FDA to regulate healthcare mobile apps

The Food and Drug Administration's (FDA's) recent guidance on how it might regulate mobile health applications used by physicians and consumers will affect only a small portion of the apps on the market, the agency said, reveals the Information Week.

However, the FDA's expanded regulation of device-related software will affect device manufacturers and the growing number of firms marketing health apps for smartphones and tablets.

“The majority of the folks who I've been dealing with do fall within the scope of that guidance document,” says Bradley Thompson, a New York attorney specialising in medical device regulation.

According to eWeek, a separate FDA rule regarding medical device data systems took effect on 18 April, requiring IT companies to register healthcare hardware and software that transfers, stores, converts or displays health care data.

The FDA's Centre for Devices and Radiological Health oversees regulations for companies manufacturing, repacking, relabeling or importing medical devices in the United States.

The Federal Communications Commission governs smartphone airwave signals, while the FDA regulates medical devices that provide treatment or therapy.

The smartphone platforms for which medical apps would be regulated under the draft guidelines include Android, BlackBerry and iPhone. Mobile apps in question would reside directly on a smartphone or on the Web.

The Los Angeles Times also reveals that the mobile applications the FDA is eyeing for regulation include those that "are used as an accessory to 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”, noted the FDA.