ONC seeks comment on Trusted Exchange and Common Agreement

The Office of the National Coordinator for Health Information Technology convened industry stakeholders at a kick-off meeting on Monday in Washington to help develop consensus around enabling network-to-network exchange of healthcare data nationally.

Charged with supporting nationwide interoperability under the 21st Century Cures Act, Section 4003 of the law directs ONC to establish a trusted exchange framework for policies and practices as well as a common agreement for exchange between health information networks. In addition, the legislation mandated that ONC bring together public and private stakeholders to discuss those efforts.

“Medical information is extremely heterogeneous, so to just sort of say, ‘It will all connect,’ is obviously a challenge,” said National Coordinator for Health IT Donald Rucker, MD, during Monday’s initial meeting to discuss the Cures Act’s Trusted Exchange and Common Agreement.

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According to Rucker, there are use cases that must be considered in supporting the interoperable flow of health information across disparate networks: patients are able to directly get their data electronically without any special effort using an app, payers who buy healthcare in bulk—corporate America—are able to access the data, and the creation of a “modern Internet” for healthcare without “traffic toll gates” that impede data exchange.

ONC, in collaboration with the National Institute of Standards and Technology, is to provide technical assistance on how to implement the Trusted Exchange and Common Agreement including:

  • A common method for authenticating trusted health information network participants
  • A common set of rules for trusted exchange
  • Organizational and operational policies to enable the exchange of health information among networks, including minimum conditions for such exchange to occur; and
  • A process for filing and adjudicating non-compliance with the terms of the common agreement

Elise Sweeney Anthony, director of ONC’s Office of Policy, told the meeting that although trust infrastructures exist today to exchange health information electronically, the agency “knows there are several that are in place now, but we also know that there might be needs that may exist that may not be reflected” in the current environment.

“Looking at that and where there may be a disconnect—or connect—is important for us,” she said. “We know that there’s probably going to be some intense viewpoints on either side of the equation in terms of what is important for exchange (and) what pieces of the puzzle are necessary.”

“We have some paths and directions of where we need to go as we look at this,” added Rucker. “The frameworks reflect their evolution, and I’m confident that we can get to some sort of more common understanding of it—that is clearly, without doubt, the intent of Congress.”

Several organizations that currently support existing exchange frameworks presented at Monday’s meeting, including: Carequality, CARIN Alliance, CommonWell, Digital Bridge, DirectTrust, eHealth Exchange, National Association for Trusted Exchange (NATE), as well as the Strategic Health Information Exchange Collaborative (SHIEC).

“One of the things you’re seeing is how much work is already being done in the industry on security and trust frameworks from different kinds of organizations,” said David Kibbe, MD, president and CEO of DirectTrust, during his presentation to the meeting. Aaron Seib, CEO of NATE, added that “there’s a great amount of collaboration that occurs between all the folks that have been on this panel.”

Anthony referenced the fact that ONC through its “contractor” Audacious Inquiry has “gotten an idea of what the landscape looks like in terms of some of the current exchange frameworks or exchange formats that might be in place, depending on how you define them.” An ONC spokesman indicated that the analysis by Audacious Inquiry is not yet completed and that information is still being collected.

Nonetheless, Audacious Inquiry did provide a presentation at the meeting on some of the “gaps” among current trust agreements, including:

  • Some organizations limit the permitted purposes for which data can be exchanged to treatment only, while others allow broader uses (e.g. public health, operations).
  • Some have established a single set of permitted purposes that apply across all data exchanged, while others align the permitted purposes by use case.
  • Even in instances where data exchange arrangements are supporting similar use cases, they often use differing technical standards and infrastructure to enable exchange among their participants.
  • The data available for exchange among participants in an arrangement varies based on the data captured by the participants.
  • These variances in data availability and permitted purposes for the use of data uniquely inform each arrangement and may lead to conflicts across arrangements.
  • The variability of permitted participants can create concerns about the exchange of data across networks—an issue closely tied to the permitted purposes for which data can be used.

Genevieve Morris, previously a health IT senior director at Audacious Inquiry who is currently serving as ONC’s principal deputy national coordinator for HIT, said that arguably there is still a lot of work that remains to be done, given the lack of widespread interoperability.
“We need to continue to push hard towards interoperability and really advance where we’re at,” Morris noted in her concluding remarks at the meeting. “As we push forward on this work that Congress asked us to do, we are opening up a 30-day public comment period.

ONC will accept comments here until August 25 from stakeholders on how best to support or develop the Trusted Exchange Framework and Common Agreement. Morris added that the agency is specifically soliciting feedback in six topic areas: standardization, transparency, cooperation and non-discrimination, security and patient safety, access, data-driven choice, as well as a general comments category.

A listening session is slated for mid-September in the form of a public webinar and a follow-on listening session will be held later this year, according to Morris. “Sometime this winter, we will have a draft of the Trusted Exchange Framework and Common Agreement out for public comment,” she said, with the final version of the document to be released in 2018.

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