What the U.S. government really needs now is a federal safety center for health IT.
That was the consistent drumbeat during a three-day workshop of the FDA’s Safety and Innovation Act efforts, replete with a variety of industry stakeholders and the involvement of other agencies the FDA works with, among those the Federal Communications Commission and Office of the National Coordinator for Health IT.
“This safety center needs to be in place as soon as possible,” said Michael Hodgkins, MD chief medical information officer at the American Medical Association, adding that it will be “where the rubber meets the road.”
Indeed, the FDASIA HIT regulatory report came out April 1, and federal officials are synthesizing thought-leaders’ contributions on how to go about nailing this moving target. One thing is for certain: the HIT safety center will play a key role.
“We are committed to the safety center,” said Jodi Daniel, director of ONC’s office of policy planning, who moderated a panel discussion on the issue at the FDASIA workshop. ONC put money into this year’s federal budget to fund the center, which, Daniel said, will provide “a venue for learning.”
[See also: 3 takeaways from the 3-day FDASIA meeting.]
The question, however, is exactly how the safety center will function. Panelists, experts, stakeholders at the workshop were adamant that the center should not play any role as an enforcer, but rather should serve more as a convener and a gatherer of data on safety incidences.
Janet Marchibroda, director of the Health Innovation Initiative at the Bipartisan Policy Center urged that the federal government leverage existing processes and systems rather than creating something completely from scratch. The goal of the center is to not be redundant but complementary to other groups, added William Maisel, MD, chief scientist with the FDA’s Center for Devices and Radiological Health.
David Mayer, managing director of the National Transportation Safety Board came to the workshop to offer advice on industry safety methods from his own experience: Only have as much governance as is absolutely necessary, and make sure the participants get something that they cannot find elsewhere.
Ideally, participating organizations would use the information gathered by the center to implement health IT “better, faster, cheaper and safer,” said Matt Quinn, FCC’s director of healthcare initiatives.
ONC, for its part, would like to see the center provide what Daniel called the three “Es,” those being education, engagement, and evidence.
But getting good data will be hard, some contended, unless the disclosers feel safe and easily recognize what is to be gained in return for participating.
“It needs to be a value proposition,” Marchibroda said.