ISO/TR 19669:2017
(Main)Health informatics — Re-usable component strategy for use case development
Health informatics — Re-usable component strategy for use case development
ISO/TR 19669:2017 specifies a use case development methodology, facilitated by a dynamic catalogue of re-usable components. Use cases are a basic tool in describing requirements for health and healthcare settings, service provision, information technology and software products. Use case development often follows a uniform template with components such as actors, roles, scenarios, event steps, actions, data objects/elements and requirements statements. ISO/TR 19669:2017 includes a basic use case template and the methods of component identification, capture, cataloguing and re-use. This document also includes guidance for software designed to implement the methodology in the form of a use case authoring tool.
Informatique de santé — Stratégie de composants réutilisables pour le développement de cas pratiques
General Information
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Standards Content (Sample)
TECHNICAL ISO/TR
REPORT 19669
First edition
2017-10
Health informatics — Re-usable
component strategy for use case
development
Informatique de santé — Stratégie de composants réutilisables pour
le développement de cas pratiques
Reference number
ISO/TR 19669:2017(E)
©
ISO 2017
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ISO/TR 19669:2017(E)
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ISO/TR 19669:2017(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols and abbreviated terms . 3
5 Objectives for the re-usable component strategy . 4
6 Use case basics . 4
6.1 General . 4
6.2 Use case scenarios, events and actions . 4
6.3 Use case actors . 4
7 Use case component candidates . 4
7.1 General . 4
7.2 Identify-ability . 5
7.3 Catalogue-ability . 5
7.4 Commonality . 5
7.5 Computability . 5
8 Use case components . 5
8.1 General . 5
8.2 Requirements . 5
8.3 Actors and roles . 6
8.4 Scenarios, events and actions . 6
8.5 Data objects and elements . 6
9 Use case scenarios . 7
9.1 General . 7
9.2 Events and event steps . 7
9.3 Actors and roles . 7
9.4 Actions taken . 7
9.5 Inputs and outputs . 7
10 Use case requirements template . 7
10.1 Preface and introduction . 7
10.2 Initiative overview . 8
10.2.1 General. 8
10.2.2 Initiative challenge statement . 8
10.3 Use case scope . 8
10.3.1 General. 8
10.3.2 Background. 8
10.3.3 In scope . 8
10.3.4 Out of scope . 8
10.3.5 Stakeholders . 8
10.4 Value statement . 9
10.5 Use case assumptions . 9
10.6 Pre-conditions . 9
10.7 Post-conditions . 9
10.8 Actors and roles . 9
10.9 Use case diagram .10
10.10 Use case scenario(s) .10
10.11 User story .11
10.12 Activity diagram .11
10.13 Flow .11
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ISO/TR 19669:2017(E)
10.13.1 Base flow .11
10.13.2 Alternate flow .12
10.13.3 Functional requirements .12
10.13.4 Information interchange requirements .13
10.13.5 System requirements .13
10.13.6 Sequence diagram .13
10.14 Risks, issues and obstacles .13
10.15 Dataset requirements .13
11 Methodology for component capture, cataloguing and re-use .14
11.1 General .14
11.2 Component — Requirements .14
11.3 Derivation of common requirements from existing use case template .14
11.3.1 General.14
11.3.2 Re-use of common requirements in new use case scenario.14
11.4 Component – Actors/roles .17
11.4.1 General.17
11.4.2 Derivation of common actors/roles from existing use case template .17
11.4.3 Re-use of common actors/roles in new use case scenario .17
11.5 Component — Scenarios .17
11.5.1 General.17
11.5.2 Derivation of scenarios from existing use case template .18
11.5.3 Re-use of common scenarios in new use case .18
11.6 Component — Events .18
11.6.1 General.18
11.6.2 Derivation of events from existing use case template .18
11.6.3 Re-use of common events in new use case scenario.18
11.7 Component — Actions .20
11.7.1 General.20
11.7.2 Derivation of actions from existing use case template .20
11.7.3 Re-use of common actions in new use case scenario event steps .20
11.8 Component — Data objects/elements .21
11.8.1 General.21
11.8.2 Derivation of data objects/elements from existing use case template .21
11.8.3 Re-use of common data objects/elements in new use case data requirements .21
12 Progression — Use case development to implementation .23
12.1 General .23
12.2 Use case requirements phase .23
12.2.1 General.23
12.2.2 Subject matter experts .24
12.2.3 Use case analysts.24
12.2.4 Initial sketch of the clinical/business case .24
12.2.5 Comprehensive statement of the clinical/business case .24
12.2.6 Components of the clinical/business case .24
12.2.7 Finalization of clinical/business case requirements .24
12.3 Anchor for traceability .24
12.4 Fulfilment of clinical/business case requirements.25
Bibliography .26
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ISO/TR 19669:2017(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 on 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 the following
URL: www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics.
This document is based in part on ISO/TR 21089 and ISO/HL7 10781.
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ISO/TR 19669:2017(E)
Introduction
Use cases are often utilized to establish key objectives and requirements for software design and
development, system testing, certification and implementation. This document offers a methodology
for use case development that discovers common components of use case scenarios, then establishes
a component catalogue for subsequent re-use and re-purposing of those components in new use case
scenarios. The methodology establishes re-use as a key foundation for consistent infrastructure and
build-out of software application systems in healthcare (and potentially other industries). Re-use of
requirements often leads to re-use of software solutions (to those requirements). The methodology
leads to uniformity in, and optimization of, requirement specification, standards and implementation
guidance, software development, testing and certification and ultimately implementation. The
methodology establishes the basis for requirements traceability, at each progression step, and end-to-
end (use case to implementation).
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TECHNICAL REPORT ISO/TR 19669:2017(E)
Health informatics — Re-usable component strategy for
use case development
1 Scope
This document specifies a use case development methodology, facilitated by a dynamic catalogue of
re-usable components. Use cases are a basic tool in describing requirements for health and healthcare
settings, service provision, information technology and software products. Use case development often
follows a uniform template with components such as actors, roles, scenarios, event steps, actions, data
objects/elements and requirements statements. This document includes a basic use case template and
the methods of component identification, capture, cataloguing and re-use. This document also includes
guidance for software designed to implement the methodology in the form of a use case authoring tool.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
3.1
action
activity or task performed by an entity at a given point in time
Note 1 to entry: A use case event is comprised of one or more actions occurring in sequence.
Note 2 to entry: It can also be defined as an element of an event (step) that a user performs during a procedure
(see ISO/IEC 26514).
3.2
actor
health professional, healthcare employee, patient/consumer, sponsored healthcare provider, healthcare
organisation, subject of care, device, system or application that acts (performs a role) in a health related
communication or service
[SOURCE: ISO 17090-1:2013, 3.1.3, modified]
3.3
assumption
condition that is accepted as true
Note 1 to entry: It can also be defined as factors that, for planning purposes, are considered to be true, real, or
certain without proof or demonstration (see ISO/IEC/IEEE 24765) or a statement that describes the expected
behaviours of a system or actors who will use the system (see Reference [20]).
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ISO/TR 19669:2017(E)
3.4
data element
data concept represented by a specific value domain and that describes a single atomic property about
an object class
[SOURCE: ISO 14817-1:2015, 4.17, modified - Note 1 to entry deleted]
3.5
data object
collection of data that has a natural grouping and may be identified as a complete entity
Note 1 to entry: It can also be defined as a collection (set) of logically related data elements, e.g. “patient vital
signs typically comprise heart rate, respiration rate, temperature and blood pressure”.
[SOURCE: ISO/TS 27790:2009, 3.20, modified - Note 1 to entry has been added]
3.6
electronic health record
repository of information regarding the health of a subject of care, in computer processable form
Note 1 to entry: It can also be defined as comprehensive, structured set of clinical, demographic, environmental,
social, and financial data and information in electronic form, documenting the health care given to a single
individual (ASTM 1769) or information relevant to the wellness, health and healthcare of an individual, in
computer-processable form and represented according to a standardized information model (ISO 18308).
[SOURCE: ISO 13606-2:2008, 4.7, modified - Note 1 to entry replaced]
3.7
event
performance of a specified set of functions or operations
Note 1 to entry: It can also be defined as a health care interaction that involves a patient and that may be delivered
[21]
by a health care provider or be provided as a service .
[SOURCE: ISO/IEC 23006-2:2016, 3.1.6, modified - Note 1 to entry has been added]
3.8
entity
legal (e.g. a corporation, labour union, state or nation) or natural person or system (e.g. device, software)
[SOURCE: ISO 15782-1:2009, 3.35, modified - text has been added to the definition and the example has
been deleted]
3.9
health/care
health and/or healthcare
EXAMPLE Health/care providers support individual health and provide healthcare services.
3.10
initiative
collaboration of business/clinical experts to develop one or more use cases
3.11
pre-condition
condition which must be true prior to undertaking use case action(s)
3.12
post-condition
condition which must be true after undertaking use case action(s)
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ISO/TR 19669:2017(E)
3.13
requirement
requirement statement
declaration of necessary condition(s)
Note 1 to entry: “specified requirement” is a need or expectation that is stated (requirements are intended to
define some feature of a real implementation and offer the possibility of testing) (see ISO/IEC 17007:2009, 3.4).
3.14
re-usable component
element of the use case description that can be excerpted, labelled, catalogued and retained (in a
persistent file) for selection and inclusion in a future use case or scenario
3.15
scenario
sequence of event (steps) necessary to complete a business/clinical process
Note 1 to entry: It can also be defined as a description of high level business activities defining process and
requirements (see ISO/IEC 19501:2005).
3.16
subject of care
one or more persons scheduled to receive, receiving, or having received a health service
Note 1 to entry: It can also be defined as any person who uses, or is a potential user of, a health care service (see
ISO/TS 22220:2011).
[SOURCE: ISO 18308:2011, 3.47, modified - definition has been amended and Note 1 to entry added]
3.17
use case
set of scenarios which address a particular business/clinical domain or topic
Note 1 to entry: It can also be defined as a specification of interactions between external actors and the system
to attain particular goals (technopedia.com) or methodology used in system analysis to identify, clarify, and
organize system requirements (whatis.com).
3.18
user story
simple narrative illustrating the user goals that a software function will satisfy
[SOURCE: ISO/IEC/IEEE 26515:2011, 4.16]
4 Symbols and abbreviated terms
EHR electronic health record
EHR-S electronic health record system
HIT health information technology
SKMT ISO TC215 Standards Knowledge Management Tool
SME subject matter expert
UCR use case requirements
UCA use case analyst
UCAT use case authoring tool
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ISO/TR 19669:2017(E)
5 Objectives for the re-usable component strategy
The re-usable component strategy (for use case development) is based on the following objectives.
a) To formalize a process of identifying and cataloguing common use case components and patterns
of re-use from developing use cases.
b) To save new resource investment by allowing business requirements analysts to quickly identify
and re-use catalogued use case components already specified or to add new ones, when appropriate.
c) To formalize a process of identifying and cataloguing implementable software modules and data
objects, either commercial or open source, which implement various aspects of required use case-
identified software functionality, data/record management and exchange.
d) To save new resource investment by allowing software developers to readily identify and re-use
cata
...
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