Health Informatics -- Requirements for a knowledge base for clinical decision support systems to be used in medication-related processes

This document specifies the requirements for developing a knowledge base for drug-related problems that cohere with the intended drug use, to be used in rule-based clinical decision support systems (CDSS), such as the criteria for selecting a raw data source and the quality criteria for the development and maintenance for the rules or clinical rules for drug safety. It also describes the process of how to develop a knowledge base, the topics to be considered by the developers of a knowledge base, and it gives guidance on how to do this. This document gives guidelines for the development of a knowledge base: — with rules to enhance decisions and actions in drug-related problems that cohere with the intended drug use; — which can be used by all kinds of healthcare professionals, such as those who prescribe, dispense, administer or monitor medicines; — which can be used in every care setting, including chronic and acute care, primary and specialized care; — which is a repository of evidence/practice bases rules, assessed by experts; — which is meant to be used in conjunction with a medicinal product dictionary; — whose knowledge is structured in rules and therefore to be used in the type of rule-based CDSS. This document does not: — describe the exact content of a knowledge base i.e. the outcome of the process of developing rules. — provide the requirements for a clinical decision support system, the software that uses the knowledge base combined with the patient's data, and presents the outcome of the rules to the healthcare professional. These requirements are described in ISO/DTS 22703[1]. — give the requirements for non-medication knowledge bases. Some aspects of the requirements in this document are general in nature and applicable to other kinds of knowledge bases, but this document does not address all of the requirements of non-medication knowledge bases. [1] Under preparation. Stage at the time of publication: ISO/DTS 22703.

Informatique de santé -- Exigences relatives aux bases de connaissances pour systèmes d’aide à la décision clinique à utiliser dans le cadre des processus liés aux médicaments

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Published
Publication Date
20-Sep-2020
Current Stage
5060 - Close of voting Proof returned by Secretariat
Start Date
03-Aug-2020
Completion Date
03-Aug-2020
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TECHNICAL ISO/TS
SPECIFICATION 22756
First edition
2020-09
Health Informatics — Requirements
for a knowledge base for clinical
decision support systems to be used in
medication-related processes
Informatique de santé — Exigences relatives aux bases de
connaissances pour systèmes d’aide à la décision clinique à utiliser
dans le cadre des processus liés aux médicaments
Reference number
ISO/TS 22756:2020(E)
ISO 2020
---------------------- Page: 1 ----------------------
ISO/TS 22756:2020(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 © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/TS 22756:2020(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

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

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

3 Terms and definitions ..................................................................................................................................................................................... 2

4 Abbreviations........................................................................................................................................................................................................... 4

5 Positioning of a CDS knowledge base .............................................................................................................................................. 5

5.1 Knowledge in healthcare ................................................................................................................................................................ 5

5.2 Knowledge for drug-related problems that cohere with the intended drug use ........................... 5

5.3 The structure of the knowledge ............................................................................................................................................... 6

5.4 Knowledge base in relation to the healthcare information system ........................................................... 7

5.4.1 Introduction ......................................................................................................................................................................... 7

5.4.2 Relation with EHR ...................................................................... ..................................................................................... 7

5.4.3 Relation with medicinal product data ........................................................................................................... 8

5.4.4 Relation with a CDSS .................................................................................................................................................... 8

6 Requirements for the development of a knowledge base ......................................................................................... 8

6.1 Introduction .............................................................................................................................................................................................. 8

6.2 The governance of a knowledge base .................................................................................................................................. 8

6.3 Structure of the rules ......................................................................................................................................................................... 9

6.4 Scoping of the knowledge base content ............................................................................................................................ 9

6.5 Evidence for the rules ....................................................................................................................................................................... 9

6.6 Medicinal product data used in the rules ......................................................................................................................10

6.6.1 Medicinal product dictionary ............................................................................................................................10

6.6.2 IDMP ........................................................................................................................................................................................10

6.6.3 Interface with an MPD or with IDMP ..........................................................................................................11

6.7 Dosage data used in the rules .................................................................................................................................................11

6.8 Patient data variables used in the rules .........................................................................................................................12

6.8.1 Introduction ......................................................................................................................................................................12

6.8.2 Interface with the EHR ............................................................................................................................................12

6.9 Right information at the right time ....................................................................................................................................13

6.10 Quality of the rules ...........................................................................................................................................................................13

6.11 Relation with a CDSS .......................................................................................................................................................................14

6.12 Maintenance ...........................................................................................................................................................................................14

Annex A (normative) Identifying IDMP fields in relation to a knowledge base ...................................................16

Annex B (informative) Example of a knowledge base rule .........................................................................................................25

Bibliography .............................................................................................................................................................................................................................30

© ISO 2020 – All rights reserved iii
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ISO/TS 22756:2020(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, in collaboration

with the European Committee for Standardization (CEN) Technical Committee CEN/TC 251, Health

informatics, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna

Agreement).

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.
iv © ISO 2020 – All rights reserved
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ISO/TS 22756:2020(E)
Introduction
0.1 Safe and effective usage of medicines is important

When a patient gets his/her medicines prescribed and dispensed, it is not only important that the

patient gets the correct medicine and that ordering and reimbursement is supported by using a

Medicinal Product Dictionary (MPD), but it is also important that the medicine is safe and effective with

respect to the specific situation of the patient.

Because an MPD contains just the identification of the medicines, it is important that an MPD is enriched

with clinical decision support (CDS). The aim of CDS is to help prescribe and dispense the medicine

that fits the patient’s personal situation in respect of effectiveness and toxicity of the medicine.

Based on a knowledge base combined with the patient's situation such as comedication, comorbidity,

age, laboratory values, diet, allergy, a healthcare professional can be warned for likely side effects or

ineffectiveness, and change the therapy.
0.2 Need for a standardized knowledge base

To achieve the aim described in Clause 0.1, there are several success factors, in literature, referred to as

[28]
the ‘five rights’ :

— The right information: the information should be evidence based and give concrete guidance for action.

— To the right person: the alerts should be presented to the person who is the most likely one to take

action (e.g. the clinician, the pharmacist, the caretakers).

— In the right CDS intervention format: such as an alert, a request to measure certain laboratory

parameters, or an answer to a clinical question.

— Through the right channel: this can be the clinical information system like the pharmacy information

system, or a web-browser that makes available the data of the knowledge base.

— At the right time in workflow: for example, during prescription or dispensing, or in batch at night to

have certain data available the next morning.

To provide the right information, a knowledge base is necessary; and also providing the knowledge to

the right person, the right format and at the right time in the workflow is part of a knowledge base, as far

as it concerns the ‘knowledge’ of it.

There are clinical decision support systems (CDSSs) that provide this knowledge, but Helmons stated

that there are several barriers for implementing a CDSS, one of them being ‘content issues’ like:

‘Typically installed without any validated decision rules, which have to be developed and/or validated

[26]
in each individual institution (also called ‘having to reinvent the wheel’)' .

Therefore, a (technically) validated, standardized knowledge base is the recommended basis for CDS.

The needs for a standardized knowledge base are as follows:

— There is an overwhelming amount of data in the summary of product characteristics (SPC),

guidelines, literature and handbooks. Prescribers, physicians and pharmacists cannot easily find

what to do for a certain drug combination or drug-disease combination. The most relevant data and

accompanying recommendations are curated from literature and put in rules in a knowledge base.

— Information about the availability, safety and efficacy of medication to be used for the prescription

by physicians is often outdated even when the information is available electronically (e.g. in the drug

interaction management system in a doctor's office). Linking the information from the Medicinal

Product Dictionary to a CDSS that uses a validated, standardized knowledge base makes sure that

during prescribing/dispensing up-to-date information is always used.
© ISO 2020 – All rights reserved v
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ISO/TS 22756:2020(E)

— While the population is still growing, people become older and have more comorbidity and

polypharmacy, the need for smart knowledge base rules that provide the basis for generating alerts

with a high specificity and sensitivity, is increasing.

— Besides assuring that the most precise and current information is to be used in the knowledge base

for the benefits of the patient, this specification will also provide a basis or 'handles' how to map the

information to the MPD, the IDMP vocabulary and their own local data in EHR and pharmaceutical

domains.

0.3 Focus — A knowledge base for drug-related problems that cohere with the intended drug use

This document is about a standardized knowledge base to be used in medication-related processes. In

the context of this document, this means a knowledge base that has its focus to enhance decisions and

actions in drug-related problems that cohere with the intended drug use, namely once a drug has been

chosen, in any domain of prescribing, dispensing, administering of the drug and monitoring the patient.

Aspects like choosing the right drug according to guidelines and patient coaching for the correct usage

are not included in the scope of this document (which does not mean that the requirements that are

described in this document are not useful for knowledge bases with such kind of scopes).

0.4 Why this document: general principles versus medication specific aspects for developing a

knowledge base

Describing how a structured, standardized knowledge base should be developed, what are the criteria

to take into account, is a rather general process. As such it is not specific for medication processes.

Assessing literature and developing rules is also applicable for other domains.

In this respect, this document contains two sorts of requirements. First, there is the overarching

level, not specific for medication processes. This includes, for example, the requirements for selecting

and assessing literature, updating the knowledge base. Secondly, there is a medication-specific level

in this document. This includes the area to which the requirements are applied: if the requirement

is to determine which kind of people will assess the rules, the document mentions the disciplines in

healthcare: such as pharmacists, physicians.
0.5 Use cases

The use cases for a knowledge database for drug-related problems are primarily decision support based

on validated, standardised rules to enhance decisions in the process of:
— prescribing
— dispensing
— administering
— monitoring the therapy of the patient.

Besides that, decision support based on a standardised knowledge base can also be useful for (not

exhaustive):
— travel medicines
— health counselling.
0.6 Target users of this document

The target users of this document for a knowledge base in medication-related processes include:

— Academic organisations in the field of pharmaceutical healthcare, that develop knowledge bases for

medicines;
vi © ISO 2020 – All rights reserved
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ISO/TS 22756:2020(E)

— Vendors and other parties developing CDSSs (based on knowledge bases as described in this

document), like (not exhaustive):
— clinical or pharmacy information systems
— hospital ward information system
— doctor‘s office information systems
— decision aids for patients.
© ISO 2020 – All rights reserved vii
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TECHNICAL SPECIFICATION ISO/TS 22756:2020(E)
Health Informatics — Requirements for a knowledge
base for clinical decision support systems to be used in
medication-related processes
1 Scope

This document specifies the requirements for developing a knowledge base for drug-related problems

that cohere with the intended drug use, to be used in rule-based clinical decision support systems

(CDSS), such as the criteria for selecting a raw data source and the quality criteria for the development

and maintenance for the rules or clinical rules for drug safety. It also describes the process of how to

develop a knowledge base, the topics to be considered by the developers of a knowledge base, and it

gives guidance on how to do this.
This document gives guidelines for the development of a knowledge base:

— with rules to enhance decisions and actions in drug-related problems that cohere with the intended

drug use;

— which can be used by all kinds of healthcare professionals, such as those who prescribe, dispense,

administer or monitor medicines;

— which can be used in every care setting, including chronic and acute care, primary and

specialized care;
— which is a repository of evidence/practice bases rules, assessed by experts;
— which is meant to be used in conjunction with a medicinal product dictionary;

— whose knowledge is structured in rules and therefore to be used in the type of rule-based CDSS.

This document does not:

— describe the exact content of a knowledge base i.e. the outcome of the process of developing rules.

— provide the requirements for a clinical decision support system, the software that uses the

knowledge base combined with the patient’s data, and presents the outcome of the rules to the

healthcare professional. These requirements are described in ISO/DTS 22703 .

— give the requirements for non-medication knowledge bases. Some aspects of the requirements in

this document are general in nature and applicable to other kinds of knowledge bases, but this

document does not address all of the requirements of non-medication knowledge bases.

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 11615, Health informatics — Identification of medicinal products — Data elements and structures for

the unique identification and exchange of regulated medicinal product information

ISO/TS 19256, Health informatics — Requirements for Medicinal Product Dictionary Systems for Healthcare

1) Under preparation. Stage at the time of publication: ISO/DTS 22703.
© ISO 2020 – All rights reserved 1
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ISO/TS 22756:2020(E)
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
clinical decision support

type of service that assists healthcare providers in making medical decisions, which typically require

input of patient-specific clinical variables and provide patient-specific recommendations

[SOURCE: ISO/TR 14639-2:2014, 2.8, modified — Note 1 to entry has been deleted.]
3.2
clinical decision support system

software designed to be a direct aid to clinical decision-making, in which the characteristics of an

individual patient are matched to a computerized clinical knowledge base, whereafter patient-specific

assessments or recommendations are presented to the clinician or the patient to aid in the process of

making evidence based clinical decisions

[SOURCE: Ida Sim e.a., Clinical decision support systems for the practice of evidence-based medicine, J Am

Med Inform Assoc. 2001 Nov-Dec; 8(6): 527–534, modified]
3.3
dispensing

process by which an individual healthcare provider takes in a prescription, assesses that prescription,

selects the prescribed medicinal product and delivers that medicinal product to the subject of care

or their representative

Note 1 to entry: In most cases, but not necessarily always, the individual healthcare provider concerned will be a

Pharmacist.
[SOURCE: ISO/TS 19256:2016, 3.9]
3.4
dispense record
record of dispensed medicinal product and dispense process

Note 1 to entry: Note 1 to entry: Dispensed medicinal product includes the actual product dispensed identifiers,

brand, type, form, quantity etc. Dispense process record includes details of the delivery method, date and

recipient (where this is not the subject of care) and the dispenser. The ability to record a comment where

assessments of prescriptions are undertaken might also be part of this record.
[SOURCE: ISO/TS 19256:2016, 3.10]
3.5
dose instructions

instructions pertaining to the medication, which describe the amount of medication per dose, method

of administration, the frequency or interval of dose, associated instructions for dosing or skipped doses,

and other associated parameters necessary for appropriate administration of the medication

[SOURCE: ISO/TS 17251:2016, 2.1]
3.6
drug-related problem

occurrence related to the drug therapy of the patient which (can) lead to a suboptimal outcome of the

treatment
2 © ISO 2020 – All rights reserved
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ISO/TS 22756:2020(E)
3.7
electronic health record

repository of information regarding the health of a subject of care, in computer processable form

[SOURCE: ISO/TR 20514:2005, 2.11, modified — Note 1 to entry has been deleted.]
3.8
identifier

sequence of characters, capable of uniquely identifying that with which it is associated, within a

specified context
[SOURCE: ISO/TS 19256:2016, 3.15]
3.9
knowledge base

facts, information and skills acquired through research, experience, reasoning or education on a

specific topic as a set of declarative, hierarchical organization of such statements, and relationships

between declarative statements, which serves as the underpinning of decision support systems

[SOURCE: ISO/TS 19256:2016, 3.19 modified]
3.10
medicinal product

substance or combination of substances that may be administered to human beings (or animals) for

treating or preventing disease, with the view to making a medical diagnosis or to restore, correct or

modify physiological functions

Note 1 to entry: A medicinal product may contain one or more manufactured items and one or more

pharmaceutical products.

Note 2 to entry: In certain jurisdictions a medicinal product may also be defined as any substance or combination

of substances which may be used to make a medical diagnosis.

Note 3 to entry: Medicinal Product MPID XXXX87456 Slaapdiep tablet / Slaapdiep20 mg tablets National – has a

name dedicated to a specific jurisdiction (the code number is just an illustration, not a real identifier).

[SOURCE: ISO/TS 19256:2016, 3.24]
3.11
medicinal product dictionary

consistent representation of medication concepts (set of identifiers) at various levels of detail and with

meaningful relationships between the concepts, in order to support use cases in healthcare in which

medication plays a role
[SOURCE: ISO/TS 19256:2016, 5.5, modified]
3.12
pharmaceutical product

qualitative and quantitative composition of a medicinal product in the dose form authorized for

administration by a regulatory authority, and as represented with any corresponding regulated

product information

Note 1 to entry: A medicinal product can contain one or more pharmaceutical products.

Note 2 to entry: In many instances, the pharmaceutical product is equal to the manufactured item. However,

there are instances where the manufactured item undergoes a transformation before being administered to the

patient (as the pharmaceutical product) and the two are not equal.
[SOURCE: ISO/TS 19256:2016, 3.30, modified — Note 3 to entry has been deleted.]
© ISO 2020 – All rights reserved 3
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ISO/TS 22756:2020(E)
3.13
prescribing
process of creating a prescription
[SOURCE: ISO/TS 19256:2016, 3.33]
3.14
prescription

direction created by an authorized healthcare person, to instruct a dispensing agent regarding the

preparation and use of a medicinal product or medicinal appliance to be taken or used by a subject of care

Note 1 to entry: The term “prescription” alone is best avoided as it is colloquially used at random for the following

terms: new prescription message, prescription set and prescription item. Further, it is also used to describe a

prescription form. The use of the terms prescription set, prescription item and new prescription message where

appropriate is recommended.
[SOURCE: ISO/TS 19256:2016, 3.34]
3.15
decision rules

logic used to represent the facts to support a logical decision based upon knowledge

[SOURCE: Handbook. Guide to the principles and desirable features of clinical decision support systems,

Council of Standards Australia, Sydney 2007]
3.16
substance

matter of defined composition that has discrete existence, whose origin may be biological, mineral or

chemical

Note 1 to entry: Substances can be single substances, mixture substances or one of a group of specified substances.

Single substances are defined using a minimally sufficient set of data elements divided into five types: chemical,

protein, nucleic acid, polymer and structurally diverse. Substances may be salts, solvates, free acids, free bases

or mixtures of related compounds that are either isolated or synthesized together. Pharmacopeial terminology

and defining characteristics will be used when available and appropriate. Defining elements are dependent on

the type of substance.

Note 2 to entry: Discrete existence refers to the ability of a substance to exist independently of any other

substance. Substances can either be well-defined entities containing definite chemical structures, synthetic (i.e.

isomeric mixtures) or naturally occurring (i.e. conjugated oestrogens) mixtures of chemicals containing definite

molecular structures, or materials derived from plants, animals, microorganisms or inorganic matrices for which

the chemical structure may be unknown or difficult to define. Substances may be salts, solvates, free acids, free

bases and mixtures of related compounds that are either isolated or synthesized together.

[SOURCE: ISO/TS 19256:2016, 3.41]
4 Abbreviations
For the purposes of this document, the following abbreviations apply.
CDS clinical decision support
CDSS clinical decision support systems
EHR electronic health record
HL7 Health Level Seven
ICD international classification of diseases
4 © ISO 2020 – All rights reserved
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ISO/TS 22756:2020(E)
ICH international council for harmonization of technical requirements for
pharmaceuticals for human use
ICPC international classification of primary care
ICSR individual case safety report
IDMP identification of medicinal products
LOINC logical observation identifiers names and codes
MPD medicinal product dictionary
S[m]PC summary of product characteristics
SNOMED-CT systematized nomenclature of medicine – clinical terms
5 Positioning of a CDS knowledge base
5.1 Knowledge in healthcare

In healthcare, there are a lot of different processes that can be supported by CDS. ‘CDS’ is therefore a

broad term that includes all kinds of support for enhancing health-related decisions and actions, with

pertinent, organized clinical knowledge and patient information to improve health and healthcare

delivery.

Examples are CDS for overall efficiency, identifying disease early, aid in accurate diagnosis, for preventive

care, for treatment or monitoring and follow-up, or for optimization of drug therapy from different

perspectives like quality, cost-efficiency or preventing drug-related problems. CDS for optimising drug

therapy often support the check for known drug allergies of patients, comparison of drug and diagnostic

test results to
...

TECHNICAL ISO/TS
SPECIFICATION 22756
First edition
Health Informatics — Requirements
for a knowledge base for clinical
decision support systems to be used in
medication-related processes
Informatique de santé — Exigences relatives aux bases de
connaissances pour systèmes d’aide à la décision clinique à utiliser
dans le cadre des processus liés aux médicaments
PROOF/ÉPREUVE
Reference number
ISO/TS 22756:2020(E)
ISO 2020
---------------------- Page: 1 ----------------------
ISO/TS 22756:2020(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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii PROOF/ÉPREUVE © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/TS 22756:2020(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

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

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

3 Terms and definitions ..................................................................................................................................................................................... 2

4 Abbreviations........................................................................................................................................................................................................... 4

5 Positioning of a CDS knowledge base .............................................................................................................................................. 5

5.1 Knowledge in healthcare ................................................................................................................................................................ 5

5.2 Knowledge for drug-related problems that cohere with the intended drug use ........................... 5

5.3 The structure of the knowledge ............................................................................................................................................... 6

5.4 Knowledge base in relation to the healthcare information system ........................................................... 7

5.4.1 Introduction ......................................................................................................................................................................... 7

5.4.2 Relation with EHR ...................................................................... ..................................................................................... 7

5.4.3 Relation with medicinal product data ........................................................................................................... 8

5.4.4 Relation with a CDSS .................................................................................................................................................... 8

6 Requirements for the development of a knowledge base ......................................................................................... 8

6.1 Introduction .............................................................................................................................................................................................. 8

6.2 The governance of a knowledge base .................................................................................................................................. 8

6.3 Structure of the rules ......................................................................................................................................................................... 9

6.4 Scoping of the knowledge base content ............................................................................................................................ 9

6.5 Evidence for the rules ....................................................................................................................................................................... 9

6.6 Medicinal product data used in the rules ......................................................................................................................10

6.6.1 Medicinal product dictionary ............................................................................................................................10

6.6.2 IDMP ........................................................................................................................................................................................10

6.6.3 Interface with an MPD or with IDMP ..........................................................................................................11

6.7 Dosage data used in the rules .................................................................................................................................................11

6.8 Patient data variables used in the rules .........................................................................................................................12

6.8.1 Introduction ......................................................................................................................................................................12

6.8.2 Interface with the EHR ............................................................................................................................................12

6.9 Right information at the right time ....................................................................................................................................13

6.10 Quality of the rules ...........................................................................................................................................................................13

6.11 Relation with a CDSS .......................................................................................................................................................................14

6.12 Maintenance ...........................................................................................................................................................................................14

Annex A (normative) Identifying IDMP fields in relation to a knowledge base ...................................................16

Annex B (informative) Example of a knowledge base rule .........................................................................................................25

Bibliography .............................................................................................................................................................................................................................30

© ISO 2020 – All rights reserved PROOF/ÉPREUVE iii
---------------------- Page: 3 ----------------------
ISO/TS 22756:2020(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, in collaboration

with the European Committee for Standardization (CEN) Technical Committee CEN/TC 251, Health

informatics, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna

Agreement).

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 22756:2020(E)
Introduction
0.1 Safe and effective usage of medicines is important

When a patient gets his/her medicines prescribed and dispensed, it is not only important that he/she

gets the correct medicine and that ordering and reimbursement is supported by using a Medicinal

Product Dictionary (MPD), but it is also important that the medicine is safe and effective with respect

to the specific situation of the patient.

Because an MPD contains just the identification of the medicines, it is important that an MPD is enriched

with clinical decision support (CDS). The aim of CDS is to help prescribe and dispense the medicine

that fits the patient’s personal situation in respect of effectiveness and toxicity of the medicine.

Based on a knowledge base combined with the patient's situation such as comedication, comorbidity,

age, laboratory values, diet, allergy, a healthcare professional can be warned for likely side effects or

ineffectiveness, and change the therapy.
0.2 Need for a standardized knowledge base

To achieve the aim described in Clause 0.1, there are several success factors, in literature, referred to as

[28]
the ‘five rights’ :

— The right information: the information should be evidence based and give concrete guidance for action.

— To the right person: the alerts should be presented to the person who is the most likely one to take

action (e.g. the clinician, the pharmacist, the caretakers).

— In the right CDS intervention format: such as an alert, a request to measure certain laboratory

parameters, or an answer to a clinical question.

— Through the right channel: this can be the clinical information system like the pharmacy information

system, or a web-browser that makes available the data of the knowledge base.

— At the right time in workflow: for example, during prescription or dispensing, or in batch at night to

have certain data available the next morning.

To provide the right information, a knowledge base is necessary; and also providing the knowledge to

the right person, the right format and at the right time in the workflow is part of a knowledge base, as far

as it concerns the ‘knowledge’ of it.

There are clinical decision support systems (CDSSs) that provide this knowledge, but Helmons stated

that there are several barriers for implementing a CDSS, one of them being ‘content issues’ like:

‘Typically installed without any validated decision rules, which have to be developed and/or validated

[26]
in each individual institution (also called ‘having to reinvent the wheel’)' .

Therefore, a (technically) validated, standardized knowledge base is the recommended basis for CDS.

The needs for a standardized knowledge base are as follows:

— There is an overwhelming amount of data in the summary of product characteristics (SPC),

guidelines, literature and handbooks. Prescribers, physicians and pharmacists cannot easily find

what to do for a certain drug combination or drug-disease combination. The most relevant data and

accompanying recommendations are curated from literature and put in rules in a knowledge base.

— Information about the availability, safety and efficacy of medication to be used for the prescription

by physicians is often outdated even when the information is available electronically (e.g. in the drug

interaction management system in a doctor's office). Linking the information from the Medicinal

Product Dictionary to a CDSS that uses a validated, standardized knowledge base makes sure that

during prescribing/dispensing up-to-date information is always used.
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— While the population is still growing, people become older and have more comorbidity and

polypharmacy, the need for smart knowledge base rules that provide the basis for generating alerts

with a high specificity and sensitivity, is increasing.

— Besides assuring that the most precise and current information is to be used in the knowledge base

for the benefits of the patient, this specification will also provide a basis or 'handles' how to map the

information to the MPD, the IDMP vocabulary and their own local data in EHR and pharmaceutical

domains.

0.3 Focus — A knowledge base for drug-related problems that cohere with the intended drug use

This document is about a standardized knowledge base to be used in medication-related processes. In

the context of this document, this means a knowledge base that has its focus to enhance decisions and

actions in drug-related problems that cohere with the intended drug use, namely once a drug has been

chosen, in any domain of prescribing, dispensing, administering of the drug and monitoring the patient.

Aspects like choosing the right drug according to guidelines and patient coaching for the correct usage

are not included in the scope of this document (which does not mean that the requirements that are

described in this document are not useful for knowledge bases with such kind of scopes).

0.4 Why this document: general principles versus medication specific aspects for developing a

knowledge base

Describing how a structured, standardized knowledge base should be developed, what are the criteria

to take into account, is a rather general process. As such it is not specific for medication processes.

Assessing literature and developing rules is also applicable for other domains.

In this respect, this document contains two sorts of requirements. First, there is the overarching

level, not specific for medication processes. This includes, for example, the requirements for selecting

and assessing literature, updating the knowledge base. Secondly, there is a medication-specific level

in this document. This includes the area to which the requirements are applied: if the requirement

is to determine which kind of people will assess the rules, the document mentions the disciplines in

healthcare: such as pharmacists, physicians.
0.5 Use cases

The use cases for a knowledge database for drug-related problems are primarily decision support based

on validated, standardised rules to enhance decisions in the process of:
— prescribing
— dispensing
— administering
— monitoring the therapy of the patient.

Besides that, decision support based on a standardised knowledge base can also be useful for (not

exhaustive):
— travel medicines
— health counselling.
0.6 Target users of this document

The target users of this document for a knowledge base in medication-related processes include:

— Academic organisations in the field of pharmaceutical healthcare, that develop knowledge bases for

medicines;
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— Vendors and other parties developing CDSSs (based on knowledge bases as described in this

document), like (not exhaustive):
— clinical or pharmacy information systems
— hospital ward information system
— doctor‘s office information systems
— decision aids for patients.
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TECHNICAL SPECIFICATION ISO/TS 22756:2020(E)
Health Informatics — Requirements for a knowledge
base for clinical decision support systems to be used in
medication-related processes
1 Scope

This document specifies the requirements for developing a knowledge base for drug-related problems

that cohere with the intended drug use, to be used in rule-based clinical decision support systems

(CDSS), such as the criteria for selecting a raw data source and the quality criteria for the development

and maintenance for the rules or clinical rules for drug safety. It also describes the process of how to

develop a knowledge base, the topics to be considered by the developers of a knowledge base, and it

gives guidance on how to do this.
This document gives guidelines for the development of a knowledge base:

— with rules to enhance decisions and actions in drug-related problems that cohere with the intended

drug use;

— which can be used by all kinds of healthcare professionals, such as those who prescribe, dispense,

administer or monitor medicines;

— which can be used in every care setting, including chronic and acute care, primary and

specialized care;
— which is a repository of evidence/practice bases rules, assessed by experts;
— which is meant to be used in conjunction with a medicinal product dictionary;

— whose knowledge is structured in rules and therefore to be used in the type of rule-based CDSS.

This document does not:

— describe the exact content of a knowledge base i.e. the outcome of the process of developing rules.

— provide the requirements for a clinical decision support system, the software that uses the

knowledge base combined with the patient’s data, and presents the outcome of the rules to the

healthcare professional. These requirements are described in ISO/DTS 22703 .

— give the requirements for non-medication knowledge bases. Some aspects of the requirements in

this document are general in nature and applicable to other kinds of knowledge bases, but this

document does not address all of the requirements of non-medication knowledge bases.

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 11615, Health informatics — Identification of medicinal products — Data elements and structures for

the unique identification and exchange of regulated medicinal product information

ISO/TS 19256, Health informatics — Requirements for Medicinal Product Dictionary Systems for Healthcare

1) Under preparation. Stage at the time of publication: ISO/DTS 22703.
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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
clinical decision support

type of service that assists healthcare providers in making medical decisions, which typically require

input of patient-specific clinical variables and provide patient-specific recommendations

[SOURCE: ISO/TR 14639-2:2014, 2.8, modified — Note 1 to entry has been deleted.]
3.2
clinical decision support system

software designed to be a direct aid to clinical decision-making, in which the characteristics of an

individual patient are matched to a computerized clinical knowledge base, whereafter patient-specific

assessments or recommendations are presented to the clinician or the patient to aid in the process of

making evidence based clinical decisions

[SOURCE: Ida Sim e.a., Clinical decision support systems for the practice of evidence-based medicine, J Am

Med Inform Assoc. 2001 Nov-Dec; 8(6): 527–534, modified]
3.3
dispensing

process by which an individual healthcare provider takes in a prescription, assesses that prescription,

selects the prescribed medicinal product and delivers that medicinal product to the subject of care

or their representative

Note 1 to entry: In most cases, but not necessarily always, the individual healthcare provider concerned will be a

Pharmacist.
[SOURCE: ISO/TS 19256:2016, 3.9]
3.4
dispense record
record of dispensed medicinal product and dispense process

Note 1 to entry: Dispensed medicinal product includes the actual product dispensed identifiers, brand, type,

form, quantity, etc. Dispense process record includes details of the deliver method, date and recipient (where this

is not the Subject of Care) and the dispenser. The ability to record a comment where assessments of prescriptions

are undertaken might also be part of this record.
[SOURCE: ISO/TS 19256:2016, 3.10]
3.5
dose instructions

instructions pertaining to the medication, which describe the amount of medication per dose,

methodology of administration, the frequency or interval of dose, associated instructions for dosing

or skipped doses, and other associated parameters necessary for appropriate administration of the

medication
[SOURCE: ISO/TS 17251:2016, 2.1]
3.6
drug-related problem

occurrence related to the drug therapy of the patient which (can) lead to a suboptimal outcome of the

treatment
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3.7
electronic health record

repository of information regarding the health of a subject of care, in computer processable form

[SOURCE: ISO/TR 20514:2005, 2.11, modified — Note 1 to entry has been deleted.]
3.8
identifiers

sequence of characters, capable of uniquely identifying that with which it is associated, within a

specified context
[SOURCE: ISO/TS 19256:2016, 3.15]
3.9
knowledge base

knowledge on a specific topic as set of declarative statements, hierarchical organization of such

statements, and relationships between declarative statements, which serves as the underpinning of

decision support systems

[SOURCE: ISO/TS 19256:2016, 3.19 modified — database changed to base and ‘system in which’ deleted.]

3.10
medicinal product

substance or combination of substances that may be administered to human beings (or animals) for

treating or preventing disease, with the view to making a medical diagnosis or to restore, correct or

modify physiological functions

Note 1 to entry: A medicinal product may contain one or more manufactured items and one or more

pharmaceutical products.

Note 2 to entry: In certain jurisdictions a medicinal product may also be defined as any substance or combination

of substances which may be used to make a medical diagnosis.

Note 3 to entry: Medicinal Product MPID XXXX87456 Slaapdiep tablet / Slaapdiep20 mg tablets National – has a

name dedicated to a specific jurisdiction (the code number is just an illustration, not a real identifier).

[SOURCE: ISO/TS 19256:2016, 3.24]
3.11
medicinal product dictionary

consistent representation of medication concepts (set of identifiers) at various levels of detail and with

meaningful relationships between the concepts, in order to support use cases in healthcare in which

medication plays a role
[SOURCE: ISO/TS 19256:2016, 5.5, modified]
3.12
pharmaceutical product

qualitative and quantitative composition of a medicinal product in the dose form authorized for

administration by a regulatory authority, and as represented with any corresponding regulated

product information

Note 1 to entry: A medicinal product can contain one or more pharmaceutical products.

Note 2 to entry: In many instances, the pharmaceutical product is equal to the manufactured item. However,

there are instances where the manufactured item undergoes a transformation before being administered to the

patient (as the pharmaceutical product) and the two are not equal.
[SOURCE: ISO/TS 19256:2016, 3.30, modified — Note 3 to entry has been deleted.]
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3.13
prescribing
process of creating a prescription
[SOURCE: ISO/TS 19256:2016, 3.33]
3.14
prescription

direction created by an authorized healthcare person, to instruct a dispensing agent regarding the

preparation and use of a medicinal product or medicinal appliance to be taken or used by a subject of care

Note 1 to entry: The term “prescription” alone is best avoided as it is colloquially used at random for the following

terms: new prescription message, prescription set and prescription item. Further, it is also used to describe a

prescription form. The use of the terms prescription set, prescription item and new prescription message where

appropriate is recommended.
[SOURCE: ISO/TS 19256:2016, 3.34]
3.15
decision rules

logic used to represent the facts to support a logical decision based upon knowledge

[SOURCE: Handbook. Guide to the principles and desirable features of clinical decision support systems,

Council of Standards Australia, Sydney 2007]
3.16
substance

matter of defined composition that has discrete existence, whose origin may be biological, mineral or

chemical

Note 1 to entry: Substances can be single substances, mixture substances or one of a group of specified substances.

Single substances are defined using a minimally sufficient set of data elements divided into five types: chemical,

protein, nucleic acid, polymer and structurally diverse. Substances may be salts, solvates, free acids, free bases

or mixtures of related compounds that are either isolated or synthesized together. Pharmacopeial terminology

and defining characteristics will be used when available and appropriate. Defining elements are dependent on

the type of substance.

Note 2 to entry: Discrete existence refers to the ability of a substance to exist independently of any other

substance. Substances can either be well-defined entities containing definite chemical structures, synthetic (i.e.

isomeric mixtures) or naturally occurring (i.e. conjugated oestrogens) mixtures of chemicals containing definite

molecular structures, or materials derived from plants, animals, microorganisms or inorganic matrices for which

the chemical structure may be unknown or difficult to define. Substances may be salts, solvates, free acids, free

bases and mixtures of related compounds that are either isolated or synthesized together.

[SOURCE: ISO/TS 19256:2016, 3.41]
4 Abbreviations
For the purposes of this document, the following abbreviations apply.
CDS clinical decision support
CDSS clinical decision support systems
EHR electronic health record
HL7 Health Level Seven
ICD international classification of diseases
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ICH international council for harmonization of technical requirements for
pharmaceuticals for human use
ICPC international classification of primary care
ICSR individual case safety report
IDMP identification of medicinal products
LOINC logical observation identifiers names and codes
MPD medicinal product dictionary
S[m]PC summary of product characteristics
SNOMED-CT systematized nomenclature of medicine – clinical terms
5 Positioning of a CDS knowledge base
5.1 Knowledge in healthcare

In healthcare, there are a lot of different processes that can be supported by CDS. ‘CDS’ is therefore a

broad term that includes all kinds of support for enhancing health-related decisions and actions, with

pertinent, organized clinical knowledge and patient information to improve health and healthcare

delivery.

Examples are CDS for overall efficiency, identifying disease early, aid in accurate diagnosis, for preventive

care, for treatment or monitoring and follow-up, or for optimization of drug therapy from different

perspectives like quality, cost-efficiency or preventing drug-related problems. CDS for optimisin

...

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