[Updated, see below] With more than 60,000 health-related smartphone and tablet apps already available in the iTunes App Store and Google Play—the Android app marketplace—it’s clear that consumers are going to be getting more and more of their health information, and possibly even diagnosis and treatment, from their mobile gadgets. In Washington, DC, last week, the House Energy and Commerce Committee held three days of hearings aimed at clarifying whether and how the Food and Drug Administration will regulate this burgeoning universe of mobile medical apps and devices.
While FDA officials said a lot at the hearings about what they don’t plan to regulate—for one thing, they aren’t going to treat smartphones and tablets as medical devices just because they can run medical apps—they didn’t say as much about what they will regulate, and the agency’s draft guidelines on mobile medical technology may not be finalized until this fall.
Which means entrepreneurs at health-IT startups still can’t predict with precision whether the apps or devices they’re building will be subject at some point to FDA review. That’s a question that can make or break a young company, given the potential length and complexity of the review process. And in the business world, uncertainty is almost always a bad thing.
Into this breach steps Rock Health, the San Francisco-based startup accelerator for digital health companies. Today the accelerator released a report aimed at helping entrepreneurs understand which types of apps are likely to require FDA clearance, and how they can work with the agency to anticipate the regulatory requirements they’ll need to meet.
The 26-page report—released on Slideshare, and embedded below this article—gives a brisk but detailed overview of the agency’s evolving stance toward mobile medical apps. The FDA has evaluated only about 100 apps since 1997, but it said in draft guidance issued in 2011 that it plans to apply its regulatory authority in the future to any app that meets the current definition of a medical device—namely, “an instrument, apparatus, implement, machine, contrivance, implant, or in vitro reagent that is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man, or intended to affect the structure or any function of the body.”
That’s a pretty broad definition, but in practice, it’s likely that very few apps and devices will be singled out for thorough review. The rest are in a regulatory gray area where the agency says it will pursue a policy of “selective enforcement.” The big, still unanswered question is how many startups and apps will be selected. The point of Rock Health’s report is to sift through draft guidelines and existing rules to help entrepreneurs predict whether their product is likely to attract the FDA’s attention.
“The FDA has a wealth of information, it’s just not easy to understand,” says Malay Gandhi, Rock Health’s chief strategy officer. “We tried as best we could to visually and more legibly summarize not just the mobile medical apps draft guidance, but existing device regulations.” The report also includes “best practices” based on interviews with health entrepreneurs who have already submitted their apps or devices for FDA review.
[Updated 3:45 pm 3/25/13 after further communication with Rock Health] If an app diagnoses, treats, or mitigates a medical condition, the report explains, it will be subject to some level of FDA clearance or approval. In one hypothetical example from the report, a simple bandage intended to cover a wound would be subject to minimal review. A “smart bandage” that merely reports wound temperature wirelessly to a smartphone app could require some clearance, because it poses a medium level of risk to patients. But a medication-infused smart bandage that communicates with a smartphone app to determine what dose of drugs to dispense could be subject to full review, including pre-market approval, since it’s actively treating a medical condition and could pose a significant risk to patients.
“Knowing what things you might do that might push you over the edge [into high-risk territory] allows you to innovate up to that edge,” Gandhi says. “There is already so much uncertainty in doing a startup that anything else that can be clarified would help.”
Gandhi says Rock Health is in favor of clear regulations and strong enforcement by the FDA—and not just so that the entrepreneurs at Rock Health-backed companies will know how to proceed.
“We obviously encourage all of our companies to behave ethically and in full compliance with the law,” he says. “But we’re also worried about this proliferation of apps and new hardware devices and people who are making marketing claims that they should not be allowed to make about their ability to diagnose or treat conditions. We don’t want to see a lot of companies coming from other sectors and seeing an opportunity to grab healthcare share and not have to follow the rules.”
