Reps. Blackburn & Green Introduce SOFTWARE Act

Press Release

Representatives Marsha Blackburn (R-TN) and Gene Green (D-TX) today introduced the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act.

This bipartisan legislation would categorize health IT based upon the level of risk and create regulatory certainty for innovators by removing the lowest risk software from the purview of the Food and Drug Administration (FDA).

"At the core of the promise of 21st Century Cures is technology ---- technology that will bring new therapies and treatments to doctors and their patients. Health software is at the core of this promising technology," said Energy and Commerce Committee Vice Chair Blackburn. "Brilliant minds across the nation are developing software that will change the face of medicine. It is the goal of the SOFTWARE legislation to bring our nation's regulatory framework into the 21st century so that innovation may flourish and we might speed these changes along.

"We need to rally the nation and its creative minds around an unwavering commitment to finding cures. Our SOFTWARE legislation is a crucial first step toward that commitment and I look forward to once again working with Rep. Green in this bipartisan effort."

Congressman Gene Green, Ranking Member of the Energy and Commerce Health Subcommittee said, "As new technologies emerge, it's important that federal regulatory agencies like the FDA are properly equipped to provide a common sense level of oversight that is appropriate for the characteristics of the product. This bill builds on the progress made by the FDA in their recently released guidance documents, focuses federal regulation on software products that pose a true risk to patients, and gives certainty to innovators so we can unleash the next generation of health information technology."

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