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Senate Bill Would Exempt Low-Risk Apps From FDA Oversight

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 authority over administrative and financial software, wellness and lifestyle products,...

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