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Last Tuesday will be a day remembered for the healthcare community with the U.S. Department of Health and Human Services (HHS) announcing that the Office of the National Coordinator for Health Information Technology (ONC) has published the Trusted Exchange Framework and Common Agreement – Version 1 (TEFCA).
TEFCA has been in progress since the 21st Century Cures Act was signed by the Obama administration on December 13, 2016, and has been a bipartisan initiative over the last three administrations.
TEFCA outlines a common set of principles, terms, and conditions to support the development of the Common Agreement and was created to enable the nationwide exchange of electronic health information (EHI) between health information networks (HINs). The ONC's goal with TEFCA is to establish universal interoperability standards across the country between health information networks (HINs). It's important to remember that TEFCA is not a rule. The Trusted Exchange Framework is a document of non-binding principles and the Common Agreement is a contract between the Sequoia Project (the Recognized Coordinating Entity (RCE) and Qualified Health Information Networks (QHINs).
Below we discuss the evolution and timeline of TEFCA, provide an overview of TEFCA V1, and dive into what is coming next for Health Gorilla.
The Beginnings of TEFCA
The Trusted Exchange Framework and Common Agreement both stem from the signing of the 21st Century Cures Act in 2016. The Cures Act was developed to accelerate medical product development and deliver innovations to patients so they can effectively access their medical records with fewer barriers. It also advocates for the delivery of more significant interoperability standards to prevent electronic health information (EHI) blocking between health systems, promotes the adoption of electronic health records (EHRs), and supports additional human services programs.
Soon after the Cures Act was signed, the Office of the National Coordinator for Health Information Technology (ONC) was called on to develop TEFCA. In addition to the benefits discussed above, TEFCA, and more specifically the Common Agreement, will establish our country's first QHINs.
QHINs will be the designated entities responsible for facilitating the national exchange of health information and will act as connectivity brokers to ensure interoperability between their networks. QHINs will follow a "network of networks" structure and serve as the supernodes responsible for facilitating the national exchange of data between QHINs, participants, and subparticipants.
In August 2019, The Sequoia Project, a non-profit 501(c)(3), was awarded a cooperative agreement by ONC as the RCE for TEFCA. The RCE was and will continue to be responsible for developing, implementing, and maintaining the Common Agreement component of the TEFCA.
According to the RCE and ONC, "the RCE will also collaborate with ONC to designate and monitor QHINs, modify and update any accompanying QHIN Technical Framework, engage with stakeholders through virtual public listening sessions, adjudicate noncompliance with the Common Agreement, and propose sustainability strategies to support TEFCA beyond the cooperative agreement's period of performance."
The Timeline to TEFCA
Before the release of TEFCA V1, there were multiple drafts published, public feedback opportunities, and various educational webinars produced to educate the community on the impacts of TEFCA.
When the ONC released the original draft specifications for TEFCA on January 5, 2018, it included two primary components. The first was to establish the principles for trusted exchanges to ensure trust between Health Information Networks. These principles included:
- Standardization - States that data exchanges follow industry and federally recognized standards, procedures, and operations.
- Transparency - Ensures that all data exchanges are done openly and are transparent.
- Cooperation and Non-Discrimination - Ensures that collaboration with stakeholders, including direct competitors for an organization, occurs when exchanging health information.
- Security and Patient Safety - Outlines the importance of exchanging data securely and ensures data integrity, patient safety, and privacy.
- Access - Ensures that patients and their healthcare providers can easily access the data necessary to make informed and timely decisions.
- Data-driven Accountability - Allows participants of a network to share multiple records at one time to ensure correct identification, decrease the cost of care and promote the health of populations.
The second component included in the TEFCA draft discussed the Minimum Required Terms and Conditions for Trusted Exchange. This portion of TEFCA is more technical and discusses the requirements Health Information Networks need to implement and follow to be considered a QHIN. These terms and conditions include offering the following:
- An accepted authentication process for health information network members.
- A universal set of rules for trusted exchanges
- An agreed-upon set of organizational and operational guidelines that facilitate the exchange of data and information among networks
On April 19, 2019, HHS and ONC released the first update to TEFCA. The update defined the exchange purposes under TEFCA and included a specific subset of payment and health care operations purposes previously left out. The exchange purposes proposed in the second draft included:
- Treatment
- Public Health
- Payment
- Benefits Determination
- Healthcare Operations
- Individual Access Services
For a complete description of each exchange purpose, check out our blog A Guide to TEFCA's Six Exchange Purposes
The second draft of TEFCA also included a broadened QHIN definition to enhance the application pool, provided clarifying information on the exchange security requirements, and discussed the exchange modalities that QHINs will be expected to carry out.
One of the last steps the ONC and RCE took before releasing TEFCA V1 was releasing a timeline and process to achieve a successful launch of the TEFCA framework. The timeline was released on July 31, 2021 and highlighted critical milestones for the framework between 2021 and 2023.
A few key milestones included the release of TEFCA V1 in the first quarter of 2022, which just took place, QHINs being able to start signing the Common Agreement in 2022, and the selection process, which is expected to begin at the end of the year.
An Overview TEFCA V1
The release of TEFCA V1 last week was a massive accomplishment for the ONC as they continue to work through the 21st Century Cures Act requirements. Many of the elements outlined in the drafts released in 2018 and 2019 were included in the final version, but there were a few adjustments that are worth going over.
The primary change was the reduction to the exchange purposes included. As we mentioned above, the drafts of TEFCA had six exchange purposes, but TEFCA V1 reduced those to two. These include treatment and individual access services. While it did come as a surprise to see these reduced, our team does expect the exchange purposes to expand over time.
There was also an adjustment to the exchange modalities in TEFCA V1 compared to the initial drafts. TEFCA now specifies that QHINs must have the technology and operating procedures to respond to patient queries, document queries, document retrievals, and direct messaging. It is important to keep in mind that the ONC has stated, “that entities in a QHIN's network are required to respond to queries for Exchange Purposes in accordance with the Common Agreement and applicable law but do not have to be able to receive data sent to them using message delivery.”
Regardless of the adjustments made between the drafts and TEFCA V1, the overall goals of TEFCA have remained the same:
- Establish a universal policy and technical floor for nationwide interoperability.
- Simplify connectivity for organizations to securely exchange information to improve patient care, enhance the welfare of populations, and generate health care value.
- Enable individuals to gather their health care information.
How Does TEFCA Impact Health Gorilla
Our team at Health Gorilla has been eagerly awaiting TEFCA V1 and has been preparing for our QHIN designation since announcing our intention to pursue the designation on October 6, 2021. We have been working with ONC and RCE for some time and believe we are positioned well to bridge the gap between TEFCA's interoperability goals and the private sector.
We have built a FHIR-native data Health Interoperability Platform, compliant with R4 profiles, based on the TEFCA requirements and believe our advanced technology satisfies TEFCA and ONC's goal to establish a nationwide floor of universal interoperability. Our library of APIs and software products power fundamental healthcare workflows and data exchange scenarios and enable an easy "on-ramp" to the national exchange of data.
We are currently in the process of switching existing HIN members to new TEFCA agreements and have already implemented our first state-wide HIN in Puerto Rico in collaboration with the Puerto Rico Department of Health.
As a designated QHIN, we will continue to offer our well-known interoperability solutions but also expand our services as we begin facilitating data exchanges for new purposes. This will allow us to provide our services to a larger pool of the healthcare community and increase how current and future clients can leverage our solutions.
Overall the QHIN designation will increase our ability to facilitate access to health data across the country and allow us to deliver additional efficiencies and value to our participants and subparticipants. By ensuring interoperability between the networks we represent and minimizing one-off connections, we will simplify data exchanges for our network.
Ready to Expand Your Access to Clinical Data?
If you are part of a healthcare organization and interested in expanding the data available to your physicians or patients, the Health Gorilla team is here to help. We offer a comprehensive implementation plan which includes a dedicated implementation specialist and solutions architect who will work with you to configure the connection between our suite of APIs and your application. We tailor our implementation to your organization's unique clinical data workflows and provide access to the Health Gorilla development sandbox. Our team of experts is available to answer any questions through the testing and validation period. If you have any additional questions or are interested in exploring a partnership with Health Gorilla, please contact us.
References and Helpful Articles:
https://www.healthit.gov/sites/default/files/page/2022-01/Trusted_Exchange_Framework_0122.pdf
https://www.healthit.gov/sites/default/files/page/2019-04/TEFCADraft2UsersGuide.pdf
