The Office of the National Coordinator (ONC) is preparing to launch a formal rulemaking to establish rules of the road for the nationwide health information network, a process policymakers hope will clear the way for large and small organizations to use the NHIN.

By completing a rulemaking on NHIN governance, ONC hopes to work through some of the remaining legal and policy questions that stand in the way of its plan to rapidly expand health information exchange among health care organizations and information exchange providers. The 2009 HITECH Act called for a mechanism for official NHIN governance, which had been lacking.

With established rules of the road, "all the (NHIN) participants can have confidence that the exchange information has the right protections for confidentiality and security, that the information is being exchanged accurately and that it is used to improve health," said Mary Jo Deering, a senior policy advisor in ONC's Office of Policy and Planning.

ONC plans to release a proposed rule in early 2011 and finalize it next summer, she said in an interview.

The governance rules will also repair a policy gap that has prevented organizations and firms without an existing contract or grant with the federal government from applying to participate in NHIN Exchange, a group of federal health care agencies and their contractors that has pioneered high-level health information exchange using the NHIN.

Members of the NHIN Exchange include the Veterans Affairs and Defense departments, the Social Security Administration, Kaiser Permanente and MedVirginia, the Richmond, Va.-based regional HIE, among others.

Without a formal governance system, only organizations that hold a contract or grant with the federal government " and thus have rights to sue for redress under the legal doctrine of "˜privity' " can apply to participate in the NHIN Exchange, Deering explained.

New organizations without a contract or grant with the federal government also lack a right to sue the federal government if, for instance, their application to participate in the NHIN Exchange is denied by the Health and Human Services Department. The lack of privity has limited access to NHIN Exchange projects by new health organizations, officials said.

Although the NHIN Exchange agencies held to a version of governance, including participation in the Data Use and Reciprocal Support Agreement (DURSA) and various technical and coordinating committee guidelines, those policies do not constitute formal governance, Deering said.

"Since we can't recognize the current mechanism as official governance, that only entities that have a contractual or grant relationship with the federal government can apply because that way if they are turned down they have an appeals process, a right of redress," she said.

Deering would not say how the rulemaking would lift those restrictions " HHS policymakers want the open rule-making process to take its course " but she said the intention is to craft a set of policies that will protect the rights of the NHIN Exchange participants while multiplying their numbers.

"All this is subject to the process over the coming year to gather information about the best way to proceed," she said. "It is safe to say that the intention is to permit a wave of exchange " with the assurances of both privacy and security on one side and interoperability on the other side."

Meanwhile, momentum is building among NHIN Exchange participants to expand their networks.

"There are partners who are already exchanging data and want to exchange with more partners, but they are limited with whom they can expand that exchange until rulemaking is done," said Deering. "From the point of view of that initial group of partners with the federal agencies, they urgently need some clarity on how to proceed."

Although the current NHIN Exchange restrictions have existed for some time, "it's becoming something that is much more visible and that is creating additional complexity," added Dr. Doug Fridsma, acting director of ONC's standards and interoperability office.

"They're willing to sign the DURSA, use the specifications of the software, and follow all of the policies," he said. "Once we have a fair process that has gone through rulemaking, it will become much easier for us to bring those people into the fold."