FDA to Facilitate Information Access by Proposing Smartphone 'Mobile Medical Applications'

August 1, 2011

With the continuing increase in the utilization of smartphone applications (apps), the Food and Drug Administration (FDA) has decided to jump on the bandwagon. The goal for the FDA is to provide accurate and up to date information for consumers and patients, partly to address the increasing number of ‘health’ applications that may not always be accurate or from reliable sources.

With the continuing increase in the utilization of smartphone applications (apps), the Food and Drug Administration (FDA) has decided to jump on the bandwagon. The goal for the FDA is to provide accurate and up-to-date information for consumers and patients, partly to address the increasing number of health applications that may not always be accurate or may contain information from unreliable sources. One function of a currently available health app is calorie-intake monitoring, which facilitates the maintenance of a healthy weight. Another app allows doctors to view a patient’s radiology images, and it's this type of function that the FDA is concerned about and one of the reasons for this new initiation.

The FDA has announced the availability of the 'Mobile Medical Applications' draft guidance that will go into effect sometime after October 19, 2011. In the meantime, consumers may submit comments to the FDA by this date during the public comment period.

“We want to hear from as many consumers, advocacy groups, health care professionals, and software creators and distributors as possible to help us finalize the proposed guidelines,” says Bakul Patel, the FDA policy advisor.

The director of the FDA’s Center for Devices and Radiological Health, Jeffrey Shuren, MD, JD, emphasizes that the draft guidelines are focused on those medical apps that will directly affect patient care.

"The use of mobile medical apps on smartphones and tablets is revolutionizing healthcare delivery," said Dr. Shuren. "Our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don’t work as intended."

The agency will initially oversee a few mobile apps. The scope of the apps will be both individual wellness as well as some apps that will target healthcare providers to improve and assist patient care.

The FDA policy advisor states that “some of the new mobile apps are designed to help consumers manage their own health and wellness-like the National Institutes of Health’s LactMed app, which gives nursing mothers information about the effects of medicines on breast milk and nursing infants.” Another app, the Radiation Emergency Medical Management (REMM) app, will give healthcare providers guidance on diagnosing and treating radiation injuries. There are also proposed apps for topics such as diagnosing rashes and heart irregularities.

Two medical mobile apps that have already received clearance from the FDA for use by clinicians are the smartphone-based ultrasound and an application for iPhones and iPads that allows doctors to view medical images and X-rays.

The FDA will need to be rigorous about the medical app oversight, as some of the apps will facilitate patient care and diagnosis, such as the medical images app. All apps that will be used as an accessory to an FDA-regulated medical device or transform a mobile platform into a regulated medical device will require the oversight. An example of the latter is an app that turns a smartphone into an electrocardiography, or ECG, machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.

During the creation of these guidelines, the FDA is encouraging “feedback from manufacturers, healthcare providers and others on how its proposal may support the balance between promoting innovation and assuring safety and effectiveness.”