ISO/TS 22756:2020

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 2020
© ISO 2020
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ii © ISO 2020 – All rights reserved

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
Foreword
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This document was prepared by Technical Committee ISO/TC 215, Health Informatics, in collaboration
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iv © ISO 2020 – All rights reserved

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.
— 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
...