July 2011

Images on the Move
By David Yeager
Radiology Today
Vol. 12 No. 7 P. 12

MIM Software’s mobile application is the first to receive FDA 510(k) clearance as a diagnostic app. Radiologists are examining how it will fit into imaging workflow.

In February, the FDA granted 510(k) clearance to MIM Software’s Mobile MIM application. The mobile radiology app designed for use with iPhones and iPads is the first to be cleared for diagnostic imaging. It is approved for use with CT, MR, and nuclear medicine exams.

Obtaining clearance wasn’t an easy process. Partly because there wasn’t an analogous product on the market, it took 2 1/2 years and several tries before the FDA cleared the app. Given that there are already nondiagnostic mobile apps available, it seems there would have been a little temptation to bypass the FDA, but Mark Cain, chief technology officer at MIM Software, Inc, says the company never considered that route.

“If you’re going to put it in the hands of doctors, and they’re going to be looking at images in a practical and useful way, which would be when you can’t get to a workstation or when you need to know something right away, there was no doubt ever in our minds that a doctor using that software would be using it to make clinical decisions,” Cain says. “Therefore, there was no other choice but to take it to the FDA because that’s what the definition of a medical device is.”

Even though the product changed very little during the clearance process, the fact that it presented a new paradigm in medical devices—it’s a software component, but MIM doesn’t control the hardware—slowed down the approval. The fact that it’s mobile was also an issue.

One sticking point in the FDA process was background lighting. It’s nearly impossible to find anything approaching a proper reading environment outside of … a proper reading environment. The difficulty is compounded by the fact that different devices can have different levels of luminance, even if they’re the same model. MIM solved this problem by including a gray square on the display that’s a slightly different shade than the rest of the background. If a radiologist can see and tap the square, there’s sufficient light to properly view the images.

How Will It Be Used?
How this app is likely to be used by clinicians remains to be seen. Cain says most users are still trying to determine how best to incorporate it for clinical care. Issues such as whether to purchase iPads for staff, whether a facility’s IT people can support an influx of iPads, and how to coordinate the app’s use with HIPAA policies need to be ironed out; Cain expects it to take some time. There have been hints, however, about how it might be used.

One facility that Cain has spoken to, a level 2 trauma center, sees time-saving potential in the app. Rather than waiting for the CDs that come with a patient, which have to be loaded onto the hospital’s system when the patient arrives, a center’s trauma surgeons could be reviewing the patient’s images while the patient is being transported. This would not only save time in diagnosing the patient, but the surgeons would also be able to determine whether the patient should go to the level 2 center or be sent to a level 1 center. The app could also potentially allow multiple trauma surgeons in different locations to offer opinions.

“In the world of trauma, where every second counts, the fact that you can’t know—until the patient lands and you [look at the] CD—what’s going on inside [the patient] is troubling to these doctors because you lose people,” says Cain.

But this is one of the more dramatic possibilities. The goal for any type of HIT is to disseminate information as quickly and efficiently as possible to aid patient care. Generally speaking, people are still trying to figure out how Mobile MIM can best do that. Whether the true value of the app lies in its ability to render diagnostic quality images has yet to be determined.

Nature vs. Nurture
Although many radiologists are excited about Mobile MIM, not everybody believes it’s necessary—or even desirable—for the FDA to bless mobile apps. Paul J. Chang, MD, FSIIM, a radiology professor and vice chair of radiology informatics at the University of Chicago Medical Center, points out that the resolution of an iPad is the same as many computer monitors years ago. He’s not worried about the image quality. But, he says, while FDA approval speaks to the technical capability of a product, it doesn’t have much to do with professional standards.

“I don’t care that the FDA actually says you can do it. My question is, should we do it?” says Chang. “And my point is the following: My job as a radiologist is more than just looking at an image. My job is providing the absolute highest-quality image consultation to my clinical colleagues to help manage their patients, and what that means is I look at more than just the image. I correlate with prior studies. I correlate with lab values, the pathology. I am a physician. I’m going to do that on an iPad? You think I’m going to do that on the golf course, when I just hooked it off the fairway and into the rough behind a tree? I’m not going to do that.”

Emergency and Convenience
While reading on the golf course poses obvious obstacles to providing in-depth consultation, a more important factor than the reading environment is the user. Just as technological advances allow people to improve the way they work, they often also allow people to cut corners, whether those corners should be cut or not. Chang believes some radiologists may be tempted to stretch themselves too thin, rationalizing that they’re covering their bases because they have a diagnostic app on their iPhone or iPad. Although MIM touts the ability to read cases in emergency situations, the definition of a true emergency largely depends on how a situation is perceived.

“One person’s emergency, a lot of times, is another person’s convenience,” says Chang. “My belief is those emergent situations are actually convenience scenarios, and there shouldn’t be ever a need to use this in an emergent situation because I should be where my mind’s at, and that is either in the reading room or at a workstation at home [that is] optimized for that task.”

For his part, Cain believes the concern about lazy reading habits is overblown. He says there have always been good doctors and bad doctors, and a new piece of technology isn’t going to change that.

“Doctors dedicate their lives to the treatment of their patients,” says Cain. “If you have a doctor that’s that crass, that unconcerned with the quality of care he’s providing, it wasn’t the arrival of our app that made it possible for him to be so lax. He was probably already being lax.”

Still, Chang has reservations about how the technology may be used. He says convenience thinking can take many forms. For example, if a doctor on call is awakened at 3 AM to look at an image, he or she will often view it in their home office. But what if that doctor has diagnostic-quality images available on his iPad?

“Do you want me to read your mom’s CT at 3 in the morning on an iPad, or would you rather have me get out of bed, splash some water on my face, get up to my workstation in my study, boot up my workstation, but, more importantly, boot up my mind?” asks Chang. “Boot me up so that I’m ready to optimize the consultation I give to your mom.”

One thing Chang and Cain agree on is the potential for mobile apps to greatly enhance physician collaboration. Cain cites several instances where the app could cut down waiting time and provide more opportunities to share expertise. He says in a situation where a radiologist may not be near a workstation on a particular day but the referring physician would like the radiologist to see the image that day, Mobile MIM could make it possible to consult with that radiologist.

It could also be helpful if an expert is needed for a very difficult case. Cain says currently only one or two people read an image. If there’s a 10% uncertainty, most people aren’t going to call the senior radiologist and ask him or her to come to the hospital for a look.

“Do you call him and irritate him just to rule out that 10%? No. You don’t do that,” says Cain. “But if it was as easy as saying, ‘I just want to send this to you,’ and wherever he’s at he can pull it up and look and agree or say, ‘Did you consider this?’ I think what you’re going to get is many more people actually taking advantage of the fact that their experts [and] their peers are available in ways that they’ve never been available before.”

Fabio Almeida, MD, medical director of Southwest PET/CT Institute in Tucson and Yuma, Ariz., and Indian Wells, Calif., and at the Arizona Molecular Imaging Center in Phoenix, says Mobile MIM adds an extra layer of communication between him and his referrers. With four offices in two states, Almeida is frequently on the move. He’s found that the app helps him provide a better level of service to referrers and patients.

“Even though I will have read the study, it might be the next day or the day after [that] a different clinician, who is now seeing the patient, needs some additional questions answered,” says Almeida. “So being able to access it on the fly wherever I am, if I’m in the hospital, at a tumor board, or if I’m at one of the clinics [and], for whatever reason, I don’t have access right in front of me, this gives me that additional access point that just gives me more flexibility.”

Almeida hasn’t had to use Mobile MIM as a diagnostic tool, but he says it’s not out of the question. He has numerous workstations available to him in his daily practice, and he doesn’t plan on retiring his keyboard or mouse, but he says upgrades that MIM is planning to make to its PACS and cloud structures will make the app more accessible. Almeida encouraged MIM to seek FDA approval early on, and he says knowing that the app is FDA approved gives him extra confidence in using it.

Communicate With Referrers
Although Mobile MIM will always be an adjunct to Almeida’s practice, he believes mobile capability will have a significant effect on his referrers’ practices. Almeida and his colleagues plan to roll out Mobile MIM to their referrers soon. He believes this will add value to the services he provides.

“From a radiologist’s perspective, we have diagnostic workstations all over the place. That’s our general scenario. We’re not going to be replacing, I think, our workstations, as a routine, with an iPad-type of application,” says Almeida. “But I think where this is going to be the most useful is in the hands of our referring physicians, our oncologists, radiation oncologists who, although they have access to the images somewhat ubiquitously, it’s not nearly the same as it is for myself.”

Chang is all for using mobile devices in this way. He says he’d like the ability to alert a clinician to an emergent finding through a pop-up application that would allow him to discuss the finding with the clinician in the proper context. And it may not be too long before he has that opportunity. The MIM app is likely just the first of a stream of mobile radiology apps. Now that MIM has taken the first steps by working through the FDA process, it’s nearly certain that others will follow the path.

“You’re going to find, by this year’s RSNA, everybody in this space is going to have FDA approval,” says Chang.

— David Yeager is a freelance writer and editor based in Royersford, Pa.