ISO 18308:2011
Current
Current
The latest, up-to-date edition.
Health informatics — Requirements for an electronic health record architecture
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Language(s)
French, English
Published date
04-07-2011
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ISO 18308:2011 defines the set of requirements for the architecture of a system that processes, manages and communicates electronic health record (EHR) information: an EHR architecture. The requirements are formulated to ensure that these EHRs are faithful to the needs of healthcare delivery, are clinically valid and reliable, are ethically sound, meet prevailing legal requirements, support good clinical practice and facilitate data analysis for a multitude of purposes.
ISO 18308:2011 does not specify the full set of requirements that need to be met by an EHR system for direct patient care or for other use cases, but the requirements defined by ISO 18308:2011 do contribute to the governance of EHR information within such systems.
| Committee |
ISO/TC 215
|
| DevelopmentNote |
Supersedes ISO/DIS 18308 and ISO TS 18308. (04/2011)
|
| DocumentType |
Standard
|
| Pages |
27
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| BS ISO 18308:2011 | Identical |
| BIS IS/ISO 18308 : 2011 | Identical |
| NEN ISO 18308 : 2011 | Identical |
| NF ISO 18308 : 2011 | Identical |
| AS ISO 18308:2022 | Identical |
| BS PD ISO/TR 20748-2 : 2017 | INFORMATION TECHNOLOGY FOR LEARNING, EDUCATION AND TRAINING - LEARNING ANALYTICS INTEROPERABILITY - PART 2: SYSTEM REQUIREMENTS |
| PD ISO/TR 14639-1:2012 | Health informatics. Capacity-based eHealth architecture roadmap Overview of national eHealth initiatives |
| PD ISO/IEC TR 20748-1:2016 | Information technology for learning, education and training. Learning analytics interoperability Reference model |
| I.S. EN 16844:2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
| ISO/TR 19669:2017 | Health informatics Re-usable component strategy for use case development |
| S.R. CEN ISO/TS 14441:2013 | HEALTH INFORMATICS - SECURITY AND PRIVACY REQUIREMENTS OF EHR SYSTEMS FOR USE IN CONFORMITY ASSESSMENT (ISO/TS 14441:2013) |
| ISO/TS 21089:2018 | Health informatics Trusted end-to-end information flows |
| I.S. EN 16844:2017+A2:2019 | Aesthetic medicine services - Non-surgical medical treatments |
| S.R. CEN ISO/TS 13972:2015 | HEALTH INFORMATICS - DETAILED CLINICAL MODELS, CHARACTERISTICS AND PROCESSES (ISO/TS 13972:2015) |
| S.R. CEN ISO/TS 19256:2017 | HEALTH INFORMATICS - REQUIREMENTS FOR MEDICINAL PRODUCT DICTIONARY SYSTEMS FOR HEALTH CARE (ISO/TS 19256:2016) |
| ISO/HL7 16527:2016 | Health informatics — HL7 Personal Health Record System Functional Model, Release 1 (PHRS FM) |
| ISO/TR 14639-1:2012 | Health informatics Capacity-based eHealth architecture roadmap Part 1: Overview of national eHealth initiatives |
| CEN ISO/TS 13972:2015 | Health informatics - Detailed clinical models, characteristics and processes (ISO/TS 13972:2015) |
| CEN ISO/TS 14265:2013 | Health Informatics - Classification of purposes for processing personal health information (ISO/TS 14265:2011) |
| BS ISO 19465:2017 | Traditional Chinese medicine. Categories of traditional Chinese medicine (TCM) clinical terminological systems |
| PD CEN ISO/TS 13972:2015 | Health informatics. Detailed clinical models, characteristics and processes |
| I.S. EN ISO 13940:2016 | HEALTH INFORMATICS - SYSTEM OF CONCEPTS TO SUPPORT CONTINUITY OF CARE (ISO 13940:2015) |
| 13/30278952 DC : 0 | BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES |
| BS EN ISO 13940:2016 | Health informatics. System of concepts to support continuity of care |
| PD ISO/TR 14292:2012 | Health informatics. Personal health records. Definition, scope and context |
| UNI CEN ISO/TS 14441 : 2014 | HEALTH INFORMATICS - SECURITY AND PRIVACY REQUIREMENTS OF HER SYSTEMS FOR USE IN CONFORMITY ASSESSMENT |
| PD CEN ISO/TS 14265:2013 | Health Informatics. Classification of purposes for processing personal health information |
| ISO/IEC TR 20748-2:2017 | Information technology for learning, education and training Learning analytics interoperability Part 2: System requirements |
| 15/30317874 DC : 0 | BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
| BS EN ISO 10781:2015 | Health Informatics. HL7 Electronic Health Records-System Functional Model, Release 2 (EHR FM) |
| PD CEN ISO/TS 19256:2017 | Health informatics. Requirements for medicinal product dictionary systems for health care |
| UNE-EN 16372:2015 | Aesthetic surgery services |
| 12/30254927 DC : 0 | BS EN 16372 - AESTHETIC SURGERY SERVICES |
| S.R. CEN ISO/TS 14265:2013 | HEALTH INFORMATICS - CLASSIFICATION OF PURPOSES FOR PROCESSING PERSONAL HEALTH INFORMATION (ISO/TS 14265:2011) |
| I.S. EN 16372:2014 | AESTHETIC SURGERY SERVICES |
| UNI CEN ISO/TS 14265 : 2013 | HEALTH INFORMATICS - CLASSIFICATION OF PURPOSES FOR PROCESSING PERSONAL HEALTH INFORMATION |
| EN 16844:2017 | Aesthetic medicine services - Non-surgical medical treatments |
| ISO/TR 13054:2012 | Knowledge management of health information standards |
| DD ISO/TS 14265 : 2011 | HEALTH INFORMATICS - CLASSIFICATION OF PURPOSES FOR PROCESSING PERSONAL HEALTH INFORMATION |
| ISO/TR 14639-2:2014 | Health informatics Capacity-based eHealth architecture roadmap Part 2: Architectural components and maturity model |
| ISO 19465:2017 | Traditional Chinese medicine — Categories of traditional Chinese medicine (TCM) clinical terminological systems |
| ISO/IEC TR 20748-1:2016 | Information technology for learning, education and training Learning analytics interoperability Part 1: Reference model |
| ISO/TS 14265:2011 | Health Informatics - Classification of purposes for processing personal health information |
| ISO/TS 14441:2013 | Health informatics — Security and privacy requirements of EHR systems for use in conformity assessment |
| ISO/TS 19256:2016 | Health informatics — Requirements for medicinal product dictionary systems for health care |
| ISO/TS 13972:2015 | Health informatics Detailed clinical models, characteristics and processes |
| EN 16372:2014 | Aesthetic surgery services |
| EN ISO 10781:2015 | Health Informatics - HL7 Electronic Health Records-System Functional Model, Release 2 (EHR FM) (ISO 10781:2015) |
| EN ISO 13940:2016 | Health informatics - System of concepts to support continuity of care (ISO 13940:2015) |
| DIN CEN ISO/TS 13972;DIN SPEC 32987:2016-03 | Health informatics - Detailed clinical models, characteristics and processes (ISO/TS 13972:2015); English version CEN ISO/TS 13972:2015 |
| BS EN 16372:2014 | Aesthetic surgery services |
| 15/30301318 DC : 0 | BS ISO 19465 - TRADITIONAL CHINESE MEDICINE - CATEGORIES OF TCM CLINICAL TERMINOLOGICAL SYSTEM |
| UNE-EN ISO 13940:2016 | Health informatics - System of concepts to support continuity of care (ISO 13940:2015) |
| PD ISO/TR 14639-2:2014 | Health informatics. Capacity-based eHealth architecture roadmap Architectural components and maturity model |
| PD CEN ISO/TS 14441:2013 | Health informatics. Security and privacy requirements of EHR systems for use in conformity assessment |
| BS EN 16844 : 2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS |
| I.S. EN ISO 10781:2015 | HEALTH INFORMATICS - HL7 ELECTRONIC HEALTH RECORDS-SYSTEM FUNCTIONAL MODEL, RELEASE 2 (EHR FM) (ISO 10781:2015) |
| ISO/TR 14292:2012 | Health informatics Personal health records Definition, scope and context |
| ISO 13940:2015 | Health informatics — System of concepts to support continuity of care |
| ISO/HL7 10781:2015 | Health Informatics — HL7 Electronic Health Records-System Functional Model, Release 2 (EHR FM) |
| CEN ISO/TS 19256:2017 | Health informatics - Requirements for medicinal product dictionary systems for health care (ISO/TS 19256:2016) |
| ISO/TS 25237:2008 | Health informatics Pseudonymization |
| ISO/TS 22600-1:2006 | Health informatics Privilege management and access control Part 1: Overview and policy management |
| ISO/IEC 2382-17:1999 | Information technology Vocabulary Part 17: Databases |
| ISO 1087-1:2000 | Terminology work Vocabulary Part 1: Theory and application |
| ISO 13606-1:2008 | Health informatics Electronic health record communication Part 1: Reference model |
| IEEE 830-1998 | IEEE Recommended Practice for Software Requirements Specifications |
| ISO/TR 22221:2006 | Health informatics - Good principles and practices for a clinical data warehouse |
| ISO 21090:2011 | Health informatics — Harmonized data types for information interchange |
| EN 1068:2005 | Health informatics - Registration of coding systems |
| EN 13940-1:2007 | Health informatics - System of concepts to support continuity of care - Part 1: Basic concepts |
| ISO/IEC 6523-1:1998 | Information technology — Structure for the identification of organizations and organization parts — Part 1: Identification of organization identification schemes |
| ISO 7498-2:1989 | Information processing systems Open Systems Interconnection Basic Reference Model Part 2: Security Architecture |
| ISO/IEC 2382-4:1999 | Information technology Vocabulary Part 4: Organization of data |
| ASTM E 1769 : 1995 | Standard Guide for Properties of Electronic Health Records and Record Systems (Withdrawn 2004) |
| ISO/IEC 2382-8:1998 | Information technology Vocabulary Part 8: Security |
| SA/SNZ TR ISO/IEC 20748.1:2020 | Information technology for learning, education and training - Learning analytics interoperability Reference model |
| ISO/TS 29585:2010 | Health informatics — Deployment of a clinical data warehouse |
| ISO/TS 13606-4:2009 | Health informatics Electronic health record communication Part 4: Security |
| ISO/HL7 10781:2015 | Health Informatics — HL7 Electronic Health Records-System Functional Model, Release 2 (EHR FM) |
| ISO/IEC 10746-2:2009 | Information technology Open distributed processing Reference model: Foundations Part 2: |
| SA/SNZ TR ISO/IEC 20748.2:2020 | Information technology for learning, education and training - Learning analytics interoperability System requirements |
| ISO/IEC 10746-1:1998 | Information technology — Open Distributed Processing — Reference model: Overview — Part 1: |
| ISO/TR 20514:2005 | Health informatics Electronic health record Definition, scope and context |
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