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ONC’s Triple Play: Structure, Policy, and Community

“ONC’s Triple Play: Structure, Policy, and Community”

December 2023 proved to be a productive time for the Office of the National Coordinator for Health IT (ONC). Within the same week, ONC announced the go-live of the Trusted Exchange Framework and Common Agreement (TEFCA) for electronic health information exchange; released the Health Data, Technology, and Interoperability (HTI-1) Final Rule; and hosted the ONC Annual Meeting in Washington D.C. The confluence of these three milestones will have a significant impact on payers, providers, and health information technology (HIT) vendors in 2024 and beyond.

Go-Live of TEFCA QHINs

The first qualified health information networks (QHINs) adopted the TEFCA Common Agreement on December 12, 2023, and began to exchange data as specified in this framework. The TEFCA Common Agreement establishes a governance, policy, and technical baseline for sharing between health information networks comprised of national networks and several regional, state, or local health information exchanges. The TEFCA Common Agreement laid out a rigorous set of requirements for organizational requirements and technical testing to make health information exchange across the many networks and exchanges standardized and secure. These first QHINs are the fruit of decades of health information exchange efforts, requirements of the 21st Century Cures Act (2016), and the expertise of clinicians, health IT software developers and vendors, standards developers, and government policy makers.

These first QHINs are eHealth Exchange, Epic Nexus, Health Gorilla, KONZA, and MedAllies. Together, these QHINs include most hospitals, several thousand providers, and have processed billions of transactions annually across all 50 states. By becoming QHINs, these organizations enable exchange of health information across them all, making it possible for a provider in one network to access health information on patients that a provider in another network may maintain. For example, a hospital in Florida may now request and have access to patient records from another provider in Illinois through these QHINs connecting to shared data from their respective health information network participants.

Before this, health information exchange was limited to sharing within a given network, and if the Florida hospital and Illinois provider were not in the same health information exchange network, there was no reliable expectation that data sharing would be possible. Scalability across networks has been a challenge for data exchange use cases, including individual patient access and other use cases relevant to both payers and providers.

As a trust framework, TEFCA will help scale secure access for these and other use cases and reduce burden on providers, payers, and patients. For example, using multiple portals or mobile apps to access patient health data that resides in distinct networks is burdensome for those requiring patient data. ONC is also working with the Centers for Disease Control (CDC) to enable electronic case reporting via TEFCA QHINs to address interoperability challenges across providers and public health reporting and surveillance.

ONC’s TEFCA efforts also have a pathway charted into the future. As ONC and CMS requirements expand the use of FHIR®, incorporating FHIR API exchange in QHIN capabilities will be essential, particularly for payer-provider data exchange. On December 11, 2023, ONC and the TEFCA Recognized Coordinating Entity, the Sequoia Project, released the second version of its FHIR Roadmap for TEFCA Exchange, where direct FHIR exchange between a TEFCA Participant or Sub-participant and a FHIR endpoint will be “facilitated” by QHINs. These direct FHIR exchanges will be facilitated by QHIN-to-QHIN interactions to locate where a patient’s data may be found and the corresponding FHIR endpoints for the direct exchange. TEFCA aims to enable FHIR-based exchange in the Common Agreement version 2.0 expected in the first quarter of 2024.

More about TEFCA and the new QHINs can be found at ONC’s website with blog posts including the announcement of the TEFCA go-live.

Health Data, Technology, and Interoperability (HTI-1) Final Rule

On December 13, 2023, ONC published the HTI-1 Final Rule to meet the requirements of the 21st Century Cures Act for reporting on certified HIT and five executive orders focused on public health and health equity. Public health provisions in the HTI-1 final rule require information sharing for data-driven responses to COVID-19 and future public health threats that may be significant. To advance transparency and “health equity by design,” HTI-1 includes provisions for capturing expanded patient demographics known as social determinants of health (SDOH).

The final rule also calls for the certification of “decision support interventions” (DSIs) in the design and use of artificial intelligence and machine learning-based algorithms in decision support tools for transparency and the benefit of the general population. It further aims to reduce bias in algorithms that impedes health equity.  

By December 31, 2024, certified health IT developers are required to update to meet the new DSI criterion. The new criterion expands the “source attributes” or information about evidence-based DSIs and newly defined predictive DSIs. These source attributes are aimed at gaining increased transparency for organizations and users of decision support so they can determine whether predictive DSIs are fair, appropriate, valid, effective, and safe. This is the first revision to decision support certification criteria since 2012.

From now through the calendar year 2025, ONC is raising the baseline of available data to meet interoperability requirements from USCDI version 1 to USCDI version 3. Beginning on January 1, 2026, health IT developers will be required to use USCDI version 3, which adds new data that health IT developers must begin to collect data to report on when exchanging health information.

The key difference between USCDI version 1 and 3 is primarily the addition of new data elements related to SDOH, health insurance information, patient-provider encounters, and other patient health information. For health IT developers using FHIR for exchange of USCDI version 3 data, a new version of the U.S. Core FHIR specification is available. Where USCDI standardizes the minimum data to be exchanged, the U.S. Core FHIR standard specifies how health IT developers would exchange data using FHIR to meet USCDI requirements.

Beginning January 1, 2026, health IT developers shall begin collecting data for measures to report regarding criteria for conditions and maintenance of certified health IT, now called “Insights Condition.” Health IT developers will submit an initial report on “Insights Condition” measures by July of the following year. New measures are added annually in 2027 and 2028 to complete the set of Insight Condition measures. Reporting on Insights Condition is a cumulative process that starts over three years (2026-2028, reported in July 2029) with the full set of measures reporting occurring annually after that.

The HTI-1 final rule impacts health IT developers who are required to certify their health IT products via the ONC Health IT Certification Program. It also impacts entities that exchange health information, as ONC has updated definitions in the information blocking regulations in 45 CFR part 171 and has made modifications to the exceptions to information blocking. The final rule is available in the Federal Register. ONC has made fact sheets available. ONC is also sponsoring several information sessions for the public, which can also be found with the fact sheets.

2023 ONC Annual Meeting

December 14-15, 2023, ONC held its annual meeting in Washington D.C. This was the first in-person annual meeting ONC hosted since the COVID-19 pandemic. With the announcement of the go-live of QHINs and the publication of the HTI-1 final rule just days before, this was a vital opportunity for the health IT community to convene and interact on the direction of certified and emerging health IT. The backdrop of 2020 to 2023 in health IT was colored by requirements to incorporate FHIR and new applications of artificial intelligence in healthcare, as well as assuring health IT supports the aims of health equity, and all coincide with the lessons learned following the COVID-19 health emergency. Convening the health IT community also included bringing together clinicians and HIT subject matter experts from the private sector with ONC and other federal agencies such as Centers for Disease Control and Prevention (CDC), Veterans Affairs (the VA), Food and Drug Administration (FDA), the Office of Civil Rights (OCR), and others.

The ONC Annual Meeting was kicked off by Micky Tripathi and immediately recapped the go-live of TEFCA and the initially designated QHINs. The White House, Congressional representatives, other federal agencies, and a roundtable of representatives from the new QHINs gave their perspectives of TEFCA benefits. Following the TEFCA segment, breakout sessions focused on Leading Edge Acceleration Projects (LEAP in Health IT Program), public health modernization at local, state, and federal levels (inclusive of behavioral health), and the relationship between clinician documentation burden and payment models (e.g. fee-for-service or value-based care).

Later breakout sessions also focused on the HTI-1 rule, ONC’s USCDI+ initiative to align standards for cancer care, patient and clinical perspectives on the documentation and exchange of social needs and SDOH data, engaging patients via patient access to their health data, and the integration of behavioral health data with primary care and in-health information exchange. The first day concluded with a general session on how the Global Digital Health Partnership strengthens The Netherlands’ strategy on health data availability and interoperability, as a parallel to how federal interoperability efforts in the US play out across the nation at regional, state, and local levels.

The second day of the ONC Annual meeting expanded more on topics of health equity, transparency of artificial intelligence algorithms, and information exchange with speakers representing private and public sector technology, federal agencies, and academic institutions. A general session on Rooting out Racial Bias in Health Care AI was facilitated by Dan Gorenstein, Executive Editor of the health policy podcast Tradeoffs. Follow-up sessions covered the EMS data summit, laboratory data, the HTI-1 rule, alignment across federal agencies in health IT policy, how to train public health workers for the future, and additional FHIR information.

The ONC Annual Meeting was a fitting capstone to the week’s events and an opportunity for the health IT community to learn more about the direction of ONC and other federal agencies’ efforts in interoperability. With the relationship between ONC health IT policies and those of agencies like FDA, CDC, CMS, and the continued evolution of FHIR and AI, the ONC Annual Meeting afforded policy leaders and health IT implementers, providers, payers, and patients to better understand the progress and future direction of health IT.

Many of the topics discussed at the ONC Annual Meeting will impact regulation and initiatives from other federal agencies and state-level mandates. For example, the CMS Interoperability and Patient Access rule references ONC policies for information payers must make available to members. As CMS has finalized an Advancing Interoperability and Improving Prior Authorization Processes rule, it depends on ONC rules such as HTI-1, for example, for the sharing expanded data specified in USCDI. And as ONC has released its HTI-1 final rule, it is working on a future proposed rule, HTI-2, which will extend requirements for interoperability beyond those mandated in HTI-1.

More on the ONC Annual Meeting is available here.