ISO/TS 22756:2020

Overview

ISO/TS 22756:2020 provides requirements and guidance for developing a standardized knowledge base to be used by rule-based clinical decision support systems (CDSS) in medication-related processes. The technical specification focuses on knowledge that addresses drug-related problems that cohere with the intended drug use (prescribing, dispensing, administering and monitoring). It defines how to select raw data sources, structure and validate rules, and maintain high-quality, evidence-based rule repositories that work in conjunction with a Medicinal Product Dictionary (MPD) and standardized medicinal product vocabularies such as IDMP.

Key topics and technical requirements

• Scope and positioning of a medication-focused knowledge base within health IT ecosystems (relation to EHR, MPD and CDSS).
• Governance: roles and responsibilities for rule authorship, expert assessment and lifecycle management.
• Structure of rules: how knowledge should be organized as actionable rules for rule-based CDSS.
• Scoping and content: criteria for what drug-related issues to include and how to align rules with intended drug use.
• Evidence requirements: sourcing, appraisal and documentation of literature, SPCs and practice guidelines used to derive rules.
• Medicinal product data: integration with an MPD and mapping to IDMP fields (Annex A guidance).
• Dosage and patient variables: requirements for dosage data, laboratory values, comorbidity, age, allergies and other patient inputs.
• Right information at the right time: ensuring alerts and interventions are delivered to the appropriate user, format and workflow point.
• Quality and maintenance: validation, testing, update cycles and traceability for rules.
• Interoperability: interfaces with EHRs, MPDs and CDSS software (note: ISO/TS 22756 does not specify CDSS software requirements; see ISO/DTS 22703).

Applications and who uses it

ISO/TS 22756:2020 is designed for organizations that create or consume medication knowledge bases:

• Academic and clinical knowledge producers developing validated drug-safety rules
• Vendors of CDSS, clinical and pharmacy information systems, hospital and office systems
• Pharmacists, prescribers, nurses and other healthcare professionals wanting standardized, evidence-based decision support
• Health IT integrators mapping knowledge to MPDs, IDMP vocabularies and local EHR data

Practical applications include alerting for drug–drug interactions, dose adjustments, contraindications, monitoring prompts and other drug-safety interventions across care settings.

Related standards

• ISO/DTS 22703 - requirements for CDSS software (referenced; under preparation at publication)
• IDMP-related specifications - for medicinal product identification and mapping referenced in Annex A

Keywords: ISO/TS 22756:2020, knowledge base, clinical decision support systems, CDSS, medication-related processes, Medicinal Product Dictionary, IDMP, drug-related problems, rule-based CDSS, evidence-based rules.