ISO/TS 17117-2:2022
(Main)Health informatics — Terminological resources — Part 2: Implementation Capability (TIC)
Health informatics — Terminological resources — Part 2: Implementation Capability (TIC)
This document defines the components (benchmarks) of capability of terminological resources implementation in healthcare software products, including electronic health record systems. It is intended that these benchmarks form the basis of a maturity model. The document will support analysis of requirements to meet use cases in the implementation of terminological resources in healthcare. This document does not specify requirements for any specific terminological resource. It is intended to provide a basis from which requirements for terminological resources capabilities can be specified in the future. The tooling being used can impact the level of maturity reached but is not covered in detail in this document. Terminological resources include code systems of all types, terminologies, classifications, value sets, and value domains. The impact of tooling (computer–assisted coding, speech recognition, template development) on the capability of the terminological resources is not covered in detail in this document.
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Standards Content (Sample)
TECHNICAL ISO/TS
SPECIFICATION 17117-2
First edition
2022-03
Health informatics — Terminological
resources —
Part 2:
Implementation Capability (TIC)
Reference number
ISO/TS 17117-2:2022(E)
© ISO 2022
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ISO/TS 17117-2:2022(E)
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ISO/TS 17117-2:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 The terminology implementation capability pillars . 2
5 Design of the data (data specifications) . 3
5.1 General . 3
5.2 Choice of terminological resource. 3
5.3 Relationship to the information model . 4
5.4 Tool functionality . 5
5.5 Design conformity to standards . 5
5.6 Capability of governance processes and data management . 5
5.7 Capability of workforce to make terminology resource decisions and
implementation . 6
6 Data capture (user interface) in healthcare implementations . 7
6.1 General . 7
6.2 Capability to display code system content . 7
6.2.1 Code selection support. 7
6.2.2 Tooling . 8
6.2.3 Standards conformance . 8
6.2.4 Workforce . 8
7 Data storage . 8
7.1 Semantic concept permanence . 8
7.2 Governance of data storage . . 9
8 Data retrieval .9
8.1 Display or retrieval of previously captured coded data . 9
8.2 Terminology capability functionality . 9
9 Data exchange and re-use .10
9.1 Terminology in a message . 10
9.2 Mapping and messaging . 10
9.3 Governance of terminology in information exchanged . 10
9.4 Workforce requirements for terminology exchange . 10
Bibliography .11
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ISO/TS 17117-2:2022(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
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ISO/TS 17117-2:2022(E)
Introduction
0.1 Objective
The aim of the ISO 17117 series is to enable health care organizations, vendors (including cloud services
and conventional software products), governments and other decision makers to
— understand requirements for implementation of terminology in healthcare systems, and
— describe organization capability needed when using terminological resources.
This document defines the capability of implemented terminological resources based on the information
lifecycle. Terminology implementation is assessed by review of each of the following 5 terminological
implementation component parts:
— Data design;
— Data capture;
— Data storage;
— Data retrieval;
— Data exchange (interoperability) and re-use.
And reviewed according to the implementation processes and capabilities as defined across 5 areas:
— Terminological resource functionality;
— Tool functionality;
— Workforce capability;
— Governance;
— Conformity to standards.
0.2 Stakeholders and audience
The users of this document include
— health care organizations – to assess product capabilities and plan future directions and purchases;
— vendors (including cloud services and conventional software products) to
— support implementation of terminological resources in their products,
— enable semantic interoperability across different systems, and
— assess product requirements influencing future directions for software development.
— government and other decision makers to identify areas of terminology practice that require
improvement or should be included in purchasing or tender arrangements,
— educators and educational organizations to educate the health informatics and healthcare
communities on the requirements for terminology implementation, and
— terminological resource developers to assist in defining the services needed to best support their
resources.
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TECHNICAL SPECIFICATION ISO/TS 17117-2:2022(E)
Health informatics — Terminological resources —
Part 2:
Implementation Capability (TIC)
1 Scope
This document defines the components (benchmarks) of capability of terminological resources
implementation in healthcare software products, including electronic health record systems. It is
intended that these benchmarks form the basis of a maturity model. The document will support analysis
of requirements to meet use cases in the implementation of terminological resources in healthcare.
This document does not specify requirements for any specific terminological resource. It is intended
to provide a basis from which requirements for terminological resources capabilities can be specified
in the future. The tooling being used can impact the level of maturity reached but is not covered in
detail in this document. Terminological resources include code systems of all types, terminologies,
classifications, value sets, and value domains.
The impact of tooling (computer–assisted coding, speech recognition, template development) on the
capability of the terminological resources is not covered in detail in this document.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO/TS 22287, Health informatics — Workforce roles and capabilities for terminology and terminology
services in healthcare (term workforce)
ISO/TS 21564, Health Informatics — Terminology resource map quality measures (MapQual)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
term
word or words corresponding to one or more concepts
Note 1 to entry: Value domains can be enumerated (e.g. Total centimetres NNN) or non-enumerated (e.g. Sex code
N).
3.2
code system
organized, managed collection of codes, each of which has associated designations, meanings and in
some cases relationships, properties or rules
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ISO/TS 17117-2:2022(E)
3.3
classification
exhaustive set of mutually exclusive categories to aggregate data at a pre-prescribed level of
specialization for a specific purpose
3.4
terminology implementation
process of taking a terminological system and applying it for concept representation to achieve efficient
and accurate concept representation
3.5
map
device that provides an index from one term to another, sometimes using rules that allow translation
from one representation top another indicating the degree of equivalence
3.6
terminology
structure, human and machine-readable representation of concepts
3.7
workforce capability
ability of those working on terminology implementation in an organization to perform their job properly
Note 1 to entry: Properly implies that the job is done in a manner which supports safe representation of concepts
in the health record and health data supply chain, as well as efficient practice.
3.8
terminological resource
controlled set of terms in healthcare
4 The terminology implementation capability pillars
Terminology implementation capabilities are viewed across different functional areas to support
identification of measures associated with terminology implementation maturity. These functional
areas include
— data requirements for terminology implementation in healthcare software including the use of
terminology in health records and health data,
— functional requirements of terminology implementation including its use in health records, clinical
information systems, clinical guidelines or decision support systems, and
— tooling as a delivery mechanism for terminology representation or collection or the management of
such implementations.
The capabilities of terminological resources implemented in healthcare information systems are
defined considering the information lifecycle (data specification (design), capture, management,
storage, and use). Specific components of the capability assessment will include
— choice of terminology resource to represent semantic concepts appropriately,
— user interface issues,
— meaning maintenance in health record content, and
— terminology resources implementation functionality (often provided by tooling).
This document will provide the following benefits to the health community:
— Define the capability of terminological resource implementation which deliver required safe
outcomes for use in healthcare;
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ISO/TS 17117-2:2022(E)
— Support healthcare software vendors and organizations to
— compare terminological resource capabilities and organizational requirements for those
resources, and
— plan improvements, i.e., align requirements and capabilities, as needed.
— Improve the safety and utility of healthcare information systems and the data in them, such as
implementation of clinical decision support systems;
— Enable information sharing (semantic interoperability) between organizations;
— Support of short- and long-term analytics within the organization and more broadly to enable
knowledge acquisition.
5 Design of the data (data specifications)
5.1 General
The choice of a terminological resource is the first key to quality implementation. The resource chosen
shall be suited to the task and robust if it is to be used in health records and systems which share
data and persist over time. The key requirements for initial design of the data from a terminology
implementation perspective are provided in this clause.
5.2 Choice of terminological resource
No matter which type of terminological resource, Terminology, Classification, Code System, Value set
or Value domain, is being discussed, the concept representation influences the ability of the resource to
meet implementation needs and to represent the data elements accurately and appropriately.
For further information on the attributes of a terminological resources see ISO 17117-1.
The following apply to the choice of a terminological resource for any specific use case:
a) Terminological resources for clinical use
i. shall have the ability to represent a concept at different levels of granularity,
ii. shall have the ability to represent the precise meaning of that concept,
iii. shall have the ability to persist meaning over time, and
iv. shall support retrieval of concepts by multiple attributes (multi-hierarchical).
b) Terminological resources for statistical use
i. shall have the ability to represent not otherwise specified or unspecified concepts, and
ii. shall support data aggregation at a specified level of granularity so that concepts can be
counted.
c) Scope of the terminological resource content shall be able to represent all content required for the
use case
i. when a terminological resource is chosen, it shall include all concepts that are needed for
representation in the use case. In many cases, the terminological resource will have more
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