Organizations and Initiatives
Accredited Standards Committee (ASC X12) – Develops electronic data interchange (EDI) standards and related documents for national and global markets. With more than 315 X12 EDI standards and a growing collection of X12 XML schemas, ASC X12 enhances business processes, reduces costs, and expands organizational reach. ASC X12’s diverse member base includes 3000+ standards experts representing over 340 companies from multiple business domains, including communications, finance, government, insurance, supply chain, and transportation. Chartered in 1979 by the American National Standards Institute. http://www.X12.org.
American Health Information Management Association (AHIMA) – An association of health information management (HIM) professionals committed to advancing the HIM profession in an increasingly electronic and global environment through leadership in advocacy, education, certification, and professional education. AHIMA’s more than 61,000 members are dedicated to the effective management of personal health information to support quality healthcare. Founded in 1928. http://www.ahima.org.
American Medical Association (AMA) – A voluntary association of physicians in the USA. It promotes the art and science of medicine and the betterment of public health. The American Medical Association helps doctors help patients by uniting physicians nationwide to work on the most important professional and public health issues. Founded in 1847. http://www.ama-assn.org.
American National Standards Institute (ANSI) – A not-for-profit organization that oversees the creation, promulgation, and use of thousands of norms and guidelines that directly impact businesses in nearly every sector, including acoustical devices, construction equipment, dairy and livestock production, energy distribution, and healthcare. ANSI is also actively engaged in accrediting programs that assess conformance to standards – including globally recognized cross-sector programs such as the ISO 9000 (quality) and ISO 14000 (environmental) management systems. ANSI is also the US representative to the ISO. Founded in 1918. http://www.ansi.org.
American Society for Testing and Materials (ASTM) – A globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. Formed in 1898 by chemists and engineers from the Pennsylvania Railroad. http://www.astm.org.
European Committee for Standardization or Comité Européen de Normalisation (CEN) – A major provider of European standards and technical specifications. It is the only recognized European organization according to Directive 98/34/EC for the planning, drafting, and adoption of European standards in all areas of economic activity with the exception of electrotechnology (CENELEC) and telecommunication (ETSI). The Vienna Agreement − signed by CEN in 1991 with ISO (International Organization for Standardization), its international counterpart − ensures technical cooperation by correspondence, mutual representation at meetings and coordination meetings, and adoption of the same text, as both an ISO standard and a European standard. Founded in 1961. http://www.cen.eu/cen/pages/default.aspx.
European Committee for Electrotechnical Standardization (CENELEC) – A nonprofit Belgian organization, CENELEC is responsible for standardization in the electrotechnical engineering field. CENELEC prepares voluntary standards, which help facilitate trade between countries, create new markets, cut compliance costs, and support the development of a European Single Market. Created in 1973. http://www.cenelec.eu/index.html.
European Telecommunications Standards Institute (ETSI) – A not-for-profit organization that produces globally applicable standards for information and communications technology. Their approach is one of openness and knowledge accessibility within standardization. Created in 1988. http://www.etsi.org/website/homepage.aspx.
Clinical Data Interchange Standards Consortium (CDISC) – A global, open, multidisciplinary, nonprofit organization that has established standards to support the acquisition, exchange, submission, and archive of clinical research data and metadata. The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. CDISC standards are vendor neutral, platform independent, and freely available via the CDISC website. Began as a volunteer group in 1997. http://www.cdisc.org/.
Digital Imaging and Communications in Medicine (DICOM) – A joint committee formed from the American College of Radiology (ACR) and the National Electrical Manufacturers Association (NEMA) to create a standard method for the transmission of medical images and their associated information. The DICOM Standards Committee exists to create and maintain international standards for communication of biomedical diagnostic and therapeutic information in disciplines that use digital images and associated data. The actual DICOM Standard (currently in version 3.0) defines an upper layer protocol (ULP) that is used over TCP/IP (independent of the physical network), messages, services, information objects, and an association negotiation mechanism. These definitions ensure that any two implementations of a compatible set of services and information objects can effectively communicate. Committee formed in 1983. DICOM Standard versions released in 1995, 1988, and 1993. http://medical.nema.org/.
GS1 – An international not-for-profit association with member organizations in over 100 countries. GS1 is dedicated to the design and implementation of global standards and solutions to improve the efficiency and visibility of supply and demand chains globally and across sectors. The GS1 system of standards is the most widely used supply chain standards system in the world. Founded in 1977. http://www.gs1.org/.
Healthcare Information and Management Systems Society (HIMSS) – A cause-based, not-for-profit organization exclusively focused on providing global leadership for the optimal use of information technology and management systems for the betterment of healthcare. Its mission is to lead healthcare transformation through the effective use of health information technology. It was founded in 1961. http://www.himmss.org.
Health Level Seven International (HL7) – A not-for-profit, ANSI-accredited standards developing organization dedicated to providing 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. HL7’s 2300+ members include approximately 500 corporate members who represent more than 90% of the information system vendors serving healthcare. Founded in 1987. http://www.hl7.org.
Institute of Electrical and Electronics Engineers (IEEE) – The world’s largest technical professional society and an association dedicated to advancing innovation and technological excellence for the benefit of humanity. It is designed to serve professionals involved in all aspects of the electrical, electronic, and computing fields and related areas of science and technology that underlie modern civilization. IEEE was established in 1963 as a merger of the Institute of Radio Engineers (founded in 1912) and the American Institute of Electrical Engineers (founded in 1884). http://www.ieee.org.
Integrating the Healthcare Enterprise (IHE) – An initiative by healthcare professionals and industry to improve the way computer systems in healthcare share information. IHE promotes the coordinated use of established standards such as DICOM and HL7 to address clinical need and support optimal patient care. Systems developed in accordance with IHE communicate with one another better, are easier to implement, and enable care providers to use information more effectively. http://www.ihe.net.
International Conference on Harmonisation (ICH) – ICH’s mission is to make recommendations toward achieving greater harmonization in the interpretation and application of technical guidelines and requirements for pharmaceutical product registration, thereby reducing or obviating duplication of testing carried out during the research and development of new human medicines. Founded in 1990. http://www.ich.org.
International Health Terminology Standards Development Organisation (IHTSDO) – A not-for-profit association that develops and promotes the use of SNOMED CT to support safe and effective health information exchange. SNOMED CT is a clinical terminology and is considered to be the most comprehensive, multilingual healthcare terminology in the world. Formed in 2006. http://www.ihtsdo.org/. As of 2018, the organization is now called SNOMED International.
International Organization for Standardization (ISO) – The world’s largest developer and publisher of international standards. Its network consists of 162 countries, coordinated by a general secretariat in Geneva, Switzerland. It is a nongovernmental multinational organization that forms a bridge between public and private sectors. Founded in 1947. http://www.iso.org/iso/home.html.
Joint Initiative Council (JIC) – A harmonization process between standards development organizations (SDOs) to enable common, timely health informatics standards by addressing and resolving issues of gaps, overlaps, and counterproductive standardization efforts, particularly between ISO TC215 and HL7. The Council consists of leaders and appointed liaison members of the participating SDOs and strategically oversees the Joint Initiative on SDO Global Health Informatics Standardization. Currently, the participating SDOs are ISO/TC 215, HL7, CEN/TC 251, CDISC, IHTSDO, and GS1. The Charter was signed in 2007. http://www.jointinitiativecouncil.org/.
National Council for Prescription Drug Programs (NCPDP) – is a not-for-profit, ANSI-accredited standards development organization representing the pharmacy services industry. http://www.ncpdp.org.
National Quality Forum (NQF) – A nonprofit organization with a mission to improve the quality of American healthcare by building consensus on national priorities and goals for performance improvement and working in partnership to achieve them, endorsing national consensus standards for measuring and publicly reporting on performance, and promoting the attainment of national goals through education and outreach programs. NQF’s membership includes a wide variety of healthcare stakeholders, including consumer organizations, public and private purchasers, physicians, nurses, hospitals, accrediting and certifying bodies, supporting industries, and healthcare research and quality improvement organizations. The NQF was established in 1999 in response to the recommendation of the Advisory Commission on Consumer Protection and Quality in the Health Care Industry, which concluded that an organization was needed to promote and ensure patient protections and healthcare quality through measurement and public reporting. http://www.qualityforum.org.
OpenEHR – An international, not-for-profit foundation working toward developing an interoperable, lifelong electronic health record. To this end, it is developing open specification, open-source software, and knowledge resources. It also participates in international standards development. http://www.openehr.org.
Professional societies, for example, the American College of Cardiology (ACC) – The American College of Cardiology is a nonprofit medical association of 39,000 members to advocate for quality cardiovascular care through education, research, development, and applications of standards and guidelines. It also works to influence healthcare policies. Established in 1949. http://www.cardiosource.org/acc.
Radiological Society of North America (RSNA) – The mission of the Radiological Society of North America is to promote and develop the highest standards of radiology and related sciences through education and research. The Society seeks to provide radiologists and allied health scientists with educational programs and materials of the highest quality and to constantly improve the content and value of these educational activities. The Society seeks to promote research in all aspects of radiology and related sciences, including basic clinical research in the promotion of quality healthcare. Founded in 1916 as the Western Roentgen Society, it was given its present name in 1919. http://www.rsna.org.
SDO Charter Organization (SCO) – Provides an environment that facilitates effective coordination and collaboration on US national healthcare informatics standards development. Among its purposes are to facilitate the coordination of conventions for enhanced interoperability among diverse standards development organizations in the areas of health data acquisition, processing, and handling systems and to communicate and coordinate when appropriate with the US Technical Advisory Group (US TAG) in order to facilitate a unified representation of US standards (this is not intended to supersede any member’s existing coordination with the US TAG). Established in 2008. http://scosummit.com/; http://www.ncpdp.org/resources_sco.aspx.
SNOMED International – A not-for-profit association that develops and promotes use of SNOMED CT to support safe and effective health information exchange. SNOMED CT is a clinical terminology and is considered to be the most comprehensive, multilingual healthcare terminology in the world. The organization has over 29 member countries. It was founded in 2006 as the International Health Terminology Standards Development Organisation, IHTSDO.
World Health Organization (WHO) – WHO is the directing and coordinating authority for health within the UN system. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries, and monitoring and assessing health trends. Established in 1948. http://www.who.int/en.
US Government Organizations Developing and Naming Standards
Centers for Disease Control and Preservation (CDC) – One of the major operating components of the Department of Health and Human Services. Its mission is to collaborate to create the expertise, information, and tools that people and communities need to protect their health – through health promotion, prevention of disease, injury and disability, and preparedness for new health threats. It began on July 1, 1946 as the Communicable Disease Center. http://www.cdc.gov.
Centers for Medicare and Medicaid Services (CMS) – Part of the Department of Health and Human Services, this agency is responsible for Medicare health plans, Medicare financial management, Medicare fee for service operations, Medicaid and children’s health, survey and certification, and quality improvement. Founded in 1965. http://www.cms.gov.
Department of Defense (DOD) – The mission of the DOD is to provide the military forces needed to deter war and to protect the security of our country. Defense.gov supports the overall mission of the Department of Defense by providing official, timely, and accurate information about defense policies, organizations, functions, and operations, including the planning and provision of healthcare, health monitoring, and medical research, training, and education. Also, Defense.gov is the single, unified starting point for finding military information online. Created in 1789 as the War Department, in 1949 it became known as the Department of Defense. http://www.defense.gov.
The US Department of Health and Human Services (HHS) – The principal government agency for supervising the health of American citizens and providing essential human services, particularly for vulnerable populations. Representing almost a quarter of all federal outlays, it administers more grant dollars than all other federal agencies combined, including the Medicare and Medicaid healthcare insurance programs. HHS programs are directed by the Office of the Secretary and administered by 11 operating divisions, including 8 agencies in the US Public Health Service and 3 human services agencies. The department includes more than 300 programs, which provide health services, support equitable treatment of recipients nationwide, and enable national health and data collection. Originally founded in 1953 as the Department of Health, Education, and Welfare (HEW), it was officially renamed in 1979. http://www.hhs.gov/.
Department of Homeland Security (DHS) – With the passage of the Homeland Security Act by Congress in November 2002, the Department of Homeland Security formally came into being as a stand-alone, cabinet-level department to further coordinate and unify national homeland security efforts, opening its doors on March 1, 2003. The DHS has five departmental missions: to prevent terrorism and enhance security, to secure and manage our borders, to enforce and administer US immigration laws, to safeguard and secure cyberspace, and to ensure resilience to disasters. http://www.dhs.gov.
Federal Health Architecture (FHA) – An E-Government Line of Business initiative managed by the United States’ Office of the National Coordinator for Health IT. FHA was formed to coordinate health IT activities among the more than 20 federal agencies that provide health and healthcare services to citizens. FHA and its federal partners are helping build a federal health information technology environment that is interoperable with private sector systems and supports the president’s plan to enable better point-of-service care, increased efficiency, and improved overall health in the US population. http://www.hhs.gov/fedhealtharch.
Food and Drug Administration (FDA) – An agency within the US Department of Health and Human Services, it is responsible for protecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products, medical devices, the nation’s food supply, cosmetics, dietary supplements, and products that give off radiation. Though FDA can trace its history back to the appointment of chemist Lewis Caleb Beck to the Agricultural Division in the Patent Office in 1848, its origins as a federal consumer protection agency began with the passage of the 1906 Pure Food and Drugs Act. This law was the culmination of about 100 bills over a quarter-century that aimed to rein in long-standing, serious abuses in the consumer product marketplace. http://www.fda.gov.
National Cancer Institute (NCI) – The National Cancer Institute (NCI) is part of the National Institutes of Health (NIH), which is one of 11 agencies that compose the Department of Health and Human Services (HHS). The NCI, established under the National Cancer Institute Act of 1937, is the federal government’s principal agency for cancer research and training. The National Cancer Act of 1971 broadened the scope and responsibilities of the NCI and created the National Cancer Program. Over the years, legislative amendments have maintained the NCI authorities and responsibilities and added new information dissemination mandates as well as a requirement to assess the incorporation of state-of-the-art cancer treatments into clinical practice. http://www.cancer.gov.
National Institute for Standards and Technology (NIST) – A nonregulatory federal agency within the US Department of Commerce. Its focus is on promoting innovation and industrial competitiveness by advancing measurement science, standards, and technology in ways that enhance economic security and improve our quality of life. The NIST also managed the Advanced Technology Program between 1990 and 2007 to support US businesses, higher education institutions, and other research organizations in promoting innovation through high-risk, high-reward research in areas of critical national need. Founded in 1901. http://www.nist.gov/.
National Institute of Neurological Disorders and Stroke (NINDS) – Part of the NIH, NINDS conducts and supports research on brain and nervous system disorders. It also supports training of future neuroscientists. Created by Congress in 1950. http://www.ninds.nih.gov.
National Institutes of Health (NIH) – A division of the US Department of Health and Human Services and the primary agency of the US government responsible for biomedical and health-related research. The purpose of NIH research is to acquire new knowledge to help prevent, detect, diagnose, and treat disease and disability by conducting and supporting innovative research, training of research investigators, and fostering communication of medical and health sciences information. The NIH is divided into “extramural” divisions, responsible for the funding of biomedical research outside of NIH, and “intramural” divisions to conduct research. It is headed by the Office of the Director and consists of 27 separate institutes and offices. It was initially founded in 1887 as the Laboratory of Hygiene but was reorganized in 1930 as the NIH. http://www.nih.gov/.
The US National Library of Medicine (NLM) – Located in the National Institutes of Health, a division of the US Department of Health and Human Services. The NLM is the world’s most extensive medical library with medical and scientific collections which are comprised of books, journals, technical reports, manuscripts, microfilms, and images. It also develops electronic information services, including the free-access PubMed database and the MEDLINE publication database. The NLM provides service scientists, health professionals, historians, and the general public both nationally and globally. Originally founded in 1836 as the Library of the Office of the Surgeon General of the Army, it has been restructured multiple times before finally reaching its current configuration in 1956. http://www.nlm.nih.gov/.
Office of the National Coordinator for Health Information Technology (ONC) – Located within the US Department of Health and Human Services as a division of the Office of the Secretary. It is the nationwide coordinator for the implementation of new advances in health information technology to allow electronic use and exchange of information to improve healthcare. Prior to 2018, the ONC made recommendations on standards, implementation specifications, and certification criteria through two federal advisory committees, the Health IT Policy Committee (HITPC) and the Health IT Standards Committee (HITSC). The HITPC developed a policy framework for the development and adoption of a nationwide health information infrastructure, including standards for the exchange of patient medical information. The HITSC developed a schedule for the annual assessment of the HITPC’s recommendations and advised on testing of standards and implementation specifications by the National Institute for Standards and Technology (NIST). The position of national coordinator was created through an executive order in 2004 and legislatively mandated in the Health Information Technology for Economic and Clinical Health Act (HITECH Act) of 2009. The Health Information Technology Advisory Committee (HITAC) was established in the 21st Century Cures Act and will recommend policies, standards, implementation specifications, and certification criteria, relating to the implementation of an infrastructure that will advance the electronic access, exchange, and use of health information. HITAC unifies the roles of, and replaces, the HITPC and the HITSC. http://healthit.hhs.gov/.
Veterans Health Administration (VHA) – Component of the US Department of Veterans Affairs that implements the medical assistance program through the administration and operation of numerous outpatient clinics, hospitals, medical centers, and long-term care facilities. The first VHA hospital dates back to 1778. http://www.va.gov/health/default.asp.
Controlled Terminologies (Standards)
Current Procedural Terminology (CPT) – A registered trademark of the American Medical Association (AMA), CPT codes are used in medical billing to describe medical, surgical, and diagnostic services and are designed to communicate uniform information about medical services and procedures for administrative, financial, and analytic purposes. http://www.ama-assn.org.
International Classification of Diseases (ICD) – The classification used to code and classify mortality data from death certificates. The International Classification of Diseases, Clinical Modification is used to code and classify morbidity data from the inpatient and outpatient records, physician offices, and most National Center for Health Statistics (NCHS) surveys. In 1893, a French physician, Jacques Bertillon, introduced the Bertillon Classification of Causes of Death at the International Statistical Institute in Chicago. A number of countries adopted Dr. Bertillon’s system, and in 1898, the American Public Health Association (APHA) recommended that the registrars of Canada, Mexico, and the USA also adopt it. Since 1959, the US Public Health Service published several versions of this classification system which is the standard to code diagnostic and operative procedural data for official morbidity and mortality statistics in the USA. It is currently in its tenth edition. http://www.cdc.gov/nchs/icd.htm.
Logical Observation Identifiers Names and Codes (LOINC) – A universal code system for identifying laboratory and clinical observations. Mapping local terms to LOINC makes it possible to exchange and pool data from many independent systems for clinical care, research, outcomes management, and lots of other purposes. Initiated in 1994 and maintained by the Regenstrief Institute. http://loinc.org.
Medical Dictionary for Regulatory Activities (MedDRA) – A terminology that applies to all phases of drug development, excluding animal toxicology. It also applies to the health effects and malfunction of medical devices. It was developed by the International Conference on Harmonisation (ICH) and is owned by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) acting as trustee for the ICH Steering Committee. MedDRA is used to report adverse event data from clinical trials and for postmarketing reports and pharmacovigilance. http://meddramsso.com/index.asp.
RxNorm – Provides normalized names for clinical drugs and links its names to many of the drug vocabularies commonly used in pharmacy management and drug interaction software, including those of First DataBank, Micromedex, Medi-Span, Gold Standard Alchemy, and Multum. By providing links between these vocabularies, RxNorm can mediate messages between systems not using the same software and vocabulary. RxNorm now includes the National Drug File – Reference Terminology (NDF-RT) from the Veterans Health Administration. NDF-RT is a terminology used to code clinical drug properties, including mechanism of action, physiologic effect, and therapeutic category. http://www.nlm.nih.gov/research/umls/rxnorm.
Systematized Nomenclature of Medicine – Clinical Terms (SNOMED CT) – A comprehensive clinical terminology, originally created by the College of American Pathologists (CAP) and, as of April 2007, owned, maintained, and distributed by SNOMED International (formerly the International Health Terminology Standards Development Organisation, IHTSDO), a not-for-profit association. http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html.
Resources
NIH Common Data Element (CDE) Resource Portal – NIH encourages the use of common data elements (CDEs) in clinical research, patient registries, and other human subject research in order to improve data quality and opportunities for comparison and combination of data from multiple studies and with electronic health records. This portal provides access to information about NIH-supported CDEs, as well as tools and resources to assist investigators developing protocols for data collection. https://www.nlm.nih.gov/cde/
Cancer Data Standards Registry and Repository (caDSR) – Database and a set of APIs (application programming interfaces) and tools to create, edit, control, deploy, and find common data elements (CDEs) for use by metadata consumers and information about the UML models and forms containing CDEs for use in software development for research applications. Developed by National Cancer Institute for Biomedical Informatics and Information Technology. https://cabig.nci.nih.gov/concepts/caDSR.
National Center for Biomedical Ontology (NCBO Bioportal) – An open repository of biomedical ontologies. Supports ontologies in OBO, OWL, RDF, Rich Release Format (RRF), Protégé Frames, and LexGrid XML. The goal of the NCBO is to support biomedical researchers by providing online tools and a Web portal, enabling them to access, review, and integrate disparate ontological resources in all aspects of biomedical investigation and clinical practice. Funded by the US NIH and National Centers for Biomedical Computing. Created in 2007. http://www.bioontology.org.
National Drug File-Reference Terminology (NDF-RT) – An extension of the VHA National Drug File (NDF). It organizes the drug list into a formal representation and can be considered as a knowledge base or ontology for classifying drugs and medication products. NDF-RT is used for modeling drug characteristics including ingredients, chemical structure, dose form, physiologic effect, mechanism of action, pharmacokinetics, and related diseases. http://bioportal.bioontology.org/ontologies/40402?p=terms#40402?p=summary&_suid=426.
Unified Medical Language System (
UMLS) – A set of files and software that brings together many health and biomedical vocabularies and standards to enable interoperability between computer systems. UMLS can be used to enhance or develop applications, such as electronic health records, classification tools, dictionaries, and language translators. The UMLS has three tools, which are called the Knowledge Sources:
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Metathesaurus: Terms and codes from many vocabularies, including CPT®, ICD-10-CM, LOINC®, MeSH®, RxNorm, and SNOMED CT®
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Semantic network: Broad categories (semantic types) and their relationships (semantic relations)
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SPECIALIST Lexicon and Lexical Tools: Natural language processing tools
Created in 1986. http://www.nlm.nih.gov/research/umls.
