future.