The ever-growing number of health-related software applications, or apps, for smartphones, tablets, and personal digital assistants have caught the eye of the US Food and Drug Administration (FDA). The agency announced today that is considering providing oversight of some of these mobile apps and is seeking input from the public.
It is estimated that by 2015, about 500 million smartphone users worldwide will be using a health care app.
Of interest are apps that will allow physicians to conduct patient care. Specifically, the FDA is focusing on 2 subsets of health apps that may affect the performance or function of medical devices already regulated.
One subset involves apps that are used as an accessory to a medical device already regulated by the FDA, such as an app that allows a physician to make a specific diagnosis by viewing a radiological image on a smartphone or tablet. The other subset involves apps that transform a mobile communication device attached to sensors or other equipment into a regulated medical device—for example, an app that turns a modified smartphone into an electrocardiograph, or ECG, machine to detect abnormal heart rhythms.
However, the agency is not planning to regulate apps that are aimed directly at consumers to help them in activities such as recording caloric intake or physical activity that pose little risk to patient health.
“The use of mobile medical apps on smart phones and tablets is revolutionizing health care delivery,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health in a release. “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.”