Bi-partisan legislation introduced in the U.S. House would clarify that “clinical software and health software shall not be subject to regulation” under the Food and Drug Administration.
“Under current law, the FDA could use its definition of a medical device to assert broad regulatory authority over a wide array of software,” according to an explanation of the bill. “The SOFTWARE Act tailors their authority to the realities of the 21st Century by focusing their authority onto the products that pose a potential risk to human health.”
Rep. Marsha Blackburn (R-TN) sponsors the bill with co-sponsorship from Reps. Gene Green (D-TX), Phil Gingrey, M.D. (R-GA), Diana DeGette (D-CO), Greg Walden (R-OR) and G.K. Butterfield (D-NC).
Under the bill, “the term ‘health software’ means software (including any associated hardware and process dependencies) that is not medical software or clinical software and “(A) that captures, analyzes, changes or presents patient or population clinical data or information; (B) that supports administrative or operational aspects of health care and is not used in the direct delivery of patient care; or (C) whose primary purpose is to act as a platform for a secondary software, to run or act as a mechanism for connectivity, or to store data.”
The proposed “Sensible Oversight for Technology Which Advances Regulatory Efficiency Act of 2013” also encourages a risk-based regulatory framework for clinical and health software that appears similar to what the Office of the National Coordinator for Health Information Technology, FDA and Federal Communications Commission are putting together and expecting to release in early 2014. “It is the sense of Congress that the President and the Congress should work together to develop and enact legislation that establishes a risk-based regulatory framework for such clinical software and health software that reduces regulatory burdens, promotes patient safety and fosters innovation,” the bill states.
The legislation, H.R. 3303, was referred to the House Committee on Energy and Commerce and is available here.
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