ONC extends comment period for interoperability rules, updates TEFCA

The extension had been sought by many industry groups, who see the proposed rules as "too important to not get right." Draft two of the Trusted Exchange Framework and Common Agreement is now also open for comment.
By Mike Miliard
12:12 PM

National Coordinator for Health IT Dr. Donald Rucker

The Office of the National Coordinator for Health IT made interoperability news on several fronts Friday: granting a much-requested 30-day extension for public comments on its proposed data exchange, information blocking and patient access rules and publishing the second draft of its Trusted Exchange Framework and Common Agreement.

WHY IT MATTERS
ONC says the new due date for public comments, now June 3, will allow additional time for the public to review the proposed rules.

"The Centers for Medicare & Medicaid Services and ONC understand that both rules include a range of issues having major effects on healthcare," the agency noted. "The extension of the public comment deadline will maximize the opportunity for meaningful input and further the overall objective to obtain public input on the proposed provisions to move the healthcare ecosystem in the direction of interoperability."

Healthcare industry groups such as Premier, which had requested the extension alongside organizations such as CHIME, AMA, MGMA, AHIMA and others in March, immediately applauded the move, saying the ONC regs are "too important to not get right."

Stakeholders now have plenty of regulations to digest, as ONC on April 19 also published the second draft of its Trusted Exchange Framework and Common Agreement for public comment, meant to advance nationwide, network-to-network exchange of health information.

"Specifically, the documents being released for comment are: (1) a second draft of the Trusted Exchange Framework, (2) a second draft of the Minimum Required Terms and Conditions for trusted exchange, and a first draft of a Qualified Health Information Network Technical Framework," ONC explained. "These documents will form the basis of a single Common Agreement that QHINs and their participants may adopt."

This goal of the common agreement is to "create baseline technical and legal requirements for sharing electronic health information on a nationwide scale across disparate networks," according to the ONC, which is focused on three goals: providing a single "on-ramp" for system connectivity across the country; ensuring that electronic health data flows freely where and when it's needed, and making sure that connectivity is scalable nationwide.

The public comment period on the TEF, MRTCs, and QHIN Technical Framework ends on June 17, 2019.

"We expect that the implementation of the Trusted Exchange Framework and the Common Agreement, will bring us all that much closer to achieving the administration’s goals of nationwide interoperability," said National Coordinator for Health IT Dr. Donald Rucker.

THE LARGER TREND
In an interview with Healthcare IT News earlier this month, Rucker had initially said that the comment period on the proposed interoperability rules – which was originally scheduled to close on May 3 – would not be extended.

"The issue with delay is you have to balance whatever additional input you might get, versus the impact on the public from the delay," he explained.

But Rucker noted the importance of public feedback, and said that every comment on the rules is read and considered.

"Under the Administrative Procedure Act, with a notice of proposed rulemaking there is an entire process of analyzing everybody's comments," he explained. "They're all read. When I used to be on the other side of the fence, writing comments, I was always wondering, is anyone going to read what we've spent so much effort putting together? But they're all read, are all processed and then, where there should be changes in the public interest, we incorporate those, and that goes through another large internal clearance process before the final rule."

ONC's extension of the comment period would seem to be a recognition of the importance of the rules, which should have sweeping implications for the continuing evolution of healthcare interoperability at a pivotal moment.

As Dr. Doug Fridsma, CEO of AMIA and former chief scientist at ONC told us this month, his organization takes the public comment process very seriously.

"We as an organization have developed three response teams that are meeting every week for the next five weeks," he said. "So we've got kind of about 30 hours of work from our members, times about 30 or 40 members. So we'll have a lot of eyes and thought into this. I'm hopeful that we'll be able to produce something that is thoughtful and constructive, because this is really what's going to define health information exchange and the health IT space for the next five to 10 years."

ON THE RECORD
The two proposed rules, which follow the interoperability mandates of the 21st Cures Act, were first published at the outset of HIMSS19 on February 11. They're meant to "increase choice and competition while fostering innovation that promotes patient electronic access to and control over their health information," according to ONC.

"Together the proposed rules address both technical and healthcare industry factors that create barriers to the interoperability of health information and limit a patient’s ability to access essential health information. Addressing those challenges will help to drive an interoperable health IT infrastructure across systems, enabling healthcare providers and patients to have access to health data when and where it is needed.

For evidence of the importance of public feedback when it comes to rule shaping, Rucker noted that the updated draft of TEFCA came after ONC "considered the more than 200 comments we received on our previous draft," and incorporate suggested changes such as the updating the purposes for which information can be exchanged, adding a "push" method of data exchange, adding a technical framework for QHINs, and extending timelines for participating entities to implement changes that will be required by the Common Agreement.

The future agreement, said Rucker, "will provide the governance necessary to meet the interoperability demands of diverse stakeholders, including patients, healthcare providers, and health plans."

Twitter: @MikeMiliardHITN
Email the writer: mike.miliard@himssmedia.com

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