Last week the Office of the National Coordinator for Health Information Technology (ONC) announced that it was dropping its request for information (RFI) for a governance framework for the Nationwide Health Information Network (NwHIN). Many IT leaders applaud this effort in light of a waning regulatory bandwidth as the industry focuses on requirements for Stage 2 meaningful use, ICD-10, and the three Medicare programs, value-based purchasing, avoidable readmissions reduction, and healthcare-acquired conditions reduction, mandated under the Affordable Care Act (ACA).
“One concern I’ve heard repeatedly was that the very act of beginning a regulatory process may actually slow the development of trusted exchange at a time when we cannot afford that,” said Farzad Mostashari, M.D., national coordinator for health information technology, ONC, in his Health IT Buzz blog post on September 7.
Farzad Mostashari, M.D.
In May the ONC set out through a regulatory rule-making process to define “conditions of trusted exchange” (safeguards, technical aspects, and business practices), and establish a voluntary accreditation and certification process for validating organizations as being legitimate participants in the Nationwide Health Information Network (NwHIN).
Brian Ahier, health IT evangelist at the 49-bed Mid-Columbia Medical Center in The Dalles, Ore., says he worked with several organizations including the Healthcare Information and Management Systems Society (HIMSS), the EHR Association, the eHealth Initiative, and others, to voice concerns with the RFI during the comment period. “Many of the same concerns that were raised throughout these groups centered on how aggressive the timing seemed to be,” says Ahier. “The industry [would] actually wind up being stifled rather than spurred through this process.”
Beyond the restrictive timeline, “trying to impose this governance structure in the midst of all this change going on and all the good work that these people are doing,” would be distracting, says Ahier. “The most powerful argument that I saw for holding off on regulations at this time, was that there is a great deal of work underway right now. We’ve got Healtheway, you have DirectTrust.org, and there is an EHR-HIE Interoperability Workgroup that has been working hard in collaboration with the exchange folks; and there’s the Western States Consortium. There’s been a lot of work going on [with activities] in parallel with each other, so it almost seemed like this RFI and proposed governance structure wasn’t really taking the existing work into account.”
Ahier points out that there are other mechanisms that the ONC and HHS can use to provide governance, such as continuing to support and promote validation processes being created by current public/private collaborations. “In the HITECH Act there is a requirement that the ONC would establish a governance mechanism for the Nationwide Health Information Network, so they have a statutory obligation for governance; however, they do not have any mandate for regulation.”
In his blog, Mostashari wrote that the ONC would continue to highlight best practices for trusted and interoperable exchange, “actively engage with entities currently serving in governance/oversight roles,” use its convening authority to promote guidance and tools, and “evaluate how and what consumer protections can be appropriately applied to health information exchange through existing regulatory frameworks.”
Ahier points out in his blog that he “appreciates that ONC is taking their time and being careful and flexible in their approach.” He gives a caveat that if results—like clinicians being able to seamlessly exchange information with trusted partners within their clinical workflows—are not seen in the near future, then the ONC might have to intervene to progress interoperability nationwide.
Mostashari added in his blog, “if systemic problems or market break-downs emerge that might require regulatory action, we will again seek input from the public and our stakeholders, including the Health IT Policy and Standards Committees.”
“That trust fabric for HISPs [Health Information Service Providers] to be able to exchange securely and be able to expose their provider directories in a way that that you can [use for secure exchange], that is going to be another key milestone,” says Ahier. “All this is going to require some level of governance, but it doesn’t necessarily have to be a federal government regulatory approach. I have a lot of faith in the work going on already in the public/private [space].”