SOFTWARE Act Will Enhance Patient Safety and Medical Innovation

October 23, 2013

WASHINGTON (October 23, 2013) - The Information Technology and Innovation Foundation (ITIF) praised the introduction of the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act, arguing that it will create a more effective regulatory framework for medical software, improve patient safety and spur more innovation.

"As long as there is regulatory uncertainty about medical software, many companies will avoid developing new technology for this market," says Daniel Castro, Senior Analyst with ITIF. "The SOFTWARE Act would have the FDA focus its regulatory oversight on those technologies that pose the greatest risk to human health, while allowing lower risk products into the marketplace more rapidly."

The SOFTWARE Act redefines the FDA's regulatory authority over medical software and provides companies with a better understanding of what applications require review and approval. This will speed up innovation while also freeing regulators to increase their oversight of the medical applications, devices and drugs with the highest potential risk.

"Health IT is a growing field with tremendous potential to improve clinical care and increase health care efficiency," Castro adds. "If we want fast-paced innovation in health care technology, we need a regulatory environment built for the 21st century. The SOFTWARE Act is a tremendous step in the right direction."

The bill was introduced today by a bipartisan group of Representatives including: Marsha Blackburn (R-TN-07) Gene Green (D-TX-29), Phil Gingrey (R-GA-11), Diana DeGette (D-CO-01), Greg Walden (R-OR-02), and G. K. Butterfield (D-NC-01).

Read the bill. 


The Information Technology and Innovation Foundation (ITIF) is a non-profit, non-partisan think tank whose mission is to formulate and promote public policies to advance technological innovation and productivity internationally, in Washington, and in the states. Recognizing the vital role of technology in ensuring prosperity, ITIF focuses on innovation, productivity, and digital economy issues. Learn more at

Contact: Samantha Greene
Phone: (202) 626 5744