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Waiting for the app-ocalypse: Will toughening FDA regulations disconnect the medical smartphone app industry?

by Brendon Nafziger, DOTmed News Associate Editor | July 22, 2010

"You've got a couple of companies out there that say, 'Oh, look, you can see your study.' But if it's really that important, you can find a workstation to see it. [These apps are] not a read-at-home story," he said.

Nonetheless, even the suggested use brings us into murky waters. Deciding whether a study is good enough to keep for later is still something of an act of medical interpretation, even if no actual diagnosis is made off the viewer. Even more so is the radiologist-on-the-golf-course example. A spokesperson from Merge and representatives from other companies used the analogy of the clinic or perhaps a puzzled colleague sending an image to a radiologist on the golf course to ask for advice or an opinion.

"Can you take a look? Is it diagnostic? Is it a gray area?" asked Kulbago. "Yeah, it's a gray area."

"It's kind of the same thing with the ultrasound," he said. "Is there some kind of medical [act] going on? For sure. Is it an appropriate use of the technology to prevent patient callbacks, patient frustrations and lower costs and improve health care? It probably is."

Comparable clarity?
Dr. Klufas said that while he has no data to support his observations, in his practice he has checked chest X-rays on his workstation and on the eFilm Mobile viewer and wasn't able to see a big difference.

"The images are definitely comparable," he said, "though I would assume that the matrix is not quite obviously the same as it's going to be on a regular diagnostic workstation."

He suspects that for MRI and CT scan images, but perhaps not for film, it will, one day, be diagnostically useful.

While clinical evidence is at the early stages, a study conducted earlier this year and published in the American Journal of Roentgenology found that radiologists making (test) diagnoses on software on an iPhone and a PDA did about the same, if not slightly better, than when working on other secondary class (non-diagnostic quality) monitors.

Clinical diagnosing in Canada
In any case, the age of mobile diagnoses is already upon us, at least across the 49th parallel. In April, Canada Health, our northern neighbor's version of the FDA, OK'd radiologists making clinical diagnoses off Calgary Scientific's ResolutionMD, the company said.

Using PureWeb - a "zero footprint" product - the app basically runs off a web browser on the iPhone, iPad or Android, and lets the mobile device, in essence, "tap" into a workstation. Unlike most viewers, the app itself is hosting none of the software, a fact Byron Osing, CEO and chair of Calgary Scientific, credits with its approval by Canada Health. (Though made by Calgary, it is distributed in Canada through Belgium-based film and software giant Agfa, Osing said.)