FDA Grapples with How to Regulate Digital Health: Like Odysseus in Greek Mythology
(ED NOTE: The FDA is in a situation, similar to that of Odysseus, in Greek Mythology. Odyssesus, after the Trojan War, back on his way to Ithaca from Troy, had to pass, prudently, through the “Straits of Syclla and Charybdis”, to continue on his way home; one one side was the monster “Scylla”, on the other side, the whirlpool of Charybdis. If he got too close to either, his ship would be doomed. The FDA is in a similar spot; one one side, they have to protect the saftey of the consumers; on the other side, they do not want to stifle innovation, with excess regulation)
U.S. regulators are working hard to keep up with the rapidly evolving digital health care sector, according to WilliamMaisel, chief scientist of the FDA’s Center for Devices and Radiological Health.
Speaking last week during BIOMEDevice San Jose, Maisel said the FDA is “very committed to the appropriate balance between benefits and risks and bringing new technology to patients as quickly as possible,” according to a report in anMPMN sister publication EE Times.
The Food and Drug Administration issued guidance in 2013 about how it views mobile medical apps as well as security and wireless technology choices in medical devices — and it hopes to release guidelines on interoperability next year, Maisel says.The FDA plans to regulate only a small subset of medical apps, focusing on those where patient risk is greatest. And the agency is scaling back from the old Class I, II, and III buckets originally created by Congress.”We shouldn’t regulate just because we can or always have regulated that way,” Maisel says. “A large number of medical apps will not be regulated because the patient risk is sufficiently low — the part we focus on is really just the tip of the iceberg.”
The FDA has evaluated about 100 medical apps over the past decade. Meanwhile, Apple’s Store alone hosts 43,000 health apps, nearly half of which would be considered medical apps, according to Maisel.
In his talk, Maisel pointed to smartphone-based ECG apps as an example of devices in need of regulation. Although they work in a manner that is technologically different than conventional ECG systems, what they do from a functional perspective is similar and the accuracy of such devices will be scrutinized by FDA in the future.