Mobile technology is expanding in health care and radiologists tend to be early adopters. The advancing technology allows them to remotely access patient images and reports when needed. To that end, radiologists must keep up with the latest news that will affect the devices they use and how they use them.
Last month, David Hirschorn, MD, director of radiology informatics at Staten Island University Hospital in New York, participated in a panel discussion at ACR 2015 called Reshaping Radiology Through Mobile: Apps, Technologies, and FDA Regulations. The conference was held in Washington, DC. Diagnostic Imaging spoke with Dr. Hirschorn about the future in mobile apps and devices for radiologists.
Why are you interested in mobile apps and its future in radiology?
I’ve studied radiology displays for probably over 10 years, trying to understand what radiologists really need in order to read a CT scan, MRI or X-ray. When mobile apps entered the arena, questions arose about the image quality available on mobile devices. People wondered if you can read an X-ray or CT scan, or anything off of a mobile device.
Mobile displays are different than what you have on a desktop display. For example, what is the effect of the ambient light? Even if the device is functioning perfectly normally, if you’re at the beach or on the ski slope, where it’s just too bright around you, you need to be able to see that screen.
How popular do you see these mobile apps? How accepting are the radiologists of them?
These apps are very popular. Radiologists definitely want remote access to their images. They’d love to be able to sign-off on their reports remotely. They definitely need access to radiology information on their phone. There’s barely a radiologist left who doesn’t own a smartphone and would love to use this stuff.
But it’s not so simple. Getting these apps isn’t like buying a game, when you buy it, you have it. These apps generally only work in conjunction with a server within a computer system that was purchased by the radiologist’s institution. The apps don’t do anything by themselves. They’re not going to do much for you unless your hospital has a server for them to connect to and can give you your patients’ images.
But it’s different when it comes to references, and radiologists use a lot of references. They can have their educational material, guidelines and things like that. If they want to test their own skills or whether you want them to learn something, there are plenty of apps for that. When it even comes to scheduling and other things, they can get the apps for that.
How does the FDA fit into the development of mobile apps for radiology?
In 2011, the FDA put out a draft guidance to mobile medical applications, which was finalized in 2013. This included the definition of terms as to what is a mobile medical application, what is in scope, and what is out of scope. For example, smartphone and tablet manufacturers are not medical device manufacturers. So they’re not going to be held accountable if you, or I, or anyone, take them and use them for a medical purpose.
The companies that write the software are the ones that are going to be held responsible for making sure that the hardware and software function properly, and whatever quality control they need to do to make sure that this is an appropriate function.
The federal government recognizes that the old rules wouldn’t apply to the new arena of mobile devices. They’re getting other government agencies involved and they’re reaching out to the industry and professional community. They’re getting stakeholders involved, everyone from patient advocate groups to professional societies, like the American College of Radiology, and the companies that manufacture medical applications, to insurance companies. They want input from everyone into what they’re calling the Health IT Safety Center.
So, with the input from all stakeholders, instead of just the government doing whatever they think best, they know that they don’t know. They are making a pretty applaudable effort to reach out to all stakeholders involved, not just the traditional ones. They’re trying to make sure that they’re doing what’s best for the American patient.
How is the FDA doing that?
For example, the FDA said that high-risk designation is for something that’s being used to diagnose a patient or to decide how much radiation therapy to give a patient; in other words, something that’s going to directly affect the diagnosis or treatment of a patient. High risk is what the FDA will continue to regulate.
But other government departments can regulate medium and lower risk issues. Medium risks can be a little more amorphous, something like a computer program that tells a doctor best practice guidelines. Reference books, on the other hand, are low risk. You read them to gather your own information.
The bulk of the responsibility, for the medium risk issues, is going to go over to ONCHIT.
There is still a lot to come in both the development and regulation of mobile devices and applications, but Dr. Hirschorn believes that the FDA is taking the right approach as it comes up with better ideas on how to regulate medical software overall, not just mobile apps.