FDA Silent on Mobile Health and That May Not Be Bad
The FCC isn't the only federal agency that will play a part in mobile health's future. The Food and Drug Administration is mulling over several guidance documents that will help healthcare organizations, application developers and end users understand the increasingly complex mHealth marketplace.
While the agency may be skeptical of, say, energy drinks, "FDA really likes mHealth," says Bradley Thompson, general counsel for the mHealth Regulatory Commission, an advocacy group that includes vendors, healthcare providers, clinicians and consumers. "From a public health standpoint, they realize this is game changing, and they want to make sure it will thrive."
The challenge, Thompson says, is that the FDA is reluctant to impose guidance on an industry that is changing so rapidly. The agency seems to be taking a "first do no harm" approach, knowing that Congress will keep it accountable if something does happen.
This leaves the FDA "a bit frozen," he says, and mobile health advocates frustrated at times-especially as ethical developers wait for FDA guidance before releasing their applications while "fly-by-night" developers release mHealth apps based on questionable science, only to disappear before action can be taken. "There needs to be a middle ground," Thompson says.
At the moment, the FDA is working on three guidance documents. The one closest to completion, having been held up by the presidential election, concerns what the agency calls mobile medical applications; a second, currently in draft form, looks at clinical decision support software, and a third examines at what point hardware, software and other accessories that connected to an FDA-regulated device such a heart monitor themselves "become" a regulated device. By and large, apps that merely collect data won't be regulated, but those that manipulate data will be.
Thompson says the coalition wants to see FDA guidance on a fourth topic: a distinction between wellness apps and medical apps. It's an important distinction, especially in the context of the Pew Research Center survey, since exercise, diet and weight apps are far and away the most popular mHealth apps for smartphone users.
If you track your heart rate while you exercise, that app is unregulated, Thompson says. But if the app connects to a clinical system that your doctor can see, has the app been transformed? "It's an open question if a doctor's involvement means it's no longer for general wellness," he says.
Mobile Health's Future: Huge Growth Ahead
The right regulatory framework, the mHealth Regulatory Commission wrote in an Oct. 19, 2011 letter to the FDA, is one "that promotes innovation and discovery of new ways to improve the delivery of care; reduces the cost of healthcare; facilitates private investment in the mHealth industry by large and small businesses; and stimulates job creation in the United States."
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