Standards Development Organization


CDISC is a global, multidisciplinary, non-profit organization that has established open global standards to support the acquisition, exchange, submission/reporting and archive of medical research data. The CDISC mission is to develop and support platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. CDISC has a Charter Agreement with HL7, in place since 2001, with a commitment to harmonize clinical research and healthcare standards. CDISC has Liaison A status with ISO TC 215 for Healthcare Standards and has been accepted as a member of the Joint Initiative Council (JIC) along with HL7, ISO, and CEN. The CDISC standards are freely available via the CDISC website.

CEN/TC 251

CEN/TC 251 is addressing the needs of the stakeholders to have interoperable and implementable standards that will allow for safe and secure information exchange. Such standards contribute to a common technical framework and terminology for application development, procurement and implementation. CEN/TC 251's domain is the application of information and communication technology in healthcare, social care and wellness. CEN/TC 251 is a regional (European) Standards Development Organisation (SDO) among international or domain specific SDOs and its focus is almost exclusively content technology and not communication technology.

CEN/TC251 work items will be prioritised in order to meet the requirements from the EU / EC, to support work that is taking place in member states that needs an outlet or endorsement, to meet requirements from (working with) other SDOs, to accommodate updates and revision of existing CEN/TC251 standards, specifications and reports and incorporate the greater body of expert opinion and the outcomes of research and development (R&D). The European Commission has issued in 2007 a mandate to the European Standardization Organizations (ESOs), CEN, CENELEC, and ETSI, to develop a coordinated work programme for standardization in health informatics (Mandate M/403).


DICOM (Digital Imaging and Communications in Medicine – ISO 12052) is the international standard for biomedical imaging and related data. DICOM defines a full set of network services for exchange, storage and access to images and to products of image analysis applications, as well as services for imaging department workflow management. It has become indispensible to the clinical imaging departments by focusing on their needs for efficient routine production and interpretation of imaging studies. DICOM is implemented in virtually all radiology and cardiology imaging devices and systems, and increasingly in other specialty imaging areas, such as dentistry, ophthalmology, and pathology.

The DICOM Standards Committee has a long-standing policy of making the DICOM Standard available for free and without intellectual property constraints for implementers (see It has thus become a major force for the creation and evolution of the $8.6 billion medical image management market.


HL7 is an international community of healthcare subject matter experts and information scientists who work together to create accredited standards for the exchange, management and integration of electronic healthcare information. In the mid-1990s HL7 initiated a family set of standards based on a common Reference Information Model (HL7 RIM).

These RIM-based standards have been annually published since 2004 and now include the ability to exchange information and support inter- system cooperative processing through messages, electronic documents and recently services. Most data elements exchanged by HL7 standards are encoded in a terminology created and supported by other standards organizations such as IHTSDO, WHO, etc. HL7 also actively collaborates with other accredited healthcare international and country-specific standards groups that address information domains outside of HL7's.

HL7 promotes standards within and among healthcare organizations to increase the effectiveness and efficiency of healthcare delivery. The HL7 community is organized in the form of a global organization (Health Level Seven, Inc.) and country-specific affiliate organizations. HL7 affiliate organizations exist in over 30 countries. HL7's standards are accredited by the US ANSI organization and many HL7 standards have also been adopted as ISO standards.


IHE (Integrating the Healthcare Enterprise) is 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 specific clinical needs in support of 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. IHE has Liaison A status with ISO TC 215 for Healthcare Standards and is an active member of the Joint Initiative Council (JIC) along with CDISC, HL7, ISO, and CEN. The IHE technical frameworks are freely available via the IHE website.


The International Health Terminology Standards Development Organisation, a not-for-profit Danish association formed in 2007, purchased SNOMED CT from the College of American Pathologists (CAP) in April 2007 and is now responsible for its ongoing maintenance, development, quality assurance, and distribution. The goal of the change in ownership was to promote international adoption and use of SNOMED CT.

The IHTSDO was formed by 9 charter members (from Australia, Canada, Denmark, Lithuania, Netherlands, New Zealand, Sweden, United Kingdom, and the United States). As of June 2009, Singapore, Cyprus, and Spain have also become members, and other countries are in the process of joining. The IHTSDO recently announced that SNOMED CT licenses are now available free of charge in another 49 countries designated as low income economies by the World Bank.

ISO TC 215 on Health Informatics

Technical Committee 215 of the International Standards Organization (ISO) on Health Informatics was formed in 1998 following a decade of increasingly international cooperation among health informatics standards organizations. The parent ISO organization is based in Geneva, and has the status of a non-governmental organization, recognized by law in many countries. ISO accepted the United States offer to hold the Secretariat for TC215; the Secretariat is managed by HIMSS (Healthcare Information and Management Systems Society) on behalf of ANSI (American National Standards Institute) who is the US member to the ISO community.

TC215 is structured into four core Working Groups: Data Structure (frameworks and models), Data Interchanges (harmonization and messaging), Semantic Content (terminology and knowledge), and Security (confidentiality, integrity, and availability). Two application groups, Pharmacy and Medication together with Business Requirements for an EHR, complement these core activities. The organization meets twice each year, among rotating venues, for working group efforts and plenary council.

While de novo standards are created within TC215 working groups, increasingly the Technical Committee is recognizing, harmonizing, or adopting standards efforts among related standards development organizations.  Internationally recognized agreements exist for the European CEN TC251 and HL7 to “fast track” standards balloted in those organizations. A newly established Joint Initiatives Council includes these fast-track organizations in addition to CDISC and IHTSDO, to further strengthen international collaboration and synergy among international health information standards organizations.

LOINC® (Logical Observation Identifiers Names and Codes)

LOINC® (Logical Observation Identifiers Names and Codes) is a coding system for laboratory and other clinical measures and documents used in electronic transactions between independent computer systems. LOINC codes are universal identifiers for the "question" (or variable) in measurement or laboratory test results, survey questionnaire items, and packages of such items. When LOINC codes are used in electronic messages, the receiving systems can automatically file and use results from many sources to build electronic medical record systems or research databases. Regenstrief Institute, Inc initiated and continues to direct development of LOINC, leading the LOINC Committee of volunteers from academia, industry, and government who advise and collaborate on its evolution.

LOINC is used worldwide by local hospitals and laboratories, public health departments, healthcare provider networks (e.g. Partners HealthCare and Intermountain HealthCare), electronic health information exchanges (e.g. the Indiana Network for Patient Care[1], the Electronic Child Health Network[2], and SIGA Saúde in São Paulo, Brazil), software vendors, payers and managed care organizations (e.g. United Healthcare). In 2008, interested parties from 86 different countries downloaded the LOINC database about 800 times per month (9,500 per year).


Founded by Johns Hopkins Medicine and leading professional medical societies, MedBiquitous is a not-for-profit, international group of professional medical and healthcare associations, universities, commercial, and governmental organizations dedicated to advancing healthcare education through technology standards that promote professional competence, collaboration, and better patient care. MedBiquitous is accredited by the American National Standards Institute (ANSI) to develop information technology standards for healthcare education and competence assessment.

MedBiquitous members are creating a technology blueprint for professional healthcare education. Based on XML and Web services standards, this blueprint will weave together the many activities, organizations, and resources that support the ongoing education and performance of healthcare professionals, creating more integrated access to educational resources. Ultimately, this blueprint will seamlessly support the learner in ways that will improve patient care and simplify the administrative work associated with education and competence assessment.