A Guide to the 21st Century Cures Act, TEFCA, and QHINs

Health Gorilla recently announced our intention to pursue a QHIN designation in the first quarter of 2022 under the Trusted Exchange Framework and Common Agreement (TEFCA). 

Health Gorilla has been an active stakeholder throughout the development process and wanted to make sure that the healthcare community and other stakeholders are up to date and familiar with the TEFCA and QHIN developments. To make this information more widely available and understood before the changes occur in the first quarter of 2022, we have provided a comprehensive overview of the 21st Century Cures Act, TEFCA, and Qualified Health Information Networks. 

What is The 21st Century Cures Act?

The 21st Century Cures Act, signed by President Obama in 2016, calls on the Office of the National Coordinator for Health Information Technology (ONC) to "develop or support the trusted exchange framework, including a common agreement among health information networks nationally." It was designed to help accelerate medical product development and bring innovations to patients so they can access their records more efficiently and with fewer barriers. The Cures Act 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. 

What is TEFCA?

The Trusted Exchange Framework and Common Agreement (TEFCA) outlines a standard set of principles, terms, and conditions to support the development of the Common Agreement, which was created to establish universal interoperability standards across the country between HINs. The Office of the National Coordinator for Health Information Technology (ONC has defined the Trusted Exchange Framework through multiple publications and has incorporated stakeholder feedback throughout the process. In July 2021, ONC and the Recognized Coordinating Entity (RCE) released a timeline for completing the Trusted Exchange Framework, intending to have QHINs operational in the first quarter (Q1) of the calendar year 2022. The timeline supports the release of the final Trusted Exchange Framework in the first quarter of 2022, along with the Common Agreement V1 Final and the Qualified Health Network Technical Framework V1 Final. 

How Will TEFCA Impact the Healthcare Ecosystem?

TEFCA will create a single on-ramp for Health Information Networks to send healthcare information, national scalability, and ensure that electronic health information will follow an individual when they need it. TEFCA will also decrease the healthcare industry's administrative burdens and improve organizational security by closing privacy gaps across networks and addressing vulnerabilities across HIPAA compliance, cyber protection, and ransomware prevention.

What are Six Exchange Purposes Permitted Under TEFCA?

The Common Agreement, released in September 2021, included the following exchange purposes.

  • Treatment: Discusses the administration or coordination of healthcare and related services by one or more health care providers.
  • Payment: Supports business initiatives, including cost-management, formulary development, payment, and coverage policies. 
  • Health Care Operations: These include administrative, financial, legal, and quality improvement activities that a healthcare provider needs to support the core functions of treatment and payment. The definition is not limited to Covered Entities. 
  • Public Health: The support of public health activities and purposes that HIPAA authorizes.
  • Benefits Determination: Supports a federal or state agency's ability to determine an individual's benefits qualification for any purpose other than health care.
  • Individual Access Services: Supports the right of an individual to obtain a copy of their electronic health information and direct that copy to another person or entity when necessary. 

How Does Health Gorilla Satisfy the Six Exchange Purposes?

Health Gorilla's platform and robust data engine make us uniquely positioned to fulfill all six permitted exchange purposes. The Treatment, Payment, Healthcare Operations, and Public Health exchange purposes are satisfied through Health Gorilla's platform and FHIR-based APIs, which facilitate national bi-directional exchanges of health information for permitted purposes and include integrations with major EMR systems and diagnostic vendors. Our platform addresses the need for individual access through identity proofing and connects individuals with access to their information. Health Gorilla's recent entrance into the life insurance market addresses the process of Benefits Determination, which is done by securely providing life insurance underwriters, re-insurers, and risk assessors with HIPAA-compliant, permission-based access to structured and complete medical records.

Who and what is the RCE?

The Sequoia Project, a non-profit 501(c)(3), was awarded cooperative agreement by the ONC as the RCE for TEFCA in August 2019 and is responsible for developing, implementing, and maintaining the Common Agreement component of TEFCA. The RCE is also responsible for entering into agreements with health information networks (HINs), pursuing QHIN designations, rectifying dissent from the common agreement, and reforming TEFCA over time as new technologies, policies, and use cases arise. 

What is a Qualified Health Information Network?

QHINs are the certified entities responsible for facilitating the national exchange of health information and will act as connectivity brokers to ensure interoperability between the networks they represent. TEFCA defined the technical and legal requirements, or rules of the road, for nationwide electronic health information exchanges. The architecture will follow a "network of networks" structure, where QHINs serve as the supernodes and are responsible for connecting to other QHINs to facilitate the national exchange of data between QHINs, Participants, and Subparticipants. Each QHIN is responsible for the onboarding and management of its Participants and Subparticipants. Each QHIN will have to be certified by the Sequoia Project, the RCE, and receive a government designation by proxy. 

How Many QHINs are Expected to be Operationalized Under TEFCA?

The exact number of QHINs that will be operational under TEFCA is unknown, but we expect that numerous organizations will be applying for a designation. Each QHIN will be a high functioning, trusted, and secure broker of exchanges and be required to connect to other QHINs to exchange data securely.  

What Types of Exchanges Will be Launched as Part of TEFCA?

Message queries and Message deliveries are the two information exchange procedures outlined in the Qualified Technical Framework's technical and functional specifications. QHIN's, Participants and Subparticipants will use message queries to request standardized electronic documents from other connected participants, while QHIN message delivery will be used for sending information to a particular recipient. These recipients may include primary care providers or public health agencies. The RCE will be maintaining a directory of exchange participants connected to each QHIN to ensure that other QHINs and participants can direct their queries or message deliveries appropriately. 

Who is Expected to Exchange Data as Part of TEFCA?

QHINs, Participants, and Subparticipants are all responsible for exchanging data under TEFCA. Subparticipants enter into a contract with Participants, which contains flowdown terms that define participation requirements. Subparticipants may choose to onboard additional Subparticipates to expand the "network of networks' approach of TEFCA. Examples of Subparticipants may include but are not limited to a physician practice, hospital, pharmacy, or public health agency. Examples of participants may include, but are not limited to, Health Information Networks, electronic health information vendors, and other healthcare systems, a health IT developer, a payer, or a federal agency.

What's Next?

It is expected that the full adoption of TEFCA and the QHINs will take some time to be implemented. ONC has not specified when QHINs are expected to begin sharing data, but they have committed to releasing the final Trusted Exchange Framework in the first quarter of 2022, along with the Common Agreement V1 Final and the Qualified Health Network Technical Framework V1 Final. Once finalized, health information networks will be able to apply to become QHINs. For now, Health Gorilla will continue to prepare our services and team for our QHIN designation, provide feedback to the ONC if necessary and continue to learn alongside the rest of the healthcare community as TEFCA develops.

If you have any additional questions about the 21st Century Cures Act, TEFCA, or QHINs, or are interested in learning more about Health Gorilla or our services, please contact us.

Health Gorilla was founded in 2014 and offers a secure interoperability solution that enables the entire health care ecosystem – patients, payers, providers, digital health solutions, and labs – to seamlessly share health data and aggregate each patient's entire clinical history in one place. We offer enterprise-grade clinical data APIs, user authentication, and an unparalleled master patient index, making it easy for providers to pull their patient's information from any clinical records system. We have a team of healthcare experts who will work with you to configure the connection between the Diagnostic Network API and your application based on your organization's unique clinical data workflows.