EXTENSION Inc., a Fort Wayne, Ind.-based vendor of mobile clinical apps, has taken the unusual step of submitting a clinical alert application to the U.S. Food and Drug Administration for clearance—even though the FDA does not currently regulate the clinical mobile software market.

Todd Plesko, CEO at EXTENSION, says the decision to ask for Class III Medical Device clearance is due to his certainty that the FDA plans to regulate the market in the near future.

“Based on the information that the FDA itself has given us, and through our participation in the mHealth Regulatory Coalition, we wholeheartedly believe that regulation is coming to the smartphone ‘endpoints’ used in the health care,” he says. “We felt it was the responsible thing to do for our customers.” EXTENSION will be exhibiting at HIMS11 in both 1773.

 The issue of whether the FDA would regulate mobile software has been kicking around for nearly two years. Speculation initially was sparked by February 2009 comments from Jeff Shuren, M.D., director of the FDA’s Centers for Devices and Radiological, about the agency’s concerns about adverse events caused by HIT devices, 260 of which at the time had been voluntarily reported to the FDA by patients, clinicians and provider facilities.

While the FDA has been quiet about smartphone regulation, the agency and the Federal Communications Commission did hold public hearings in July 2010 about whether regulation of health care wireless devices, including smartphones, was necessary. And the FDA, which very broadly defines “medical devices” under its regulation umbrella, has made its presence known: it only recently cleared the Mobile MIM application for radiology, after three years and three 510(k) applications. The software, which was released on the Apple AppStore in 2008, was pulled after a few months when the FDA sent a notice to the software’s developer, MIM Software, that it had concerns about the application.

EXTENSION has been talking to the FDA for about two years, Plesko says, and on January 20 submitted a   510(k) clearance request for the application HealthAlert for Nurses.  HealthAlert aggregates data from disparate systems and integrates the data into the Cisco Advanced Unified Communications Platform. When the software receives information it triggers context-aware alerts, which are translated to XML messages and viewable via mobile devices.

--Greg Gillespie


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