Submitted by kBLASTER Team on
By Dan Bowman for Fierce Health IT
A revised version of the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act, currently circulating through Congress in draft form, takes a more "simple and straightforward" approach than its predecessor to health IT regulation, health attorney Brad Thompson tells FierceHealthIT.
The new version of the bill--which also will be introduced by Blackburn (pictured) and Rep. Gene Green (D-Texas)--divides health IT into only two categories: medical software to be regulated by the U.S. Food and Drug Administration and health software that won't be regulated.
Medical software, according to language in the bill, "is intended to analyze patient-specific information and other information to recommend to healthcare professionals a single treatment or course of action ... without the need for such professionals to perform additional interpretation of, or to independently confirm the means for, such recommendation." Within two years of the bill becoming law, the FDA would be tasked with development of a new regulatory program specifically to oversee such software. Additionally, any software classified as medical would not be required to be approved under sections 513, 510(k) and 515.
Health software, meanwhile, would pertain more to administrative or operational support and would be considered low-risk. Such software, unlike medical software, would require professional interpretation.
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