On January 18, 2022, the Office of the National Health Information Technology Coordinator (ONC) of the United States Department of Health and Human Services (HHS) and the entity selected as contract partner, The Sequoia Project, Inc. , released the highly anticipated Framework for Exchange of Trust and Common Agreement (TEFCA) for the exchange of health information. Simply put, TEFCA is a framework that Health Information Networks (HINs) can enter to share health data with other HINs, individuals and entities. The stated goal of TEFCA is to develop uniform policies and technical requirements to expand health information exchange nationwide and ensure that HINs, health care providers, health plans , individuals and other stakeholders can access real-time, interoperable health information.
The development of TEFCA was mandated by the 21st Century Cures Act. In a broader context, ONC has worked for more than a decade on the governance of a national health information exchange. A proposed framework was published by the ONC in 2018 and was later modified after receiving public feedback. Although funded by the government, there was very little transparency about the process of drafting the framework or the process of reviewing these comments. Participation in TEFCA is voluntary and the framework is quite complex; as discussed below, it remains to be seen if, and to what extent, HINs will choose to participate.
Here are some of the basics:
What is TEFCA?
TEFCA refers to the Trusted Exchange Framework and the Common Agreement.
Trust Exchange Framework – The Trusted Exchange Framework (TEF) describes high level, without engagement the principles of trust policies and practices that can help facilitate exchanges between HINs. The TEF is based on policy principles that have underpinned ONC activities and federal health informatics policies for more than a decade.
Common agreement – The Common Agreement (CA) is a legal agreement between the Recognized Coordinating Entity (RCE), which is currently Project Sequoia, Inc., and the Qualified HINs (QHIN) that advances the principles and policies of the TEF for network-to-network data sharing. . QHINs are required to transmit certain provisions to entities that have entered into Participant-QHIN agreements (Participants), whereby QHIN agrees to transmit and receive information via a QHIN-to-QHIN exchange on behalf of the Participant. Likewise, certain provisions must arise in the downstream contracts of entities that have entered into either a participant-subparticipant agreement or a downstream subparticipant (subparticipants) agreement to allow the subparticipant to use the services. of the other contracting party to send and/or receive information for one or more exchange purposes. The CA includes 6 exchange purposes, which are reasons why information might be requested or shared through the QHIN-to-QHIN exchange:
- Healthcare operations
- Public health
- Determination of government benefits
- Individual Access Service
The QHIN Technical Framework (QTF) and Standard Operating Procedures (SOP) are separate documents, but are incorporated by reference into the CA and therefore form part of the Contract.
QHIN technical framework – The QHIN Technical Framework, developed by the RCE, describes the functional and technical requirements that a HIN must meet to serve as a QHIN under the CA to support request and message delivery. The QTF includes standards for the exchange of health information between QHIN and QHIN.
Standard Operating Procedures – SOPs, also developed by the RCE, are written procedures that provide detailed information or requirements for exchange activities under the CA. SOPs for various topics, including dispute resolution and QHIN cybersecurity coverage, are posted under “Mutually Agreed Resources” on the CEN website.
TEFCA advice – In addition, ONC and RCE have published TEFCA guidance documents:
The CA establishes a governance council composed of QHIN, participants and sub-participants. This will be led by the RCE. Advisory groups may be established from time to time, but otherwise entities not directly involved in governance, such as those with concerns about CA arrangements or patients themselves, may not have a formal mechanism to provide contributions to TEFCA. Activities.
The CA includes a number of clauses that must be included in the contracts of downstream participants and sub-participants, including:
- Cooperation and non-discrimination
- Confidentiality and responsibility
- Using the RCE Directory Service
- Uses, Disclosures and Responses
- Special legal requirements
- Individual access services
- Private life
As a general rule, HINs wishing to be QHINs should modify their participation agreements, as the requirements may conflict with the policies, operation, or objectives of the exchange.
There are some interesting notes on QTF standards. First, the QTF specifies that delivery of QHIN messages must use cross-community trusted document exchange (XCDR) rather than direct secure messaging, which is incorporated into ONC certification program regulations and is part of the work of each certified EHR system. Second, the initial versions of the CA and QTF do not explicitly incorporate the FHIR-based exchange. Although there has been a push towards the use of FHIR, ONC said that “FHIR’s network activation is still maturing in key areas.”
What happened before?
It took some time for the ONC to publish TEFCA, but it is important to note that the ONC has been looking at governance for health information exchange for many years. Here are some key activities:
Given these previous attempts to standardize the health information exchange framework nationwide, it remains to be seen whether TEFCA will prove to be a success.
Currently, no QHIN has been approved and established. HINs can apply to the NCE to become a QHIN. During the application process, the prospective QHIN must demonstrate to the REB that it meets the eligibility criteria and can comply with the requirements included in this CA, the QTF and the SOPs.
Since participation in TEFCA is voluntary, it is unknown how many entities will apply for the QHIN designation. The bigger question is whether the HINs will view participation in TEFCA as favorable enough to modify their existing policies and participation agreements to meet the requirements of the CA. There is also speculation about whether HHS will tie participation to other regulatory requirements or incentives. Depending on the future level of participation in TEFCA, contract clauses and technical standards may become “industry standards” or serve as benchmarks for contract negotiations involving HINs.
The RCE has scheduled informational webinars in the coming weeks and the RCE and ONC have asked for feedback on its approach.