HL7 Backgrounder Brief
HL7 IS THE WORLDWIDE LEADER IN INTEROPERABILITY STANDARDS
Health Level Seven International (HL7), an ANSI-accredited standards developing organization (SDO), is the global authority on standards for interoperability of health information technology. With members in more than 55 countries, HL7 is deeply involved in worldwide efforts to improve healthcare through information technology and is a founding member of the Joint Initiative Council, an international council on global health informatics standardization that is committed to developing a single standard for a single purpose. HL7 also has an agreement with the International Organization of Standardization (ISO) through which HL7 submits its ANSI-approved standards or draft standards for trial use (DSTUs) directly to ISO for approval.
Founded in 1987, HL7 International is a nonprofit organization comprised of more than 4,000 worldwide members who represent hundreds of healthcare vendors, providers, payors, government agencies, consultants and others. In the U.S. alone, 90 percent of the largest health information system vendors are HL7 members. Volunteers perform HL7's standards development work.
HL7 does not develop software. It creates standards that allow healthcare information to be communicated across and between healthcare enterprises and communities. HL7 standards facilitate the exchange of clinical and administrative data among health information systems. Specifically, HL7 provides a comprehensive framework and related standards for the exchange, integration, sharing, and retrieval of electronic health information that supports clinical practice and the management, delivery, and evaluation of health services.
The most widely used HL7 specifications are messaging standards that enable disparate healthcare applications to exchange key sets of clinical and administrative data. HL7's Version 2.x messaging standard is arguably the most widely implemented standard for healthcare in the world. In 2009, it was published as an ISO standard. In the U.S., the HL7 Version 2 messaging standard is deployed at most healthcare facilities and is an international ISO standard. The HL7 Version 3 messaging standard is used by U.S. government agencies such as the Food and Drug Administration (FDA) and the Department of Veterans Affairs. Version 3 is also widely used outside the U.S. in countries such as Canada, the United Kingdom, the Netherlands, Germany and Mexico.
The enactment of the American Recovery and Reinvestment Act in the U.S., which has earmarked $19 billion in federal funds to support the spread of health IT, has provided new opportunities for HL7. One of the criteria for showing "meaningful use" of an EHR-a requirement for receiving government financial incentives-is to exchange electronic data with other healthcare providers. The HL7 standards already in place, and those that HL7 is developing or bringing online in the U.S., will be instrumental in achieving the interoperability that will enable providers to exchange data easily across healthcare communities. In fact, the Office of the National Coordinator for Health Information Technology in the U.S. Department of Health and Human Services selected HL7 Version 2 and the HL7 Clinical Document Architecture (CDA®) / Continuity the Continuity of Care Document (CCD®) in its initial set of standards, implementation specifications and certification criteria for EHR technology.
The HL7 Clinical Document Architecture (CDA®) is an important step to achieving interoperability. The CDA® is an ISO approved standard that provides an exchange model for clinical documents (such as discharge summaries and progress notes) and brings the healthcare industry closer to the realization of an electronic medical record. There are large-scale CDA® implementations in North and South America, Europe and Asia Pacific. The Continuity of Care Document (CCD®) is a CDA® implementation of the continuity of care record (CCR), created by the American Society for Testing and Materials (ASTM). Disparate information systems can employ the CCD to exchange clinical summaries that contain key data about individual patients, such as diagnoses, medications, and allergies.
HL7 has supported the Certification Commission for Health Information Technology's (CCHIT) certification development work in key areas. For example, CCHIT referenced HL7's EHR System Functional Model and HL7's Child Health Functional Profile, which defines the child healthcare functions needed in an EHR, in developing its optional Child Health certification criteria for Ambulatory EHRs.
HL7 created the EHR System Functional Model, which includes advanced decision support features, to help lay the groundwork for national interoperability of health IT systems. The model also supplies guidance to healthcare providers in preparing for, acquiring, and making the transition to electronic health record systems and was published as an ISO standard in late 2009. The HL7 Personal Health Record System Functional Model, a draft standard, identifies the functions that should be included in a PHR and includes guidelines for data exchange between PHRs and EHRs.
Other SDOs develop standards for particular areas of healthcare, such as laboratory orders and results, electronic prescribing, and medical device connectivity. HL7 is the only SDO that provides the messaging specifications to connect all of the systems in a healthcare enterprise, such as a hospital.
Recognizing that effective standards development requires collaboration with other SDOs and stakeholders, HL7 has established formal agreements with a number of key organizations. These pacts are designed to avoid redundancy in standards creation and work products and to facilitate open communication throughout the industry. Among the organizations with which HL7 has such agreements are the Accredited Standards Committee X12N (ASC X12N), ASTM, the Clinical Data Interchange Standards Consortium (CDISC), Digital Imaging and Communications in Medicine (DICOM), European Committee for Standardization (CEN), GS1, Institute of Electrical and Electronics Engineers (IEEE), Integrating The Healthcare Enterprise (IHE), International Health Terminology Standards Development Organization (IHTSDO), North American Association for Central Cancer Registries (NAACCR), the National Council for Prescriptions Drug Programs (NCPDP) and the Health Story Project. HL7 is also a founding member of the SDO Charter Organization (SCO), a formal collaboration among SDOs which aims to facilitate the creation of industry-wide, interoperable standards that will support meaningful improvements in healthcare outcomes.
HL7's affiliates include organizations in more than 30 countries around the world, including Argentina, Australia, Austria, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Japan, Korea, Netherlands, New Zealand, Romania, Russia, Singapore, Spain, Sweden, Switzerland, Taiwan, Turkey, The United Kingdom, and Uruguay.