On July 20, the federal Food and Drug Administration (FDA) released its“Draft Guidance for Industry and Food and Drug Administration Staff-Mobile Medical Applications.” The draft guidance was released in response to questions in the healthcare industry around questions that are emerging out of the growing interoperability between medical devices, which the FDA regulates, and smartphone and other technology that is increasingly being used to harness computational power between the two types of technologies.
As the draft guidance noted, “A growing number of software applications are being developed for use on mobile platforms, which include smart phones, tablet computers, and personal digital assistants. As these mobile platforms become more user friendly, computationally powerful, and readily available, innovators have begun to develop mobile apps of increasing complexity to leverage the portability mobile platforms can offer. Some of these new mobile apps are specifically targeted to assisting individuals in their own health and wellness management. Other mobile apps are targeted to healthcare providers as tools to improve and facilitate the delivery of patient care.”
In response to the release of the draft guidance, the Washington, D.C.-based mHealth Alliance, an organization focused on mobile health (mHealth), released a statement on July 22, which welcomed the FDA’s guidance in this area, while noting that most mHealth initiatives using mobile communication devices in developing countries are untethered to medical devices.
Jody Ranck, director of Thought Leadership, Policy and Advocacy at the mHealth Alliance, spoke with HCI Editor-in-Chief Mark Hagland regarding his perspectives on this emerging area. Below are excerpts from that interview.
Broadly speaking, what is your general interpretation of the FDA guidance in this area?
I’ve done a preliminary look at it and am examining it more fully now. In essence, it primarily addresses applications where a phone is connected to a medical device that’s already regulated, or turns a phone into a medical device, or where you’re dealing with patient information that could be used in a clinical decision-making context. That could mean some forms of more sophisticated decision support applications.
Can you provide a few examples?
The first class would be where you’re connecting a phone to an EKG or a glucometer; those two examples would definitely be regulated.
And what is the second type?
There’s a growing trend for more peripherals being developed that attach to a phone. There are attachments where you can do eye exams—the pherometer, for example. When you go to the optometrist, he or she uses that scope-like device for examining your eyes. MIT [the Massachusetts Institute of Technology] has created a version of that that attaches to an Android phone. So it looks like two little binocular lenses that attach to the face of the Android phone; and within a minute, you can determine your glasses prescription.
So for that purpose, that application essentially turns your Android phone into a medical device, then?
I think so. And there is a machine learning tool for attaching eye diagnostic tools for machine learning in the cloud. That could happen in a developing-world context, where these medical device items are not in common use.
In fact, there is a trend to develop low-cost medical device peripherals that attach to the phone, with the potential to disintermediate or de-skill that sort of diagnostic capacity of healthcare workers, because of the shortages of skilled workers in the developing world. So there could be real development in those areas; but there’s tension between low price-point development and protecting patients from unnecessary risks.
So the question that will be out there that we need to pay attention to is, can we get the price points down on these devices, while also protecting folks? We have a unique situation here for the developing world, where FDA approval essentially becomes the gold standard for the world. So there have been cases—a good example to look at was in the early 2000s, there was a vaccine for the Rota virus, which is very big in the developing world. So you had an international vaccine trial that took place also in the U.S.
And the CDC noticed some side effects, and without demonstrating causality, they pulled that new vaccine off the market. So that meant that the next generation of the vaccine would have to go through a bigger clinical trial to meet the new threshold.
A much bigger clinical trial means a higher price point, which would really impact the developing world. They never demonstrated causality around the Rota Shield, but now, no minister of health in a developing country would allow that vaccine to go forward, even though it was safe. So it’s about managing risks and the innovation price point for the developing world. So harmonizing regulatory regimes can create some problems once in a while.
So it’s important to understand risks in this context. The risk of the rotavirus here in the U.S. is very low, so the risks have to be very low; but the risks are so much higher in Brazil or the Congo.
What should our audience take away from this?
The main thing is that this is just a draft guidance, and there is time for feedback. Some folks view it as, if you’re going to make a big investment in mHealth right now, you want to look at where your mHealth application is going to work. The vast majority of mHealth applications here won’t be regulated by this draft guidance. Off the top of my head, 98 percent of the applications out there won’t be touched. The trend is towards interfaces with tablets. And tablets have higher resolution, and you’re getting more… There are going to be certain areas of mHealth that will be touched by this, primarily those areas where the diagnostic and monitoring capabilities of a smartphone, particularly the monitoring capabilities, will eventually be touched by this.
So the key thing will be the monitoring uses of smartphones?
Yes, because that’s then a medical device. The EKGs and a lot of this aging and chronic disease work that is expensive to do in a hospital and much easier to do at home, will all be touched by this. So the economics of mHealth, once you add a regulatory regime to it, will shift slightly. The lawyers are going to ask, who’s liable if this doesn’t work the way it’s supposed to?