- A key HHS advisory committee on health IT unanimously passed a slew of recommendations Thursday advising the Office of the National Coordinator streamline and clarify crucial sections of the Trusted Exchange Framework and Common Agreement, an HHS blueprint meant to foster healthcare interoperability nationwide.
- Most notably, the Health IT Advisory Committee recommended ONC align TEFCA with the corresponding HHS proposed rules to crack down on the practice of information blocking and provided multiple incentives for industry adoption of the interoperability framework.
- However, HITAC's recommendations failed to address one of the most persistent industry concerns: that the government is trying to enact too much too quickly, potentially placing a heavy burden on the entire healthcare system.
Under the 21st Century Cures Act, ONC — the health IT arm of HHS — was directed to create an "on-ramp" to nationwide connectivity. The agency released the second draft of TEFCA in April in its bid to create a technical framework for health data sharing across different networks and facilities, part of HHS' larger push for interoperability nationwide.
The package contains three new TEFCA documents that form the basis of a single common agreement for health IT vendors and users to adopt. They introduce a common set of data exchange principles, outline minimum mandatory terms and conditions and detail what components of data exchange are necessary for qualified health information networks, or groups of organizations that work together to share data.
ONC published stakeholder comments on TEFCA late last month. Though payers, providers, health IT vendors and other companies generally support the government drive toward interoperability, groups expressed myriad concerns around the specifics of implementation.
Multiple organizations advocated that ONC push back the relatively short timeline for TEFCA adoption, especially in light of the financial and manpower burden it will place on players across the board. This includes the costs of TEFCA implementation and participation, staffing, privacy and security modifications, contractual changes, education and training and other issues.
Though it didn't touch on the timeline, HITAC's 28 recommendations, which run the gamut from privacy and security to data classification, address many industry complaints, including standardizing definitions between TEFCA and the HHS interoperability rules and incentivizing industry adoption.
It's not clear how ONC plans to spur adoption given the fact that Congress mandated TEFCA be voluntary in Cures. In a June meeting, HITAC floated various incentives — many of which ended up in its final recommendation. These include industry outreach, government funding and even potentially linking participation in TEFCA to participation in programs run by federal agencies like Medicare or Medicaid.
"We felt it was important to balance adoption of new requirements with existing frameworks and networks to make sure TEFCA is sufficiently adopted," Arien Malec, TEFCA task force co-chair and SVP at Change Healthcare, said at the meeting. "The basic thought was: Let's make sure that information blocking is in the driver's seat and that TEFCA is an easy or natural way or means to achieve those requirements."
However, some committee members were concerned HITAC wasn't going far enough. "I do believe everybody does need to participate and I do think that needs to be clear," panel member Christina Caraballo, director of health IT and policy company Audacious Inquiry, said.
The 30-member committee also recommended ONC clarify the definition and scope of a controversial TEFCA provision that would allow patients to consent to how their information is shared, called Meaningful Choice.
"Policy goals should ensure that 'Meaningful Choice' is not just a 'check-the-box' exercise, but that it provides meaningful information and opportunity for discussion about where and how an individual's EHI [electronic health information] will be used and disclosed," the group wrote.
Under the current definition of the provision, patients are given advance notice and time to consent to their information being shared, and are allowed to rescind that consent at any time. Additionally, organizations are forbidden from discriminating against people, or using their consent or data to force them to stay with a specific provider, pay additional fees or any other behavior.
In addition, HITAC is recommending ONC make the provision clearly explainable to patients, specific to patient circumstance and consistent with patient expectations for privacy, health and safety.
HITAC also agreed that patient use of their health information should eventually be broader than just the HIPAA right to access over time.
But during the July meeting, the committee debated the extent to which patients should be able to control the information in their personal health records, with the TEFCA task force presenting two alternative recommendations to ONC — one driving TEFCA initially to go farther and force new use cases into the framework and one with a slower timeline.
Malec said the two choices represent a "profound split" in the task force. Some committee members were concerned expanding TEFCA use cases off the bat would lead to unforeseen or complicated outcomes, such as patients being able to edit, correct or delete information from their electronic health records without clinician approval.
"I'm not ready to go there quite yet," Steven Lane, HITAC member and clinical informatics director of Sutter Health, said. "I think we need to lay a foundation for that."