NY Times – October 15 2011
Those Scan Results Are Just an App Away
EVEN in the vast world of apps, Dr. Patrick J. Gagnon has one with an unusual distinction: it had to be cleared for use by the Food and Drug Administration.
Dr. Gagnon, a radiation oncologist, uses the app when he sees patients in his Fairhaven 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 FDA’s attention.
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. “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.”
Questions for the Doctor?
What is an Oncologist ?
Can you put the phrasal verb “to pull out” into a sentence?
For what would you need “magnetic resonance imaging” for?
Is tomography like photography?
At the hospital, do you have a workstation ?
Do you think this app could “prove useful” ?
How often do you attend a workshop?
Can you think of a similar word for subset ?
How many is a myriad ?
If Sherlock Holmes said “lets take a close look”, what could happen?
Describe the ambient noise and light right now.
Tell me one thing that requires acuity ?(a cu e t)
What’s the best way to mitigate Mourinho?
Discussion:
Is this technology a help or a hindrance?
Do you think it could get approval in Europe?
Would you like to try it?
Video:
http://www.youtube.com/watch?v=1xxSaRAhHUE
Version 3.0 of the Mobile MIM radiology app recently was cleared by the FDA. The app is now cleared for X-rays and radiation oncology, and is optimized for the iPad and iPhone. MIM CTO Mark Cain provides a tour of the Mobile MIM app’s newest features.
