A draft framework developed by the Office of the National Coordinator for Health IT meant to help achieve nationwide interoperability across disparate health information networks is counterproductive, according to prominent HIT experts.

Released this past January, the Trusted Exchange Framework and Common Agreement (TEFCA) is designed to support nationwide interoperability by outlining a common set of principles, as well as minimum terms and conditions for trusted data exchange.

“It will seek to scale interoperability nationwide and enable participating networks to work together to provide an on-ramp to electronic health information regardless of what health IT developer a provider uses, health information exchange or network a provider contracts with, or how far across the country the patients’ medical records are located,” wrote National Coordinator for HIT Donald Rucker, MD, in a blog post last month.

“This means patients who have received care from multiple doctors and hospitals should have their medical history electronically accessible on demand by any other treating provider in a network that signed the Common Agreement,” Rucker added.

Part A of the TEFCA, the principles for trusted exchange, provides a set of core principles by which qualified health information networks—as well as all HINs—and data sharing arrangements for data exchange should abide. Part B aligns to and builds on these principles to address a minimum set of terms and conditions to enable network-to-network exchange of electronic health information.

“Part A good, Part B not so much,” says John Halamka, MD, chief information officer at Boston’s Beth Israel Deaconess Medical Center. TEFCA “tries to give us a set of common guidelines and policies—and that’s actually okay—the problem is that Part B dictates the technologies we should use to accomplish this, and that’s just not okay.”

John Halamka, MD, (left) talks to Henry Feldman, MD, at Beth Israel Deaconess Medical Center
John Halamka, MD, (left) talks to Henry Feldman, MD, at Beth Israel Deaconess Medical Center

According to Halamka, government entities such as ONC could never “predict or control” the technologies necessary to facilitate interoperability. “I believe the role of government is to align incentives to achieve a desired outcome rather than specify how that outcome is to be achieved,” adds Halamka. “Part A of TEFCA outlines the what, Part B outlines the how. As written, Part B suggests specific standards, which may not be suitable for purpose in 2018 since they are very old.”

While Micky Tripathi, president and CEO of the Massachusetts eHealth Collaborative, believes standards are important, he questions the appropriateness of the “invocation of very proscriptive, detailed technical standards in a federal regulation,” calling it a “regulatory wet blanket” and asks “why don’t we just let CommonWell, Carequality and the networks figure out what are the best standards?”

In addition, Tripathi points out that the draft TEFCA includes “old, very cumbersome standards” from the Integrating the Healthcare Enterprise (IHE) interoperability initiative. For instance, IHE’s Cross-enterprise Document Sharing (XDS) is an interoperability profile for exchanging medical documents that facilitates the registration, distribution and access across health enterprises of patient electronic health records.

“Developers won’t touch those things with a 10-foot pole,” adds Tripathi, who is manager of the Argonaut Project, an industry-wide effort to accelerate the development and adoption of HL7’s emerging Fast Healthcare Interoperability Resources (FHIR) standard that leverages RESTful web services.

“I agree that IHE specifications are old, and I would love to not have to use them—but, that is where the industry is at right now,” acknowledges Genevieve Morris, ONC’s principal deputy national coordinator. “There are no newer specs for exchanging a document, other than the FHIR implementation guide for documents or being able to do it under our certification program—which doesn’t specify FHIR as the requirement for the document exchange but most folks have used that.”

Halamka observes that while “TEFCA has its problems,” Part B of the document does include HL7’s FHIR standard. “Part B lists many standards,” he notes. “Maybe a better way to say it is that FHIR enables many new possibilities, rendering a number of historical approaches obsolete.”

Stan Huff, MD, chief medical informatics officer at Intermountain Healthcare, and a strong supporter of FHIR, agrees with Halamka’s and Tripathi’s assessments.

“Some of the technologies in Part B are very old, and better solutions are forthcoming,” says Huff. “Putting explicit technology requirements in the document will slow the development and implementation of new technical solutions. Also, though many pieces of the proposed technology have been proven in working systems, the set of solutions has not been tested as an integrated whole, so there is a risk that the envisioned environment will not be fast, efficient and maintainable.”

Overall, Huff contends that there are “too many untested and complex processes” in the TEFCA, noting that he is “in favor of piloting the whole set of recommendations at scale across enterprises before we mandate the proposed solution on the country.”

“We did hear from a lot of folks that a legal agreement is not really the best place for specific standards,” says Morris. “We happen to agree with that criticism, and we’ve stated very publicly already that we’re looking to move towards implementation guides for the standards that would be used by networks that adopt the TEFCA.”

Part B includes the minimum required terms and conditions for trusted exchange that a Recognized Coordinating Entity (RCE)—selected through a competitive process—will use to develop a single common agreement that qualified health information networks and their participants will voluntarily agree to adopt.

“We tried our best not to specify legal terms and conditions in areas where the industry has figured out or primarily agrees on those terms and conditions—and really tried hard to focus Part B on the areas of variation that exist between the agreements that are out there today,” adds Morris.

An ONC spokesman said that the agency received more than 200 comments in response to the draft Trusted Exchange Framework and that stakeholders “mostly loved” the document.

Also See: Groups weigh in on ONC data exchange plan

“Our team has been carefully reviewing all of the comments to ensure we understand concerns and suggestions and expect to update the next version of the Trusted Exchange Framework to reflect that feedback,” according to Rucker.

The final TEFCA will include Parts A and B—as well as the common agreement—and is slated to go out for public comment in late 2018.

“At the end of the day, what we want is for every provider who has an EHR system to have a network that they can join that will enable them to exchange records and find data on their patients no matter where their patients went for care,” concludes Morris. “There are large areas of our country right now that are not covered by a network and have very little options for exchange, other than Direct.”

However, Tripathi comments that if TEFCA “is what it means to be serious about interoperability, then I wish (ONC) wasn’t serious about interoperability, because it will stifle rather enhance it.”

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