Senators Deb Fischer (R-NE) and Angus King (I-ME) have introduced legislation “to protect jobs, reduce regulatory burdens, and provide greater certainty for health information technologies (health IT).”
Their bill, the “Preventing Regulatory Overreach To Enhance Care Technology (PROTECT) Act of 2014” attempts to offers a regulatory framework for health IT innovation, and balances protecting patient safety. Senator Fischer described their motivation as, “Federal overregulation is one of the key challenges holding back entrepreneurs and job creators in Nebraska and across the country …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.”
Fischer and King’s bill is a companion to Rep. Marsha Blackburn’s (R-TN) “Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act of 2013”(HR 3303). This week Rep. Blackburn distributed a “Dear Colleague” letter to Members of Congress asking them to co-sponsor the SOFTWARE Act. “The goal of this legislation is to provide regulatory clarity regarding mobile medical applications, clinical decision support, electronic health records, and other health care related software. This legislation tailors the FDA’s authority to the realities of the 21st century by focusing its authority on those products that pose a potential risk to human health.”
In November 2013, the HIMSS Board of Directors approved a HIMSS position on regulating health IT in a letter to HHS Secretary Kathleen Sebelius. Regulating health IT will be part of the dialogue at HIMSS14 when FDA, ONC, and FCC present the latest information on the pending Report to Congress that was required in FDASIA. “Health IT Regulation and the FDASIA Report” is scheduled for February 25th at 10:00 am in Room 208C.