Consumer Groups Oppose FDA's 'Secondary Role' In HIT Reg Framework

A coalition of patient, consumer and public health groups opposes a proposed tri-agency, risk-based regulatory framework for health IT that puts the Office of the National Coordinator for Health IT in charge of regulating products not considered medical devices, saying the plan undermines FDA's mission to protect public health by not guaranteeing all HIT products are safe and effective. FDA is the agency best suited to regulate those products, said the group that includes the National Center for Health Research...