After months of development, ONC released its Trusted Exchange Framework and Common Agreement (TEFCA) draft in an effort to push the healthcare industry closer toward its goal of achieving true interoperability characterized by advanced health data exchange.
In accordance with provisions of the 21st Century Cures Act, the framework primarily aims to give patients access to their electronic health data without special effort and help providers and payer organizations receive population-level health data. Additionally, the framework will help ensure the health IT community utilizes open and accessible application programming interfaces (APIs) to encourage innovation.
The framework has met with nearly unanimous support from stakeholders throughout the healthcare industry. Leaders from organizations including AHA, HIMSS, DirectTrust, and others agree TEFCA tackles a worthy goal.
However, stakeholders also largely agree health information exchanges (HIEs) have a long road ahead to meet the aims of the framework within ONC’s ambitious timeline. As drafted, the framework should be fully operational by the end of 2019.
Indiana Health Information Exchange (IHIE), Colorado Regional Health Information Organization (CORHIO), and CliniSync of Ohio are interested in taking on the challenge of participating in the voluntary framework and common agreement. Executives at all three HIEs agreed the framework represents a critical step in improving interoperability for providers, patients, and payer organizations.
“When it first came out we were very excited,” CliniSync CEO Dan Paoletti told EHRIntelligence.com. “Coordination among HIEs and national interoperability efforts across the country is both desirable and necessary to enabling full interoperability.”
However, taking this critical next step in coordinating HIEs and HIE networks will increase the costs and complexities associated with facilitating health data exchange. These complications will primarily stem from participation agreement changes.
The Challenge of Changing HIE Participation Agreements
In order to improve nationwide interoperability and health data exchange standardization through a common agreement, HIEs will need to modify their contractual relationships with participating organizations. These changes will support provisions such as permitted disclosures of health information by qualified health information networks (QHINs).
“We believe that these changes are necessary for us to meet the objectives identified by Congress and will enable providers and patients to have a single ‘on-ramp’ to exchange,” wrote ONC in the framework draft.
HIE leaders are well aware of the challenges of making these changes.
“I’m not sure I’ve encountered anyone who says this is going to be easy,” said IHIE CEO John Kansky.
These participation agreement changes will likely be time-consuming and could lead to myriad complications, according to CORHIO Chief Operating Officer (COO) Kate Horle.
“For me to go back to one of our bigger partner systems and say we’re going to have to rebuild your entire agreement — opening that can of worms could take years,” she said.
Though CORHIO is up for the challenge, Horle is still seeking clarification on several questions pertaining to the changes she and other HIEs will need to make to contractual agreements.
“Am I going to have to go to every one of my participants in the next year and change these participant agreements?” she said. “Are these participant agreement changes only going to be affected going forward, which creates disparities between the ways the data will be shared between new and old? For us, that’ll be a really interesting conundrum.”
Kansky also stressed how arduous the process of changing contractual agreements could be.
“It’s very difficult to make changes to contracts and get those all re-signed. No one would look forward to that exercise,” said Kansky. “ONC understands that what they’re proposing is likely to require organizations to do that. Obviously between the draft and the final we’d hope that the most problematic aspects of that would be mitigated.”
Meanwhile, Paoletti and others at CliniSync seek clarification about how the HIPAA minimum necessary rule will apply to health data exchange for TEFCA participants.
“Am I going to have to go to every one of my participants in the next year and change these participant agreements?”
Paoletti said using continuity of care documents (CCD) as the standard for exchange is a great idea, but he is curious about how using this standard aligns with the concept of using the minimum amount of protected health information (PHI) necessary to accomplish an intended purpose.
“We need to understand the details of what TEFCA is trying to accomplish around the additional uses of information for those purposes and how that affects what changes we need to make to our governance,” said Paoletti.
Ensuring behavioral health data can be part of exchange will also be a priority, Paoletti said.
In addition to further clarity surrounding participation agreement changes and the kinds of data that will be included in exchange, some HIE leaders also want more information about the definition of a qualified health information network (QHIN).
QHIN Eligibility, Infrastructure Requirements
According to the framework as drafted, ONC will choose a Recognized Coordinating Entity (RCE) from the private sector to further build out the framework into a single set of guidelines and technical standards comprising the common agreement. HINs can agree to follow requirements laid out in the common agreement to become QHINs.
A QHIN is a network of organizations working together to share data.
“QHINs will connect directly to each other to ensure interoperability between the networks they represent,” stated ONC in an infographic.
QHIN participants may include HIEs and HINs, health IT companies, healthcare organizations, payer organizations, federal agencies, and other entities. QHIN participants can connect to each other and organizations in other QHINs through QHIN-to-QHIN connectivity. Through connectivity brokers, QHINs will provide master patient indexes, record locator, health data exchange, and directed query services.
Though some HIE leaders have expressed interest in meeting requirements to become a QHIN, Kansky stated this is not possible.
“Individual HIEs or individual EHR vendors do not meet the eligibility to be a QHIN,” he said. “That is something we need to understand and think about in terms of our comments.”
“ONC is looking for organizations that are already bridging multiple health information networks as they define them in TEFCA,” he continued. “They’re going for a network-of-networks. At the QHIN level, they’re looking for organizations that are already running a network that meets the eligibility requirements, including their participant neutral definition.”
CliniSync will follow the advice of its stakeholders when deciding to join a QHIN in any capacity.
“It doesn’t appear ONC would consider us as a good fit to be a QHIN,” said Paoletti. “Our stakeholders are going to be comfortable with whatever QHIN infrastructure is available for us to join.”
Paoletti also wants more information about the uses and security requirements of QHINs because of the breadth of data a QHIN could be storing.
“The secondary uses of information, the security of that data, the data for research — there’s a whole bunch of questions we can’t make recommendations on because we just don’t know enough,” he said.
Answering these questions and putting the necessary infrastructure and governance in place to run a QHIN within the timeline set forth by ONC could be a daunting process, Paoletti said.
“If you think about the infrastructure a QHIN could have to put in place to manage all this and then the business model around that — those are also things that are going to be difficult to get in place in such a short period of time,” he said. “I’m hoping what we end up with is something we can begin to work with right away — whether in a phased approach or not.”
Paoletti also hopes QHIN infrastructure and governance builds off the example set by national HIE collaboratives such as the Strategic Health Information Exchange Collaborative (SHIEC).
Meanwhile, CORHIO leaders want ONC to more clearly delineate the responsibilities of all parties involved in ensuring a QHIN succeeds.
“We need to make sure we understand what the responsibilities are for this creature called a broker, what the QHIN responsibilities will be, and what the participant responsibilities will be,” said Horle.
In order to get answers to these and other questions, Kansky emphasized the importance of submitting comments to ONC about the best ways to further build out the framework.
Submitting Feedback to ONC
ONC kept an open line of communication between policymakers and industry stakeholders throughout the draft’s six-month development process. Since July 2017, ONC has held three public listening sections, one public comment period, and multiple stakeholder meetings to gather input from stakeholders about the principles and terms and conditions that will govern the framework.
With the draft now open for public comment until February 20, Kansky underscored that HIE leaders need to submit feedback about any remaining questions, concerns, or recommendations for ONC to consider when developing the final framework.
“Everybody has to work to comment and figure out how to take the document from where it is to where it needs to be,” said Kansky. “There are potentially less prescriptive approaches that could be taken. The key is going to be allowing the current positive trajectory to continue without creating prescriptive requirements that are going to get in the way or make us backtrack.”
Requesting further clarity and raising any concerns before the final draft is issued will help to ensure HIEs feel confident enough to step up and be voluntary participants.
“As a member of HITAC, I’m looking forward to getting and considering all of the comments that ONC receives,” said Kansky. “IHIE participates in organizations like HIMSS and SHIEC, and they’ll both be submitting comments. We are definitely actively participating in efforts to inform the comments of SHIEC and HIMSS and that may be all that’s necessary for us to get our views in the mix.”
“Individual HIEs or individual EHR vendors do not meet the eligibility to be a QHIN.”
CORHIO, IHIE, CliniSync, and others plan to weigh in to ensure TEFCA builds off the successful efforts of interoperability initiatives such as Carequality, DirectTrust, SHIEC, and CommonWell while also improving connectivity and alignment between HIEs to accelerate improvements.
“We are going to try to make constructive comments around some of these things that help us get to the next level,” said Paoletti. “At the end of the day, it comes down to what’s best for our stakeholders.”
While implementing the framework within ONCs timeframe is an ambitious undertaking, leadership at CORHIO, CliniSync, and IHIE agree the goals of the draft are realistically attainable.
Fulfilling the Aims of the Health Data Exchange Framework
After the framework is finalized and built out in more detail, Kansky said ONC’s vision of a nationwide network-of-networks could certainly become a reality.
“I can picture an ecosystem that allows the current interoperability approaches that are making progress to continue making progress with the government having created just the right balance of structure over the top of it to accelerate us and give some guidance,” he said.
“But the organizations part of that ecosystem need to be willing and even eager to do those things,” he added.
While Horle foresees CORHIO participating in TEFCA, she expressed concern about whether most HIEs will be motivated to join.
“Whether this whole thing works is going to be based on how many HIEs volunteer to do this work,” said Horle. “Because it is voluntary to do all this work.”
Horle stated CORHIO likely has the resources to make the necessary changes to participate in TEFCA, but not all HIEs are as advanced or well-funded.
“It could potentially create a little bit of a digital divide among HIEs,” she said. “For organizations like CORHIO that are pretty advanced in terms of developing tools that further interoperability, it’s not a particularly onerous or challenging process. But for small HIEs who don’t have significant access to funding and for whom survivability is a day-to-day adventure, this could be extraordinarily challenging.”
“It could box out smaller HIEs because they may not be able to meet the requirements,” she continued.
Kansky stated any organization interested in participating in TEFCA should be able to do so if ONC allows organizations enough time to become comfortable adopting new requirements.
“If the final TEFCA is crafted well and maybe takes on a phased approach that allows organizations to be comfortable stepping into their roles and then steadily moving the country toward higher levels of interoperability, volunteers will step forward and the thing will gather momentum,” he said.
“The art of getting to a final TEFCA is making sure we get the details right and don’t scare off the organizations we’re counting on to step up and be voluntary participants,” Kansky continued.
Executing the aims of TEFCA is also contingent on reducing the complexity of the framework’s governance standards as much as possible, according to Paoletti.
“Once we sign on we have a very short time to get all that governance in place,” he said. “If the framework complements all the things that are going on right now with DirectTrust and the Sequoia Project, we can do it. If they add another layer of difficult governance standards and technical aspects, it could be a challenge.”
While fulfilling the goals of the framework will require hard work and dedication from HIEs and other participants, HIE leaders agree the end result will be worth the effort
“ONC has been a really good partner to HIEs since their inception,” said Horle. “Their heart is in the right place. They are trying to create stronger interoperability and fulfill the goals of meaningful use and I applaud them for doing that.”