U.S. Senators Deb Fischer (R-Neb.) and Angus King (I-Maine) have introduced legislation that would ensure a wide array of "low-risk" health IT systems are not subjected to heavy regulatory oversight.
The legislation, which Fischer and King call the Preventing Regulatory Overreach To Enhance Care Technology (PROTECT) Act of 2014, was referred to the Committee on Health, Education, Labor, and Pensions. If passed, it would shift the Food and Drug Administration's (FDA) regulatory process to focus on products that pose a legitimate risk to human health.
The new law would also relieve these categories of low-risk clinical and health software from the medical device tax. Currently, FDA has oversight of what Fischer and King call "low-risk health IT," including mobile wellness apps, scheduling software, and electronic health records.
"Federal overregulation is one of the key challenges holding back entrepreneurs and job creators in Nebraska and across the country,” Senator Fischer said in a statement. “While economic growth remains sluggish, it’s critical we prevent these costly and time-consuming bureaucratic hurdles from hurting one of the fastest growing sectors of our economy – technology. The PROTECT Act increases regulatory efficiency over health IT to promote innovation, expand consumer access to information, and improve patient safety. Current law is in desperate need of a make-over, and I’m pleased to work with Senator King on this commonsense solution.”
The law also asks the National Institute of Standards and Technology (NIST) to be the Federal agency that has oversight over technical standards used by clinical software. It asks NIST to work with the Federal Communications Commission (FCC), the National Patient Safety Foundation, and the Office of the National Coordinator for Health Information Technology (ONC), to work on certification processes and promote best practices.
U.S. Senator Marco Rubio (R-Fla.) is an original cosponsor of the legislation. Congressman Marsha Blackburn (R-TN), who introduced similar legislation back in October, was supportive of PROTECT Act. The senators have also garnered support from several noted healthcare IT vendors including athenahealth, IBM, McKesson, as well as nonprofits like The Newborn Coalition and The Software & Information Industry Association.
Here's a video of the Senators announcing the PROTECT Act, posted by Senator King.