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Bipartisan Policy Center Statement on the SOFTWARE Act of 2013

Friday, October 25, 2013

Washington, D.C. – The Bipartisan Policy Center (BPC) issued the following statement by Janet Marchibroda, Director of BPC’s Health Innovation Initiative, regarding the introduction of bipartisan legislation, the Sensible Oversight for Technology Which Advances Regulatory Efficiency (SOFTWARE) Act of 2013.

“BPC recognizes U.S. Representatives Marsha Blackburn (R-TN), G.K. Butterfield (D-NC), Diana DeGette (D-CO), Dr. Phil Gingrey (R-GA), Gene Green (D-TX), and Greg Walden (R-OR) for their bipartisan collaboration and introduction of the SOFTWARE Act of 2013.

“The SOFTWARE Act provides important clarity regarding how different types of health information technology (IT) should fit within a risk-based approach for oversight and regulation. The categories outlined in the Act mirror those identified in BPC’s recent report, An Oversight Framework for Patient Safety in Health Information Technology.

“This legislation, similar to BPC’s recommendations, identifies three categories of health IT based on levels of risk, including medical software, which constitutes the highest level of risk; clinical software, which is used to inform care delivery, such as electronic health records; and health software, such as software used for administrative or population health purposes. It also calls for the development of a new risk-based regulatory framework for clinical software and health software that promotes patient safety, reduces regulatory burdens, and fosters innovation.

“We commend the bipartisan cooperation and leadership on this legislation, which will help pave the way for improved patient safety and continued innovation in the use of technology to improve health and health care.”

BPC developed its recommendations through a collaborative effort, engaging more than 100 organizations representing clinicians, consumers, health plans, hospitals, patient safety organizations, research and academic institutions, and technology companies, to develop a set of principles and recommendations for an oversight framework that protects patient safety, is risk-based, promotes innovation, is flexible, leverages existing quality and patient safety-related systems and processes, and avoids regulatory duplication.

The SOFTWARE Act aligns with many of the principles and concepts set forth by the Food and Drug Administration Safety Innovation Act (FDASIA) Workgroup convened by the Department of Health and Human Services (HHS) earlier this year. Public comments received in response to an HHS request for comments on FDASIA, along with the recommendations of the Workgroup, are expected to inform the development of a proposed strategy and recommendations for an appropriate, risk-based regulatory framework pertaining to health IT, including mobile medical applications, by January 2014. Click here for BPC’s formal public comments on FDASIA.

Key Links:

BPC Report: An Oversight Framework for Patient Safety in Health IT

BPC Event: A Framework for Assuring Patient Safety in Health IT

BPC Response to HHS Request for Comments on Risk-Based Regulatory Framework

Joann Donnellan
[email protected]
(703) 966-1990

2013-10-25 00:00:00