ISO 18308:2011
Health informatics — Requirements for an electronic health record architecture
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.
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1 Scope
2 Notation
3 Terms and definitions
4 Abbreviations
5 EHR business objectives
5.1 Introduction
5.2 Health system objectives
5.3 Clinical practice objectives
5.4 Citizen inclusion objectives
6 Requirements for an electronic health record architecture
6.1 Requirements for the representation of clinical information
6.1.1 Kinds of health record entries
6.1.2 Structure of health record entries
6.1.3 The representation of context within health record entries
6.1.4 Intra-record links
6.1.5 The representation of data values within health record entries
6.1.5.1 Textual entries
6.1.5.2 Terms
6.1.5.3 Quantities and numeric data
6.1.5.4 Time
6.1.5.5 Boolean data
6.1.5.6 Graphical and multimedia data
6.1.5.7 Externally referenced data
6.1.6 EHRA data retrieval and views
6.1.7 Representation and support of clinical processes and workflow
6.1.7.1 Support for clinical processes and workflow
6.1.7.2 Decision support, guidelines, and protocols
6.1.7.3 Care planning
6.1.7.4 Support of orders and services
6.1.7.5 Integrated care
6.1.7.6 Quality assurance
6.2 Communication and interoperability requirements
6.3 Ethical and legal requirements
6.3.1 Health record provenance
6.3.2 Subject of care
6.3.3 Identification, authorization and attestation for EHR data entry
6.3.4 Healthcare locations
6.3.5 Dates and times
6.3.6 Version management
6.4 Fair information principles
6.4.1 Accountability
6.4.2 Identifying purposes
6.4.3 Consent
6.4.4 Limiting collection, use, disclosure, retention
6.4.5 Access policies
6.4.6 Subject access
6.4.7 Auditability
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1 Scope
2 Notation
3 Terms and definitions
4 Abbreviations
5 EHR business objectives
5.1 Introduction
5.2 Health system objectives
5.3 Clinical practice objectives
5.4 Citizen inclusion objectives
6 Requirements for an electronic health record architecture
6.1 Requirements for the representation of clinical information
6.1.1 Kinds of health record entries
6.1.2 Structure of health record entries
6.1.3 The representation of context within health record entries
6.1.4 Intra-record links
6.1.5 The representation of data values within health record entries
6.1.5.1 Textual entries
6.1.5.2 Terms
6.1.5.3 Quantities and numeric data
6.1.5.4 Time
6.1.5.5 Boolean data
6.1.5.6 Graphical and multimedia data
6.1.5.7 Externally referenced data
6.1.6 EHRA data retrieval and views
6.1.7 Representation and support of clinical processes and workflow
6.1.7.1 Support for clinical processes and workflow
6.1.7.2 Decision support, guidelines, and protocols
6.1.7.3 Care planning
6.1.7.4 Support of orders and services
6.1.7.5 Integrated care
6.1.7.6 Quality assurance
6.2 Communication and interoperability requirements
6.3 Ethical and legal requirements
6.3.1 Health record provenance
6.3.2 Subject of care
6.3.3 Identification, authorization and attestation for EHR data entry
6.3.4 Healthcare locations
6.3.5 Dates and times
6.3.6 Version management
6.4 Fair information principles
6.4.1 Accountability
6.4.2 Identifying purposes
6.4.3 Consent
6.4.4 Limiting collection, use, disclosure, retention
6.4.5 Access policies
6.4.6 Subject access
6.4.7 Auditability