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Standards Development

HL7 (Health Level Seven)

Health Level Seven is one of several ANSI-accredited Standards Developing Organizations (SDOs) operating in the healthcare arena. Most SDOs produce standards (sometimes called specifications or protocols) for a particular healthcare domain such as pharmacy, medical devices, imaging or insurance (claims processing) transactions. Health Level Seven’s domain is clinical and administrative data. HL7’s mission is to: “To provide standards for the exchange, management and integration of data that support clinical patient care and the management, delivery and evaluation of healthcare services. Specifically, to create flexible, cost effective approaches, standards, guidelines, methodologies, and related services for interoperability between healthcare information systems.”

There are several healthcare standards development efforts currently underway throughout the world. HL7 is singular in its focus on the interface requirements of the entire healthcare organization, while most other efforts focus on the requirements of a particular department. The group addresses the unique requirements of already installed hospital and departmental systems, some of which use mature technologies. At the moment HL7 is the dominant healthcare standards organization in many countries, including the US.

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Integrating the Healthcare Enterprise (IHE)

The IHE initiative is a project designed to advance the state of data integration in healthcare. Sponsored by the Radiological Society of North America (RSNA) and the Healthcare Information and Management Systems Society (HIMSS), it brings together medical professionals and the healthcare information and imaging systems industry to agree upon document standards and demonstrate standards-based methods of sharing information in support of optimal patient care.

The goal of the IHE initiative is to stimulate integration of healthcare information resources, beginning with Picture Archiving and Communication Systems (PACS), through the use of open standards. IHE also encourages comprehensive integration among the full array of imaging and other healthcare information systems.

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ANSI (American National Standards Institute)

The American National Standards Institute (ANSI) is a private, non-profit organization that administers and coordinates the U.S. voluntary standardization and conformity assessment system. ANSI currently provides a forum for over 270 ANSI-accredited standards developers representing approximately 200 distinct organizations in the private and public sectors. These groups work cooperatively to develop voluntary national consensus standards and American National Standards (ANS).

In order to maintain ANSI accreditation, standards developers are required to consistently adhere to a set of requirements or procedures known as the“ ANSI Procedures for the Development and Coordination of American National Standards,” which govern the consensus development process. Due process is the key to ensuring that ANSs are developed in an environment that is equitable, accessible and responsive to the requirements of various stakeholders. The ANS process is intended to be open and fair to help ensure that all interested and affected parties have an opportunity to participate in a standard’s development. It also is intended to serve and protect the public interest since standards developers accredited by ANSI must meet the Institute’s requirements for openness, balance, consensus and other due process safeguards.

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Organized in 1898, ASTM International is one of the largest voluntary standards development organizations in the world. The subjects encompassed for standardization are broad. Generally, ASTM develops standards on characteristics and performance of materials, products, systems and services. Its technical committees are involved currently in categories such as: Ferrous Metals; Nonferrous Metals; Cementitous, Ceramic, Concrete and Masonry Materials; Materials for Specific Applications; etc.

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Committee E31 on Healthcare Informatics

ASTM’s Committee E31 develops standards related to the architecture, content, storage, security, confidentiality, functionality, and communication of information used within healthcare and healthcare decision making, including patient-specific information and knowledge.

More on Committee E31 on astm.org

The International Health Terminology Standards Development Organisation® SNOMED (Systematized Nomenclature of Medicine)

SNOMED CT® (Systematized Nomenclature of Medicine-Clinical Terms) is considered to be the most comprehensive, multilingual clinical healthcare terminology in the world. SNOMED CT® was a joint development between the NHS in England and the College of American Pathologists (CAP) to develop an international clinical terminology and was formed in 1999 by the convergence of SNOMED RT and the United Kingdom's Clinical Terms Version 3 (formerly known as the Read Codes). It has greater depth and coverage of healthcare than the versions of Clinical Terms (Read Codes) that it replaces.

SNOMED CT® provides the core general terminology for the electronic health record (EHR) and contains more than 357,000 concepts with unique meanings and formal logic-based definitions organized into hierarchies. When implemented in software applications, SNOMED CT® represents clinically relevant information consistently, reliably and comprehensively as an integral part of producing electronic health records.

The ongoing maintenance and development of SNOMED CT® is now under the direction of International Health Terminology Standards Development Organisation®.


LOINC (Logical Observation Identifiers Names and Codes)


LOINC is the primary terminology used in the exchange of laboratory test information and results and vital signs. The Regenstrief Institute is responsible for the ongoing maintenance and development of LOINC terms.

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ICD-9 and ICD-10 (International Classification of Disease

The International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) is based on the World Health Organization's Ninth Revision, International Classification of Diseases (ICD-9). ICD-9-CM provides a coding and classification system used to identify diagnoses and procedures that occur during a clinical encounter.

ICD-10 is the current version of ICD; there is ongoing discussion about the need to move US HIT systems from an ICD-9 base to the newer ICD-10 version.

NCPDP (National Council for Prescription Drug Programs)

The National Council for Prescription Drug Programs, Inc. (NCPDP) is a not-for-profit ANSI-Accredited Standards Development Organization consisting of over 1,300 members representing virtually every sector of the pharmacy services industry. NCPDP's Telecommunication Standard Version 5.1 was named the official standard for pharmacy claims in the Health Insurance Portability and Accountability Act (HIPAA). This has significant impact on physicians as well as on the pharmacy and pharmacy benefits world.

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DICOM (Digital Imaging and Communications in Medicine)

The Digital Imaging and Communications in Medicine (DICOM) Standard was developed for the transmission of images and is used internationally for Picture Archiving and Communication Systems (PACS). This standard was developed by a joint committee of the ACR (the American College of Radiology) and NEMA (the National Electrical Manufacturers Association) to meet the needs of manufacturers and users of medical imaging equipment for interconnection of devices on standard networks. All imaging systems use their standards for delivery of images and information surrounding the production of the image.

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ASC (Accredited Standards Committee ) X12

The American National Standards Institute Accredited Standards Committee X12 (ASC X12) selected X12N as the standard for electronic data interchange (EDI) used in administrative and financial healthcare transactions (excluding retail pharmacy transactions) in compliance with the Health Insurance Portability and Accountability Act (HIPAA). This standard is used for external financial transactions, financial coverage verification and insurance transactions and claims.

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