The Health Information Technology Advisory Committee, a federal advisory committee to the Office of the National Coordinator for Health IT (ONC), voted Wednesday to approve nine recommendations to update the list of data elements that vendors must exchange to be considered interoperable.
The 21st Century Cures Act established the HIT Advisory Committee, which replaces two separate health IT policy committees that were previously overseen by ONC—the Health IT Policy and Standards Committees. Its role will be to provide guidance on policies, standards, implementation specifications, and certification criteria relating to the implementation of a health information technology infrastructure that advances the electronic access, exchange, and use of health information.
The nine draft recommendations were developed by the U.S. Core Data for Interoperability Task Force, a specialized task force within the 30-member HITAC. The U.S. Core Data for Interoperability (USCDI) standards, and the process for updating core data sets, will eventually funnel into the Trusted Exchange Framework and Common Agreement (TEFCA) draft, an outline of minimum standards that health information networks must meet to be able to exchange patient health data. The approved HITAC recommendations will go to ONC in a letter that its staff will consider while crafting TEFCA.
One key recommendation centers around establishing a six-stage maturation process through which data classes would be promoted, starting with when a new data element is proposed through its inclusion as a new USCDI data class and then to widespread adoption.
The goal of the data class maturation process is to identify data classes with broad applicability to advance interoperability. In stage 5, for instance, policy levers will be used to promote widespread adoption of the USCDI data class, and qualified health information networks (QHINs) and their participants are required to update their technology to support the new USCDI data class. TEFCA establishes QHINs as a vehicle to help facilitate a standardized methodology for HIE inter-connectivity, along with a new administrative organization, the Recognized Coordinating Entity (RCE).
The co-chairs of the USCDI task force, Christina Caraballo and Terry O’Malley, M.D., pointed out that in stage 1, any stakeholder can propose data objects and use cases in a shared public resource. “The purpose is to widely seek out nominations for data of value,” O’Malley, who is a geriatrician at Massachusetts General Hospital, said.
HITAC also approved the recommendation to publish the USCDI annually as a reference edition, with quarterly bulletins as data elements progress from one stage to the next.
The other recommendations approved were:
- Expand the USCDI as each data class completes Stages 1-4 without a predetermined timeline
- Incorporate public feedback in each stage
- Test USCDI Process by Addressing Critical Trusted Exchange Framework Requirements
- Ensure the Voice of the Patient is Represented and Heard
- Support the Process of Data Item Harmonization as a Condition for Data Class Advancement
- Establishing a data management process to modify established USCDI data classes
- Establishing a data governance structure for USCDI
HITAC committee members discussed many of the challenges facing the group as it works on the structure and process for updating USCDI standards. The committee members noted the need for a Data Class Work Group as a group of stakeholders with the responsibility to define the data class, apply applicable semantic standards, harmonize data elements and produce a data class sufficiently specified to be tested. The DCWG will be steward of the data class through cycles of testing and revision.
One challenge will be the cost and resources to stand-up a public resource for data elements to be proposed and the work required for pilot testing, as well as the time and resources required to stand up a data class work group and the impact to ONC.
“The data class has to have a steward, an interested party, who wants to see it through. It’s going to take effort and structure to get that done,” O’Malley said.
Another committee member noted that the process of harmonization is critical and will be very difficult. “It will take time and effort to do this well. That’s going to be one of the challenges for this group. The point of this stage (stage 2) is to get something that can be tested. Some data elements have no problem getting through stages 1 and 2 and there are some that need work, particularly the attachments of standards to them,” the committee member said.
Another committee member voiced concerns about the timeline to deliver updated USCDI data elements to the marketplace and the need to keep patients at the center of interoperability efforts. “You should consider making it a condition of payment, so no one gets paid for medical services unless there is a digital record provided to the patient. You should look at the approach of delivering stage 1 in a human readable form that could be shared with patients as soon as it is digitally available. Make it a condition of payment; HHS [the U.S. Department of Health and Human Services] and CMS [the Centers for Medicare and Medicaid Services] have that leverage to make that domino fall into place.”
USCDI task force members also emphasized the importance of ensuring the voice of the patient is represented and noted the challenge of how to engage patients and consumers in the process. To this end, the task force recommended establishing a process that engages patient representatives in data class creation, and noted that specifically designated representatives may be required for the DCWGs. In its presentation, the USCDI task force noted that “This is no longer a ‘nice to have’ but rather a ‘must have’ as we shift into patient-centric, value-based healthcare delivery.”