Responding to the federal government’s second draft of its Trusted Exchange Framework and Common Agreement (TEFCA) for connecting health information networks, industry stakeholders are showing concern over various elements of the framework.
In April, after receiving more than 200 comments on the first draft of TEFCA—a federally-constructed plan to jolt interoperability by creating a unified data exchange infrastructure for healthcare stakeholders—the U.S. Department of Health and Human Services (HHS) released the long-awaited second draft and a four-year funding announcement for a nonprofit Recognized Coordinating Entity (RCE) to manage the network of networks.
Many of the key changes between the first and second drafts came in direct response to issues raised by health information exchange stakeholders and the Office of the National Coordinator for Health IT’s (ONC’s) own Health Information Technology Advisory Committee, and can be read in more detail in this April article from Senior Editor David Raths.
Looking at what some of the most prominent industry stakeholders had to say this time around, following the public release of Draft 2, one issue they seem to universally agree on is confusion over how ONC’s plans dovetail with existing trust frameworks, especially ones that have invested significant time and resources in attempting to improve the nation’s health information exchange ecosystem. For example, the Electronic Health Record (EHR) Association, comprised of more than 30 health IT solution providers, said in its comments that it is “unclear how this proposal enables continued growth and support of current initiatives. We see this proposal as an independent effort, rather than complementary to existing initiatives, thus resulting in duplicative efforts that distract from current initiatives, slow progress, and creates uncertainty for all stakeholders on where to focus.”
The EHRA went on to write, “Existing private-sector exchange efforts such as Carequality, CommonWell, eHealth Exchange and networks established in different regions have come a long way, moving from how to exchange data to which types of data to exchange. We believe that building on established networks and processes like these is preferable to developing what would be essentially a duplicate framework, as is proposed in Draft 2 of TEFCA. The introduction of a new framework could prove disruptive to current levels of interoperability and/or cause a hesitancy to connect to existing initiatives until TEFCA is well established.”
The group further pointed out that Congress intended for TEFCA to be a voluntary, non-prescriptive approach to addressing governance and trust. “However, the proposed approach is more prescriptive; through both the proposed Minimum Required Terms and Conditions (MRTC) and the QHIN Technical Framework (QTF), it creates a framework parallel to existing trusted exchange frameworks/networks. Because other programs and initiatives, such as potential information blocking exceptions, might require participation in the TEFCA defined framework, this approach introduces effectively a mandatory transition to the TEFCA defined framework, contrary to Congressional intent,” the EHRA stated.
The College of Healthcare Information Management Executives (CHIME) agrees with the EHRA, noting that while much has been discussed by ONC regarding its desire about leveraging existing work underway, “Draft 2 is silent on how they anticipate this will all work together. We worry that, if not properly harmonized, this could slow down interoperability progress and distract from the work that is already underway. Vendors and providers only have so much bandwidth. It will be critical to have a clear path forward,” CHIME wrote in its letter, which was drafted in conjunction with the Association for Executives in Healthcare Information Technology (AEHIT).
CHIME and AEHIT also said they strongly support that ONC use a phased approach to rollout TEFCA, including the use of pilots. Pilots should begin with the three use cases ONC has targeted (targeted query, broadcast query and message delivery), they said. They added that the timetable changes necessary to support TEFCA “must be thoughtfully sequenced; otherwise we risk unnecessary administrative burdens and complexity.”
Further regarding proposed timelines, CHIME noted that ONC has identified 2020 as when the agency plans on releasing the first draft of the Common Agreement. If ONC finalizes its information blocking/ certification rule by January 2020 as suggested, then vendors would have until January 2022 to begin rolling out products. “Based upon the complexity associated with certified product development changes proposed by ONC, we anticipate this would take far longer than 24 months and in fact it would be preferable to have an entirely new Edition of certified technology,” the letter stated.
Also related to timing, while originally, QHINs were slated to have 12 months to update agreements and technical requirements, that timeframe was extended to 18 months in Draft 2. In response to this element, the EHRA said, “If the scope is intended to mean that within 18 months of a HIN becoming a QHIN that all technical capabilities are to be in place and all agreements with its participants and their members at the time the HIN became a QHIN are to be converted to Participants and Participant Members—with all having therefore signed the applicable ARTCs and MRTCs --then this seems unrealistic.”
CHIME also said pointed out that ONC’s and CMS’ proposed interoperability rules could require participating in a trusted health information exchange network for some stakeholders, which could include participation in a health information network that is part of TEFCA. “CHIME and AEHIT believe it is entirely premature to consider requiring participation in TEFCA when the framework has not been finalized, the Recognized Coordinating Entity (RCE) has not been selected, and the number and makeup of the Qualified Health Information Networks (QHINs) remains unknown,” the organizations wrote.
What’s more, the 16-member Health Information Technology Advisory Committee also outlined a series of recommendations itself, starting by advising that ONC align TEFCA rules and requirements with the Interoperability Rule. For instance, key definitions such as “actors” and “EHI” should be the same across both rules; “therefore, the definitions should be crafted in such a manner as to be rational and effective when applied in both the Interoperability Rule and the TEFCA contexts,” the task force wrote.
The committee also agreed with other associations on forcing stakeholders into certain initiatives, noting, “Participation in TEFCA should not be a condition of certification or requirement for information blocking requirements. It should, however, be the easiest and most direct path to address relevant requirements.”
