Magazine article Medical Economics

Health Apps for Physicians Will Face New FDA Regulations

Magazine article Medical Economics

Health Apps for Physicians Will Face New FDA Regulations

Article excerpt

In recent years, the mobile application market has been flooded with mobile health apps (mHealth) that do everything from count calories to perform electrocardiography.

The Epocrates 2013 Mobile Trends Report showed that about 4 out of 5 physicians, nurse practitioners, and physician assistants are using smart phones every day, and more than 50% of physicians use tablets daily.

But now the Food and Drug Administration (FDA) has announced that it will start regulating medical apps that physicians may be using on smart phones and tablets. Its guidelines, "Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff," offer information regarding the new regulatory requirements and why they are important for app developers and patients.

"As is the case with traditional medical devices, certain mobile apps can post potential risks to public health," the document states. "Moreover, certain mobile medical apps may pose risks that are unique to the characteristics of the platform on which the mobile medical app is run. For example, the interpretation of radiological images on a mobile device could be adversely affected by the smaller screen size, lower contrast ratio, and uncontrolled ambient light of the mobile platform."

Not all medical apps will be subject to regulation. The FDA will focus on apps meant for physicians and other healthcare providers to use as diagnostic tools and to facilitate patient care.


The FDA is taking a tailored, risk-based approach that focuses on the small subset of mobile apps that meet the regulatory definition of "device" and that:

I are intended to be used as an accessory to a regulated medical device, or

I transform a mobile platform into a regulated medical device. …

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