Rep. Marsha Blackburn (R-Tenn.), vice chair of the House Energy and Commerce Committee, is predicting that legislation to curb the FDAs authority to regulate health IT will pass the Congress in early 2015.
Blackburn in October 2013 first introduced the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act. Blackburns bill would establish a risk-based regulatory framework for health IT divided into three broad categories of software--clinical, health and medical--with the two former software types not subject to regulation under the proposed legislation. A companion bill, the PROTECT Act, was introduced in the Senate in early 2014. Both the SOFTWARE Act and the PROTECT Act would exempt so-called "clinical software" and "health software" from FDA oversight, leaving the regulatory agency to focus on medical softwareposing the highest risk to patient safety.
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