FDA's Digital Health Innovation Action Plan

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Questions About The FDA’s New Framework For Digital Health

Nathan G. Cortez, Nicolas Terry, and I. Glenn Cohen | Health Affairs Blog | August 16, 2017

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 This plan is an important step in FDA regulation of this area, a process that began in 2011 with a draft guidance, followed by significant congressional actions.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...

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