WASHINGTON (February 10, 2014) - The Information Technology and Innovation Foundation (ITIF) praised the introduction of the Preventing Regulatory Overreach To Enhance Care Technology (PROTECT) Act of 2014, arguing that it will create a more effective regulatory framework for medical software, improve patient safety and spur more innovation.
Under current law, the Food and Drug Administration (FDA) has broad authority to regulate health information technologies as medical devices, even in cases where the devices pose a low risk to patient safety. This regulatory uncertainty slows innovation while also distracting regulators from focusing on the medical applications, devices and drugs with the highest potential risk. The PROTECT Act would redefine the FDA's regulatory authority and provide companies with a better understanding of what applications require review and approval.
"Improving health care for patients should be a top priority for Congress," says Daniel Castro, senior analyst with ITIF. "This legislation hits the mark by focusing the FDA on high-risk areas to ensure patient safety while also helping unleash innovation in medical software to promote better care for patients."
The bill was introduced today by Senators Deb Fischer (R-NE) and Angus King (I-ME).
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