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This document specifies the requirements for medication safety alert systems and the topics which are relevant to alert system vendors. This document applies to clinical decision support systems (CDSSs) whether or not these are medical devices.

This document addresses:

—    requirements for terminology used in medication safety alerts;

—    requirements for choosing a knowledge base for medication safety alert systems;

—    requirements for the proper functionality of CDSSs as related to medication safety alert systems;

—    requirements for medication safety alert display;

—    requirements for quality measurements to improve the effectiveness of medication safety alerts.

The following are out of the scope of this document:

—    the development of content (rule-based knowledge base) for CDSS;

—    the development of algorithms for generating medication safety alerts in CDSS;

—    the development of alert processors for medication safety alerts in CDSS.