The Department of Health and Human Services (HHS) has released the draft Trusted Exchange Framework, as required by the 21st Century Cures Act of 2016. Federal health IT officials call the Framework “a significant step towards achieving interoperability.”
In the 21st Century Cures Act (Cures Act), Congress identified the importance of interoperability and set out a path for the interoperable exchange of electronic health data. Specifically, Congress directed ONC (the Office of the National Coordinator for Health IT) to “develop or support a trusted exchange framework, including a common agreement among health information networks nationally.”
The draft Trusted Exchange Framework, released on Jan. 5, 2018, outlines a common set of principles for trusted exchange and minimum terms and conditions for trusted exchange. This is designed to bridge the gap between providers’ and patients’ information systems and enable interoperability across disparate health information networks (HINs), according to ONC officials.
According to the announcement today, the Trusted Exchange Framework “proposes policies, procedures, and technical standards necessary to advance the single on-ramp to interoperability requested by Congress.” And it will be “facilitated through ONC in collaboration with a single recognized coordinating entity (RCE) to be selected through a competitive process.”
The RCE will use the Trust Exchange Framework policies, procedures, technical standards, principles, and goals to develop a single Common Agreement that qualified health information networks and their participants will voluntarily agree to adopt. Following a 45-day public comment period and refinements to the draft document, a final draft of the combined Trusted Exchange Framework and Common Agreement will be released. The Trusted Exchange Framework and Common Agreement (TEFCA) will be published in the Federal Register in 2018, according to officials.
What’s more, the draft Trusted Exchange Framework would not prevent existing or new organizations from creating point-to-point or individual agreements between organizations that have a particular business need to exchange information—while preventing potential information blocking—that may be different from those outlined in the proposal, according to officials.
On a call with members of the health IT media today, Don Rucker, M.D., National Coordinator for Health IT, and Genevieve Morris, Principal Deputy National Coordinator, said that they expect a number of submissions for the RCE and that experience in building cooperative agreements and having an understanding of governance principles will be key for whoever is selected.
When asked if the RCE will specifically have a “policing” role, Rucker said that the oversight will be more about coordinating than policing. “It’s not dissimilar from network governance [in other industries]. A lot of it is general governance,” he said, noting that “most folks have an incentive to participate.” However, ONC’s Morris did add that the RCE will have a responsibility to oversee security in the network, dealing with data breaches if they were to happen, and having processes in place for dealing with bad actors. More broadly, the RCE will be tasked with operationalizing the Trusted Exchange Framework.
To this point, Rucker went on to say that, as outlined by Congress, one of the core interoperability provisions in the Cures legislation was to create a “network of networks” in which regional health information exchanges (HIEs) that have been around for a while, and that move similar sets of health data around, would become connected to one another. “The goal of Congress in [the health IT section of Cures] was that ONC would work to provide what Congress framed as ‘a common agreement in these networks.’ So this brings us immediately to what is potentially very challenging in interoperability. It’s a national challenge and it hasn’t been easy. Folks have made great progress but there is lot of work to be done,” he said.
As such, one approach to solving this problem is this Trusted Exchange Framework. “This is a network-facing issue,” noted Rucker, adding that the Cures Act also includes other interoperability approaches, such as emphasizing the use of APIs [application programming interfaces]. Rucker contended that these approaches can be viewed as “complimentary” and that ONC is currently working on rulemaking for open APIs and for information blocking.
Historically, said Rucker, interoperability has been thought of in a very narrow context, such as provider-to-provider, but now, Congress is looking at it with a broader perspective that includes factors such as patients being empowered and shopping for their own care. “These broader [use] cases can bring in capital and new investments and make [interoperability] more robust,” he said. Rucker added, “Getting this larger coordination is an opportunity to allow the current participants to expand the scope of their services. That’s the unambiguous desire of Congress.”