Before U.S. physicians can hop on the nationwide health information exchange highway, they need to know the rules of the road. They may have to leave it in park for a while though — as these rules don’t yet exist.
Under the Public Health Service Act section 3001(c)(8), the Office of the National Coordinator for Health Information technology (ONC) is required to “establish a governance mechanism for the nationwide health information network,” also known as the NHIN or NwHIN.
In other words, it’s up to the ONC to establish the “road rules” for nationwide health information exchange. That doesn’t mean the ONC is responsible for actually governing the NHIN — just that it must set up the mechanism for doing so.
To assist with this gargantuan task, the ONC has published a request for information (RFI) to get input from the public on the key areas related to electronic health information exchange. The RFI seeks comments on 5 areas in particular:
Establishing the conditions for trusted exchange, or CTE, which are broken down into three categories. Safeguard CTEs focus on the protection of personally identifiable information. Interoperability CTEs focus on the technical standards needed for electronic health information exchange. And CTEs related to business practices focus on the operational and financial aspects of trusted health information exchange.
Determining the eligibility criteria for becoming a nationwide health information network validated entity (NVE). NVE validation would consist of testing or certifying products or technology and accreditation of services. The ONC would select an Accreditation Body to accredit Validation Bodies, who would be authorized to validate an entity’s CTE compliance.
CMS anticipates that NVEs might include EHR developers, integrated delivery networks, health information exchanges, health information service providers and state and federal agencies.
CMS also wants to establish “an inclusive and transparent” process to update and retire CTEs. It has come up with a classification system to identify CTEs as emerging, pilot or national.
The governance system could include a process to annually review the technical standards and implementation specifications, and provide direction on what gaps need to be filled to support nationwide health information exchange.
Finally, the ONC wants to include a process for monitoring and oversight of the NHIN governance mechanism. This may include a process for receiving and addressing complaints from participants, or a process for revoking an organization’s NVE status.
For more information about the RFI on governance of the nationwide health information network, watch the NeHC presentation by Steve Posnack, director of the ONC’s federal policy division.