A core pain point that the healthcare industry has long faced is that data sharing cannot be conducted freely and without hindrance—a contradiction that was particularly prominent in the early stages of the COVID-19 response. For this reason, when the Biden administration released its long-awaited governance framework for nationwide health information exchange in January, hospitals and other health organizations generally welcomed it.

The framework, known as the Trusted Exchange Framework and Common Agreement (TEFCA), aims to enable secure information sharing between different organizations by setting legal and technical requirements.

Before long, health information networks, exchanges, and other enterprises will be able to apply to become Qualified Health Information Networks (QHINs)—that is, collections of organizations that agree to adopt the same data-sharing infrastructure, whose participants (including healthcare providers, payers, and public health agencies) will be able to interoperate health information across the United States.

Healthcare Dive spoke with Mariann Yeager about TEFCA at the HIMSS annual healthcare conference in Orlando on Monday. Yeager is the CEO of the Sequoia Project, the nonprofit organization selected in 2019 to serve as the Recognized Coordinating Entity (RCE), responsible for developing, updating, and maintaining the common agreement and overseeing the operation of QHINs.

Yeager shared more details about the TEFCA implementation timeline, why organizations should join the voluntary framework, and how the Sequoia Project and the Office of the National Coordinator for Health Information Technology (ONC) are at the beginning of a long-term process—monitoring and continuously updating a "living document." If the framework achieves widespread adoption, it could shape the landscape of U.S. health data exchange for decades to come.

"We are very proud of the work we have done," Yeager said.

1. Industry feedback is positive, but regulators are focusing on areas that need further refinement

At every stage of TEFCA's creation, the Sequoia Project and ONC held educational sessions and workshops for stakeholders. Because this feedback has been reflected in the final framework, "we have received a positive response," Yeager said.

In developing TEFCA, Sequoia and ONC sought to strike a balance between setting appropriate policy goals and accommodating the realities of the market. Yeager is confident they achieved this goal, but some details still need to be refined.

"We know that some wording sometimes needs clarification, or there may be unintended consequences. Therefore, we anticipate that, like any living, operational endeavor, it will need to be adjusted and refined as we move forward," Yeager said.

Yeager has more than two decades of experience in the health information technology field. She said there is nothing that needs major adjustment, but some subtle wording has caused confusion among stakeholders. For Sequoia, this is often the norm when establishing operational frameworks—the organization has been doing this type of work for nearly a decade.

"Even in contract language, someone may have a different understanding of a particular clause or scenario—although we try to anticipate it, or may not have received feedback on it—the way it is expressed can indeed create a need for greater clarity," Yeager said.

2. 'Strong interest': The competitive advantages of joining the system

TEFCA is entirely voluntary, so the future of the framework depends largely on industry adoption, although experts point out that the competitive advantages of joining could be a significant driver for many organizations.

Yeager told Healthcare Dive that organizations are currently evaluating whether to apply, but some networks may not want to become QHINs themselves, but rather participate as participants in a QHIN (or other variations).

"Ultimately, this is a business decision, and any organization considering applying to become a QHIN should seriously assess whether it has the capability to meet the expected requirements," Yeager said.

"Interest is very strong... Ultimately, the key is what derived value comes from participating in TEFCA—whether you are a QHIN or a participant. I think the net added value will be in facilitating and supporting information exchange for payment and healthcare operations purposes," Yeager said. "In these areas, by providing information in a more automated, standardized way, significant efficiencies can be achieved without the need for one-to-one connections or customized solutions—this is especially important for any organization serving multiple markets."

The industry hopes that the more networks that participate in TEFCA, the more its value proposition will be validated. Experts point out that the framework may reach a reasonable tipping point: when enough organizations and exchange networks join, those that are excluded will appear outdated.

"It's like anything else... It starts with early adopters who truly invest time and effort in promoting a new way of exchanging information. As you begin to gain traction, the value comes from being able to access and share information more seamlessly and simply—again, without proprietary or non-standardized point-to-point methods," Yeager said.

3. Balancing incentives and constraints

Some believe the government should do more to incentivize TEFCA participation. A health IT advisory committee has proposed various methods to promote industry participation, including requiring entities to participate in TEFCA if they want to participate in other federal programs such as Medicare or Medicaid.

ONC head Micky Tripathi has been evasive about this idea. Tripathi told Healthcare Dive last year that the goal is to empower the private sector to achieve network-level governance, but without mandating specific methods. The hope is to bring order to the market without stifling technological innovation or making enemies of regulated, well-funded health IT players.

On this issue, Sequoia has chosen to stay behind the scenes.

"This is definitely not a topic we discuss with ONC. I believe they are considering it in close consultation with federal agencies," Yeager said. "Our role is to truly focus on the operational aspects of this endeavor and how we can functionally support and advance its implementation."

"Ensuring that we build and take into account the current market conditions to deliver practical results, while also being able to evolve and innovate forward-looking, is very important," Yeager continued. "TEFCA is also, in a sense, becoming a unifying force, bringing the private sector and government onto the same page. This synchronized approach is beneficial."

4. Defining the timeline

To become a QHIN, entities must sign the Common Agreement, which establishes the infrastructure model and governance approach that helps users in different networks share information with each other under mutually agreed expectations.

The Sequoia Project will sign this 64-page contract with each new QHIN, after which QHINs will implement TEFCA policies within their respective networks.

ONC and Sequoia expect the first QHINs to come online and begin data sharing within this year. But the application process is not yet open.

"We are waiting for ONC's feedback and approval on the QHIN eligibility criteria and the standard operating procedures for designation, which will detail the step-by-step process and what applicants need to meet in order to be designated as a QHIN," Yeager said.

Yeager expects the document to be released in the second quarter of this year, allowing Sequoia to begin onboarding networks in the latter half of the quarter.

But "even after we release the application and required process, we will not accept applications for at least 60 days" to ensure networks have sufficient time to conduct due diligence and gather the necessary information, Yeager said.

"We want to ensure that we truly work with those organizations interested in seeking QHIN status, help them understand the process, and ensure that if someone applies, they understand what is involved and have thought it through—is this a good strategic fit?" Yeager said. "Do they have the capability and can they meet the standards? Then we will open the application."

5. Ordering and phasing exchange purposes

Initially, QHINs participating in TEFCA must respond to data requests for treatment and individual access purposes. Subsequently, ONC and Sequoia plan to phase in other exchange purposes such as payment, healthcare operations, public health, and government benefits determination.

Regulators say these will be rolled out in phases to ensure stakeholders have sufficient time to implement.

"Starting with requiring responses to treatment and individual access requests is a natural starting point because that is where the market is—these capabilities are widely available today. And treatment is the primary reason for information sharing today. So starting with these is entirely reasonable," Yeager said.

Currently, Carequality, an interoperability framework that is part of the RCE team, is developing implementation guides for future use cases, clarifying which subcategories are required for payment and healthcare operations, Yeager said. This includes expectations around minimum necessary data—for example, what data a QHIN should provide when a health plan requests information for payment purposes.

"There are different viewpoints. Some believe that for payment and healthcare operations purposes, all information should be shared. Others are concerned about this, or believe it may not align with HIPAA obligations," Yeager said. "So the question is achieving a certain level of precision—not extreme precision, but enough clarity—so that it is not only clear what information is shared and for which subcategory... but also so that all parties have consistent expectations about information sharing, and the party holding the information is confident that the information is being released for that purpose."

This is an area where TEFCA's developers received very consistent feedback. The initial proposal, in terms of policy direction, required payment and healthcare operations to be included in the early stages along with treatment and individual access.

This created many nuances, leading Sequoia and ONC to delay the timeline for other use cases until after the first two. However, regulators are currently drafting requirements around payment and healthcare operations use cases, Yeager said.

There is currently no specific timeline for when these requirements will be released for stakeholder feedback, but in 2022, "we are moving forward and hope to put forward an initial proposal," Yeager said.

6. The final form of TEFCA

In summary, Yeager emphasized that TEFCA is primarily a "living document" that will be continuously updated to reflect the various use cases the healthcare industry will need in the future. It demonstrates the progress the industry has made in facilitating information exchange in a relatively short period of time, although difficulties remain.

"We now have a lot of experience to draw on that we didn't have years ago. This is entirely new policy, implementation-level policy, codified into an agreement," the Sequoia Project CEO said. "I think the collective experience of our industry is truly driving TEFCA forward, and we have a more mature starting point than we did 10 years ago—when some information exchange was still in its infancy."

However, America's struggles with information exchange have received more public attention than its successes.

During the pandemic, public health agencies reported that due to the lack of standardization and fragmentation in data collection and exchange, they struggled to obtain the data needed to track new outbreaks and monitor the virus's impact. This hampered the frontline response to the pandemic and may have contributed to deaths.

If TEFCA is realized and can connect a trusted set of health information networks nationwide, it could streamline administrative burdens and help address future crises.

The framework "as it evolves and matures, aims to truly become the backbone of the critical infrastructure we rely on daily—from our healthcare to the functioning of the healthcare delivery system, to novel and innovative uses," Yeager said.

"The real opportunity here, I think, is improving preparedness for future emergencies and epidemics. And ultimately, making it easier for us to access our own information," Yeager said. "That is the real promise it holds."