Questions About The FDA ’s New Framework For Digital Health

In June 2017, the new Food and Drug Administration (FDA) commissioner Scott Gottlieb pre-announced his agency’s Digital Health Innovation Action Plan that indicates notable shifts in the agency’s approach to digital health technologies. This plan is an important step in FDA regulation of this area, a process that began in 2011 with a draft guidance, followed by significant congressional actions. The new changes should not be surprising, given critiques published by Gottlieb prior to re-joining the FDA. In 2014, he wrote that smartphones are “purposely dumbed down” due to the “risk of unwieldy FDA regulation,” and in 2015, he argued that what most considered the FDA’s “light touch” on digital health was still too heavy-handed. The new plan signals two major shifts: first, a shift from premarket to postmarket review by the FDA; and second, a shift from oversight by the FDA to oversight by independent, nongovernment certifiers. These changes may be bellwethers for how a Trump-era FDA approaches areas far beyond digital health. The FDA And Digital Health The FDA’s current approach to digital health began in 2011 when it reclassified some medical device software to its lowest-risk Class I category and when it published a “Draft Guidance on Mobile Medical Applications.” The guidance (which was withdrawn after passage of the 21st Century Cures Act) tried to clarify which applications, hardware, and software platforms might qualify as medical devices. For exam...
Source: Health Affairs Blog - Category: Health Management Authors: Tags: Featured Health IT 21st Century Cures Act digital health Food and Drug Administration medical devices mHealth mobile health Scott Gottlieb Source Type: blogs