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 original incarnation of the bill, introduced in October 2013 by Rep. Marsha Blackburn (R-Tenn.), defines three classification levels of software: clinical software, health software and medical software. Per the proposed legislation, technology within the first two classifications would not be regulated, while medical software would be regulated.
Comparatively, 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.
What's more, the bill defines an accessory as a tool "intended ... to be used together with a particular device or software product to extend that device's or software product's intended use or functionality." However, it also names accessories as products in their own right that should be interpreted and classified as such.
"Accessories have been historically overregulated because they tend to be classified with a parent medical device," Thompson, of Epstein Becker Green, says. "Perhaps not coincidentally, just last Friday, FDA came out with a guidance document trying to define what an accessory is."
In that guidance, the FDA stresses that some device accessories can have lower risk profiles than their parent devices, advising device makers to use the de novo classification process to request risk-based classifications.
Thompson, who was critical of the bill's first iteration, says this version is different.
"Overall, in my opinion, it's a huge step forward in the sense that it is much clearer, and in some ways more focused, than the earlier version," he says.
To learn more:
- check out the draft version of the bill (.pdf)