One of the hallmarks of the 21st Century Cures Act signed into law in 2016 was the creation of a “trusted exchange framework” to support the safe and interoperable exchange of electronic health information among providers and between providers and their patients.  The Cures Act charges the Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) with creating a “single on-ramp” for health information exchange based on a unifying set of policies, procedures and technical standards and a common agreement among disparate health networks nationally.

ONC published a draft framework on January 5, 2018 that includes a proposed set of principles, terms and conditions to “guide the nation on its path to interoperability for all” and “help improve patient care, care coordination and the overall health of the nation,” Don Rucker, MD, national coordinator for health information technology, said in a statement.

In addition to creating an on-ramp for health information exchange, the goals of the framework are to:

• Build on and extend existing work done by the health information technology industry
• Offer scalability that will support health information exchange for the entire nation
• Build a competitive market that enables all to compete on information services
• Achieve a national network with long-term sustainability

The proposed framework is also designed to support ONC’s goals for interoperability in three areas:

• Patient access: the ability for patients to access their electronic health information without any special effort
• Population-level data exchange:  the ability for payers and providers to access population-level health information in order to analyze health trends, outcomes and costs; identify at-risk groups; and track progress on quality improvement initiatives
• Open and accessible application programming interfaces: access to APIs to encourage innovation that would make health information more readily available and improve electronic health record usability

The draft framework describes six principles to which all stakeholders are expected to adhere in facilitating health information exchange and interoperability across the entire continuum of care:

• Principle 1 – Standardization:  Adhere to industry and federally recognized standards, policies, best practices and procedures.
• Principle 2 – Transparency: Conduct all exchange openly and transparently.
• Principle 3 – Cooperation and Non-Discrimination: Collaborate with stakeholders across the continuum of care to exchange electronic health information, even when a stakeholder may be a business competitor.
• Principle 4 – Privacy, Security and Patient Safety: Exchange electronic health information securely and in a manner that promotes patient safety and ensures data integrity.
• Principle 5 – Access: Ensure that individuals and their authorized caregivers have easy access to their electronic health information.
• Principle 6 – Data-driven Accountability: Exchange multiple records for a cohort of patients 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.

To implement the Trusted Exchange Framework, ONC will collaborate with a Recognized Competitive Entity (RCE) chosen through a competitive process.  The RCE will be responsible for developing a single Common Agreement for Qualified Health Information Networks (Qualified HINs) based on the framework’s policies, procedures, technical standards, principles and goals.  Following the public comment period (which ends on February 18, 2018) and refinements to the draft document, a final draft of the combined Trusted Exchange Framework and Common Agreement (TEFCA) will be released and published in the Federal Register in 2018.

“We know that many stakeholders, including healthcare providers, health systems, developers and existing health information networks have extensive experience in trust agreements and common exchange networks and strongly encourage stakeholders to share that insight with us,” Dr. Rucker said.

ONC has released a variety of resources related to TEFCA, including a User’s Guide to Understanding the Draft Trusted Exchange Frameworkand the Draft U.S. Core Data for Interoperability and Proposed Expansion Process.  Comments on the draft framework can be sent to exchangeframework@hhs.gov.