Major standards organisations in health care

Technical Committee 251 of the European Committee for Standardisation (CEN/TC 251) is committed to delivering and maintaining the best quality specifications and standards for the European Member States and for the European Community, thereby boosting European Union action within the Digital Single Market applicable to the healthcare domain. The products CEN/TC 251 delivers reduce the noise in the market place by providing important architectures, frameworks, concepts and terms that enable consistent and coherent implementations.

Whilst CEN/TC 251 does develop standards by itself when required, it prefers to produce specifications in co-operation with other SDOs at a global level and to adapt or adopt international standards for implementation in the European context and jurisdiction. This too helps the European market by making its products accessible to a global consumer base. It also prevents the danger of swamping from other powerful nations by providing a level, open, and consensus based playing field. CEN/TC 251 recognises and supports stakeholder wishes for fewer, but more universal standards applicable throughout the world without curbing innovation.

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 indispensable 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. It has thus become a major force for the creation and evolution of the $8.6 billion medical image management market.

HL7 (Health Level Seven) is an international community of health care subject matter experts and information scientists who work together to create accredited standards for the exchange, management and integration of electronic health care 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 services. Most data elements exchanged by HL7 standards are encoded in a terminology created and supported by other standards organisations such as IHTSDO or WHO. 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 health care organisations to increase the effectiveness and efficiency of health care delivery. The HL7 community is organised in the form of a global organisation (Health Level Seven, Inc.) and country-specific affiliate organisations. HL7 is supported by more than 1,600 members from over 50 countries, including 500+ corporate members representing health care providers, government stakeholders, payers, pharmaceutical companies, vendors/suppliers, and consulting firms. HL7’s standards are accredited by the US ANSI organisation and many HL7 standards have also been adopted as ISO standards.

IHE (Integrating the Healthcare Enterprise) is an initiative by health care professionals and industry to improve the way computer systems in health care 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 IHTSDO (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). Trading as SNOMED International, the organization has grown to 40 Members in the Americas, EMEA and Asia Pacific (2021).

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 organisations. The parent ISO organisation is based in Geneva, and has the status of a non-governmental organisation, 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 (harmonisation 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 organisation 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 recognising, harmonising, or adopting standards efforts among related standards development organisations. Internationally recognised agreements exist for the European CEN TC251 and HL7 to “fast track” standards balloted in those organisations. A newly established Joint Initiatives Council includes these fast-track organisations in addition to CDISC and IHTSDO, to further strengthen international collaboration and synergy among international health information standards organisations.

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, health care provider networks, electronic health information exchanges), software vendors, payers and managed care organisations. In 2008, interested parties from 86 different countries downloaded the LOINC database about 800 times per month.