House Could Tackle Federal Health IT Oversight in Legislative Package

November 10, 2014 in News

House Lawmakers reportedly are considering adding a modified bill that would clarify federal regulation of health IT to a bipartisan package of House legislation aimed at increasing medical innovation, Modern Healthcare reports.


In October, Sens. Deb Fischer (R-Neb.), Marco Rubio (R-Fla.) and Angus King (I-Maine) introduced legislation that would clarify FDA’s regulatory framework for health IT and ensure that “low-risk” products are not the focus of oversight (Tahir, Modern Healthcare, 11/7).

The Preventing Regulatory Overreach To Enhance Care Technology — or PROTECT — Act of 2014 is the Senate companion bill to the bipartisan House SOFTWARE Act (HR3303). Specifically, the bill aims to clarify the agency’s regulatory process to make sure it primarily focuses on technologies that pose the most health risks (iHealthBeat, 2/26).

Details of Negotiation, Modified Bill

According to sources familiar with the negotiations, lawmakers on the House Energy and Commerce Committee are considering adding a revised version of the SOFTWARE Act to the 21stCentury Cures legislative package.

According to Modern Healthcare, the package of legislation is more likely to pass since Republicans gained control of both the House and Senate.

The sources said that the modified bill would separate FDA’s oversight framework into three parts:

  • High-risk software that directly controls regulated medical devices, which would fall under FDA’s authority and be regulated as a medical device;
  • High-risk clinical decision-support software, which would be regulated under FDA’s lowest-risk category; and
  • A low-risk category of software that would be excluded from FDA’s oversight.

In addition, the bill could address health care software updates (Modern Healthcare, 11/7).

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