ASTP Partnership with HL7 Advances Standards Development

Often functioning behind the scenes, standards play an enormous role in our daily lives. Nearly every aspect of our modern world is shaped by standards, including our homes (building codes, electrical outlets), cars (safety requirements, fuel efficiency), and the food we eat (nutrition labels). Standards in healthcare impact medical education, clinical practice, quality of care, and patient safety. Likewise, modern health information technology (IT) systems, like electronic health records (EHRs), rely on data standards to record and exchange health information.

As the nation's health IT coordinator, the Office of the Assistant Secretary for Technology Policy and Office of the National Coordinator for Health IT (hereafter referred to as ASTP) has a duty to ensure standards are in place that support federal policy goals and enable developers to create interoperable health IT products. Our commitment to the development and adoption of health care standards includes a series of cooperative agreements between ASTP and Health Level Seven International® (HL7®) that began in 2015. This collaboration has supported the development and growth of crucial health IT standards incorporated by ASTP regulations and the ONC Health IT Certification Program (Certification Program), as well as tooling and resources for HL7's standards development community.

ASTP has long supported adoption and implementation of health IT standards through the Certification Program. Many of the technical capabilities described by the Certification Program are enabled by specific standards created by standards development organizations (SDOs) like HL7. For example, certified EHR technology (CEHRT) must provide access to health information through an application programming interface (API) using the HL7 Fast Healthcare Interoperability Resources® (FHIR®) standard and HL7 FHIR US Core Implementation Guide (IG). The requirements for the Certification Program and associated standards are defined by ASTP regulations, including the 21st Century Cures Act Final Rule, HTI-1 Final Rule, and HTI-2 Proposed Rule.

Standards development can be a long and complex process, often involving multiple rounds of drafting, testing, and review before finalization-all before they are included in ASTP regulations. SDOs help facilitate the process of creating standards by providing governance and infrastructure for communities of interested parties to collaborate and build consensus. However, SDOs often lack the resources to fully support standards development activities, especially when their standards are made freely available to the public. SDOs like HL7, for example, rely heavily on volunteers to do much of the heavy lifting to create and update standards like FHIR.

Through the cooperative agreements, ASTP funds ongoing development of HL7 standards like Consolidated Clinical Document Architecture (C-CDA) and the FHIR US Core IG (US Core). ASTP regulations use these standards to enable access to electronic health information via CEHRT. Both standards implement ASTP's United States Core Data for Interoperability (USCDI) and describe the format and content of much of the health information exchanged between organizations today. ASTP's cooperative agreements with HL7 provide the necessary resources to ensure US Core and C-CDA are regularly updated to include the latest data classes and elements defined in USCDI. In 2023, HL7 published US Core version 6.1.0 and the C-CDA Companion Guide version 4.1, with content from USCDI version 3. These new versions were included in Certification Program criteria updates in the HTI-1 Final Rule.

ASTP also supports HL7's Gender Harmony Project, which provides guidance on how to exchange clinical sex and gender affirming information using HL7 standards. The Gender Harmony project aims to address the common problem that health IT systems often capture both sex and gender information in a single data element, conflating these distinct concepts. The project complements ASTP policy priorities related to health equity, as reflected in the evolution of sex and gender data included in USCDI and the Certification Program. In HTI-1, for example, we updated the code systems associated with patient demographic and observation information for elements including sex, sexual orientation, gender identify, sex parameter for clinical use, and pronouns to better align with the Gender Harmony Project. Likewise, USCDI v5 includes a new data element for sex parameter for clinical use. The HL7 Gender Harmony Cross-Paradigm IG was formally published in September 2023.

Even modest investments in standards can have a major impact on interoperability and the availability and accessibility of electronic health information. We applaud the work of SDOs like HL7 and look forward to continuing to collaborate with the standards development community to further advance interoperability.