About CEN
The European Committee for Standardization is one of three European Standardization Organizations (together with CENELEC and ETSI) that have been officially recognized by the European Union and by the European Free Trade Association (EFTA) as being responsible for developing and defining voluntary standards at European level.
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Project
| Reference | EN ISO 13972:2022 |
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| Title | Health informatics - Clinical information models - Characteristics, structures and requirements (ISO 13972:2022) |
| Work Item Number | 00251356 |
| Abstract/Scope | This document: — 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 examples; — 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 for the transformation and application of clinical information models through the wide variation of health information technology. This document excludes: — Requirements on the content or application of any particular clinical information model or clinical information modelling methodology; — 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 does 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. |
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Published
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| Reference Document |
ISO 13972:2022 (EQV)
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| date of Availability (DAV) | 2022-03-09 |
| ICS | 35.240.80 - IT applications in health care technology |
| A-Deviation(s) | |
| Special National Condition(s) |
Legal
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| Mandate(s) | |
| Citation in OJEU |
Implementation Dates
| date of Ratification (DOR) (1) | 2021-10-20 |
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| date of Availability (DAV) (2) | 2022-03-09 |
| date of Announcement (DOA) (3) | 2022-06-30 |
| date of Publication (DOP) (4) | 2022-09-30 |
| date of Withdrawal (DOW) (5) | 2022-09-30 |
Relations
| Supersedes | CEN ISO/TS 13972:2015 |
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| Superseded by | |
| Normative reference (6) | |
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(1) Date of ratification (dor) date when the Technical Board notes the approval of an EN (and HD for CENELEC), from which time the standard may be said to be approved
(2) Date of availability (dav) date when the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat
(3) Date of announcement (doa) latest date by which the existence of an EN (and HD for CENELEC), a TS or a CWA has to be announced at national level
(4) Date of publication (dop) latest date by which an EN has to be implemented at national level by publication of an identical national standard or by endorsement
(5) Date of withdrawal (dow) latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn
(6) This list of normative references is purely indicative. The only official list of normative reference is the list of the published standard.
In the case of undated standard, a link to the last dated version is provided.
In the case of series, a link to each standard identified in the series is provided.
We also invite you to check (via the website) whether corrigenda and/or amendments shall be read in conjunction with the main standard.