A revised draft bill regarding software classification levels suggests the U.S. Food and Drug Administration only regulate medical software and not health software.
Rep. Marsha Blackburn (R-Tenn.) originally introduced the Sensible Oversight for Technology which Advances Regulatory Efficiency Act in October 2013. The SOFTWARE Act classifies three levels of health IT software: clinical software, health software and medical software.
The newly revised version of the bill, to be introduced by Rep. Blackburn and Rep. Gene Green (D-Texas), would only require the FDA to regulate the first two levels.
The bill defines medical software as software that "is intended to analyze patient-specific information and other information to recommend to healthcare professionals a single treatment or course of action." It defines health software as software "intended for use in clinical, laboratory or administrative workflow and related record-keeping, including electronic health records."