In the weeks since the Office of the National Coordinator for Health IT released its roadmap for the creation of a health IT safety center -- recently redubbed the "Collaboratory" to better articulate the center's vision -- the response has been largely positive, in principle. But some industry stakeholders question its ultimate operating potential and efficacy given that the Collaboratory's funding has not been assured.

The Collaboratory aims to serve as an open forum and educational venue for private- and public-sector organizations and individuals to improve health IT safety and promote and support safer use of the technology. The key objective, according to ONC CMIO Andrew Gettinger, is to convene stakeholders to collaborate on solutions that are informed by evidence.

"I think it's important to keep in mind that this [envisioned center] involves a voluntary system, where, ideally, stakeholders will be willing to share openly," Gettinger said. "I'm optimistic about the Collaboratory's potential for several reasons, but a key one is that RTI International, which developed the roadmap, was able to convene some strange bedfellows to get this moving."

The broad-based task force that RTI -- the North Carolina firm that received the grant to develop the center's roadmap -- managed to assemble includes members from the EHR Association, the American Hospital Association and the American Medical Association, as well as more than a dozen of the country's top informatics, safety, risk management and quality improvement leaders.

The key elements of ONC's roadmap for the center include:

• Creating a forum for promoting shared learning and responsibility in a trusted, non-punitive environment;
• Using existing and emerging evidence on health IT-associated safety risks and hazards to identify and prioritize areas where improvement is most needed and focus on solutions; and
• Leveraging existing private-sector initiatives to further the Collaboratory's mission and objectives.

Gettinger noted that the center's core functional areas are to convene stakeholders, research solutions to recognized health IT safety issues and disseminate findings in the form of evidence reports. The center also would produce educational materials and, ultimately, issue best practices that organizations – from health IT vendors to health care delivery organizations -- can implement. 

In the face of concern -- and criticism -- about the proposed center potentially acting as a quasi-regulatory entity when it has no statutory authority to do so, ONC has gone to considerable effort in recent weeks to clarify what the center will not do. The Collaboratory will neither directly investigate health IT safety issues nor conduct associated surveillance. In addition, it will not direct data collection on safety issues and events. Further, Gettinger pointed out that ONC and HHS are working to ensure that the Collaboratory doesn't duplicate efforts of activities that other federal entities perform.

Focus on Collaboration Suggests Tone Shift

The new name evolved for another strategic reason, too, according to Dean Sittig, a longtime health IT and safety researcher at the UTHealth School of Biomedical Informatics in Texas and a board member at the American Medical Informatics Association. "The name change was a clear response to some of the pushback the ONC has been receiving from vendors and others about the term 'safety center'," Sittig said, noting that some viewed that term as an implication that the center will focus on reporting and investigating safety problems.

"I think the ONC's intention for the Collaboratory is to get people working together and talking openly, and that's good -- because the vendors have a lot to lose if they don't talk about safety. The question is, 'Will they talk?' One of the key issues we've had is that no one wants to say openly that we have a safety problem in [health] IT."

Sittig said he thinks that the center, as a concept and as described in the roadmap, represents an opportunity to do something that the entire health care sector has long needed: stop the finger-pointing between health IT developers and the provider community about safety issues.

"That's been one of the hardest things -- getting people to acknowledge that there's a shared responsibility here, and that the safety issues that exist aren't the 'fault' of vendors or users," he said. "But we've got to do that if we're going to make progress. The proposed center is a step forward, but it will need sustained support from all of the key stakeholders, including vendors, researchers and policymakers." 

Funding Issue Is Significant

Another current stumbling block is how the Collaboratory will be funded. The roadmap calls for seed funding from the federal government, with a hoped-for infusion from the center's stakeholders and other supporters over the years. RTI's cost estimates, for the initial five years, are approximately $1 million annually for optimal startup funding and $600,000 for basic "functional" startup funding.  RTI's roadmap identifies optimal funding -- the sum needed to enable the center to function robustly, operate effectively and achieve its outlined goals -- in the $17.8 million to $20.6 million range over five years. The idea is that the center would eventually become self-sustaining.

Tom Leary, vice president for government relations at the Healthcare Information and Management Systems Society, says that HIMSS supports the Collaboratory's goal of creating an integrated health IT learning system that leverages existing efforts, but the group is concerned about its funding.

"The direction that ONC is proposing matches our vision of the practical approach to advancing patient safety, and the health IT community is ready to begin implementing an HIT safety center if it focuses on gaining evidence and knowledge ... and isn't a regulatory or oversight body," Leary said.

Leary noted, however, that the fiscal year 2016 federal appropriations process makes it "highly unlikely that any new funds would be included to support the center." Beyond the seed money, which isn't assured, Leary said that having a sustainable funding plan will be "critical to the center's long-term future."

Sittig said that getting Congress to approve the funding needed to do what the Collaboratory hopes to do is a long shot at this stage. "I don't think the center will get the funding, unfortunately, even though it's a good step in the right direction. And that's unfortunate, because one of the things we have learned about health care safety is that if you take the time to really look at what's not working well and spend enough money, you can and will improve safety," Sittig said.

Leaders Remain Optimistic

Despite the obstacles to operationalizing the Collaboratory's proposed functions, some industry leaders are upbeat about both the ONC center's vision and its potential for improving health IT safety.

The ECRI Institute -- a Pennsylvania not-for-profit organization that researches and supports initiatives to improve health care safety and efficacy -- convened a multi-stakeholder collaborative, the Partnership for Health IT Patient Safety, that is already carrying out many of the activities recommended in ONC's roadmap. 

Ronni Solomon-- executive vice president and general counsel at the ECRI Institute and a task force member for the ONC project -- said, "I am optimistic about achieving meaningful safety improvements because the Partnership is a broadly representative multi-stakeholder effort, and it's already getting things done." For example, the first set of Partnership best practices will be published in October on the safe use of copy and paste. 

 "At the same time, there needs to be both public and private funding for this to work because there are many, many health IT safety issues to tackle, and what we really need is a genuine non-punitive environment," Solomon said.

The key point, in Solomon's view, is that ONC's stated goals encourage the adoption of a shared-responsibility mentality that's needed to improve health IT safety. "I like the roadmap's tagline, 'collaborate on solutions, informed by evidence,' because it captures where we all need to be going now," she said.