FDA proposes regulation of mobile healthcare apps
The Food and Drug Administration has introduced a proposal that would allow it to regulate smartphone and tablet apps that relate to health and medical needs.
The FDA on Tuesday said it would seek "input on its proposed oversight approach for certain mobile applications specific to medicine or healthcare called mobile medical applications ('apps') that are designed for use on smartphones and other mobile computing devices."
The agency said in a statement that its proposed approach "encourages the development of new apps, focuses only on a select group of applications and will not regulate the sale or general consumer use of smartphones or tablets."
"The use of mobile medical apps on smartphones and tablets is revolutionizing healthcare delivery," said Jeffrey Shuren, who directs the FDA's Center for Devices and Radiological Health, in the statement. "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 mobile applications the FDA is eyeing for regulation include those that "are used as an accessory to [a] medical device already regulated by the FDA," such as apps that allows doctors to make a specific diagnosis by viewing a medical image on a smartphone or tablet, the FDA said.
Also included would be apps that "transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices" such as those that can turn a smartphone "into an ECG machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack," the statement said.
The next step? The FDA is looking for the public to comment and weigh in on its app regulation proposals.
Comments can be submitted for 90 days online or in writing to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
The agency said that an expected 500 million smartphone users across the world will be using some sort of healthcare app by 2015.
-- Nathan Olivarez-Giles
Photo: Cardiologist Dr. Jose Soler demonstrates to hospital Chief Executive Dianne Goldenberg, left, and Chief Nursing Officer Cathy Philpott an app on an iPad to review medical tests on one of his patients at Northwest Medical Center in Margate, Fla., in May. Credit: Emily Michot / Miami Herald/MCT