U.S. Sens. Deb Fischer (R-Neb.) and Angus King (I-Maine) responded unfavorably to the health information technology (health IT) framework released this week by the The Office of the National Coordinator for Health IT (ONC), the Federal Communications Commission (FCC), and the Food and Drug Administration (FDA).
The framework, released yesterday, aims to provide guidance on health IT products in order to help determine what they do and what risk they have to patients who will use them. It was developed as part of the Food and Drug Administration Safety and Innovation Act (FDASIA), in 2012, which specified it be introduced by Jan. 1, 2014.
Senators Fischer and King, in February, introduced legislation of their own that would aim to ensure a wide array of "low-risk" health IT systems are not subjected to heavy regulatory oversight. That law, the Preventing Regulatory Overreach To Enhance Care Technology (PROTECT) Act of 2014, was referred to a committee, where it eventually died.
“I’m glad to see that the FDA’s report, though four months late, agrees with the need for a more risk-based structure as outlined in the PROTECT Act,”Fischer said in a statement. “However, instead of providing a concrete framework that supports innovation and safety, the report’s approach maintains the status quo under which the FDA retains unlimited discretion over regulation of low-risk health IT. As technologies converge, regulatory overlap is becoming more pronounced. That’s exactly why Congress must act and codify an appropriate, risk-based framework that provides certainty for health IT.”
Fischer and King say they are disappointed that the guidance preserves the FDA’s authority to change these rules as they see fit. They say that action is needed to ensure that there is less regulation and oversight from the FDA.