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FDA signals it will regulate medical apps

A practical look at information technology issues and usage

By — Posted May 30, 2011.

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As more medical mobile applications get developed, one thorny question has arisen: Is there anyone who should be verifying whether these apps are effective and safe?

The question has come up, in particular, because of apps that claim to have a clinical component. They're a small part of the app universe, but experts expect clinical apps to hit the market in a big way over the next few years.

As it turns out, someone is already beginning to answer that question. A handful of developers has sought and received Food and Drug Administration clearance for their mobile apps considered to be clinical devices. And the FDA, which hasn't involved itself in regulating or enforcing any rules that might be related to clinical app development, has indicated that it will be more proactive in monitoring that class of product.

Elisa Maldonado-Holmertz, vice president of business development for Emergo Group, which provides regulatory guidance to companies seeking FDA approval, recently learned about the agency's efforts to regulate apps. At a town hall meeting she attended with the FDA in March, she found out that the agency's Center for Devices and Radiological Health plans to issue guidance on mobile medical applications later this year.

So far, the app market has gone unregulated for the most part, although many clinical apps probably would fall under FDA 510(k) rules, an FDA classification reserved for medical devices. In February, the FDA finalized the rule that defines so-called Medical Device Data Systems. Under the rules, devices that transmit data but do not control or alter the function of a medical device are defined as MDDS, a Class I device that is exempt from 510(k) rules. The 510(k) classification is reserved for devices used for patient monitoring.

Physician focus

Monique Levy, senior director of research at Manhattan Research, said most of the apps on the market have focused on meeting the physicians' need for quick and easy access to information.

"We really haven't seen this kind of next generation of apps," she said. The next generation she is referring to are apps that go beyond information source and serve as an actual clinical device used to make diagnosis or treatment decisions. However, "We think that's something we'll see coming up," she said.

A few companies have come to the FDA for approval. One of the first app developers to receive FDA clearance was AirStrip Technologies in San Antonio, for its AirStrip OB application. The app, which the FDA cleared in 2005, was made available in the marketplace in 2006. It allows physicians to monitor mother and baby remotely during delivery. The app received FDA clearance for use on the iPhone in 2009, and it was the first health care app in the Apple App Store to have received FDA clearance. (See correction)

The company has three mobile apps with FDA clearance. The apps are considered to be true clinical tools, because physicians are using the information to make clinical decisions. The company said the FDA clearance gave it the confidence it needed to market it as a clinical tool and not a simple mobile app.

Many of the FDA-cleared apps are designed to work with an existing stationary system. AirStrip apps, for example, are sold only to hospitals to work with existing hospital monitoring systems. They are not available for download from a publicly available app store.

In February, the FDA granted clearance to MobiUS, an app developed by Mobisante, a medical device company in Redmond, Wash. The app allows viewing of medical images for diagnostic purposes. Mobile MIM, a remote diagnostic imaging tool developed by Cleveland-based MIM Software, was granted clearance the same month.

Bruce Brandes, chief sales officer for AirStrip, said seeking FDA approval helped the company develop a better product because of the quality standards the agency required. But he doesn't think widespread FDA clearance for mobile apps would be a good thing for the industry.

"It would probably inhibit a lot of companies from innovating things that do have good utility to the consumer," he said. There would be a lot of companies that would not make the investment that is required to seek FDA clearance, he said.

Manhattan Research's Levy said meeting FDA regulations may not be the biggest hurdle in getting more mobile medical devices in physicians' hands.

"Putting the FDA to the side and privacy of data, you've got simply integrating data into practice systems. That's already something challenging, but I think that jump will be a bigger step than this first level," she said.

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