U.S. Senators Deb Fischer (R-Neb.) and Angus King (I-Maine) announced today that they have introduced legislation to protect jobs, reduce regulatory burdens, and provide greater certainty for health information technologies (health IT). The Preventing Regulatory Overreach To Enhance Care Technology (PROTECT) Act of 2014 offers a more specific regulatory framework for health IT that promotes innovation and job creation while protecting patient safety.
"Federal overregulation is one of the key challenges holding back entrepreneurs and job creators in Nebraska and across the country," said Fischer. "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."
"Not only is Health IT one of the most innovative and rapidly growing fields of technology in the country, but it's also fundamentally transforming the way we think about health care," said King. "As these technologies develop, it's critical to implement a clear, risk-based framework that would protect patient health and ensure that FDA rules are appropriately targeted to support and not stifle innovation. The PROTECT Act would provide important regulatory clarity that will safeguard patient safety, make the health care sector more efficient, and allow businesses across Maine and the nation to continue developing groundbreaking ideas. Having a well-defined, risk-based framework will serve to promote the continued success of health IT, and I'm pleased to join Senator Fischer in introducing this bill."
Under current law, the Food and Drug Administration (FDA) can use its definition of a medical device to assert broad regulatory authority over a wide array of low-risk health IT, including mobile wellness apps, scheduling software, and electronic health records.
The PROTECT Act gives clarity to FDA's regulatory process to focus on products that pose a legitimate risk to human health. This more effective, risk-based framework boosts patient safety by prioritizing FDA's attention to technologies that pose the greatest health risk. It also protects low-risk health IT from unnecessary regulatory burdens that stifle opportunities for job creation, innovation, and improved care. Notably, the legislation relieves categories of low-risk clinical and health software from the medical device tax.
U.S. Senator Marco Rubio (R-Fla.) is an original cosponsor of the legislation.
The PROTECT Act is supported by IBM, Verizon, athenahealth, Software & Information Industry Association, Newborn Coalition, and McKesson.
Similar legislation addressing health software, the SOFTWARE Act (H.R. 3303), was introduced in the House of Representatives by Rep. Marsha Blackburn (R-Tenn.) in October. Blackburn released the following statement applauding the introduction of Fischer and King's legislation:
"I am pleased that Senators Fischer and King are joining our bipartisan House effort to address this issue head on and promote the innovation of these low-risk health technologies," said Blackburn. "It is imperative that we work to encourage the continued development of new technologies to improve healthcare and create new jobs without added regulatory burdens that would place disincentives on private sector innovation."