Bradley Merrill Thompson Quoted in Article, “The FDA Takes On Mobile Health Apps”

IEEE Spectrum: Inside Technology

Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "The FDA Takes on Mobile Health Apps."

Following is an excerpt:

The FDA is expected to finalize guidelines within the next two months for medical apps, more than a year after releasing draft guidelines. For the industry, the expected rules bring both relief and trepidation: App makers are eager for clarity on how much red tape they'll encounter in the future, but they're also nervous that overly broad rules will stifle innovation. ?...

Here are some of the top requests to the FDA:

Take the example of a workout-tracking app, says Brad Thompson. "An app that records how many miles I run in a given week is just an exercise app," he says. "But if that same app says, 'If you are challenged by obesity, you need to exercise more, and you can use this app to track your exercise,' then it's linked to a disease." By presenting exercise as a treatment for the disease of obesity, the app may have crossed the line from a wellness app to a medical app. Once the FDA has more clearly defined the line, says Thompson, app makers will have to be more careful with their marketing claims. ?...

The draft guidelines issued in 2011 said that the FDA will exercise "enforcement discretion" when it comes to mobile medical apps. Thompson says this discretion will likely be based on how much risk an app poses to a user if it doesn't work correctly. "The FDA is saying, 'Look, there's a bunch of low-risk stuff out there that's not worth our time to enforce. So while they're technically medical devices, we're not going to be out there enforcing against those companies, because [the apps are] so low risk,' " he explains. ?...

Thompson says the FDA needs to establish a system for modular apps that work together, either by passing data between each other or by controlling each other, to form a health-management system. If one of those apps is regulated by the FDA, must all the others be as well? "The FDA has to determine that software does what it says it will do," says Thompson. "If another app can interfere with that FDA-regulated app, that's a risk they have to manage."