The National Institutes of Health is encouraging NIH-supported clinical research programs and researchers to adopt and use the standardized set of data classes, data elements, and associated vocabulary standards specified in the United States Core Data for Interoperability (USCDI) standard.
Through a notice from the Office of the Director, NIH said the use of USCDI will facilitate the use of clinical data in research studies and enable greater consistency in clinical research data that are shared.
USCDI is composed of 15 data classes which are an aggregation of various data elements by a common theme or use case (e.g., patient demographics, clinical notes). Each data class is composed of one or more data elements, which are the most granular level at which a piece of data is represented in the USCDI for exchange (e.g., date of birth, discharge summary note).
USCDI will enable NIH researchers to benefit from the opportunities created by the increased availability of clinical data from EHRs for research and improved approaches for making data from a single research study useful for other research endeavors.
It can complement use of the the HL7 FHIR standard, which NIH encouraged researchers to use in a Guide Notice issued on July 30, 2019 to facilitate researcher access to clinical data in EHRs and to facilitate the sharing of research data. While the use of FHIR will enable the standardized sharing of health information for research, NIH said it is also critical to ensure the underlying data are consistently structured to enable research data sharing and discovery at scale.
The USCDI will enable researchers to leverage structured clinical data for research and enhance the ability to aggregate research data sets and enable discovery. USCDI defines the coding systems required for different classes of data applicable to all of the U.S. clinical data exchange standards.
On May 1, 2020, the Office of the National Coordinator for Health Information Technology (ONC) published the Cures Act Final Rule, which requires that EHR systems certified under the ONC’s Health Information Technology (IT) Certification Program adopt and use USCDI v1. Most of the clinical data covered by the USCDI has been required for EHR certification since 2012. Therefore, USCDI-organized data currently exist in EHR systems for research use.
Adoption of USCDI will allow care delivery and research organizations to use the same coding systems for key data elements that are part of the USCDI data classes. The USCDI includes widely adopted coding systems that are supported by the National Library of Medicine (NLM) and are important to the interoperable exchange of electronic health data, such as, RxNorm for medications, SNOMED CT for conditions and many specialized terms, and LOINC for tests and measurement. This coding consistency is essential to data aggregation across healthcare organizations, and has been important to the tracking of the COVID-19 epidemic. NLM-supported USCDI code systems are used to organize clinical data in smart phone-based mobile health applications and across several institutional research systems.
Leveraging the USCDI to Accelerate Discovery
NIH research investments generate and leverage vast amounts of data, and ensuring those data are findable, accessible, interoperable, and reusable (FAIR) can be achieved in part through more consistent use of data standards.
Through this notice, NIH encourages NIH-supported clinical programs and researchers to adopt and use the standardized set of healthcare data classes, data elements, and associated vocabulary standards in the USCDI v1, as they are applicable, to enable greater interoperable exchange of health information for clinical care and research. As with all NIH-funded or supported research involving human participants, and as is currently the expectation using USCDI, investigators must obtain participant consents and follow applicable national, tribal, and state laws and regulations, as well as relevant institutional policies, for the protection of human subjects.
