About CEN
The European Committee for Standardization is one of three European Standardization Organizations (together with CENELEC and ETSI) that have been officially recognized by the European Union and by the European Free Trade Association (EFTA) as being responsible for developing and defining voluntary standards at European level.
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Project
| Reference | CEN ISO/TS 22756:2020 |
|---|---|
| Title | Health Informatics - Requirements for a knowledge base for clinical decision support systems to be used in medication-related processes (ISO/TS 22756:2020) |
| Work Item Number | 00251341 |
| Abstract/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[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. |
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Published
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| Reference Document |
ISO/TS 22756:2020 (EQV)
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| date of Availability (DAV) | 2020-09-30 |
| ICS | 35.240.80 - IT applications in health care technology |
| A-Deviation(s) | |
| Special National Condition(s) |
Legal
| Directive(s) | |
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| Mandate(s) | |
| Citation in OJEU |
Implementation Dates
| date of Ratification (DOR) (1) | 2020-09-04 |
|---|---|
| date of Availability (DAV) (2) | 2020-09-30 |
| date of Announcement (DOA) (3) | 2020-12-31 |
| date of Publication (DOP) (4) | |
| date of Withdrawal (DOW) (5) |
Relations
| Supersedes | |
|---|---|
| Superseded by | |
| Normative reference (6) |
ISO 11615
ISO/TS 19256 |
| Sales Points |
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(1) Date of ratification (dor) date when the Technical Board notes the approval of an EN (and HD for CENELEC), from which time the standard may be said to be approved
(2) Date of availability (dav) date when the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat
(3) Date of announcement (doa) latest date by which the existence of an EN (and HD for CENELEC), a TS or a CWA has to be announced at national level
(4) Date of publication (dop) latest date by which an EN has to be implemented at national level by publication of an identical national standard or by endorsement
(5) Date of withdrawal (dow) latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn
(6) This list of normative references is purely indicative. The only official list of normative reference is the list of the published standard.
In the case of undated standard, a link to the last dated version is provided.
In the case of series, a link to each standard identified in the series is provided.
We also invite you to check (via the website) whether corrigenda and/or amendments shall be read in conjunction with the main standard.