Office of the National Coordinator of Health IT reacts to industry pushback on proposed rules for Nationwide Health Information Network.
8 Health Information Exchanges Lead The Way
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Bowing to widespread industry objections to its proposals for governing the Nationwide Health Information Network (NwHIN), the Office of the National Coordinator of Health IT (ONC) has tabled the project, at least for now.
In comments at a recent meeting of the Health IT Policy Committee and in a blog post, National Health IT Coordinator Farzad Mostashari made it clear that his office was responding to the intense industry pushback it has received since issuing an official request for information in May.
"We heard that there are a lot of promising health information exchange activities currently underway and emerging, perhaps more than is widely appreciated," he wrote on ONC's HealthITBuzz blog. "There are also existing and emerging consortia and voluntary governance bodies, both for directed as well as query-based exchange. One concern we 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."
That would be a mistake, he noted, especially at a time when the government is trying to implement Meaningful Use Stage 2, which includes a major emphasis on health information exchange.
Mostashari said ONC might resuscitate some kind of NwHIN governance strategy in the future. (Indeed, the office is required to do so by law.) But he did not specify whether that would be a top-down regulatory approach, like the one outlined in the RFI, or a public-private partnership, as some industry groups have requested.
The Certification Commission for Health IT (CCHIT) said in July that governance of the NwHIN by an independent public-private entity "may be a more effective approach in establishing trust, gaining wide adoption, and allowing for multi-stakeholder representation." The eHealth Initiative (eHI) and the HIMSS Electronic Health Record Association (EHRA) also supported this approach.
If the government defined standards for information exchange, the EHRA pointed out, it could easily become a "de facto mandate" for all health information exchanges (HIEs). And the American Hospital Association (AHA) opposed having ONC formulate regulations on "conditions of trusted exchange" because it feared they might be applied, not just to community HIEs but also to private exchanges created by healthcare systems.
eHI argued that many community HIEs are still in a nascent stage and need more time to develop before being regulated under a national governance structure.
The RFI suggested a framework in which governance would be subject to oversight, not only by ONC, but also by the Federal Trade Commission and the Department of Health and Human Services' Office of Civil Rights. To private sector groups, this was altogether too much government regulation.
Not everyone believes the NwHIN governance initiative was misguided, however. Deven McGraw, co-chair of the Health IT Policy Committee and director of the Health IT Privacy Project at the Center for Democracy and Technology, said she didn't think that regulation of NwHIN would stifle innovation, as some claimed. But in the wake of ONC postponing its initiative, she suggested that the HIPAA law could provide guidance on data security and privacy in health information exchanges.
Consumer groups and providers have recently expressed concerns about the privacy safeguards for personal health information in HIEs. The Health IT Policy Committee's "Tiger Team" workgroup, chaired by McGraw, earlier this year proposed several principles for HIE data privacy. Included were patient access to their aggregated records, a mechanism to correct erroneous information, the opportunity for patients to make "informed decisions" about how their data is collected, used and disclosed, safeguards to prevent unauthorized disclosures, and accountability of providers for complying with these requirements.
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