The call for a new health IT safety center has been answered, but will it actually impact your clients?
Federal IT regulators are busy figuring out how to put teeth into the new Health IT Safety Center, and you and your clients should take notice.
Two years ago, the Food And Drug Administration Safety And Innovation Act (FDASIA) became law. In that law was included a requirement that the FDA, the Office of the National Coordinator for Health Information Technology (ONC), and the Federal Communications Commission (FCC) work together to develop a cohesive approach toward IT in health — specifically, mobile medical applications, promotion of innovation, patient safety, and regulatory simplicity.
Ultimately the initiative was intended to simplify health IT regulations, to give companies a clearer picture of which agency requirements (FDA or FCC) they should be meeting when bringing a product to market.
The final report (Proposed Strategy And Recommendations For A Risk-Based Framework), released April of this year, called for the creation of a “Health IT Safety Center” which would be run by ONC as a public-private entity that took input from the FDA, FCC, and the Agency For Healthcare Research And Quality. The entity would be responsible for patient safety, as well as “assisting in the creation of a sustainable, integrated health IT learning system that avoids regulatory duplication and leverages, and complements existing and ongoing efforts.”
The ONC’s policy advisory committee has endorsed recommendations for the safety center, with its workgroup recommending that the center stay focused on the “three Es”:
According to the Regulatory Affairs Professionals Society, legislators are concerned that the center reaches too far into regulatory territory, encroaching on the authority of the FDA. Karen DeSalvo, the national coordinator for health IT, insists that the center is a coordinating body and will not be involved in regulation. She states,
“The report did not propose that the Health IT Safety Center would have the authority to regulate health IT. The draft report recommends that no new or additional areas of FDA oversight are needed. Instead, the draft report promotes flexibility and recommends a ‘limited narrowly tailored approach that primarily relies on ONC-coordinated activities and private sector capabilities.’”
According to Health IT Outcomes, this means that providers will only feel “a light regulatory touch from federal agencies.”
So while this may not be an issue on the front burner for your clients, it’s one that you should pay attention to as government and private entities show more interest in patient safety in health IT.