SIIA Supports SOFTWARE Act, Says Legislation is Critical to Promoting Medical Safety while Advancing Innovative Software
(Targeted News Service Via Acquire Media NewsEdge) WASHINGTON, Oct. 23 -- The Software and Information Industry Association issued the following news release:
SIIA President Ken Wash made the following statement:
"Patient safety and product innovation are not mutually exclusive. SIIA supports the SOFTWARE Act, bipartisan legislation to establish an effective regulatory framework for medical software that will promote safety while advancing innovation.
"New information technology products and services powered by software promise to revolutionize health outcomes and lower costs for patients and providers. However, an overly-broad regulatory framework that sweeps in a wide range of software would drastically stifle this innovation.
"The SOFTWARE Act takes necessary steps to establish regulatory framework for medical software without compromising safety. Specifically, the SOFTWARE Act would create a bright line that delineates when the Food and Drug Administration (FDA) should regulate medical software, and when it should not, calling for FDA regulation of software only when it has the ability to change the end user's current state of physiology with limited or no opportunity for informed human intervention.
"SIIA thanks Representatives Marsha Blackburn (R-TN), Gene Green (D-TX), Phil Gingrey (R-GA), Diana DeGette (D-CO), Greg Walden (R-OR), and G. K. Butterfield (D-NC), and we look forward to working with them and other cosponsors to advance this critical legislation."
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