“Some of the [mHealth] technologies that come before us certainly fit squarely into the model we traditionally have for regulatory oversight,” Jeffrey Shuren, MD, JD, Director, Center for Devices and Radiological Health at the FDA said during a panel discussion at the mHealth Summit in Washington DC this week. “Some of the things we are thinking about are… Where do we want to draw that line? Our thinking is, we would not draw it as we traditionally do. There will probably be many kinds of technologies that might fall below the definition of a medical device. We may say, you know what, it’s low enough risk — we should take a stand back. Maybe we want to know what’s out there, but you know, let things move forward and let a thousand flowers bloom.”
Shuren said that the FDA is more likely to focus on those wireless or mobile health devices that are more like traditional medical devices involved in the treatment or diagnosis of patients: “We may focus more attention there,” he said.
Shuren also noted that the FDA was looking to facilitate “a test bed or network of test beds here in the US.”
“One of the challenges with mHealth is you want to have the opportunity to experiment,” Shuren said. “You want to do that in a relatively safe environment. We think FDA has a role to play here; FCC has a role to play here; others, too. There’s an onus on government, industries and others to try and develop that kind of infrastructure for that kind of testing.”
Shuren also noted that interoperability was the third key area where the FDA would be involved with mHealth:
“As we move forward, if we don’t tap those standards for interoperability,” Shuren warned, “all the good work we are doing today will be of limited value. As of today, much of the clinical environment is not integrated. You deal with technologies most of them proprietary and most of them don’t talk to each other. When they do it’s on a proprietary infrastructure.”
“We need to be moving towards open sourced, independent infrastructure where you have components of different manufacturers that can plug and play,” he said. “FDA is looking to the development of those different types of standards to get the biggest bang for our buck.”
If you’re interested in a more in-depth look at the FDA’s potential regulatory moves in mHealth, be sure to read our free report on the regulatory environment of mobile health over in our research section.