Nicolas Terry

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AirStrip, Humetrix and others advise Congress on FDA, FTC, HIPAA

Jonah Comstock | Mobi Health News | July 13, 2016

At a congressional hearing on mobile medical apps today, experts from different sectors of the industry weighed in on the ways they think federal regulation needs to change to create a robust digital health industry while still protecting the safety and wellbeing of patients. The conversation spanned various regulatory bodies and federal programs including HIPAA, the FDA, the FTC, and Medicare. “The regulatory framework for most of these apps is complicated and in some cases troubling,” Nicolas Terry, a law professor at Indiana University said in his prepared testimony. “Here, the oversimplified binary of regulation versus innovation is a poor frame...

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 This plan is an important step in FDA regulation of this area, a process that began in 2011 with a draft guidance, followed by significant congressional actions.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