Legislation to curb the FDA’s authority to regulate health IT will pass the Congress in early 2015, predicted Rep. Marsha Blackburn (R-Tenn.), vice chair of the House Energy and Commerce Committee.
Blackburn in October 2013 first introduced the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act. Blackburn’s 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 software”—posing the highest risk to patient safety.
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