Bipartisan House Bill Introduced To Curb FDA Health IT Oversight
This article was originally published in The Gray Sheet
Executive Summary
The SOFTWARE Act, introduced in the House by Rep. Marsha Blackburn, R-Tenn., with support from House members on both sides of the aisle, attempts to redefine regulation of health information technology, and, in particular, limit FDA’s oversight to “products that pose a potential risk to human health.”
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Industry: New SOFTWARE Act Provides Certainty
Rep. Blackburn’s SOFTWARE Act has changed substantially since it was first introduced and is being praised by device manufacturers for providing much needed clarity on how far FDA can go to regulate Medical and Health software.