The Office of the National Coordinator for Health IT plans to establish rules of the road for the nationwide health information network (NHIN Exchange) in order to expand the kinds of organizations that can participate in it.
Participation in the NHIN Exchange is currently limited to federal health agencies and healthcare organizations that contract with them or are federal grantees.
As the first step in the rulemaking process, ONC will publish a request for information in August to get public comment on the governance process. It expects to then release a proposed rule in early 2011, and to finalize it next summer, said Mary Jo Deering, senior policy advisor in ONC's Office of Policy and Planning.
The NHIN is a set of comprehensive standards and services that enable primarily large healthcare organizations to exchange information securely through the Internet.
"Without governance, the NHIN can't expand and grow beyond the current specific category of participants that are limited by legal guidance," Deering said at a meeting June 25 of the Health IT Policy Committee, which advises ONC.
Participants in the NHIN Exchange now include the Veterans Affairs and Defense departments, the Social Security Administration, Kaiser Permanente and MedVirginia, the Richmond, Va.-based regional HIE. Those current NHIN public and private sector participants are trying to decide how to move forward to bring in groups that want to work with them.
"The [HHS] general counsel has ruled that they can't do much unless we help them do it. They have no framework for doing that now, and they have no legal authority or mechanism to do that," said Dr. David Blumenthal, the national health IT coordinator.
For example, states are developing health information exchanges and have become members of the NHIN Exchange. The state HIE is where vendors and providers can link to exchange transactions.
"We need to give them a process and conditions for docking, and once you go down that route a series of legal and policy questions come up," Blumenthal said.
The HITECH Act called for ONC to create a method through rulemaking to assure basic objectives in the secure exchange of health information.
A method for governance is needed to develop nationwide interoperability, Blumenthal said, adding that "it won't happen by itself. There will be a continuing need for a referee or organizing force."
Governance sounds abstract, but it is "one of the many pants-on-fire short term issues that we have to deal with," Blumenthal said.
The exchange of patient data will ramp up as providers broadly adopt electronic health records and want to exchange information.
The NHIN Exchange needs an organizing mechanism to come up with rules of behavior that also assure patients of the privacy and security of their health information, Deering said.
"We have to be sure that patients have trust in the way their information is shared, that exchange really works, and NHIN is used to improve healthcare," she said.
Some of the questions that ONC will explore include when patient consent is needed, the degree of transparent oversight, agreed upon business and legal requirements, identity assurance and technical requirements.
One of the overarching questions is whether participants' compliance with NHIN standards, services and policies should be optional or mandatory, Deering said.
