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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 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

French, English

Published date

07-04-2011

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
DIN CEN ISO/TS 13972;DIN SPEC 32987:2016-03 HEALTH INFORMATICS - DETAILED CLINICAL MODELS, CHARACTERISTICS AND PROCESSES (ISO/TS 13972:2015)
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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