Health Informatics - Methodology for analysis of business and information needs of health enterprises to support standards based architectures

This document presents a methodology which supports and enables the development of standards based business and information architectures that contribute to good quality of healthcare and patient safety. The methodology is used to develop descriptions of healthcare enterprises from different aspects. Those aspects are covering what, how, where, who, when, why[1] and are based on standards.

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Publication Date
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24-Nov-2020
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24-Nov-2020
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TECHNICAL ISO/TS
SPECIFICATION 22272
First edition
2021-01
Health Informatics - Methodology for
analysis of business and information
needs of health enterprises to support
standards based architectures
Reference number
ISO/TS 22272:2021(E)
ISO 2021
---------------------- Page: 1 ----------------------
ISO/TS 22272:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/TS 22272:2021(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Why the BIA methodology is useful in healthcare ............................................................................................................. 2

5 Efforts to achieve the business vision ............................................................................................................................................. 4

5.1 The business mission, vision, holistic view and strategies ............................................................................... 4

5.2 Different steps in analysis work and change management .............................................................................. 7

5.3 Fundamental areas within healthcare as a system .................................................................................................. 9

5.4 Time dimensions in the BIA methodology ...................................................................................................................10

5.5 Focus of the BIA methodology and business aspects .........................................................................................12

5.6 The basic concepts in the BIA methodology...............................................................................................................14

6 The route to semantic interoperability .....................................................................................................................................15

6.1 A mutual understanding of the business .......................................................................................................................15

6.2 Prerequisites for a semantic interoperability ...........................................................................................................16

6.3 Why is a common methodology for analysis needed? .......................................................................................17

7 Business and information needs analysis ...............................................................................................................................17

7.1 General ........................................................................................................................................................................................................17

7.2 Steps in the BIA methodology .................................................................................................................................................17

7.3 Goals, objectives and stakeholder analysis ..................................................................................................................20

7.3.1 Purpose of stakeholders and objectives analysis .............................................................................20

7.3.2 How do you do this? ...................................................................................................................................................22

7.3.3 Model notation ...............................................................................................................................................................22

7.4 Process analysis ..................................................................................................................................................................................22

7.4.1 Analysis of processes from a value processing perspective ....................................................22

7.4.2 Types of processes ......................................................................................................................................................23

7.4.3 Dependencies...................................................................................................................................................................25

7.4.4 Value process components ...................................................................................................................................26

7.4.5 Value process criteria ...............................................................................................................................................26

7.4.6 Quality aspects ...................................................................... ..........................................................................................27

7.4.7 Purpose of the process analysis .......................................................................................................................28

7.4.8 How do you do this? ...................................................................................................................................................28

7.4.9 Process model symbols ...........................................................................................................................................29

7.4.10 Analysis of processes from a collaborative perspective .................. ............................................30

7.4.11 Purpose of the method step ................................................................................................................................30

7.4.12 How do you do this? ...................................................................................................................................................30

7.4.13 Notation of a process model from a collaborative perspective ............................................31

7.5 Concept analysis .................................................................................................................................................................................31

7.5.1 Purpose of the method step ................................................................................................................................31

7.5.2 How do you do this? ...................................................................................................................................................32

7.5.3 Concept model notation .........................................................................................................................................32

7.5.4 Concept analysis and terminology work ..................................................................................................32

7.6 Information analysis .......................................................................................................................................................................32

7.6.1 Two parts of an information analysis .........................................................................................................32

7.6.2 Information needs analysis..................................................................................................................................33

7.6.3 Purpose of the method step ................................................................................................................................33

7.6.4 Notation in the model for information needs ......................................................................................33

7.6.5 Information structure analysis .........................................................................................................................33

7.6.6 Purpose of the method step ................................................................................................................................34

7.6.7 How do you do this? ...................................................................................................................................................34

7.6.8 Information model notation ...............................................................................................................................34

© ISO 2021 – All rights reserved iii
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ISO/TS 22272:2021(E)

7.7 Analysis of code systems, classifications and terminologies ........................................................................34

7.7.1 Purpose of the method step ................................................................................................................................34

7.7.2 How do you do this? ...................................................................................................................................................35

8 BIA methodology supports standards based business and information architectures ..........35

8.1 BIA methodology supports creating branch frameworks ..............................................................................35

8.2 ISO 13940 as a conceptual basis for the business architecture in healthcare ..............................39

8.3 EN 15224 as a basis for a clinical process oriented business architecture .....................................41

8.4 Combining ISO 13940 and EN 15224 as a common basis for creation of a business

architecture in healthcare ..........................................................................................................................................................42

8.5 Standards based information architecture ..................................................................................................................43

8.6 ISO 13606-3 as a basis of content of the information architecture ........................................................43

9 BIA methodology as a driver for an effective requirements-settings work .........................................45

9.1 Methodology and development process ........................................................................................................................45

9.2 Business-driven ICT development ......................................................................................................................................46

9.3 General development process overview ........................................................................................................................46

9.4 Business and information analysis deliverables .....................................................................................................48

9.5 A development process using BIA methodology through BIA function .............................................49

9.5.1 General...................................................................................................................................................................................49

9.5.2 Information........................................................................................................................................................................49

9.5.3 Introduction ......................................................................................................................................................................49

9.5.4 Reconciliation ..................................................................................................................................................................50

9.5.5 Examination ......................................................................................................................................................................51

9.5.6 Delivery receipt ..............................................................................................................................................................52

Annex A (Informative) Examples of notation in the different model types ..............................................................54

Annex B (Informative) Ogden’s triangle approach as a bases of concept analysis ............................................59

Annex C (Informative) Business and information analysis on Healthcare guide 1177 by phone ......60

Bibliography .............................................................................................................................................................................................................................72

iv © ISO 2021 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/TS 22272:2021(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.
© ISO 2021 – All rights reserved v
---------------------- Page: 5 ----------------------
ISO/TS 22272:2021(E)
Introduction

Healthcare organizations need to have coordinated and systematic methodologies for business

management, quality management and information management. These methodologies also support

creating of a coherent business and information architectures as one of the prerequisites for achieving

semantic interoperability in both the healthcare enterprises and their information and communications

technology (ICT).

Healthcare is a business sector where high quality information is crucial for the quality of the services

delivered. In healthcare it is critical to be able to share information between different healthcare

providers regionally, nationally and sometimes also internationally. Therefore, business and

information architectures should be coherent and based on standards. To achieve this, an appropriate

methodology should be used for creation of such architectures.

This document describes the methodology for analysis of business and information needs of health

enterprises to support standards based architectures, BIA methodology. The purpose of the methodology

is to provide an efficient business and information needs analysis for an optimal healthcare enterprise

description in order to create a standards based business and information architectures.

The BIA methodology starts with describing of the organization’s mission and vision.

The organization’s mission defines the type of business to be conducted and its extent. A defined

business always has a purpose to state why it exists.

The business vision drives the business forward, stating the direction for streamlining and thereby

development of the business.

There should be a comprehensive holistic overview that describes the current state and the target state

of the business and its information management, as well as how to move from the current state to the

target state, thereby allowing the vision to be more easily achieved.

The BIA methodology is used for the analysis and descriptions of a defined business. The resultant

descriptions comprise the basis for decisions made for different purposes, ranging from the production

of a holistic overview as a basis for the business development, information supply, ICT strategies as well

as ICT requirements-setting.

The methodology consists of several steps that analyse and describe different aspects of a business. It

also defines how these aspects relate to each other in order to achieve an effective and lean analysis of

the business and its information needs. The analysis results in descriptions of:
— Goals - long-term, strategic, wider goal, not precisely quantifiable
— Objectives - more short-term, on operational level, specific measurable

— Stakeholders - roles/actors/target groups that directly interact in the business or have an interest

that business is operative
— Concepts - the concepts that are fundamental and anchored in the business

— Process from value processing perspective - patterns for action that shall ensure that the objectives

are achieved

— Process from a collaboration perspective - crystallizing of the processing perspective that shows

the business roles in collaboration

— Information needs – what type of information that business roles are needed in their collaboration

— Information structure - a comprehensive and structured description of the type of information

managed by the different roles in the process
vi © ISO 2021 – All rights reserved
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ISO/TS 22272:2021(E)

— Codes, classifications and terminologies - agreed and predefined values which describe a certain

type of information related to a specific attribute in the information structure

Using an established and specific for healthcare system methodology ensures that the result is fit for its

purpose, maintaining quality at a high level. It also increases opportunities for comparing and re-using

different analytical results as well as producing an optimal business description which can be used for

different purposes.

The BIA methodology also points out a number of International Standards to use as reference models in

development of the standards based coherent business and information architectures.

This document is targeted at experts working with strategic issues such as devising a business goals,

objectives and strategies as well as those working with the production of industry frameworks, creating

of standards based business and information architectures, business and information analyses,

information structuring and requirements setting for ICT or their information supply.

© ISO 2021 – All rights reserved vii
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TECHNICAL SPECIFICATION ISO/TS 22272:2021(E)
Health Informatics - Methodology for analysis of business
and information needs of health enterprises to support
standards based architectures
1 Scope

This document presents a methodology which supports and enables the development of standards

based business and information architectures that contribute to good quality of healthcare and patient

safety. The methodology is used to develop descriptions of healthcare enterprises from different

[1]

aspects. Those aspects are covering what, how, where, who, when, why and are based on standards.

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 9000, Quality management systems — Fundamentals and vocabulary
ISO 13940, Health informatics — System of concepts to support continuity of care
EN 15224, Quality management systems
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 9000, ISO 13940, and

EN 15224 and the following 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
business mission
purpose and scope of a business
3.2
business vision
future or ideal goals that a business strives to achieve
3.3
holistic view of the business

description of the business current state, the target state and how to move from the current to the

target state
3.4
time dimension
view of the business in the current state or the target state
3.5
strategy for transition to the target state

overall description for displacement of business from current state to target state

© ISO 2021 – All rights reserved 1
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ISO/TS 22272:2021(E)
3.6
action plan
concrete activities intended to achieve the target state
3.7
current state

description of way in which the business and its support operate, for example information management

and information and communications technology
3.8
target state

description of desired way in which the business and its support should operate, for example

information management and information and communications technology
3.9
business aspect

type of business analysis from a certain point of view in order to create a deeper understanding of the

business and its information management
3.10
set of information
the information managed by the activities in the process
3.11
stakeholder

role, actor or target group who directly interact with the business or who have an interest in the

outcomes of that business
3.12
process from a value processing perspective
patterns for action that ensure that the objectives are achieved
3.13
process from a collaborative perspective

crystallizing of the processing perspective that shows the business roles in collaboration

3.14
concept
unit of knowledge created by a unique combination of characteristics
[SOURCE: ISO 1087:2019, 3.2.7, modified — Notes removed.]
4 Why the BIA methodology is useful in healthcare

The structure and standardization of information handled in electronic systems in the healthcare has

been attempted over several decades in many different countries. It became clear that there was a need

to first define the concepts which are the basis for this information before structuring could commence.

Concepts and information structures by themselves are insufficient to create the preconditions for the

information to be unambiguously defined. Users should therefore understand the context in which this

information is created and handled.

Healthcare is an information-intensive industry, that is both knowledge- and evidence-based. Figure 1

illustrates that many different professions and roles work together in the patient care. For clarification

and the maintenance of patient safety, those roles shall understand the clinical context in which the

information was created. In addition, it is important that information is retained in such a way that it

can be reused in order to meet the needs of different stakeholders.
2 © ISO 2021 – All rights reserved
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ISO/TS 22272:2021(E)

As healthcare information shall be handled over many years, it is necessary that structures are

backwards compatible. Information structures and related regulations should be stable over time and

based on a predefined conceptual structure.

Business and information analysis methodology takes those aspects characteristic of healthcare into

account:
— many professions
— many specialties with their own development needs
— interaction with others
— to understand each other in the same way
— to protect patient safety
— information-intensive
— traceability and an audit trail of information management
— based on knowledge and evidence
— the need for follow-up
Figure 1 — Managing of a large amount of information

Healthcare professionals should focus their time and resources on patients. At the same time, it is

necessary to streamline healthcare enterprises, their information management and ICT. Healthcare

usually has a need to pass through this with quite limited resources and under the short periods of time

without disturbing the core enterprise. Therefore, enterprises should use methodologies in change

work that meets these requirements.
© ISO 2021 – All rights reserved 3
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ISO/TS 22272:2021(E)
The BIA is such a methodology that characterizes:
— well-demarcated methodology and with limited scope
— easy to understand, relatively quick to learn and get started to use
— can be used in its entirety or in less delimited parts
— enable to involve healthcare professionals in analysis
— healthcare professionals are the driving factor in analysis
— analysts play the role as help and support in analysis work

Historically, healthcare professionals were very poorly involved in business and information analysis.

ICT professionals conducted analysis with very minimalist involvement of healthcare professionals.

Such analysis was ICT-driven.

A fundamental advantage of the BIA methodology is that it is the healthcare professionals who "owns"

analysis and are at the focus in the analysis work. Analysts are seen as the help and support in this

work and stands for the structural perspective. Through agreement and consensus in analysis work,

healthcare professionals create different models. Analysts, on the other hand, help keep the focus in the

discussion in order to come to a common understanding of areas of analysis.

To be able to involve healthcare professionals in analysis, the methodology should to be easily

understood. Healthcare professionals also need to see how each step in analysis work contributes to a

qualitative end result.

Because the BIA methodology is clearly defined and made easy to understand, opportunities are

created for healthcare professionals to be the driving force in analysis work. The purpose of the BIA

methodology is to conduct business-driven analysis.
5 Efforts to achieve the business vision
5.1 The business mission, vision, holistic view and strategies

A mission defines the type of business that is to be conducted and the extent of this business. A defined

business always has a specific purpose which justifies its existence.

The vision drives the business forward, stating a direction for streamlining and thereby its development

as it shows in Figure 2. A business should have a common, agreed and established vision why it exists.

A vision doesn’t have to be measurable or even completely realistic; it serves to point out the direction

of the business’ future.
Figure 2 — Business vision
4 © ISO 2021 – All rights reserved
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ISO/TS 22272:2021(E)

Sometimes a business is not sufficiently effective enough to achieve its vision at the present time;

there should be a holistic view of the business that describes its current state, how it is viewed and

perceived the way it works today. The target state of the business, that is another part of the holistic

view, describes the desired state of how it will function in the future. Figure 3 illustrate the relationship

between business vision, current state, target state a
...

TECHNICAL ISO/TS
SPECIFICATION 22272
First edition
Health Informatics - Methodology for
analysis of business and information
needs of health enterprises to support
standards based architectures
PROOF/ÉPREUVE
Reference number
ISO/TS 22272:2020(E)
ISO 2020
---------------------- Page: 1 ----------------------
ISO/TS 22272:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii PROOF/ÉPREUVE © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/TS 22272:2020(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Why the BIA methodology is useful in healthcare ............................................................................................................. 2

5 Efforts to achieve the business vision ............................................................................................................................................. 4

5.1 The business mission, vision, holistic view and strategies ............................................................................... 4

5.2 Different steps in analysis work and change management .............................................................................. 7

5.3 Fundamental areas within healthcare as a system .................................................................................................. 9

5.4 Time dimensions in the BIA methodology ...................................................................................................................10

5.5 Focus of the BIA methodology and business aspects .........................................................................................12

5.6 The basic concepts in the BIA methodology...............................................................................................................14

6 The route to semantic interoperability .....................................................................................................................................15

6.1 A mutual understanding of the business .......................................................................................................................15

6.2 Prerequisites for a semantic interoperability ...........................................................................................................16

6.3 Why is a common methodology for analysis needed? .......................................................................................17

7 Business and information needs analysis ...............................................................................................................................17

7.1 General ........................................................................................................................................................................................................17

7.2 Steps in the BIA methodology .................................................................................................................................................17

7.3 Goals, objectives and stakeholder analysis ..................................................................................................................22

7.3.1 Purpose of stakeholders and objectives analysis .............................................................................22

7.3.2 How do you do this? ...................................................................................................................................................24

7.3.3 Model notation ...............................................................................................................................................................24

7.4 Process analysis ..................................................................................................................................................................................24

7.4.1 Analysis of processes from a value processing perspective ....................................................24

7.4.2 Types of processes ......................................................................................................................................................25

7.4.3 Dependencies...................................................................................................................................................................27

7.4.4 Value process components ...................................................................................................................................28

7.4.5 Value process criteria ...............................................................................................................................................28

7.4.6 Quality aspects ...................................................................... ..........................................................................................29

7.4.7 Purpose of the process analysis .......................................................................................................................30

7.4.8 How do you do this? ...................................................................................................................................................30

7.4.9 Process model symbols ...........................................................................................................................................31

7.4.10 Analysis of processes from a collaborative perspective .................. ............................................32

7.4.11 Purpose of the method step ................................................................................................................................32

7.4.12 How do you do this? ...................................................................................................................................................32

7.4.13 Notation of a process model from a collaborative perspective ............................................33

7.5 Concept analysis .................................................................................................................................................................................33

7.5.1 Purpose of the method step ................................................................................................................................33

7.5.2 How do you do this? ...................................................................................................................................................34

7.5.3 Concept model notation .........................................................................................................................................34

7.5.4 Concept analysis and terminology work ..................................................................................................34

7.6 Information analysis .......................................................................................................................................................................34

7.6.1 Two parts of an information analysis .........................................................................................................34

7.6.2 Information needs analysis..................................................................................................................................35

7.6.3 Purpose of the method step ................................................................................................................................35

7.6.4 Notation in the model for information needs ......................................................................................35

7.6.5 Information structure analysis .........................................................................................................................35

7.6.6 Purpose of the method step ................................................................................................................................36

7.6.7 How do you do this? ...................................................................................................................................................36

7.6.8 Information model notation ...............................................................................................................................36

© ISO 2020 – All rights reserved PROOF/ÉPREUVE iii
---------------------- Page: 3 ----------------------
ISO/TS 22272:2020(E)

7.7 Analysis of code systems, classifications and terminologies ........................................................................36

7.7.1 Purpose of the method step ................................................................................................................................36

7.7.2 How do you do this? ...................................................................................................................................................37

8 BIA methodology supports standards based business and information architectures ..........37

8.1 BIA methodology supports creating branch frameworks ..............................................................................37

8.2 ISO 13940 as a conceptual basis for the business architecture in healthcare ..............................41

8.3 EN 15224 as a basis for a clinical process oriented business architecture .....................................43

8.4 Combining ISO 13940 and EN 15224 as a common basis for creation of a business

architecture in healthcare ..........................................................................................................................................................44

8.5 Standards based information architecture ..................................................................................................................45

8.6 ISO 13606-3 as a basis of content of the information architecture ........................................................45

9 BIA methodology as a driver for an effective requirements-settings work .........................................47

9.1 Methodology and development process ........................................................................................................................47

9.2 Business-driven ICT development ......................................................................................................................................48

9.3 General development process overview ........................................................................................................................48

9.4 Business and information analysis deliverables .....................................................................................................50

9.5 A development process using BIA methodology through BIA function .............................................51

9.5.1 General...................................................................................................................................................................................51

9.5.2 Information........................................................................................................................................................................51

9.5.3 Introduction ......................................................................................................................................................................51

9.5.4 Reconciliation ..................................................................................................................................................................52

9.5.5 Examination ......................................................................................................................................................................53

9.5.6 Delivery receipt ..............................................................................................................................................................54

Annex A (Informative) Examples of notation in the different model types ..............................................................56

Annex B (Informative) Ogden’s triangle approach as a bases of concept analysis ............................................61

Annex C (Informative) Business and information analysis on Healthcare guide 1177 by phone ......62

Bibliography .............................................................................................................................................................................................................................74

iv PROOF/ÉPREUVE © ISO 2020 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/TS 22272:2020(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.
© ISO 2020 – All rights reserved PROOF/ÉPREUVE v
---------------------- Page: 5 ----------------------
ISO/TS 22272:2020(E)
Introduction

Healthcare organizations need to have coordinated and systematic methodologies for business

management, quality management and information management. These methodologies also support

creating of a coherent business and information architectures as one of the prerequisites for achieving

semantic interoperability in both the healthcare enterprises and their information and communications

technology (ICT).

Healthcare is a business sector where high quality information is crucial for the quality of the services

delivered. In healthcare it is critical to be able to share information between different healthcare

providers regionally, nationally and sometimes also internationally. Therefore, business and

information architectures should be coherent and based on standards. To achieve this, an appropriate

methodology should be used for creation of such architectures.

This document describes the methodology for analysis of business and information needs of health

enterprises to support standards based architectures, BIA methodology. The purpose of the methodology

is to provide an efficient business and information needs analysis for an optimal healthcare enterprise

description in order to create a standards based business and information architectures.

The BIA methodology starts with describing of the organization’s mission and vision.

The organization’s mission defines the type of business to be conducted and its extent. A defined

business always has a purpose to state why it exists.

The business vision drives the business forward, stating the direction for streamlining and thereby

development of the business.

There should be a comprehensive holistic overview that describes the current state and the target state

of the business and its information management, as well as how to move from the current state to the

target state, thereby allowing the vision to be more easily achieved.

The BIA methodology is used for the analysis and descriptions of a defined business. The resultant

descriptions comprise the basis for decisions made for different purposes, ranging from the production

of a holistic overview as a basis for the business development, information supply, ICT strategies as well

as ICT requirements-setting.

The methodology consists of several steps that analyse and describe different aspects of a business. It

also defines how these aspects relate to each other in order to achieve an effective and lean analysis of

the business and its information needs. The analysis results in descriptions of:
— Goals - long-term, strategic, wider goal, not precisely quantifiable
— Objectives - more short-term, on operational level, specific measurable

— Stakeholders - roles/actors/target groups that directly interact in the business or have an interest

that business is operative
— Concepts - the concepts that are fundamental and anchored in the business

— Process from value processing perspective - patterns for action that shall ensure that the objectives

are achieved

— Process from a collaboration perspective - crystallizing of the processing perspective that shows

the business roles in collaboration

— Information needs – what type of information that business roles are needed in their collaboration

— Information structure - a comprehensive and structured description of the type of information

managed by the different roles in the process
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— Codes, classifications and terminologies - agreed and predefined values which describe a certain

type of information related to a specific attribute in the information structure

Using an established and specific for healthcare system methodology ensures that the result is fit for its

purpose, maintaining quality at a high level. It also increases opportunities for comparing and re-using

different analytical results as well as producing an optimal business description which can be used for

different purposes.

The BIA methodology also points out a number of International Standards to use as reference models in

development of the standards based coherent business and information architectures.

This document is targeted at experts working with strategic issues such as devising a business goals,

objectives and strategies as well as those working with the production of industry frameworks, creating

of standards based business and information architectures, business and information analyses,

information structuring and requirements setting for ICT or their information supply.

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TECHNICAL SPECIFICATION ISO/TS 22272:2020(E)
Health Informatics - Methodology for analysis of business
and information needs of health enterprises to support
standards based architectures
1 Scope

This document presents a methodology which supports and enables the development of standards

based business and information architectures that contribute to good quality of healthcare and patient

safety. The methodology is used to develop descriptions of healthcare enterprises from different

[1]

aspects. Those aspects are covering what, how, where, who, when, why and are based on standards.

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 9000, Quality management systems — Fundamentals and vocabulary
ISO 13940, Health informatics — System of concepts to support continuity of care
EN 15224, Quality management systems
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 9000, ISO 13940, and

EN 15224 and the following 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
business mission
purpose and scope of a business
3.2
business vision
future or ideal goals that a business strives to achieve
3.3
holistic view of the business

description of the business current state, the target state and how to move from the current to the

target state
3.4
time dimension
view of the business in the current state or the target state
3.5
strategy for transition to the target state

overall description for displacement of business from current state to target state

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3.6
action plan
concrete activities intended to achieve the target state
3.7
current state

description of way in which the business and its support operate, for example information management

and information and communications technology
3.8
target state

description of desired way in which the business and its support should operate, for example

information management and information and communications technology
3.9
business aspect

type of business analysis from a certain point of view in order to create a deeper understanding of the

business and its information management
3.10
set of information
the information managed by the activities in the process
3.11
stakeholder

role, actor or target group who directly interact with the business or who have an interest in the

outcomes of that business
3.12
process from a value processing perspective
patterns for action that ensure that the objectives are achieved
3.13
process from a collaborative perspective

crystallizing of the processing perspective that shows the business roles in collaboration

3.14
concept
unit of knowledge created by a unique combination of characteristics
[SOURCE: ISO 1087:2019, 3.2.7, modified — Notes removed.]
4 Why the BIA methodology is useful in healthcare

The structure and standardization of information handled in electronic systems in the healthcare has

been attempted over several decades in many different countries. It became clear that there was a need

to first define the concepts which are the basis for this information before structuring could commence.

Concepts and information structures by themselves are insufficient to create the preconditions for the

information to be unambiguously defined. Users should therefore understand the context in which this

information is created and handled.

Healthcare is an information-intensive industry, that is both knowledge- and evidence-based. Figure 1

illustrates that many different professions and roles work together in the patient care. For clarification

and the maintenance of patient safety, those roles shall understand the clinical context in which the

information was created. In addition, it is important that information is retained in such a way that it

can be reused in order to meet the needs of different stakeholders.
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As healthcare information shall be handled over many years, it is necessary that structures are

backwards compatible. Information structures and related regulations should be stable over time and

based on a predefined conceptual structure.

Business and information analysis methodology takes those aspects characteristic of healthcare into

account:
— many professions
— many specialties with their own development needs
— interaction with others
— to understand each other in the same way
— to protect patient safety
— information-intensive
— traceability and an audit trail of information management
— based on knowledge and evidence
— the need for follow-up
Figure 1 — Managing of a large amount of information

Healthcare professionals should focus their time and resources on patients. At the same time, it is

necessary to streamline healthcare enterprises, their information management and ICT. Healthcare

usually has a need to pass through this with quite limited resources and under the short periods of time

without disturbing the core enterprise. Therefore, enterprises should use methodologies in change

work that meets these requirements.
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The BIA is such a methodology that characterizes:
— well-demarcated methodology and with limited scope
— easy to understand, relatively quick to learn and get started to use
— can be used in its entirety or in less delimited parts
— enable to involve healthcare professionals in analysis
— healthcare professionals are the driving factor in analysis
— analysts play the role as help and support in analysis work

Historically, healthcare professionals were very poorly involved in business and information analysis.

ICT professionals conducted analysis with very minimalist involvement of healthcare professionals.

Such analysis was ICT-driven.

A fundamental advantage of the BIA methodology is that it is the healthcare professionals who "owns"

analysis and are at the focus in the analysis work. Analysts are seen as the help and support in this

work and stands for the structural perspective. Through agreement and consensus in analysis work,

healthcare professionals create different models. Analysts, on the other hand, help keep the focus in the

discussion in order to come to a common understanding of areas of analysis.

To be able to involve healthcare professionals in analysis, the methodology should to be easily

understood. Healthcare professionals also need to see how each step in analysis work contributes to a

qualitative end result.

Because the BIA methodology is clearly defined and made easy to understand, opportunities are

created for healthcare professionals to be the driving force in analysis work. The purpose of the BIA

methodology is to conduct business-driven analysis.
5 Efforts to achieve the business vision
5.1 The business mission, vision, holistic view and strategies

A mission defines the type of business that is to be conducted and the extent of this business. A defined

business always has a specific purpose which justifies its existence.

The vision drives the business forward, stating a direction for streamlining and thereby its development

as it shows in Figure 2. A business should have a common, agreed and established vision why it exists.

A vision doesn’t have to be measurable or even completely realistic; it serves to point out the direction

of the business’ future.
Figure 2 — Business vision
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Sometimes a business is not sufficiently effective enough to achieve its vision at the present time;

there should be a holistic view of the business that describes its current state, how it is viewed and

perceived the way it works today. The target state of the business, that is another part of the holistic

view, describes the desired s
...

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