Government Might Begin Regulating Health And Medical Apps
July 21, 2011
It looks like the U.S. government is going to get involved in app development, but probably not in the way we’d expect. According to the L.A. Times, the country’s Food and Drug Administration (FDA) has introduced a proposal that would allow it to regulate smartphone and tablet apps that have to do with health and medical needs.
On Tuesday, the FDA 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."
In the same statement, however, the agency insisted its goal was not to stifle app development.
Jeffrey Shuren, the director of the FDA’s Center for Devices and Radiological Health stated:
"The use of mobile medical apps on smartphones and tablets is revolutionizing healthcare delivery. 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."
Specifically, the FDA seems intent to regulate those apps that act as an accessory for medical devices that the agency already oversees.
Also included in the oversight 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 FDA is currently seeking public comment on the 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.
What do you think? Leave your comments below.
[Photo: Med School Watercooler]
