Health Level Seven International (HL7) is a not-for-profit, ANSI-accredited, standards developing organization focused on the framework and related standards for electronic health information exchange and integration to support clinical practice and health services improvements.
Lantana works across HL7 to strengthen the open standards that increase the value of health information technology and electronic health records. We maintain this HL7 Snapshot as a quick reference guide to key initiatives. We report on new developments within these initiatives in Special Editions of our newsletter, Blips on Our Radar. We will continue to build out this Snapshot as a reference page for readers of our Blips and others. If there are other areas within HL7 that you would like to see covered here, please let us know. To do so or to subscribe to the newsletter, please send a request to Blips@lantanagroup.com.
HL7 ballots its standards three times each year and in occasional out-of-cycle special ballots (see Current HL7 Ballots). Members have voting rights according to their level of membership; nonmembers can vote by paying a small administrative fee. HL7 is certified by the American National Standards Institute (ANSI) and conducts ballots according to ANSI rules, which emphasize an open process designed to avoid undue influence of any one group on the outcome. Negative ballots must be accompanied by comments that justify the position and ballot sponsors engage in discussion with participants to resolve all comments.
HL7 STU standards are posted for public comment for an assigned period. Comments are reviewed and evaluated by HL7 WGs and are categorized as new feature requests or technical errors. Only technical errors are considered errata, which will be corrected and addressed through an STU errata release. The corresponding clarifications or corrections are voted on by the corresponding WG, and new errata packages are released periodically.
Clinical Document Architecture (CDA)
An ANSI-approved standard for exchange of electronic clinical documents since 2000. CDA supports continuity of care and data reuse for reimbursement, quality reporting, public health, and research. CDA Release 2 (R2), published in 2005, is a widely adopted international standard. It is the base standard for Consolidated CDA (C-CDA), Quality Reporting Document Architecture (QRDA), and Attachments.
Fast Healthcare Interoperability Resources (FHIR)
An HL7 standard for exchanging healthcare information electronically. The FHIR (pronounced “fire”) standard uses simplified syntax including JSON and Representational State Transfer (RESTful) architectures. It cut the direct reliance on the RIM and complex Version 3 data types, but maintains traceability to those models. FHIR implementations are based on “resources” and “profiles”. There are implementation guides underway for most major HL7 domains, see “Implementation Guides defined as part of FHIR”. A full list of FHIR Resources is available on the Resource Index webpage.
Clinical Quality Framework (CQF) on FHIR
A FHIR implementation guide for Clinical Decision Support (CDS) and Clinical Quality Measurement. Within the FHIR infrastructure, resources are collected under the Clinical Reasoning module. (CQF on FHIR website)
A hands-on opportunity for implementers, clinicians, and others to electronically exchange data, test data specifications, and develop interoperability solutions across multiple application. Connectathons may be organized into tracks, each track addressing a scenario, for example registering a new patient record, retrieving the patient’s history, or updating the record with a new encounter.
Consolidated CDA (C-CDA)
A collection of implementation guides that specify requirements for electronic clinical notes using CDA as the base standard. The collection includes the Continuity of Care Document (CCD), eight types of common clinical notes developed originally by the Health Story Project, and several more for a total of 13 including a Care Plan and template for patient authored notes. C-CDA is cited in Meaningful Use. The most recent edition is Release 2.1, published in August 2015.
C-CDA on FHIR
An implementation guide that defines a series of FHIR profiles on the Composition resource to represent the various document types in C-CDA. It does not directly map every C-CDA template to FHIR profiles but tries to accomplish the C-CDA use case using Composition resource profiles created under this project (the equivalent of Level 2 CDA documents), and linking to the profiles created under the Data Access Framework (DAF) project for any coded entries that would normally be included in C-CDA sections.
DSTU vs. STU
The draft designations for standards. New standards are called “Standard for Trial Use” (STU) during the 24-month use and comment period after which they may be brought to ballot as “Normative”. The older designation “Draft Standards for Trial Use” (DSTU) continues to appear on previously published specifications, so for a time we will see both DSTU and STU standards. The intent and status is identical between the two.
A language for querying a FHIR-based information model, similar to XPath for XML. Fluentpath works against the FHIR model and is agnostic to the physical representation/format of the FHIR data (i.e., does not care if FHIR data is in XML or JSON). Fluentpath has been incorporated into CQL for querying and navigation.
HL7 International and Affiliates
The international structure of HL7. HL7 is based in the US with affiliates in over 30 countries. There is no US affiliate; HL7 International works on behalf of US requirements. For information on affiliates, please see the Affiliates Contacts on HL7’s International Council page.
Health Quality Measure Format (HQMF)
A standards-based representation of quality measures as electronic documents. HQMF and the Quality Data Model (QDM) are fundamental to the CMS and Office of the National Coordinator for Health Information Technology (ONC) programs for quality monitoring. The most recent version of HQMF is Release 1, normative. (HQMF Product Brief)
A collection of FHIR profiles for quality reporting. These can be thought of as the FHIR equivalent of QRDA I templates for CDA. The Measure Report FHIR resource (defined in the CQF on FHIR IG) is the container, while the Qi-Core Profiles represent the clinical quality data for the patient.
Quality Reporting Document Architecture (QRDA)
A standard cited in Meaningful Use Stage 2 (MU2) for patient-level reporting (QRDA Category I or QRDA-I) and for aggregate reporting (QRDA Category III or QRDA-III). QRDA reports are sent to the Centers for Medicare & Medicaid Services (CMS). (QRDA Product Brief)
Quality Reporting Standards
Health information exchange standards for reporting quality of care. The Clinical Quality Information (CQI) Work Group has adopted several standards for quality reporting, including QRDA, HQMF, and the QDM.
US Core Implementation Guide
Defines the minimum conformance requirements for accessing patient data as outlined by the Argonaut pilot implementations and the ONC 2015 Edition Common Clinical Data Set (CCDS). These requirements were originally developed, balloted, and published in FHIR DSTU2 as part of the Office of the National Coordinator for Health Information Technology (ONC) sponsored Data Access Framework (DAF) project. For more information on how DAF became US Core, see the US Core change notes.
Work Groups (WGs)
HL7 volunteers, the backbone of the organization. Volunteers come from commercial and non-profit organizations and from government; most are on assignment from employers. WGs align with clinical and technical areas, such as Patient Care or Structured Documents. WGs oversee standards and implementation guide development from project origination through balloting to publication.