The health IT industry cheered on Tuesday when the Biden administration released a final draft of a framework for nationwide data exchange after an extended stint in regulatory purgatory, with the goal of creating a simple and standard connectivity infrastructure for providers, plans, patients and public health agencies in the U.S.
But the future of that road map, called the Trusted Exchange Framework and Common Agreement, hinges largely around adoption.
TEFCA is entirely voluntary, and will succeed or fail wholly depending on industry buy-in — historically, not a good prospect for a piece of health IT regulation — though experts note the competitive advantages to joining TEFCA could be a significant motivator.
Currently, to send and receive patient information and other data, stakeholders like payers, providers and public health groups have to join multiple health information networks, many of which don't share data with each other.
According to ONC, almost half of U.S. hospitals participate in more than one such network, resulting in significantly higher administrative overhead and network fees.
The goal of TEFCA is to get rid of individual legal agreements between health information networks, health plans, providers and other entities by instituting one common agreement that qualified networks and their participants sign onto, paring back on administrative burden. The framework standardizes the operational side of data exchange, while raising the privacy and security bar for entities that want to be certified as qualified health information networks (QHINs), groups of organizations that agree to the same data-sharing infrastructure.
TEFCA will bolster other interoperability regulations from CMS and ONC, and should cut down on debates over the operational side of interoperability, experts say, while having the benefit of leaning heavily on existing law, including the HIPAA privacy legislation.
It's composed of two parts: the Trusted Exchange Framework, which describes a set of principles for data-sharing across health information networks; and the Common Agreement, a legal contract signed by QHINs.
To start, QHINs participating in the common agreement will agree to respond to requests for data for treatment and individual access services (essentially, people requesting their own data). Other exchange purposes that ONC plans to phase in over time are payment, healthcare operations, public health and government benefits determination.
ONC said these will be rolled out sporadically to ensure stakeholders have enough time to implement them. The agency and its private-sector partner in developing and maintaining TEFCA, the Sequoia Project, haven't set dates, but all six exchange purposes could be implemented by the end of 2023, according to Lee Barrett, CEO of EHR standards development organization EHNAC.
The initial six purposes cover the large majority of issues, but there are additional exchange purposes ONC could consider, experts say. One thing that may be worth looking into adding is health oversight, allowing for data exchange for the purpose of state agency oversight of its insurance system through TEFCA, according to Lucia Savage, chief privacy and regulatory officer at Omada Health.
But "making other ones like responding to a subpoena in a personal injury case — the volume is low enough that you don't need to do it through TEFCA," Savage said.
Getting a nationwide network of groups of organizations that agree to the same data-sharing infrastructure could significantly streamline patient care across different geographies.
For example, if a patient from Virginia takes a vacation to California and ends up in an emergency room, doctors currently do the best they can to treat them without their medical record, which can contain valuable information about preexisting conditions, allergies and other health factors. But with a nationwide QHIN infrastructure, clinicians can query all participating networks for that patient's data and use it to inform their clinical choices, Barrett said.
That budding future all centers on buy-in.
Having participated in lots of contract negotiations, "there are reasons why people look to common agreements and reasons why people reject common agreements," Savage said.
Savage pointed to the Data Use and Reciprocal Support Agreement, a baseline agreement developed in 2009, as an example. Like TEFCA, it was meant to create a trust agreement signed by health information exchanges that wanted to participate in nationwide exchange.
"It was a decent agreement — not terrible, legally — but it never got fully taken up and I'm not sure why," Savage said. "There are a lot of different things that come into if an agreement gets taken up on."
Many, including ONC, are optimistic on TEFCA adoption, citing the competitive disadvantages to nonparticipation.
The hope is that the more networks use it, the more its value proposition will be proved. Patients will inquire why their provider doesn't have their data from other facilities, and the provider will then wonder why the exchanges it's a participant in aren't qualified to work with other networks, Barrett said.
But it will also depend on the leverage between different stakeholders, including the relationship between the parties and the value of the data they're seeking. For example, if a network has data from 200,000 lives, but that's only 2% of the lives a client needs, they're unlikely to ink a relationship with that network regardless of its qualified status or not, according to Savage.
The Sequoia Project plans to start accepting applications for QHINs in the second quarter this year, Mariann Yeager, CEO of the Sequoia Project, told reporters on Tuesday. Sequoia expects to see QHINs in operation by the fourth quarter at the earliest.
The body will take applications as they come, with Yeager noting she expects "more than one and fewer than 100."
"We hope to really expand this over time," Yeager said.
Barrett forecasted industry will see at least 10 QHINs onboarded and in operation this year, while 2023 will be a bigger implementation year.
"I think that the industry is going to recognize that if they're not playing in this sandbox and being either a participant or a subparticipant to be part of the data exchange, they're going to be competitively disadvantaged," Barrett said.
But if ONC doesn't see as much participation as it wants, the agency does have regulatory levers to lean on as a last resort.
ONC head Micky Tripathi has been vocal on his desire to strike the right balance between bringing more order to the market, but not so much that it suppresses technical innovation.
"It's certainly too early to talk about either carrots or sticks related to TEFCA participation," but ONC is working with federal agency partners on what use cases they have that might benefit from being TEFCA-enabled — including CMS and the Centers for Disease Control and Prevention, Tripathi told reporters Tuesday.
Many people expect that, as implementation continues, participation in TEFCA could be required as part of other federal programs, including Medicare, Medicaid or Veteran Community Care.
"I think if ONC in their monitoring didn't see the number of organizations they want to move to become QHINs, I believe that Medicare, Medicaid — that'll be one lever," Barrett said, though ONC will probably hold conversations to try to convince organizations to migrate first.
"That could be part of a future conversation as to whether there are added inducements or anything related to that, but certainly not anything that I can point to today," Tripathi said Tuesday. But "you've got a little bit of a chicken and an egg thing. It's hard to commit programmatic obligations to something if you don't know it's going to be successful. But on the other hand, we also recognize that sometimes that may be the inducement to make it successful."