FDA Charts Mobile Health Progress

SAN JOSE, Calif. — US regulators are making a solid effort to keep pace with the rapidly evolving digital health care sector, said a government official here. 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, said William Maisel, chief scientist of the FDA’s Center for Devices and Radiological Health.

“We are very committed to the appropriate balance between benefits and risks and bringing new technology to patients as quickly as possible,” Maisel told a group of a couple hundred attendees at the BioMedDevice conference here.

The FDA is to some extent playing catch up with a fast moving industry. The agency has long been criticized for being slow and opaque in its decisions. Device makers often launch their latest products in Europe and Asia where regulatory processes move more quickly.

The agency aims to deliver smart regulations appropriate to emerging technologies, Maisel said. “We shouldn’t regulate just because we can or always have regulated that way,” he said noting the FDA is scaling back from the old Class I, II, and III buckets originally created by Congress.

For example, the FDA aims to regulate only a small subset of medical apps, focusing on those where patient risk is greatest. To date the FDA has evaluated about 100 medical apps, the first one about a decade ago. The Apple Store alone hosts 43,000 health apps, 19,484 of which could be considered medical apps, he said.

“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,” Maisel said.

The agency maintains a “living list” online of examples of apps it will and won’t regulate. It also takes questions on the topic at MobileMedicalApps@FDA.HHS.gov, he said.