Clinical data standards are used to store and communicate information related to healthcare so that its meaning is unambiguous. They are used in clinical practice, in activity analysis and finding, and in research and development. There are many existing and proposed standards and many bodies working in this field. In addition to standards specific to the clinical domain health informatics relies on other standards that are lower in the communications stack, and on many standards from

metrology Metrology is the scientific study of measurement. It establishes a common understanding of units, crucial in linking human activities. Modern metrology has its roots in the French Revolution's political motivation to standardise units in Fra ...

Clinical data standards and interoperability

Interoperability between disparate clinical information systems requires common data standards or mapping of every transaction. However common data standards alone will not provide interoperability, and the other requirements are identified in ''"How Standards will Support Interoperability"'' from the Faculty of Clinical Informatics and ''"Interoperability is more than technology: The role of culture and leadership in joined-up care"'' from the King's Fund

Barriers to development and use

Barriers to the widespread adoption of effective data standards include: * inconsistency in and poor understanding of the concepts and language used in clinical practice, for example compared to those in chemistry or accounting * rival systems of standards * the cost of implementation or change to better standards * avoidance of commercial competition.

Existing and proposed clinical data standards

Integrating the Healthcare Enterprise Integrating the Healthcare Enterprise (IHE) is a non-profit organization based in the US state of Illinois. It sponsors an initiative by the healthcare industry to improve the way computer systems share information. IHE was established in 1998 b ...

Omaha System The Omaha System is a standardized health care terminology consisting of an assessment component (Problem Classification Scheme), a care plan/services component (Intervention Scheme), and an evaluation component (Problem Rating Scale for Outcomes). ...

SNOMED The Systematized Nomenclature of Medicine (SNOMED) is a systematic, computer-processable collection of medical terms, in human and veterinary medicine, to provide codes, terms, synonyms and definitions which cover anatomy, diseases, findings, pr ...

SNOMED CT SNOMED CT or SNOMED Clinical Terms is a systematically organized computer-processable collection of medical terms providing codes, terms, synonyms and definitions used in clinical documentation and reporting. SNOMED CT is considered to be the mo ...

ASC X12 The Accredited Standards Committee X12 (also known as ASC X12) is a standards organization. Chartered by the American National Standards Institute (ANSI) in 1979, it develops and maintains the X12 Electronic data interchange (EDI) and Context In ...

( EDI) – transaction protocols used for transmitting patient data. Popular in the United States for transmission of billing data. * CEN's TC/251 provides EHR standards in Europe including: **

EN 13606 The Health informatics - Electronic Health Record Communication (EN 13606) was the European Standard for an information architecture to communicate Electronic Health Records (EHR) of a patient. The standard was later adopted as ISO 13606 and lat ...

, communication standards for EHR information **

CONTSYS The system of concepts to support continuity of care, often referred to as ContSys, is an ISO and CEN standard (EN ISO 13940). Continuity of care is an organisational principle that represents an important aspect of quality and safety in health car ...

(EN 13940), supports continuity of care record standardization. **

HISA The European Committee for Standardization ( CEN) Standard Architecture for Healthcare Information Systems (ENV 12967), Health Informatics Service Architecture or HISA is a standard that provides guidance on the development of modular open informat ...

(EN 12967), a services standard for inter-system communication in a clinical information environment. *

Continuity of Care Record Continuity of Care Record (CCR) is a health record standard specification developed jointly by ASTM International, the Massachusetts Medical Society (MMS), the Healthcare Information and Management Systems Society (HIMSS), the American Academy ...

– ASTM International Continuity of Care Record standard *

DICOM Digital Imaging and Communications in Medicine (DICOM) is the standard for the communication and management of medical imaging information and related data. DICOM is most commonly used for storing and transmitting medical images enabling the integ ...

– an international communications protocol standard for representing and transmitting radiology (and other) image-based data, sponsored by

NEMA The National Electrical Manufacturers Association (NEMA) is the largest trade association of electrical equipment manufacturers in the United States. Founded in 1926, it advocates for the industry, and publishes standards for electrical product ...

(National Electrical Manufacturers Association) * HL7 (HL7v2, C-CDA) – a standardized messaging and text communications protocol between hospital and

physician A physician (American English), medical practitioner (Commonwealth English), medical doctor, or simply doctor, is a health professional who practices medicine, which is concerned with promoting, maintaining or restoring health through th ...

record systems, and between practice management systems *

Fast Healthcare Interoperability Resources The Fast Healthcare Interoperability Resources' (FHIR, pronounced "fire") standard is a set of rules and specifications for exchanging electronic health care data. It is designed to be flexible and adaptable, so that it can be used in a wide rang ...

(FHIR) – a modernized proposal from

HL7 Health Level Seven or HL7 refers to a set of international standards for transfer of clinical and administrative data between software applications used by various healthcare providers. These standards focus on the application layer, which is "la ...

designed to provide open, granular access to medical information *

ISO ISO is the most common abbreviation for the International Organization for Standardization. ISO or Iso may also refer to: Business and finance * Iso (supermarket), a chain of Danish supermarkets incorporated into the SuperBest chain in 2007 * Is ...

–

ISO TC 215 The ISO/TC 215 is the International Organization for Standardization's (ISO) Technical Committee (TC) on health informatics. TC 215 works on the standardization of Health Information and Communications Technology (ICT), to allow for compatibility ...

provides international technical specifications for EHRs. ISO 18308 describes EHR architectures * xDT – a family of data exchange formats for medical purposes that is used in the German public health system. *

openEHR openEHR is an open standard specification in health informatics that describes the management and storage, retrieval and exchange of health data in electronic health records (EHRs). In openEHR, all health data for a person is stored in a "one lifet ...

: an open community developed specification for a shared health record with web-based content developed online by experts. Strong multilingual capability. *

Virtual Medical Record The Virtual Medical Record (vMR) is a simplified, standardised electronic health record data model designed to support interfacing to clinical decision support (CDS) systems. vMR is compatible with Service-oriented Architecture (SOA) of CDS. The p ...

: HL7's proposed model for interfacing with clinical decision support systems. * SMART (Substitutable Medical Apps, reusable technologies): an open platform specification to provide a standard base for healthcare applications. *

Sentinel Common Data Model Sentinel may refer to: Places Mountains * Mount Sentinel, a mountain next to the University of Montana in Missoula, Montana * Sentinel Buttress, a volcanic crag on James Ross Island, Antarctica * Sentinel Dome, a naturally occurring gran ...

: Initially started as Mini-Sentinel in 2008. Use by the

Sentinel Initiative Sentinel Initiative is a set of efforts by U.S. Food and Drug Administration (FDA) that tries to improve the ability to identify and evaluate safety of medicinal products. It has several parts: Sentinel System, Postmarket Rapid Immunization Safety ...

of the USA's

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

. * OMOP Common Data Model: model that defines how electronic health record data, medical billing data or other healthcare data from multiple institutions can be harmonized and queried in unified way. It is maintained by

Observational Health Data Sciences and Informatics Observation is the active acquisition of information from a primary source. In living beings, observation employs the senses. In science, observation can also involve the perception and recording of data via the use of scientific instruments. The ...

consortium. * PCORNet Common Data Model: First defined in 2014 and used by

PCORI The Patient-Centered Outcomes Research Institute (PCORI) is a United States-based non-profit institute created through the 2010 Patient Protection and Affordable Care Act. It is a government-sponsored organization charged with funding comparative ...

and People-Centered Research Foundation. *

Virtual Data Warehouse Virtual may refer to: * Virtual (horse), a thoroughbred racehorse * Virtual channel, a channel designation which differs from that of the actual radio channel (or range of frequencies) on which the signal travels * Virtual function, a programming ...

: First defined in 2006 by HMO Research Network. Since 2015, by Health Care System Research Network.

Previous standards, projects and bodies

Health Metrics Network The Health Metrics Network (HMN) was a global health partnership focused on strengthening health information systems in low and middle income countries, launched in May 2005 during the 58th session of thWorld Health Assembly (WHA)and dissolved o ...

Read code Read codes are a clinical terminology system that was in widespread use in General Practice in the United Kingdom until around 2018, when NHS England switched to using SNOMED CT. Read codes are still in use in Scotland and in England are permitte ...

* ASTM E1238

Bodies working in the field

Health Level Seven International Health Level Seven International (HL7) is a non-profit ANSI-accredited standards development organization that develops standards that provide for global health data interoperability. The 2.x versions of the standards are the most commonly use ...

International Health Terminology Standards Development Organisation The International Health Terminology Standards Development Organisation (IHTSDO), trading as SNOMED International, is an international non-profit organization that owns SNOMED CT, a leading clinical terminology used in electronic health records. ...

Professional Record Standards Body The Professional Record Standards Body was established in the United Kingdom in April 2013 by the Academy of Medical Royal Colleges The Academy of Medical Royal Colleges (AoMRC) is the coordinating body for the United Kingdom and Ireland's 23 Medi ...

NHS England NHS England, officially the NHS Commissioning Board, is an executive non-departmental public body of the Department of Health and Social Care. It oversees the budget, planning, delivery and day-to-day operation of the commissioning side of th ...

, which provides a Data Standards Directory

References

{{Reflist Health informatics