How and when should the FDA regulate mobile medical apps that act as accessories to medical devices? When should it not regulate them at all? Those questions were taken up in a midday panel discussion on day one of FDA’s Sept. 12 and 13 workshop on its draft guidance for mobile medical device applications.
The workshop followed FDA’s July announcement that it is seeking input on its approach to oversight of “certain mobile applications specific to medicine or healthcare called mobile medical applications (apps) that are designed for use on smartphones and other mobile computing devices.”
“Traditionally an accessory just physically connects to a medical device,” said moderator Bryan Benesch, a consumer safety officer in FDA’s Center for Devices and Radiological Health, to kick off the conversation. “There may be situations where you have many products tied in a string until it ultimately gets to the device. And that’s not a situation that we generally see or regulate. So I want the panel members to tell us what they think the future will bring in the next few years regarding what we should consider an accessory.”
Before turning over the mic to the panel, Benesch cited an example: a prototype system carmaker Ford is testing that can tell diabetics on the road when to inject insulin. “That’s an interesting platform that we might need to consider,” he said.
Bradley Merrill Thompson, an attorney with Epstein Becker Green Law in Washington, D.C., who specializes in cases involving healthcare technology and teaches at Columbia Law School, began by extending a fundamental question taken up in an earlier workshop session: What makes a product a medical device accessory?
“It all comes down to three things. Words: How do I describe it? Actions: How do I position it in the marketplace? And knowledge: What do I know about how it’s being used in the marketplace? All those things together form intended use,” said Thompson. “Don’t confuse use—how a thing is actually used—with intended use, because intended use is the concept that decides whether or not it gets regulated. What does the manufacturer, the one selling the thing, intend it to be used for? If I intend for it to be a tongue depressor, it gets regulated that way. If I intend it to be a popsicle stick, it gets regulated that way.”
Thompson then turned to the Ford example. “If they go out on a marketing campaign to say, ‘This car will improve your health because it can be used to deliver care through devices you can add to it,’ they have made it a regulated accessory medical device to whatever parent devices then get put in that car pursuant to their promotion.”
In such cases, determining medical device accessory vs. non-medical device accessory requires a little digging, added Thompson. “It’s words; it’s deeds,” he said. “What design features are in it? Do they go into that car and create a power system that somehow is uniquely capable of supporting medical devices? Do they use other elements of the computer technology with protocols that make it uniquely suitable for medical devices? What have they done to tailor it? What standards do they declare conformance to? If they’re declaring conformance to certain medical standards that serve no other purpose other than delivering medical care through a medical device, what does that say about their intent for that car?”
These are “very complicated issues,” concluded Thompson. Before anyone can know whether to regulate an “accessory,” or how, “we need to get to the level of ‘What are they doing to promote it and what are they saying about it?’”
Marc Anderson, manager of new technology development with the Juvenile Diabetes Research Foundation, spoke directly to the document on the table. “I think we’re pretty excited about this draft guidance,” he said. “I think it starts to get to the heart of the matter for Type 1 diabetes. This is a mobile therapy to begin with; it’s something a person deals with daily on an ongoing basis and, by being able to use a mobile device to coordinate their multiple regulated devices, it starts to prove beneficial to quality of life and to the patient’s adherence to therapy.
“Where do we go from there with mobile devices and this connectivity? I don’t think I’m ready to talk about the car being part of that.” said Anderson. “But I think that, when we start to take an insulin pump, a continuous glucose monitor, a blood glucose monitor, and start having those interacting in an integrated fashion with a cell phone, we start to make things possible, like artificial pancreas systems and remote monitoring for caregivers. It usually ends up being a parent caring for a child with diabetes, but allowing caregivers to be a larger part of that therapy on a daily basis when they’re markedly remote from the person in their life with diabetes” represents an important advancement.
Jorge Valdes, chief technical officer for San Diego-based manufacturer DexCom, best known for its continuous glucose monitoring systems, homed in on smartphones.
“When you look at both discretion and use of a product, obviously connecting to something like a smartphone will make a big improvement in people’s lives,” he said. “From a privacy point of view, you can be looking at your blood glucose and no one else knows that you’re looking at it. You will use it more often and I think it then opens up an entire world of possibilities of what you can do. When you look at the entire ecosystem that’s available on a smartphone, it’s a huge improvement for what a company our size could ever develop on our own.”
Valdes pointed out that a common fear among diabetics—“going into a coma at night and never waking up”—is a perfect example of a patient concern the new mobile apps can help manage. “You have your alerts on your smartphone and, if somebody’s not acknowledging those alerts, you could actually send out messages that something is wrong. And that’s something that today, without a lot of gear, I haven’t seen readily available. You wouldn’t have that functionality.”
Valdes also extolled the burgeoning ability of smartphones to send data from multiple devices into one app and process it in a meaningful way. “That app may not be even the traditional model, where it’s an app that the device company makes for their own device. It could be a third party,” he said. “And the exact example right now would be an insulin pump and a continuous glucose monitor, and a third party coming and wanting to take both that glucose data and the insulin data to try to provide information about how the diabetic is doing and what they should do going forward.”
Such patient-friendly and provider-friendly functionality “probably does present a complication on the regulatory side,” said Valdes, “but I do see a lot of value-add, and I do see things headed that way, because we get those requests all the time.”
“I see two roles in my daily practice,” said Neal K. Sikka, MD, of George Washington University in Washington, D.C. “One is, we do a lot of telemedicine services, and we’re part of a multispecialty group practice, so we have pressure to start improving outcomes for our patients. That means a lot of home monitoring types of services, which crosses over into our telemedicine services and into our ER discharge patients and hospital discharge patients. How are we going to reduce their readmissions? So it gets to a lot of the extension of devices that people are going to have in the home as well as the facility, and how are we going to centrally operationalize an efficient mechanism to monitor those patients and interact with the data that we can receive now and improve patient outcomes over time.”
The discussion wrapped up with comments from Chuck Parker, executive director of Beaverton, Ore.-based Continua Health Alliance, a nonprofit in the interoperability space.
“What are we seeing in the future beyond the cars? One of the things that we’re seeing on an international basis are transdermal applications. These measurement devices are starting to be [applied] either on the skin or just under the skin,” said Parker. “We’re seeing the wearables becoming lighter, to where they can be almost permanently worn or taken off every now and then, as for a shower. They’re so light now that the power consumptions are such that they can last a year or two at a time.
“This is something that we’re going to want to understand—how these devices are passing information into systems, where the end user may never see them. In essence there is no user interface; they are going directly into the cloud and coming back in a different fashion. There are some complex systems that are out there today that are starting to be demonstrated. We’re very attuned to that and are very interested in having this discussion on how we can address not only current applications but also those that we see coming in the future.”
Other panel discussions on day one of the FDA workshop covered defining “mobile medical apps,” setting levels of oversight for mobile medical apps and categorizing standalone clinical decision support software.
FDA indicated that transcripts and other relevant information from the proceedings will be posted here as materials become available.