A critical goal of the 2009 Health Information Technology for Economic and Clinical Health (HITECH) Act was ensuring healthcare organizations could achieve healthcare information interoperability, or seamlessly share information between different clinical systems to inform patient care.

Finalized HITECH regulations established early standards to describe a common language for the process of care based on structured vocabularies (terminologies) and a set of rules that enabled the exchange of electronic health information (EHI) between health information technology (HIT) systems.

These foundational standards quickly became insufficient to meet the needs of a growing healthcare ecosystem generating increasingly complex patient data. While the Office of the National Coordinator (ONC) made changes to standards in the years after HITECH, new standards to support EHI interoperability were needed.

21st Century Cures, USCDI, and FHIR

The 2016 21st Century Cures Act (Cures) prioritized the interoperability and availability of EHI and directed developers of certified health information technology (HIT) to improve the access, exchange, and use of health information. Cures expressly prohibited information blocking by preventing, discouraging, or interfering with the access, exchange, or use of health information within certified HIT.

The ONC 2020 Cures Act Final Rule established new standards for information interoperability and certification of HIT, replacing the “Common Clinical Data Set” (CCDS) with the United States Core Data for Interoperability (USCDI) and directing the implementation of HL7 Fast Healthcare Interoperability Resources (FHIR) for data exchange between HIT.

USCDI increased the capacity for structured data, representing the process of care beyond the CCDS. The FHIR US Core Implementation Guide (IG) aligns with the USCDI and FHIR Application Programming Interfaces (APIs) to facilitate access and exchange of data between HIT systems.

The ONC integrated these new standards with the existing HL7 Consolidated Clinical Document Architecture (C-CDA) – a format that specifies the structure and semantics of “clinical documents” to be exchanged between healthcare providers and patients – easing the implementation process for HIT developers and implementors.

USCDI – designed for growth

The USCDI is a flexible specification that organizes clinical and administrative data classes by a common theme or use case for healthcare information exchange.

Data classes are defined by data elements representing concepts for information exchange. Data elements are aligned with structured data coded in applicable terminology and vocabulary standards identified in federal regulation that represents healthcare information.

Updates and expansion are easily accommodated. Data elements can be moved between data classes, and both can be expanded to incorporate new information.

The USCDI annual update process is driven by stakeholders with implementors, HIT developers, standards development organizations (SDOs), federal agencies, and other interested parties collaborating to advance the specification. This approach allows for incremental change between versions of USCDI keeping pace with the growing scope of data generated in patient care.

The ONC manages the USCDI update and publication process, ensuring that new submissions meet criteria for maturity of standards for implementation. Submission criterion include applicability of the use case to settings of care, how effectively production HIT can capture and exchange data elements represented by structured data, and how frequently data is exchanged in the process of care.

ONC-approved submissions are included in a draft version of the USCDI for public comment and review by the federally appointed Health Information Technology Advisory Committee (HITAC) before recommendation for publication.

New submissions are accepted in July and published in a draft version the following January. Public comment runs January through April. The final version is published in July with a new submission cycle beginning the same month.

USCDI and FHIR US Core

FHIR US Core operationalizes the technical specifications and implementation guidance for exchange of the data elements specified in the USCDI. The HL7 standards development process is aligned with USCDI versioning which facilitates implementation of new versions of the USCDI in production HIT.

Regulatory versions and the Standards Version Advancement Process

The ONC USCDI website provides a wealth of information about the USCDI, including the submission and public commenting process, and draft and published versions of the USCDI are posted there.

While USCDI V1 is the minimum required standard for interoperability by certified health IT until January 1, 2026, and USCDI V3 becomes the required standard after that date, published versions are far ahead of regulated versions.

The ONC maintains an annual Standards Version Advancement Process (SVAP) that allows newer versions of standards to be incorporated in certified health IT and included in the certification testing process. The ONC updates this listing in the fall of each year, ensuring that the FHIR US Core development cycle is aligned with USCDI for production implementation.

Availability of newer versions of USCDI through SVAP allows HIT developers to adapt more easily to incremental changes, reducing their development efforts when regulated USCDI versions lag behind SVAP approved versions.

The USCDI is a flexible specification with development capacity to support the growing needs of healthcare data exchange. Aligned with FHIR, the USCDI is a powerful tool to support interoperability that benefits patients and healthcare providers.