Free, unfettered data sharing remains a major pain point in the healthcare industry, something that was highlighted in the early months of the COVID-19 response. So hospitals and other health organizations cheered when the Biden administration in January released a much-anticipated governance framework for nationwide health information exchange.

That framework, the Trusted Exchange Framework and the Common Agreement (TEFCA), is meant to create legal and technical requirements to enable secure information sharing across different entities.

Soon, health information networks, exchanges and other companies will be able to apply to become qualified health information networks (QHINs), or groupings of organizations that agree to the same data-sharing infrastructure so that their participants, including providers, payers and public health agencies, will be able exchange health information across the U.S.

Healthcare Dive caught up with Mariann Yeager to talk TEFCA at the HIMSS annual healthcare conference in Orlando on Monday. Yeager is CEO of the Sequoia Project, a nonprofit that was selected in 2019 to serve as the recognized coordinating entity (RCE) charged with developing, updating and maintaining the common agreement and overseeing QHINs.

Yeager shared more details on the timeline of TEFCA implementation, why organizations should join the voluntary framework and how the Sequoia Project and the Office of the National Coordinator for Health IT are at the beginning of a long process of monitoring and modernizing a living document that, given uptake, could shape the future of health data exchange for decades into the future.

"We're really proud of the work that we've done," Yeager said.

1. Industry feedback has been positive, but regulators are zeroing in on areas for further refinement

   The Sequoia Project and ONC have been undergoing educational sessions and workshops for stakeholders at every step of TEFCA's creation. Because that feedback was reflected in the final framework, "we have had positive response," Yeager said.

   In shaping TEFCA, Sequoia and ONC set out to strike a strong balance of setting the right policy goals while meeting the market where it is. That's something Yeager is sure they achieved. But there are still some details to iron out.

   "We know that some language sometimes needs clarification, or maybe there was an unintended consequence. And so, we're anticipating just like any living, breathing, operational endeavor that you tweak and refine as you go," Yeager said.

   Yeager, who has more than two decades of experience in the health information technology field, said nothing big needed adjusting, but some small wordings have created confusion among stakeholders. That's often par for the course when it comes to standing up operational frameworks, something Sequoia has done for almost a decade.

   "Even in contract language, someone might have a read of it or a certain scenario that — while we tried to contemplate it or maybe didn't get feedback — that the way it's expressed can create a need for improved clarity," Yeager said.

2. 'There is a lot of interest': competitive advantages to joining the club

   TEFCA is entirely voluntary, so the framework's future hinges largely on industry buy-in, though experts say the competitive advantages to joining could be a significant motivator for many companies.

   Yeager told Healthcare Dive that entities are currently evaluating whether to apply, though some networks may not want to be QHINs themselves, but a participant in a QHIN (or some other variation of that).

   "It's really ultimately a business decision, and one in which any organization that's contemplating applying to be a QHIN should really take into account to have the competency to meet what's expected," Yeager said.

   "There is a lot of interest ... it really comes down to what is the derivative value that participating in TEFCA, whether you're a QHIN or a participant respectively, brings to bear. I think that the net new would be facilitating and supporting the exchange of information for payment and healthcare operations purpose," Yeager said. "Those are areas where there could be really significant improved efficiencies, by having information provided in a more automated way, in a standardized way that you don't have to do one-off connections or approaches, and that — particularly for any organization that services more than one market — is really important."

   The hope is that the more networks decide to participate in TEFCA, the more its value proposition will be proved. The framework could reach a logical inflection point, where if enough entities and exchanges join, the ones that are left out will seem outdated, experts have said.

   "It's like anything ... you start with early adopters, and they really invest their time and energy in rolling out a new approach for information exchange. And as you start to get traction, and the value will be derived from the ability to more seamlessly and simply access and share information, again, without having to do one-off point-to-point approaches that are proprietary or non-standardized," Yeager said.

3. Carrots and sticks

   Some think the government should be doing more to incentivize participation in TEFCA. One health IT advisory board has floated various methods of getting industry on board, including requiring entities to participate in TEFCA if they also want to participate in other federal programs, like Medicare or Medicaid.

   That idea is something ONC head Micky Tripathi has shied away from. Tripathi told Healthcare Dive last year that the goal is to empower the private sector to get to network-level governance, but not be prescriptive about how. The desire is to strike a balance between bringing order to the market without suppressing technical innovation, or making enemies of the deep-pocketed health IT players being regulated.

   The issue is one that Sequoia has taken a backseat on.

   "That is definitely not a conversation that we have with ONC. That's something I'm sure they're considering in close consideration with federal agencies," Yeager said. "Our role is really looking at the business of this and functionally how we're going to support and roll it out."

   "It was really important to make sure that we build and take into account where the market is to deliver something that is viable, and we can be forward looking and evolve and innovate," Yeager continued. "TEFCA is also being sort of a unifying force that brings together private sector and government on the same page. And that synchronous approach is helpful."

4. Defining a timeline

   In order to become QHINs, entities have to sign onto the Common Agreement, which establishes the infrastructure model and governing approach to help users in different networks share information with each other, under commonly agreed-to expectations.

   The Sequoia Project will sign the 64-page contract with each new QHIN, which will then execute TEFCA policies within their own networks.

   ONC and Sequoia anticipate initial QHINs will onboard the network and begin data sharing this year. But the application process isn't open yet.

   "We are waiting to get ONC's feedback and approval of the QHIN eligibility criteria and the designation standard operating procedure, which lays out the step-by-step process, and what someone who applies would need to satisfied be designated a QHIN," Yeager said.

   The executive expects that to be published in the second quarter this year, allowing Sequoia to begin onboarding networks in the latter part of the quarter.

   But, "even once we publish the application, and the process they would need to go through, we are not going to accept applications for at least 60 days" to ensure networks have ample time to do due diligence and gather the information they need, Yeager said.

   "We want to make sure that we're really working with those who are interested in seeking QHIN status, to help them understand the process and make sure that, if someone does apply that they understand what's involved, they've gone through the consideration of — is it a good strategic fit?" Yeager said, "Do they have the competencies, can they meet the criteria? And then we'll open it up for applications."

5. Exchange purpose order and rollout

   To start, QHINs participating in TEFCA will have to respond to requests for data for treatment and individual access purposes. Then, over time, ONC and Sequoia plan to phase in other exchange purposes of payment, healthcare operations, public health and government benefits determination.

   Regulators have said these will be rolled out sporadically, to make sure stakeholders have enough time to implement them.

   But, "starting with requiring responses for treatment and individual access was a natural starting point, because that's really where the market is, these capabilities exist widely today. And treatment is the most predominant reason that information is being shared today. And so that made total sense to start with those," Yeager said.

   Currently, Carequality — an interoperability framework that's part of the RCE team — is working on an implementation guide for future use cases, spelling out which subcategories of payment and healthcare operations are needed, according to Yeager. That includes expectations around minimum necessary data, or what data QHINs are expected to provide when a health plan requests information for payment purposes, for example.

   "There are different views. Some view that well, you should just share all the information you have for payment and healthcare operations. And there are others that are concerned about that or feel that that somehow might not be in keeping with our obligations under HIPAA," Yeager said. "So it's getting to that level of, not super precision, but getting precise enough to specify so that there is not only an understanding of what information is being shared, and for what subcategory ... so that there are a common set of expectations across the board, and that there is confidence and a level of comfort, that those who have the information were released it for that purpose."

   It's an area where TEFCA's creators received very consistent stakeholder feedback. The original proposal, from a policy direction, was to require payment and healthcare operations out of the gate, along with treatment and individual access.

   That was something that created a lot of nuance, resulting in Sequoia and ONC pushing back the timeline for other use cases beyond the original two. However, regulators are currently drafting requirements around the payment and healthcare operations use cases, Yeager said.

   There isn't a specific timeline for when those will be released for stakeholder feedback, but in 2022, "we're working on it and we hope to have an initial proposal, Yeager said.

6. TEFCA's final form

   All in all, TEFCA is predominantly a living document that will be updated constantly to reflect whatever use cases healthcare needs down the line, Yeager stressed. It serves as an example of the strides industry has made in facilitating exchange in a relatively short period of time, despite the ongoing difficulties.

   "We have a lot to draw from now that years ago, we didn't. It was really wholesale new policy, implementation level policies, codified in an agreement," said the Sequoia Project CEO. "I think that our collective experiences in industry is really fueling TEFCA that we're having a much more mature starting point than we might had have, say 10 years ago, when some of this information exchange was more in its nascent stage."

   But the U.S.' struggles with information exchange have been in the public eye more than its successes.

   During the pandemic, public health agencies reported difficulties getting the data they needed to track new outbreaks and survey the virus' effects, due to unstandardized and patchwork data collection and exchange. That hurt the frontline response to the pandemic and likely contributed to deaths.

   If TEFCA is brought to fruition and is able to connect a set of trusted health information networks around the nation, it could streamline administrative burden and help in responding to future crises.

   The framework, "as it evolves and matures, is designed to really serve as a backbone and part of the critical infrastructure that we rely on for everyday purposes, from our healthcare to the operation of the healthcare delivery system, in novel and innovative purposes," Yeager said.

   "The true opportunity here, I think, is improved preparedness for future emergencies and pandemics. And then ultimately, to make it much easier for us to access our own information," Yeager said. "And that's the promise that it really brings."