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12-07-2012 | Article

FDA considers regulating medical apps


NPR health blog

MedWire News: Should developers of clinical application programs (apps) for tablet computers and smart phones be left to their own devices, or should their programs be subject to Food and Drug Administration (FDA) oversight?

Jeffery Shuren, Head of the FDA's Center for Devices and Radiological Health, thinks that some mobile apps on the market are actually medical devices and should be subject to FDA approval, according to a recent report on All Things Considered, broadcast on National Public Radio (NPR) and published online in an NPR health blog.

In July 2011, the FDA invited public comment on a proposal to oversee mobile medical apps that are used as an accessory to an FDA-regulated medical device, such as an app that would allow clinicians to view medical images on, say, an Android smart phone or tablet. In addition, the FDA is considering regulating devices or programs that transform a mobile platform into a regulated medical device, such as a snap-on case that turns an Apple iPhone 4 into a mobile cardiac event recorder.

The FDA does not, however, plan to regulate apps such as exercise logs, pedometers, diet reminders, or similar programs that promote a healthy lifestyle, Shuren told NPR.

The agency's concern is that some apps intended for professional use could result in inadvertent harm or unnecessary care, such as a visit to the cardiologist and a full cardiac workup from a phone-generated electrocardiogram (ECG) recommendation.

Joseph Kvedar (Center for Connected Health, Boston, Massachusetts) told NPR that he is particularly concerned about apps that consumers can use to take photos of skin lesions and then transit the images to an online database "and be told whether it should be evaluated for a melanoma or not."

On the other hand, such devices, in the hands of professionals, can save lives. In 2011, cardiologist Eric Topol (Scripps Health, San Diego, California) used an iPhone ECG adapter to diagnose a myocardial infarction on a flight from Washington DC to San Diego. The plane made an emergency landing in Cincinnati, and the passenger was taken to a hospital where he underwent a cardiac interventional procedure with stent implantation and survived, as reported in Medical Device and Diagnostic Industry.

By Neil Osterweil