WASHINGTON – Health experts are optimistic about the U.S. Food and Drug Administration’s guidance documents on digital health oversight released in December.
“These guidance documents take us one step closer to seeing a full integration of digital health into our lives,” said Kevin Madagan, a partner in Reed Smith LLP’s Life Sciences Health Industry Group.
The three guidance documents—two draft and one final—cover clinical decision support, changes to medical software policy based on congressional mandates in the 21st Century Cures Act, and Software as a Medical Device.
The draft guidance on clinical decision support, which has been six years in the making, clarifies which types of clinical decision support and patient decision support software the FDA defines as a medical device in need of agency oversight.
In a nutshell: Analytics technology intended to support clinical diagnoses that provides room for a physician to independently review the basis of the software’s recommendations would not be regulated by the FDA; however, software that analyzes medical images or laboratory or medical tests would remain regulated.
“This guidance, even in draft form, removes significant ambiguity,” said Madagan. “Until now, we didn’t know where the FDA would draw the line on CDS functions it would regulate, or whether they would ever agree to enforcement discretion for PDS.”
The other draft guidance outlines the FDA’s interpretation of the types of software that are no longer considered medical devices. Among them: certain mobile apps.
“We’re making clear that certain digital health technologies—such as mobile apps that are intended only for maintaining or encouraging a healthy lifestyle—generally fall outside the scope of the FDA’s guidance,” said Scott Gottlieb, FDA Commissioner, in a statement.
The final guidance provides globally recognized principles for analyzing and assessing SaMD, based on the overall risk of the product.
Though the FDA guidance documents provide more clarity on digital health, Madagan said there is much work left to do.
“With advancements in digital applications being integrated into medical devices, and now even drugs, the digital oversight and real-time tracking of our health is just beginning,” he said. “And this doesn’t even account for the potential of artificial intelligence.”