policy advisory committee voted Tuesday to endorse recommendations from a workgroup for a proposed Health IT Safety Center, a cornerstone of a regulatory plan to oversee the health IT
The Safety Center concept was introduced in April in a draft framework from the FDA, FCC and ONC, and intended to serve as a place to monitor the safety of health IT products. But that broad brief left many details undefined, leaving it to a workgroup convened by ONC to add flesh to the bones.
The workgroup’s chairman, David Bates, who also serves as senior vice president for quality and safety at Brigham and Women’s Hospital, Boston, presented the group’s recommendations Tuesday. The overall focus of the center, the workgroup recommends, is on the “three Es”: engagement with providers, vendors and consumers; evidence, i.e., finding what broad safety trends are occurring in the sector; and education, including taking what’s learned, and educating the community on the best way to proceed.
The Safety Center would be supported by a large board drawn with vendor, physician and consumer members. Decisionmaking, however, would be done by a smaller executive board of perhaps 10 to 12 members, Bates suggested.
“The agenda should be driven by front-line provider concerns,” Bates said, and it should be multidisciplinary, because doctors have different issues with health IT than do nurses, who in turn have different issues than, say, pharmacists.
And those concerns need to address what Bates termed socio-technical rather than merely technical issues. Looking at the fragmentary data available so far, it appears that it isn’t merely the technology itself that causes safety issues—it’s how technology fits into a culture of work.
The center hopes to use data from patient-safety organizations and vendors, as well as providers. As envisioned, the Safety Center won’t have investigatory power, and the data that flows in will be largely voluntary.
Right now, he said, the current data flows would not get the job done. Data from patient-safety organizations is “limited,” Bates said, and industry has “not been terribly forthcoming,” despite the volumes of data it’s husbanding.
That means getting access will be tricky, and Bates called it a “significant challenge” to get more. But Bates cited the success of comparable airline industry safety centers in starting small and bringing in airlines. In essence, he said, the Health IT Safety Center needed to provide value to its constituents.
Bates said he hopes the center will be able to raise private funding in conjunction with public funds. Private funding (and whether it would be mandatory) was one of the concerns of a band of House Republicans from the Energy & Commerce Committee who questioned what statutory authority ONC had to pursue the Safety Centers.
on the lack of data available to the Safety Center have also been a theme of comments to the draft proposal for health IT regulation.
ONC says the recommendations will be presented to the agency head, though there’s no specific timeline for next steps. The agency included the Safety Center as a line item in its most recent budget. Follow Darius Tahir on Twitter: @dariustahir