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Senate Bill Would Exempt Low-Risk Apps From FDA Oversight

05 Dec 2014

The MEDTECH Act aims to limit FDA’s regulatory oversight of software and mobile apps that carry low-risk for patients, but in a more targeted manner than previous health IT bills that have been introduced in Congress in the past year.

Sens. Orrin Hatch, R-Utah, and Michael Bennet, D-Colo., have proposed a bill that would exempt low-risk medical software and mobile apps from FDA’s regulatory oversight.

The Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act, introduced on Dec. 4, limits FDA’s regulatory...