The first blog about TEFCA provided information about its three parts. This blog will provide further details about the three parts, and highlight some of the comments submitted to ONC.
Three Parts to TEFCA
Part one: The Trusted Exchange Framework (TEF)
The Trusted Exchange Framework (TEF) describes a common set of principles that facilitate trust between health information networks (HINs). These principles serve as “rules of the road” for nationwide electronic health information exchange. Broad adherence to these principles will minimize variation in technical and legal policies that restrict the secure flow of electronic health information (EHI) where and when it is needed and allow for a more innovative, efficient, and extensible electronic marketplace. This will support the ability of patients and health care providers to access EHI when and where it is needed most and help provide the foundation for improved care coordination and quality improvement.
TFF includes six principles, each with lettered sub-principles as follows:
- Principle 1 – Standardization: Adhere to industry and federally recognized standards, policies, best practices, and procedures.
- Adhere to applicable standards for EHI and interoperability that have been adopted by the U.S. Department of Health & Human Services (HHS), approved for use by ONC, or identified by ONC in the Interoperability Standards Advisory (ISA).
- Implement technology in a manner that makes it easy to use and that allows others to connect to data sources, innovate, and use data to support better, more person centered care; smarter spending; and healthier people.
- Principle 2 – Transparency: Conduct all exchange and operations openly and transparently.
- Make terms, conditions, and contractual agreements that govern the exchange of EHI easily and publicly available.
- Specify and have all HINs agree to the uses and disclosures for exchanging EHI.
- Publish, keep current, and make publicly available the HIN’s privacy practices.
- When necessary, conduct any arbitration processes with other HINs in an equitable, transparent manner.
- Principle 3 – Cooperation and Non-Discrimination: Collaborate with stakeholders across the continuum of care to exchange EHI, even when a stakeholder may be a business competitor.
- Do not seek to gain competitive advantage by limiting access to individuals’ EHI.
- Principle 4 – Privacy, Security, and Patient Safety: Exchange EHI securely and in a manner that promotes patient safety, ensures data integrity, and adheres to privacy policies.
- Ensure that EHI is exchanged and used in a manner that promotes safe care, including consistently and accurately matching EHI to an individual.
- Ensure providers and organizations participating in data exchange have confidence that individuals have the opportunity to exercise meaningful choice, if and when it is needed, prior to the exchange of EHI.
- Principle 5 – Access: Ensure that individuals and their authorized caregivers have seamless access to their EHI.
- Do not impede or put in place any unnecessary barriers to the ability of individuals to access and direct their EHI to designated third parties, and to learn how information about them has been accessed or disclosed.
- Principle 6 – Population Level Data: Exchange multiple records for a cohort of individuals at one time in accordance with applicable law to enable identification and trending of data to lower the cost of care and improve the health of the population.
- Enable participants to request and receive multiple patient records, based on a patient or member panel, 30 at one time.
Part two: Minimum Required Terms & Conditions (MRTCs)
Congress charged ONC with ensuring full network-to-network exchange of EHI through a Trusted Exchange Framework and Common Agreement. This part provides a set of MRTCs to ensure that signers of the Common Agreement agree to common practices that will engender trust, support nationwide interoperability, and align to the principles and objectives contained in the TEF. The MRTCs do not make up a full end-to-end trust agreement; rather, they focus on standardizing areas of variation among currently existing trust agreements that impede nationwide interoperability. The Recognized Coordinating Entity (RCE) will combine these MRTCs, as well as Additional Required Terms and Conditions (ARTCs), developed by the RCE and approved by ONC, into a full data sharing agreement known as the Common Agreement with which qualified health information networks (QHINs) may voluntarily agree to be bound. The Common Agreement will also include an agreed upon process for filing claims that may arise with respect to the Common Agreement and adjudicating noncompliance with the Common Agreement. Such processes will be described in the ARTCs.
Part three: Qualified Health Information Network (QHIN) Technical Framework
The Qualified Health Information Network (QHIN) Technical Framework (QTF) describes the functional and technical requirements that a Health Information Network needs to fulfill to serve as a QHIN under the Common Agreement. The QTF specifies the technical underpinnings for QHIN-to-QHIN exchange and other responsibilities described in the Common Agreement. While the Recognized Coordinating Entity (RCE) (to be selected by ONC) will establish the final operational and technical means by which QHINs exchange Electronic Health Information (EHI), the QTF Draft 1 provides an initial set of QHIN technical responsibilities for public comment. The QTF also describes high-level functional requirements QHINs must support within their health information networks.
The QTF focuses primarily on the technical and functional requirements for interoperability among QHINs, including specification of the standards QHINs must implement to enable QHIN-to-QHIN exchange of information. The technical and functional requirements described in the QTF enable the three information exchange modalities for QHINs expressed in the Common Agreement: QHIN Broadcast Query, QHIN Targeted Query, and QHIN Message Delivery. The QTF also describes high-level functional requirements QHINs must support within their health information networks.
Responses to ONC:
The Pharmacy Health Information Technology Collaborative (Collaborative) submitted comments about TEFCA draft 2; the majority of those comments were supportive for draft 2. Here are some highlights of the feedback that was provided by the Collaborative:
- The Collaborative recommended that ONC survey and review the data protection laws and regulations of other countries, particularly the EU General Data Protection Regulation before moving forward and possibly changing the MRTCs to allow this EHI exchange. Additionally, to accomplish an exchange of electronic health records (EHR) with Europe and other countries, the exchange format used by a QHIN would need to be compatible with EU exchange formats, as well as ensuring the secure exchange of EHI across borders. The European Commission has adopted a Recommendation on European Health Record exchange format for secure access to health data across EU borders. Also, if the current MRTCs Draft 2 does not permit QHINs to use or disclose EHI outside the U.S., would this be in conflict with 7.3 Individual Exercise of Meaningful Use of Draft 2, if allowed by applicable law?
- On Patient Identity Resolution, the Collaborative suggested a broader set be used as the Collaborative believes patient identifiers should not be restrictive but more inclusive to ensure the patient is securely matched with the correct patient record.
- The Collaborative believes the Qualified Technical Framework (QTF) should specify a consistent set of error messages and generate error messages when activities and 6 transactions fail. The messages should clearly communicate the cause of the error and provide details to resolve the issue, particularly to first-degree entities (e.g., participants and individual users). Error messages should be presented in a consistent format. The Collaborative also suggests that ONC consider including error handling in audit records.
In their response to TEFCA draft 2, Surescripts highlighted some of the concerns around TEFCA:
- The current draft proposes a rigid timeline for the adoption of TEFCA. networks and organizations will have a hard time meeting all of the requirements without substantial cost and effort, it is expected that it will take longer than the proposed timeframe to comply.
- Also the framework’s proposed “singular on-ramp” for all providers may hinder innovation. It is extremely important to ensure that TEFCA allows all market participants to continue to innovate, compete, encourage entrants into the market and develop new business models that create financial sustainability for networks and their participants.
The public comment period on the TEF, MRTCs, and QHIN Technical Framework ended on June 17, 2019. Stakeholders who provided comments to ONC are helping ONC shape the future of interoperable health information flow.
Authors:
Published on behalf of the GetITDone Workgroup for the Clinical Application SAG:
Amanda Bain, Pharm.D., MPH, M.B.A. Director, Pharmacy and Care Management. OSU Health Plan, Inc. Columbus, OH
Beth Prier, Pharm.D., M.S. Director of Clinical Informatics and Managing Advisor. The Robertson Group (TRG). Columbus, OH
Chezka "Mimi" Baker, Pharm.D. Informatics Specialist. Dallas, TX
Hesham Mourad, Pharm.D., BCPS, BCCCP, CPHIMS, Medication Management Informaticist. Mayo Clinic. Jacksonville, FL
Robert (Ben) McDaniel, Pharm.D., BCPS Clinical Pharmacy Informatics Specialist. The University of Texas MD Anderson Cancer Center. Houston, TX
Seth W. Hartman, Pharm.D., M.B.A. Director, Pharmacy Informatics. University of Chicago Medicine. Chicago, IL
Acronyms, references, and links for more information:
-Trusted Exchange Framework and Common Agreement. Retrieved from: https://www.healthit.gov/topic/interoperability/trusted-exchange-framework-and-common-agreement. Accessed 1/28/2020
-TEFCA in a Nutshell. Retrieved from: https://www.impact-advisors.com/regulatory/interoperability/tefca-in-a-nutshell/. Accessed 1/28/2020
- Trusted Exchange Framework and Common Agreement Draft 2. Accessed 1/28/2020
- "A User’s Guide to Understanding the Trusted Exchange Framework and Common Agreement Draft 2". Accessed 1/28/2020
- Surescripts Responds to ONC's TEFCA Draft. Accessed 4/27/2020
- Collaborative Outreach. Accessed 4/27/2020
- http://www.pharmacyhit.org/pdfs/collaborative-outreach/FINAL_PHIT_TEFCA_Draft2_Comments_6-17-19v1.pdf. Accessed 4/27/2020
HIN: health information networks.
https://www.healthit.gov/sites/default/files/what-Is-the-nhin--2.pdf Accessed 2/24/2020
HIE: health information exchanges.
https://www.healthit.gov/topic/health-it-and-health-information-exchange-basics/what-hie Accessed 2/24/2020
RCE: Recognized Coordinating Entity
The RCE is the entity selected by ONC that will enter into agreements with HINs that qualify and elect to become Qualified HINs in order to impose, at a minimum, the requirements of the Common Agreement set forth herein on the Qualified HINs and administer such requirements on an ongoing basis as described herein.
https://www.healthit.gov/sites/default/files/draft-guide.pdf Accessed 2/24/2020
EHI: Electronic Health Information
https://www.healthit.gov/sites/default/files/page/2019-02/HITACNPRMPresentation.pdf Accessed 2/24/2020
QHIN: Qualified Health Information Network
A Qualified HIN (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.
https://www.healthit.gov/sites/default/files/draft-guide.pdf Accessed 2/24/2020