ONC Delays Comment Period for Nationwide Health Information Network Framework

The Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) has extended a deadline to comment on conditions for a national information exchange. A notice from the office announced the extension of the public comment period to June 29, 2012 on its pending request for information on conditions for trusted exchange that are to be met to participate in the proposed nationwide health information network (NwHIN). The deadline had been June 14, 2012.

The nationwide health information network is a set of standards, services and policies that enable secure health information exchange over the Internet. The network will provide a foundation for the exchange of health information across diverse entities, within communities and across the country, helping to achieve the goals of the Health Information Technology for Economic and Clinical Health Act (HITECH Act). “This critical part of the national health IT agenda will enable health information to follow the consumer, be available for clinical decision making, and support appropriate use of healthcare information beyond direct patient care so as to improve population health,” says the office.

Health IT provisions in the economic stimulus law  call for all Americans to have electronic health records by 2014. The law envisions the creation of a national network as one way to make that happen. HHS is expected to issue a proposed regulation later this year on how the network itself will be run.

The Office of the National Coordinator for HIT had issued a request for information on establishing a governance mechanism for the emerging Nationwide Health Information Network in the Federal Register on May 15, 2012. The framework includes common rules expressing technical, privacy and security, and business practice requirements to create a consistent trust baseline for stakeholders. “In the absence of national guidance, states and other private sector stakeholders/consortiums are beginning to develop state/consortium-unique and potentially conflicting governance approaches to electronic health information exchange….[A] consistent, baseline set of ‘rules of the road’ for electronic exchange is desirable, and perhaps necessary.”

The RFI seeks stakeholder comment in five categories:

• Establishment of a set of conditions for trusted exchange (CTE), or “rules of the road;”
• A validation process for entities to demonstrate conformance to the CTEs and subsequently become an NVE, or Networked Virtual Environment;
• Processes to update or retire CTEs;
• A process to classify readiness of technical standards and implementation specifications to support interoperability related CTEs; and,
• Approaches for monitoring and transparent oversight.

The RFI is built around ONC’s initial list of 16 proposed CTEs, and contains 66 detailed questions that are related to one or more of those CTEs.

How the NwHIN should be governed and shaped is expected to generate some controversy. The comment deadline extension is welcome so that all interested stakeholders can carefully scrutinize the plan. Insurers and vendors may think the “rules of the road” should call for a more robust sharing of medical information. Hospitals, on the other hand, are likely to be on the other side of the argument over how much information must be shared, saying that HHS wants too much too soon in the way of information exchange.

Other groups are concerned that while the conditions of trusted exchange (CTEs) are meant to be aimed at entities like State health information exchanges, it seems a slippery slope from NVEs (nationwide health information network validated entities) to more general application of the CTEs to other entities that are engaged in the “transfer” of health information electronically, from claims clearinghouses to personal health records.

Other groups are concerned that one of the 16 proposed conditions of trusted exchange (CTEs) would prohibit an NVE from using or disclosing “de-identified health information to which it has access for any commercial purpose.” Networks set up to facilitate the exchange of health information for research purposes or PHRs that look to aggregate data from multiple covered entities would be directly affected. While the CTEs are meant to be aimed at entities like State health information exchanges, it seems a slippery slope from NVEs (nationwide health information network validated entities) to more general application of the CTEs to other entities that are engaged in the “transfer” of health information electronically, from claims clearinghouses to personal health records.

Comments on the ONC’s request for information are now due by June 29, 2012.