One of the most important provisions of the 2016 21st Century Cures Act (Cures) is the directive for the Office of the National Coordinator for Health Information Technology (ONC) to “develop or support a trusted exchange framework, including a common agreement among health information networks nationally.”
Yet how do the provisions of Cures differ from those of the 2009 Health Information Technology for Economic and Clinical Health Act, or HITECH, which established the legislative foundation for nationwide health information exchange and funded those efforts throughout the US? And how can the Cures-mandated Trusted Exchange Framework and Common Agreement (TEFCA) be successful where HITECH has not been?
HITECH’s history with interoperability in healthcare
HITECH directed funding to individual states to develop a nationwide health information network. Many states established Health Information Exchanges (HIEs) while that funding persisted, but coordination between state HIEs for interoperability was often lacking. And even when some state HIEs did establish cooperative agreements with each other, others developed competing HIEs within their own borders.
Still, without a clear framework for information exchange it was up to each HIE to define the scope of its exchange. Successful HIEs were able to establish financial viability by generating revenue from participants and supporting information exchange between independent entities – including other HIEs. But without continued funding under HITECH, many HIEs were unable to maintain these operations, and the number of HIEs declined from a peak of 119 in 2012 to 89 in 2019.
While HITECH originated the HIE, TEFCA goes further. TEFCA supports national health information exchange by establishing a common, voluntary framework for secure information exchange. TEFCA defines both the policy for connectivity – the “agreement” between participating entities – and the technical standards for the data exchanged between said entities. TEFCA is structured as a hierarchal organization in collaboration with the ONC.
The ONC oversees TEFCA and appoints a Recognized Coordinating Entity (RCE) to develop, implement, and maintain a Common Agreement defining the requirements for HIEs to be eligible for participation, which are then considered Qualified Health Information Networks (QHINs). The RCE oversees QHINs to ensure that QHINs can support the six Permitted Exchange Purposes for information exchange between each other, and for participants and subparticipants. Those purposes are:
- Healthcare operations
- Public health
- Government benefits determination
- Individual access services for patients
Participants and subparticipants include health information networks, health systems, health IT developers, payers, federal agencies, public health departments, providers, and researchers. Individual users are the subjects of the electronic health information and include patients, health plan enrollees, and patient representatives. These stakeholders maintain agreements with the QHIN to ensure that the data they receive and exchange meets the requirements of both the TEFCA policy and the technical framework.
The Common Agreement defines the information flows that QHINs, participants and subparticipants must support:
- Patient discovery
- Document query and retrieve
- Message delivery
Policy requirements define the scope of access, exchange, and use of relevant electronic health information across disparate networks and sharing arrangements for QHINs, participants, and subparticipants. For example, all participants must support and maintain the RCE Directory Service consisting of technical endpoints and other identifying information for data exchange. All participants must support data exchange for the exchange purposes.
The technical requirements for information exchange require that QHINs, participants, and subparticipants support:
- C-CDA 2.1
- Available demographics
- USCDI V1 data classes/elements
- Parsing of (instance) access consent policy
- Audit logging
- TLS 1.2+ between participant and QHIN
Where interoperability in healthcare goes next
Yet true information interoperability within the TEFCA framework requires more than policies and standard practices for exchange. A critical component is ensuring a common understanding of the meaning of the data to be exchanged.
Patient data from disparate sources – such as providers, hospitals, laboratories, community health centers, and public health agencies – that represents problems, diagnoses, lab results, and medications can be incomplete and inaccurate. However, this incomplete data can still be exchanged between QHINS, participants, and subparticipants since TEFCA’s language does not ensure data quality. It only requires that structured data meets the terminology requirements for C-CDA and the USCDI v1 that map to standard reference codes for interoperable health information exchange.
For TEFCA to be successful in not only supporting information interoperability, but also ensuring data meets the required exchange purposes, stakeholders will require comprehensive, high-quality, semantically interoperable data. QHINs and participants are uniquely positioned to ensure data quality in TEFCA. They could choose to share minimally curated data, fulfilling minimal interoperability requirements without making sense of that data, or they can ensure semantic interoperability through normalization.
Normalization driven by a robust terminology server can define discrete data elements and then ensure reliable and comprehensive mapping to standard reference codes without losing granularity or meaning. IMO Precision Normalize provides both the maps to the standard codes and a comprehensive and semantically interoperable data stream.
Normalized data shared between TECFA participants with a common understanding of that data has the potential to advance patient care; reduce errors that can impact patient safety; and avoid duplicative and costly tests when a patient is cared for by multiple providers in different organizations. TEFCA has incredible potential to advance data exchange in the US and normalization has the potential to make that data truly powerful.