The Office of the National Coordinator for Health Information Technology has unveiled the Trusted Exchange Framework and Common Agreement, an interoperability project mandated as part of the 21st Century Cures Act.
A document ONC and interoperability not-for-profit organization Sequoia Project published Tuesday outlines the legal and technical principles for a network enabling state, regional and national health information networks to share data.
Health information networks will be able to apply to become participating organizations that facilitate data exchange throughout the TEFCA network later this year, possibly as soon as this quarter, ONC previously indicated.
TEFCA is "critical to realizing the 21st Century Cures Act's goal of a secure, nationwide health information exchange infrastructure," ONC chief Micky Tripathi said in a news release. "Simplified nationwide connectivity for providers, health plans, individuals and public health is finally within reach."
TEFCA, which is voluntary, establishes federally recognized data-sharing standards for health information networks. Health information networks designated as "qualified health information networks," or QHINs, will connect with one another and route data requests and responses among providers and health plans.
TEFCA comprises two main components. The first is a "Trusted Exchange Framework" that designates shared standards for qualified health information networks. The second is the "Common Agreement," a contract participating networks sign with the Sequoia Project. ONC tapped the Sequoia Project to develop and implement TEFCA in 2019.
Essentially, TEFCA serves as "commonly agreed to rules of the road" for health information networks across the U.S., according to the ONC news release. That includes technical standards related to privacy and security as well as approaches to identify network participants and patients before exchanging data.
"The release of TEFCA today marks the beginning of the implementation phase," Sequoia Project CEO Mariann Yeager said in the news release. "We look forward to supporting everyone as they review the Common Agreement and identify their role in this new public-private paradigm advancing health information exchange nationwide."
ONC and the Sequoia Project want to give health information networks interested in participating in TEFCA at least 90 days to review materials and assess whether they plan to apply, Yeager said during a call with health IT stakeholders Tuesday. The organizations plan to begin accepting applications in the second quarter, she said.
The first group of TEFCA participants could start exchanging data as early as the fourth quarter, Yeager said. ONC and the Sequoia Project will consider applications on a rolling basis. In July, ONC indicated the TEFCA network would open for participation during the first quarter.
Nearly 70% of hospitals participated in at least one national health information network in 2019, according to a data brief ONC published last year. Nearly half of hospitals used more than one national network and 53% used a state, regional or local health information network to search for patient data.
Under TEFCA, healthcare organizations and patients will be able to request data on treatment, payment, healthcare operations, public health, government benefits determinations and individual access services. Under an initial set of standard operating procedures that hasn't been released, participants will be required to respond to treatment and patient access requests. Requests for information in the other four categories will require responses in the future when ONC and the Sequoia Project release further implementation guidelines.
"We want folks to participate in TEFCA," Yeager said on the call. "That means being incremental. We need to meet the market where it is and where folks are going to be willing to exchange."
TEFCA may someday be mandatory for providers and insurers participating in federal health programs, but it's too early to discuss incentives or disincentives ONC could create to encourage participation, Tripathi on a call with reporters Tuesday. ONC is working with other federal agencies such as the Centers for Medicare and Medicaid Services and the Centers for Disease Control and Prevention, he said.
The Cures Act, legislation President Barack Obama enacted in 2016, requires ONC to develop TEFCA. The agency published two drafts of the policy during President Donald Trump's term, and ONC further revised it after President Joe Biden took office.
In conjunction with the framework's release, the Sequoia Project released a three-year roadmap for how TEFCA will adopt Fast Healthcare Interoperability Resources, a popular data-sharing standard also known as FHIR. This standard works in conjunction with ONC and the Centers for Medicare and Medicaid Services' companion interoperability regulations, which took effect last year.
The Sequoia Project soon plans to create working groups that will develop ways to incorporate Fast Healthcare Interoperability Resources into the Common Agreement and intends to including Fast Healthcare Interoperability Resources as an optional, additional standard for qualified health information networks next year. The Sequoia Project expects to make Fast Healthcare Interoperability Resources a required capability in 2024.
That preliminary timeline will likely be adjusted as the Sequoia Project evaluates feedback, implementation experiences and market needs, according to the organization.
"The healthcare information technology landscape continues to evolve and TEFCA will have to evolve with it in order to continue to add value and, more important, to avoid holding back industry progress," the Fast Healthcare Interoperability Resources roadmap says.
This article has been updated with quotations from leaders of the Sequoia Project and the Office of the National Coordinator for Health Information Technology and with additional information about the application process.