DSF/prEN ISO 13972 ( Draft )

Health informatics – Clinical information models – Characteristics, structures and requirements (ISO/DIS 13972:2020)

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This Standard:
– Specifies clinical information models (CIMs) as health and care concepts that can be used to define
and to structure information for various purposes in health care, also enabling information reuse.
– Describes requirements for CIMs content, structure and context and specification of their
data elements, data element relationships, meta-data and versioning, and provides guidance and
– Specifies key characteristics of CIMs used in conceptual and logical analysis for use cases such
as (reference) architectures, information layers, EHR and PHR systems, interoperability, systems
integration in the health domain, and secondary use of data including for public health reporting.
– Defines a Quality Management System (QMS) for a systematic and effective governance, quality
management, and measurement of CIMs through their lifecycle of development, testing, distribution,
application and maintenance.
– Provides principles to be followed in the transformation and application of clinical information
models through the wide variation of health information technology.
This Standard excludes:
– Normative specification of the content or application of any particular clinical information model or
clinical information modelling methodology. However, informative examples are presented.
– Specific applications of clinical information models such as for dynamic modelling of workflow.
– Specifications for modelling entire domains or aggregates of many CIMs such as complete assessment
documents or discharge summaries. It will not specify CIMs compositions.
– Specification of how to involve specific clinicians, how to carry out governance including information
governance, or how to ensure patient safety.

Number of pages: 87

International relationships : prEN ISO 13972 IDT ISO/DIS 13972 IDT

ICS: 35.240.80 - IT applications in health care technology

Item number: M345604



  • CEN/TC 251
  • CEN/TC 251/WG 1
  • ISO/TC 215
  • ISO/TC 215/WG 1

Danish committee