On February 11, 2019 the U.S. Department of Health and Human Services (HHS), through by the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC), issued rules for US healthcare systems’ implementation of the 21st Century Cures Act, which was signed into law in 2016.
The new rules would require implementation of the ONC’s U.S. Core Data for Interoperability (USCDI) and Health Level Seven’s (HL7®) Fast Healthcare Information Resource (FHIR®) to support seamless and secure access, exchange, and use of electronic health information.
According to the ONC, the USCDI “is a standardized set of health data classes and constituent data elements for nationwide, interoperable health information exchange.” FHIR is an internet-based approach to sharing and exchanging healthcare information for common clinical needs.
U.S. Core Data for Interoperability (USCDI)
The USCDI is the latest evolution of a patient-centered healthcare data set that has been under standard- and rule-making development for over a decade. USCDI specifies requirements for standards-based health data classes and constituent data elements whose use are mandated by ONC and CMS to ensure improved healthcare information interoperability. USCDI includes the following data object classes. Subsidiary healthcare data elements are listed in Appendix A.
- Assessment and plan of treatment
- Care Team members
- Clinical Notes
- Health concerns
- Patient Demographics
- Smoking Status
- Unique device identifier
- Vital signs
Fast Healthcare Information Resource (FHIR)
FHIR is an internet-based approach to sharing and exchanging healthcare information to provide seamless interoperability and patient-centered, data-driven care. FHIR is a standards framework created by HL7 by combining features of V2 , HL7 V3, and CDA specifications while leveraging the latest web standards.
FHIR Core Profiles and Resources define a common platform standard that must be adapted to particular use cases. As shown in Appendices C and D, some use-cases are common or important enough to be described as a part of the specification itself. Additional profiles and extensions may be registered on the HL7 FHIR registry.
FHIR Core is the foundation for national, regional, or clinical specific implementation guides, such as FHIR US Core. The Open Group support for FHIR Core in the Federal Health Information Model (FHIM) is critical for Open Group members across the globe.
FHIR API Resource Collection in Health (ARCH)
The FHIR ARCH defines a subset of FHIR Core resources that must be supported from the FHIR Core standard to ensure interoperability of the most common healthcare information exchange. As shown in Appendix E, FHIR ARCH includes the following object classes and subsidiary healthcare elements:
FHIR US Core
The US Core Implementation Guide is based on FHIR Version 3.0.1 and defines the minimum conformance requirements for accessing patient data as defined by the ONC 2015 Edition Common Clinical Data Set (CCDS). These profiles are intended to be the foundation for future US Realm FHIR implementation guides. Under the guidance of HL7 and the HL7 US Realm Steering Committee, the content will expand in future versions to meet the needs specific to the US Realm.
Federal Health Information Model (FHIM)
The FHIM Federal Health Information Model is a logical health information model that supports semantic interoperability and harmonizes healthcare information requirements from federal partners, medical professional organizations and standards development organizations. FHIM provides an integrated picture of a healthcare information model that supports mapping of the healthcare information model across multiple standards and associated variants of the information model. The FHIM serves as a Rosetta Stone or thesaurus between standards to support consistent interoperability between health care information exchange protocols.
The ONC Notice of Proposed Rulemaking (NPRM) for the 21st Century Cares Act suggests that USCDI and FHIR “will need to continually expand the data elements and upgrade the capabilities… as the FHIR standard and its implementation specifications mature, and the National Coordinator expands the USCDI….” (ONC USCDI v1.0 Page 241-242)
As USCDI and FHIR are extended, and as focused Implementation Guides are defined, FHIM can be used to model and map between new USCDI objects and elements and new FHIR profile and resource extensions.
The FHIM can be foundational to the 21st Century Cures Act interoperability and The Open Group Healthcare Forum. The FHIM provides value as a data dictionary and organizer of healthcare data definitions into clear, complete, concise and correct information for ensuring compatible and interoperable healthcare information exchange. One cannot use information that one doesn’t understand--this is where FHIM provides the most value as it translates and transforms between multiple standards and protocols.
Appendix A: USCDI v1 Summary of Data Classes and Data Elements
Appendix B: FHIR Core Resources
Appendix C: FHIR Core Profiles
The FHIR specification is a common platform standard that must be adapted to particular use cases. Some particular use cases are common or important enough to be described as a part of the specification itself. Excluding standard extensions, the standard profiles defined in FHIR Core are:
- EHRS FM Record Lifecycle Event - Audit Event
- DataElement constraint on ElementDefinition data type
- EHRS FM Record Lifecycle Event - Provenance
- Shareable ActivityDefinition
- Shareable CodeSystem
- Clinical Document
- Profile for Catalog
- Example Lipid Profile
- Profile for HLA Genotyping Results
- Evidence Synthesis Profile
- PICO Element Profile
- Family member history for genetics analysis
- Group Definition
- Actual Group
- CDS Hooks GuidanceResponse
- Shareable Library
- CQL Library
- Shareable Measure
- Device Metric Observation Profile
- Shareable PlanDefinition
- Computable PlanDefinition
- CDS Hooks Service PlanDefinition
- Provenance Relevant History
- CDS Hooks RequestGroup
- Shareable ValueSet
Appendix D: HL7 FHIR US Core Summary of Profiles
US Core Profiles define the minimum mandatory elements, extensions and terminology requirements that MUST be present. For each profile requirements and guidance are given in a simple narrative summary. These profiles are:
- US Core AllergyIntolerance Profile
- US Core CarePlan Profile
- US Core CareTeam Profile
- US Core Condition (a.k.a Problem) Profile
- US Core Device Profile
- US Core DiagnosticReport Profile
- US Core DocumentReference Profile
- US Core Encounter Profile
- US Core Goal Profile
- US Core Immunization Profile
- US Core Location Profile
- US Core Medication Profile
- US Core MedicationRequest Profile
- US Core MedicationStatement Profile
- US Core Organization Profile
- US Core Patient Profile
- US Core Practitioner Profile
- US Core PractitionerRole Profile
- US Core Procedure Profile
- US Core Results Profile
- US Core Smoking Status Profile
- US Core adopts the Vitals Signs Profile from FHIR Core.
Appendix E: API Resource Collection in Health (ARCH)
The following resources must be supported from the Health Level Seven (HL7®) Fast Healthcare Interoperability Resources (FHIR®) standard:
- DocumentReference, for the purposes of supporting clinical notes
- Patient (including mandatory support for the “patient.address” and “patient.telecom” elements)
- Provenance (including mandatory support for “Provenance.agent.actor” (for the author and author’s organization) and “Provenance.recorded” elements).