Overview
CEN ISO/TS 22703:2021 - "Health informatics - Requirements for medication safety alerts" - defines requirements for medication safety alert systems used in clinical decision support systems (CDSSs). Published jointly by ISO and CEN, this technical specification focuses on the safe, usable and interoperable delivery of medication alerts in digital care workflows (EHR, CPOE, pharmacy systems). It applies to CDSSs whether or not they are regulated as medical devices.
Key topics and technical requirements
This specification sets out practical, implementation-focused requirements rather than prescribing clinical content or alert-generation algorithms. Major technical areas include:
- Terminology requirements
- Use of standardized clinical terminologies and coding for drug names, doses, routes and clinical conditions to ensure consistent alerting and interoperability.
- Knowledge base selection
- Criteria for choosing evidence-based knowledge sources and documentation of data sources used by the CDSS.
- CDSS functionality related to medication safety
- Required behaviors of the alerting engine, interfaces with clinical and pharmacy information systems, audit trails and logging.
- Alert display and schema
- Requirements for how medication safety alerts are presented (severity grading, schema, timing, receivers) to reduce alert fatigue and improve clinical relevance.
- Quality measurement and improvement
- Metrics and monitoring processes to measure alert effectiveness, override rates and to support iterative improvement.
- Data sources and patient data use
- Guidance on leveraging patient demographics, medication lists, lab results and other clinical data to generate context-aware alerts.
- Interfaces and standards alignment
- Recommendations for integration with EHRs, pharmacy systems and for alignment with international standards to support interoperability.
- Lifecycle recommendations
- Pre-development, development, implementation and post-deployment monitoring and management guidance.
Out of scope: development of rule content (knowledge rules), the underlying algorithms to generate alerts, and the creation of alert processors - these are explicitly excluded.
Applications and users
CEN ISO/TS 22703:2021 is intended for:
- CDSS and medication safety alert vendors designing or certifying systems
- Healthcare IT architects and implementers integrating alerting with EHR/CPOE and pharmacy systems
- Clinical safety officers, pharmacists and clinicians who set alert policies and governance
- Quality, risk and regulatory teams assessing alert effectiveness and compliance
Practical uses include improving alert relevance, reducing alert fatigue, ensuring consistent terminology use, and supporting safer prescribing, dispensing and administration workflows.
Related standards
- Developed by ISO/TC 215 (Health informatics) in collaboration with CEN/TC 251.
- The specification references and aligns with wider health informatics and interoperability standards (see clause on relation to international standards in the document).