Industry Associations Line Up to Offer Comments on ONC’s TEFCA

Feb. 21, 2018
An array of healthcare IT trade groups have sent in comments offering insight and recommendations on ONC’s draft Trusted Exchange Framework and Common Agreement (TEFCA).

An array of healthcare IT trade groups have sent in comments offering insight and recommendations on ONC’s draft Trusted Exchange Framework and Common Agreement (TEFCA).

For background, last month the Department of Health and Human Services (HHS) released its draft Trusted Exchange Framework, as required by the 21st Century Cures Act of 2016. Specifically, Congress directed ONC (the Office of the National Coordinator for Health IT) in the legislation to “develop or support a trusted exchange framework, including a common agreement among health information networks nationally.”

The draft Trusted Exchange Framework, released on Jan. 5, 2018, outlines a common set of principles for trusted exchange and minimum terms and conditions for trusted exchange. This is designed to bridge the gap between providers’ and patients’ information systems and enable interoperability across disparate health information networks (HINs) by providing a “single on-ramp” to patient information, according to ONC officials. What’s more, the TEFCA will be facilitated through ONC in collaboration with a single recognized coordinating entity (RCE).

The 45-day public comment period on TEFCA has just ended, and leading associations have made their suggestions public. Following stakeholder input, and refinements to the draft document, a final draft of the combined Trusted Exchange Framework and Common Agreement will be released. Right now, although many of the organizations are broadly showing support for the effort, they all see issues that will need to be worked out.

Leaders from the Ann Arbor, Mich.-based College of Healthcare Information Management Executives (CHIME), for one, believe that the TEFCA draft timeline “is aggressive and sharply limits thoughtful input by stakeholders.” CHIME noted, “The TEFCA draft, however, creates an expansive, complex, and rather prescriptive structure that is not amenable to cursory reading or rapid consideration.”

As such, CHIME proposes that ONC opens up an additional comment period this year for the public prior to finalizing the TEFCA. However, as reported by Healthcare Informatics Senior Editor, David Raths, at the Feb. 21 meeting of the Health Information Technology Advisory Committee (HITAC), in response to a question during the meeting, ONC officials said there would not be a second round of comments on the draft TEFCA, but there will be more comment period on the common agreement later in the year.

What’s more, CHIME said that it is also worried about the timing of the forthcoming certification/ information blocking rule expected from ONC in April. “We have found it hard to offer meaningful comments without a complete picture of the policy landscape. We have heard several concerns from members and other stakeholders that while use of the Framework is voluntary pursuant to the 21st Century Cures Act, that they worry HHS could deem providers data blockers if they are not using TEFCA,” CHIME wrote in its comments.

Regarding the RCE, which ONC has said will be tasked with operationalizing the Trusted Exchange Framework, and which will have responsibilities such as overseeing security in the network, CHIME said it should be a “broad-based, neutral entity that is a not for profit with multi-stakeholder representation—to include the provider community—on its board.” And rather than naming the RCE this spring, as intended, given its central role in the process, CHIME urges that the selection process not be hurried.

Expressing similar concerns to CHIME, the Charlotte, N.C.-based Premier said that the final TEFCA “must explain when and how other 21st Century Cures provisions (i.e., application programming interfaces (APIs), information blocking and registries) will be implemented and harmonized with the TEFCA since they are interrelated and interdependent.”

Regarding the RCE, Premier said “ONC must ensure that the RCE governance and operational processes are transparent and include multi-stakeholder oversight,” and that “the final TEFCA must include an RCE evaluation strategy, approach and process.” Premier further said that “ONC needs to better articulate specific roles and responsibilities of different types of QHINs [qualified health information networks], their participants and end users.”

Additionally, the Bethesda, Md.-based American Medical Informatics Association (AMIA), urged federal officials to develop a comprehensive timeline, which includes establishment of pilots for specific aspects of the TEFCA, and they challenged ONC to establish a “share first, structure later” data policy, so that important data elements are not trapped behind siloed systems.

AMIA recommended that ONC develop a roadmap that details an implementation plan at least three years into the future and ONC should establish specific pilot tests to inform this implementation plan. AMIA also urged ONC to seek feedback from the wider stakeholder community as the roadmap is implemented, and they requested that the lead coordinating body, the RCE, be required to hold open comment periods, listening sessions, and other accountability mechanisms.

The Pew Charitable Trusts, meanwhile, focused on patient matching in its comments. It said that “The draft TEFCA recognizes accurate patient matching as essential for electronic health information exchange: QHIN participants need to ensure some patient demographic data is used.” To this end, Pew noted that two provisions in the draft TEFCA could also help improve patient matching through the consistent use of demographic data and identity proofing.

In the meantime, while the TEFCA comments poured in, at today’s HITAC meeting, two new task forces outlined their charges and time frames, as reported by Raths. The Trusted Exchange Framework Task Force will make recommendations on the language of the TEFCA surrounding the RCE and the requirements for QHINs. It will provide feedback on the six permitted purposed for disclosure and three use cases identified, as well as standards and technical requirements that ONC should specify for identity proofing and authentication, particularly of individuals. With a fast-paced timeline for its work, the Task Force plans to present its recommendations to the full HITAC on March 21.

What’s more, the U.S. Core Data for Interoperability Task Force will provide recommendations on mechanisms/approaches to receive stakeholder feedback regarding which data classes to prioritize in the future. Version 1.0 included the common clinical data set plus provider notes and provenance. The task force plans to make final recommendations on April 18.

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