Is The FDA Slowing The Creation Of Medical & Health Apps?

See Why Your Phone Isn't as Smart as It Could Be: Silicon Valley is eager to produce health-related apps, but fear of FDA regulation is slowing innovation. By Scott Gottlieb And Coleen Klasmeier.

Dr. Gottlieb, a resident fellow at the American Enterprise Institute, is a former FDA deputy commissioner. Ms. Klasmeier is head of the FDA regulatory practice at Sidley Austin, LLP, which represents Apple in some unrelated matters. She was previously the special assistant to the FDA chief counsel. Both authors advise medical-products companies.

Excerpts:

"According to the tech publication Apple Toolbox, the FDA recently released (under a Freedom of Information Act request) a document describing its meeting with Apple executives last December. Senior agency officials told Apple that the FDA "would be more likely to regulate the software that puts [a medical] sensor to use, if use of the software alters the device's use to be a medical device." The officials also told Apple that "apps that actively measure something" health-related, like glucose meters used by diabetics, are "diagnostic" and are likely to make the entire tool subject to regulation."

"Last fall the FDA issued guidance purporting to regulate only a limited subset of apps that qualify as "devices" under the law, and only if there is a meaningful risk to patients. The guidance says the FDA will regulate apps—using the same kinds of rules that apply to joint replacements and heart valves and the like—that display, transfer, store or convert patient-specific medical device data from a monitor (for example, a heart monitor) to a mobile platform. But under the guise of enabling innovation, the agency is making an already complex regulatory climate even harder to navigate."

"Since the 1990s the FDA has adopted the bad habit of governing via guidance rather than by establishing clear rules. Regulators have also become addicted to addressing novel technologies by reflexively applying their premarket powers. The standard line is "come talk to us," a bureaucratic posture that leaves innovators in limbo while they wait sometimes long periods for a regulatory verdict."

"forces innovators to seek the FDA's nod for every new launch and every small advance."

"most of these products are not properly regarded as a medical device in the first place."

"Many consumer-focused apps that support health are not "devices"—for example, apps that help patients self-manage a health condition. This is clear from the language of the relevant statute and case law. But the FDA's guidance says that they are medical devices but that the agency chooses, at this time, not to actively regulate them. What is an app developer supposed to do with that internally contradictory position?"

"the consumer devices and medical apps under consideration have little in common with the FDA's usual fare."

"a mobile app is likely to be far more helpful in decision-making for many consumers—and certainly can't be worse—than online information sources of varying provenance and quality."

"once a medical app comes under the agency's premarket scheme, each iteration can require formal submissions and in some cases review by the agency before it can be offered to consumers."