Classen conceded that, given the FDA's existing presence in medical device regulation, it would seem to be “the natural group to regulate this, but if you look at their record, it is awful, it is beyond awful.”
Classen pointed to an FDA decision in the 1990s to begin regulating software used in the nation's blood banks in the wake of some patient safety incidents that resulted in patient deaths. That, he said, brought an end to rapid development cycles by blood bank software developers. “There hasn't been a lot of innovation in HIT for blood banks as a result,” he said.
In April, the federally chartered Health Information Technology Policy Committee added a new workgroup to advise the ONC at HHS, the Federal Communications Commission and the FDA on “key considerations to improve patient safety and promote innovation in health information technology (Health IT), including mobile medical applications.”
The panel will provide input through the ONC to the FDA, which is required by the FDA and Innovation Act of 2012 to issue a report on a regulatory scheme for health IT by January 2014, Classen said.
The direction of those deliberations indicate a likelihood that the FDA will seek a similar framework for HIT regulation that it uses for medical devices, Classen said.
During the question-and-answer period, Dr. Joseph Schneider, chief medical information officer and medical director of clinical information at Baylor Health Care System and chairman of the Texas Medical Association's ad hoc health IT committee, expressed a preference for reporting of adverse patient safety events linked to health IT systems to a single, national reporting entity, similar to what the transportation industry has in the National Transportation Safety Board.
But Classen said the current federal direction appears to have providers reporting IT safety events to existing patient safety organizations.
“The hope is all (patient safety organizations) will use common formats for reporting so all of their data can be rolled up,” Classen said.
In an interview after his presentation, Classen said FDA regulation has little backing in the clinical community. “I can't think of too many physicians that support more healthcare regulation,” he said.
The support, he said, seems to be coming from the government itself, particularly the FDA and ONC, which have a pair of health IT patient safety initiatives ongoing.
At least one AMDIS member, Dr. Rod Tarrago, CMIO of Children's Hospitals and Clinics, Roseville, Minn., wanted to shift the discussion from possible FDA regulation to patients, who, according to multiple studies, have suffered harm by the healthcare system.
“Put (an electronic health record) in front of a new resident with (only) an hour's training, and he's dangerous,” Tarrago said.
Follow Joseph Conn on Twitter: @MHJConn