Represents harmful or undesirable physiological response associated with exposure to a substance.

Data Element

Information from the submission form

Adverse Event
Description
Type of the event itself in relation to the subject

Comment

FDA Context for Adverse Event Reporting Automation Use Case

This comment is to provide additional context by the FDA for specific use case references in the submission above. Adverse event data are critical to supporting the FDA and CDC regulatory missions for safety and effectiveness. As part of the FDA Sentinel Biologics Effectiveness and Safety (BEST) initiative, our team is currently balloting an HL7 Implementation Guide (IG) utilizing the AdverseEvent FHIR resource for mapping adverse event cases from EHR data to Individual Case Safety Report (ICSR) format (https://confluence.hl7.org/display/FHIR/FHIR+Implementation+Guide+for+Transfusion+and+Vaccination+Adverse+Event+Reporting). This work leverages real-world data to detect, validate, and report adverse events. The AdverseEvent resource is a key component, not only of this solution, but for all efforts to incorporate documentation of adverse events into clinical workflow and IT systems – which will benefit patients, providers, researchers, and public health stakeholders. 

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