Seven years in the making, a nationwide network to exchange patient data called the Trusted Exchange Framework and Common Agreement is now operational, marking a critical step in establishing universal connectivity across providers.

The interoperability framework, called TEFCA, was mandated by the 21st Century Cures Act back in 2016 and was designed to create an infrastructure to enable data sharing between health information networks.

The framework provides the policies, procedures and technical standards necessary to exchange patient records and health information between providers, state and regional health information exchanges and federal agencies.

"In many ways, I feel like we're watching the Big Bang occur in 2023," said Health and Human Services (HHS) Secretary Xavier Becerra said during an event held at HHS headquarters in Washington, D.C. on Tuesday.

“After over a decade of very hard work, today marks another major milestone in our march towards a 21st century digital healthcare system,” said Secretary Becerra. “TEFCA allows patients, providers, public health professionals, health insurers, and other healthcare stakeholders to safely and securely share information critical to the health of our country and all of our people.”

Healthcare leaders attending the HHS event said the TEFCA network will enable clinicians and patients to have access to critical medical records at the time of care, regardless of EHR vendor, while also addressing health equity.

The leaders also urged providers across the country to get on board and join the TEFCA network.

"There continue to be gaps in the U.S. to achieving universal interoperability," said Rob Klootwyk, director of interoperability for Epic Nexus, a subsidiary of Epic, during the HHS event. "We all need to continue those efforts to close those gaps by engaging every physician in this country to become a participant in TEFCA. For them, TEFCA will be the single on-ramp to nationwide interoperability."

In a Health Affairs Forefront blog, Micky Tripathi, Ph.D., national coordinator for health information technology and Mariann Yeager, CEO of The Sequoia Project, said TEFCA, going live marks "one of the most important milestones in our nation’s digital health history."

As a result, patients will have increased access to their records, and healthcare providers and plans can improve their secure exchange of electronic health information, they wrote.

"The Cures Act directed ONC to develop a model of stitching together the various clinical data-sharing networks that exist across the country today," HHS Deputy Secretary Andrea Palm said during the event. "A network of networks, if you will. The result of the Cares Act directive is TEFCA, the trusted exchange framework and common agreement. TEFCA makes the very complex accessible to everyone. It defines a common technical framework and exchange policies to connect networks so electronic records can flow seamlessly and patients can access their medical histories from anywhere."

Palm noted that high-quality, reliable, shareable data is a critical piece behind the Biden-Harris administration's efforts to improve service delivery and customer experience for patients. "We can accelerate progress on priority health-related data initiatives such as our Cancer Moonshot work, our work in the behavioral health space, while also bringing human services data, a piece that has lagged for far too long, up to speed and into this conversation," she said.

ONC led a multi-year, public-private process alongside The Sequoia Project, named the Recognized Coordinating Entity (RCE) for the project, to implement TEFCA.

Earlier this year, ONC unveiled the first cohort of companies approved to begin onboarding as Qualified Health Information Networks (QHINs).These networks will connect to one another to support health information exchange nationwide.

At an event in February, Becerra recognized and congratulated CommonWell Health Alliance, eHealth Exchange, Epic Nexus, Health Gorilla, Kno2, and KONZA for voluntarily stepping up and meeting the rigorous TEFCA eligibility requirements and the terms and conditions of TEFCA participation. A seventh QHIN, MedAllies, was approved a short time later.

Five organizations were officially designated as QHINs during the HHS event on Tuesday—eHealth Exchange, Epic Nexus, Health Gorilla, KONZA and MedAllies. Those five organizations have gone live with TEFCA exchange, and the remaining two are completing their implementations, according to Tripathi and Yeager in the blog post.

These designated QHINs can immediately begin supporting the exchange of data under the Common Agreement’s policies and technical requirements, according to ONC.

With the go-live, ONC and the Sequoia Project are "turning the corner from developing the TEFCA rules of the road to overseeing operational exchange among a growing number of healthcare entities,"

QHINs are the pillars of TEFCA network-to-network exchange, providing shared services and governance to securely route queries, responses, and messages across networks for eligible participants including patients, providers, hospitals, health systems, payers and public health agencies.

"Collectively, these QHINs have networks that cover most U.S. hospitals and tens of thousands of providers; they process billions of annual transactions across all fifty states. With these QHINs working together under TEFCA, their users will now be able to connect with each other, regardless of which network they’re in," Tripathi and Yeager wrote.

“Designating these first QHINs is just the beginning. Now, we hope to see the rapid expansion of TEFCA exchange as these pioneering networks roll-out the benefits of TEFCA to their customers and members, while additional QHINs continue to onboard," Yeager said.

The network is expected to start operating in the first quarter of 2024.

The Trusted Exchange Framework is a set of nonbinding but foundational health information exchange principles, while The Common Agreement sets up the technical infrastructure and governing approach to support data exchange—all under commonly agreed-to rules-of-the-road. The Common Agreement includes support for treatment, payment, healthcare operations, individual access services, public health and government benefits determination.

The network Common Agreement Version 2.0, which is anticipated to include enhancements and updates to require support for Health Level Seven (HL7) Fast Healthcare Interoperability Resources (FHIR) based transactions, is actively under development and scheduled to be adopted by the QHINs in early 2024, ONC said.

"When clinicians can easily exchange information they can see the full medical history of their patients and provide that best care. TEFCA is bringing clarity to this country by aligning all the regional efforts under a federally endorsed framework," Epic Nexus' Klootwyk said.

Epic customers, including 498 hospitals, have already pledged to join TEFCA.

"As of this week, over 200 hospitals and around 3,000 clinics that use Epic plan to be early adopters of this framework," Klootwyk said during the event. "At full rollout, we do expect to help around 2,700 hospitals and 70,000 clinics go live on TEFCA."

He added, "And to me, a critical mass of providers adopting TEFCA as soon as possible is the key to TEFCA's success. So, I'm excited for the day when every provider in this country can answer the question 'Are you part of TEFCA?' with a resounding 'Yes.'"

About 30% of U.S. hospitals still don’t connect to a health information network, according to ONC data.

"What's going to happen with TEFCA, it's going to expand the systems that those hospitals are on and small providers are on and allow for a big jump in getting into much more universal connectivity," said A. John Blair, III, M.D, CEO of MedAllies, during the event.

"The biggest difference that I see in TEFCA relative to everything that came before, which was successful up to a point, but I think what it lacked was complete unity between the public sector and the private sector and driving forward all of our efforts combined in one direction. That's the opportunity that we have with TEFCA to build on all the work that has come before but now be unified, create the signal on-ramp," said Dave Cassel, chief customer officer at Health Gorilla.

However, Cassel noted there is the potential for a "chicken and egg problem."

"There could be so much value, but only if people are actually in it. It's hugely important to have those of us who have dedicated our careers and our lives to interoperability to get behind this and become early adopters to provide that value that then is going to allow this to take off very quickly," he said. 

ONC officials touted for the opportunities for the TEFCA public-private collaboration to address the gaps in interoperability beyond treatment exchange that have been too difficult for the private sector to tackle without public sector participation.

ONC is working with the Centers for Disease Control and Prevention (CDC) and the public health community to launch the first state/local public health agency production sites for key use cases, such as electronic case reporting, in the first half of 2024, Tripathi and Yeager said.

TEFCA also is critical to widespread scalability of FHIR-based exchange, which will help to drive payer-provider interoperability, they noted.