HHS' Office for Health Information Technology continues to lay the groundwork for a Health IT Safety Center as congressional Republicans dispute the agency's authority to regulate the field.
A panel created by the Office of the National Coordinator for Health IT
held a discussion Monday as part of a short cycle leading to recommendations for the goals, governance structure and scope of the Safety Center by July 8.
Last week, Republicans from the House Energy & Commerce Committee questioned
whether the ONC has any statutory authority to create the center, a key part of the administration’s vision for regulating health IT.
A source in the House committee said the lawmakers have yet to receive a response but expect one in a timely fashion. Nevertheless, the show goes on for the agency.
The Safety Center is part of the draft framework for regulating health IT
put out by the Food and Drug Administration, ONC and the Federal Communications Commission in April. Broadly, the center is envisioned as a public-private partnership intended to disseminate best practices, quality management principles and create a “learning system” for handling the sector.
But that leaves a number of details to be defined.
One point of agreement emerged early during Monday’s discussion, chaired by David Bates—medical director of clinical and quality systems for information systems at Partners HealthCare in Boston.
The Safety Center, Bates said, ought to focus on the risks posed by health IT, rather than safety risks that could be addressed by health IT. Participation would be voluntary, and yet the center needs to attract a significant cross section of the vendor and provider community for its data to be helpful. That has led, Bates said, to the conclusion that the center must offer “products,” perhaps educational, to make participation valuable for prospective participants.
The Safety Center also needs to account for “sociotechnical” and “human factor” issues--that is, issues that arise from the interaction of a local provider culture and workflow and the actual product itself.
And the center should “incorporate a variety of data streams, not simply adverse event reports,” Bates said, bringing up the possibility of “near-misses” and “hazard” reports.
Paul Tang, chief technology and innovation officer at Palo Alto Medical Foundation, waxed approvingly of the potential consequences of having such data available. “A lot [of data from the center] might be text and hard to parse,” but it’s so important, he said. Having someone parse through all the data as their “day job,” he said, “would be wonderful.”
That data, participants mused, could be used to compare vendors against one another. “Right now, it’s hard to do that,”Bates said, noting that “vendors have actively resisted being compared to one another in any identified way.”
But Tang’s comments regarding “day jobs” raised another issue: Who’s paying? Participants broadly agreed that the center needed funding, and ONC had put a line item in its proposed budget for such a center.
“We won’t do enforcement, but we do want to learn,” Tang said, “That requires funding.”
And that brings up a controversy that wasn’t directly discussed: the Safety Center’s status. It’s a line item in a proposed budget, resting its fate on the outcome of the broader debate over how to regulate health IT.
Some are asking why the ONC is having the discussions at all. The draft framework, after all, is still open for public comment. Stephanie Zaremba, senior manager of government affairs at athenahealth
on June 6 that, “If [the] report is still open for comment, why is ONC forming task force to decide what [Health IT] Safety Center [should] look like? It’s not final.” athenahealth has generally favored the approach taken in bills introduced in Congress (the SOFTWARE Act in the House and the PROTECT Act in the Senate) that seek to deregulate the sector, partially by removing FDA authority from certain kinds of health IT.
Dan Haley, athenahealth’s vice president of government and regulatory affairs, elaborated in an e-mail, saying, “We don't actually oppose the concept of the health IT safety center … It is possible to support the concept, however, and still observe that the agency needs statutory authority to do what it is proposing to do.”Follow Darius Tahir on Twitter: @dariustahir