As part of the 21st Century Cures Acts proposed reform of regulations governing health software, Representatives Marsha Blackburn (R-Tenn.) and Gene Green (D-Tex.) have reintroduced a new version of the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act. Whether the version is an improvement is up for debate.
First introduced by Blackburn in October 2013, the latest iteration of the SOFTWARE Act, contained in the 21st Century Cures Act, is an attempt to categorize health IT based upon the level of risk and create regulatory certainty for innovators by removing the lowest risk software from the purview of the Food and Drug Administration.
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