Dr. Gagnon, a radiation oncologist, uses the app when he sees patients in his Fairhaven, Mass., office. He pulls his iPhone out of his pocket, and then he and a patient, side by side, can view images on it and discuss treatment.
“It’s a nice way to go through a scan with a patient,” he said.
The app he uses, called Mobile MIM, made by MIM Software, can turn an iPhone or an iPad into a diagnostic medical instrument. It allows physicians to examine scans and to make diagnoses based on magnetic resonance imaging, computed tomography and other technologies if they are away from their workstations.
Dr. Gagnon says the app will also prove useful when he wants to give physicians at other hospitals rapid access to images for immediate decisions.
Mobile MIM is among a handful of medical apps that the F.D.A. has cleared for diagnostic use. Many others will probably appear as more smartphones and tablets make their way into the pockets of doctors’ white coats or onto their office desks. In preparation, the F.D.A. is working on guidelines for such apps, and in September it conducted a two-day public workshop for feedback.
Only a small subset of the myriad health apps coming to the market will actually need the agency’s regulatory attention, said Bakul Patel, a policy adviser at the Center for Devices and Radiological Health, an F.D.A. unit in Silver Spring, Md.
The focus will be on apps that help with a specific diagnosis, or transform a mobile device into a currently regulated medical device. For example, an app to turn a smartphone into an EKG machine to determine whether a patient is having a heart attack would qualify for a close look.
Mobile MIM was the first medical imaging app to be cleared by the agency. Its maker also sells medical imaging services that are used on workstations.
The app comes in two versions: Mobile MIM, for physicians, and VueMe, for patients. Both are free, though MIM Software charges on a pay-as-you-go basis for storing uploaded scans on its servers, and for letting people view them.
For instance, it costs $1 for a doctor or hospital to upload images of an examination to MIM’s cloud, said Mark Cain, the company’s chief technology officer. Even if the scan has several parts, the charge remains $1.
The charge to view the study when the doctor sends it along to a patient or asks for a second opinion from another physician is $1 on an iPhone and $2 on an iPad. Even though a study may be viewed by several patients and physicians, the charge is usually made only once, Mr. Cain said.
Achieving F.D.A. clearance for the Mobile MIM app took nearly two and a half years, Mr. Cain said. One concern was the ambient lighting under which scans might be read when using the app. Studies are usually read on workstations in the low light of reading rooms, Mr. Patel said. But doctors using their cellphones or tablets on the go might find themselves in places that are far brighter than that.
“You might not have the visual acuity you’d need for a crucial diagnosis that you’d have in a reading room,” Mr. Patel said.
The F.D.A. worked with the company on a way to mitigate this risk. The solution was software that includes an automatic test for poor lighting — users must perceive and tap a small rectangle that appears faintly on the screen. “If you can’t see the rectangle and touch it, you are in an area that is too bright,” Mr. Cain said.
Adjustments like these, Mr. Patel said, will make the devices more usable.
The F.D.A. procedures may slow down some applications’ debuts, said Dr. Iltifat Husain, an emergency medical resident at the Wake Forest University School of Medicine and editor in chief of a Web site that reviews medical apps.
But he is not worried.
“It’s exciting to see the F.D.A. getting involved,” Dr. Husain said. Both from patients and doctors, he added, “there’s a strong demand to understand these new apps.”
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