A crucial vote relating to operational rules for the nationwide health information network (NHIN), a necessary input for a proposed rule on NHIN governance due to be published early next year, has been delayed because of a lack of clarity and detail.
Dr. David Blumenthal, the national health IT coordinator, announced the delay at a Nov. 19 Health IT Policy Committee meeting, saying more time was needed to complete the work.
"We need to break this into chunks and flesh them out and then prioritize them as either broadly directional or time sensitive," he said. "That is just acknowledging the fact that this is too complicated for the group to feel comfortable voting on in this session."
One of the recommendations of the committee's governance panel that prompted many questions was the possibility of installing a single body to validate that those organizations that wish to exchange information meet the requirements for trust and interoperability. It would have the authority to resolve disputes and enforce provisions.
To speed up formation of a governance process, the enforcement/validation role could be combined with a non-governmental role because the private sector role has flexibility, said Dr. John Lumpkin, chair of the governance work group. He is also senior vice president and director of the healthcare group at the Robert Wood Johnson Foundation.
"There is concern that once you start putting that [role] in the rulemaking and FACA process, it becomes frozen," he said.
FACAs are federal advisory committees, like the Health IT Policy Committee, that go through a deliberative process to obtain the views of many interested parties.
Some committee members, including Deven McGraw, a committee member and director of the Health Privacy Project at the Center for Democracy and Technology, were concerned with the lack of detail about such a single entity and the limits of authority for such an organization.
"If we're going to say that there is going to be a central validation authority designated by ONC and that is a private organization, I would need a lot more details about what that would look like before I am comfortable with it," McGraw said.
"In the Internet context, we have a lot of industry policing of itself on advertising, and that has not worked," she said. "Requiring consumers (to come to) the table with private regulatory bodies is not a guarantee that the entity will act more in the public interest."
The Health IT Policy Committee's governance work group is tasked with developing broad rules of the road for healthcare organizations to exchange patient data through the NHIN, which is a set of standards and services that enables information to be shared securely through the Internet. The governance framework is aimed at expanding the number of organizations that use the NHIN.
The panel has had to work quickly to come up with its recommendations because the Office of the National Coordinator for Health IT plans to publish a proposed rule in early 2011 on governance and has sought the policy committee's advice.
Among the panel's proposals are that the federal government should take a leadership role in establishing conditions that organizations must meet to instill public confidence and to enable exchange. These could include policies for consent, secure transport and conformance with exchange standards, Lumpkin said.
The government should also establish the necessary technical requirements and eligibility criteria to facilitate the smooth operation of the NHIN.
Non-governmental groups involved in governance would identify issues that arise in establishing trust and interoperability and obtain feedback from various organizations, including consumers, to promote communication. The validating entity would have the authority to say which organizations met the trust and interoperability requirements.
Despite the delay on the vote, Blumenthal emphasized the importance of the role of governance. Although it is not exciting, governance is "foundational to public trust and assuring that the many organizations involved in exchange will be able to work together," he said.
