Data Element

Information from the submission form
Medication Adverse Event
Description
Type of the event itself in relation to the subject
Submitted By: Mitra Rocca / Food and Drug Administration
Data Element Information
Use Case Description(s)
Use Case Description Extracting adverse event for FDA regulated medical products from EHRs
Estimated number of stakeholders capturing, accessing using or exchanging regulators, researchers, patients and healthcare providers and medical products manufacturers
Healthcare Aims
  • Improving patient experience of care (quality and/or satisfaction)
  • Improving the health of populations
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) adverse events are mapped to MedDRA terminology
Additional Specifications The HL7 Vulcan Accelerator (https://confluence.hl7.org/display/VA/Vulcan+Accelerator+Home) has a dedicated workgroup focusing on the FHIR Adverse Event resource.
The Adverse Event resource is part of HL7 FHIR Release 5.
Current Use Not currently captured or accessed with an organization
Number of organizations/individuals with which this data element has been electronically exchanged 5 or more. This data element has been tested at scale between multiple different production environments to support the majority of anticipated stakeholders.
Supporting Artifacts Medical products manufacturers and FDA
healthcare providers and FDA
Patients also report adverse events to FDA
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) MedDRA codes are needed for some of the data elements within the adverse event resource
Restrictions on Use (e.g. licensing, user fees) MedDRA license
Privacy and Security Concerns None
Estimate of Overall Burden There is a burden to implement adverse event within EHR systems. Not sure of the level of burden.
ONC Evaluation Details
Each submitted Data Element has been evaluated based on the following 4 criteria. The overall Level classification is a composite of the maturity based on these individual criteria. This information can be used to identify areas that require additional work to raise the overall classification level and consideration for inclusion in future versions of USCDI
Maturity – Standards/Technical Specifications Level 1/2 - Must be represented by a vocabulary standard or an element of a published technical specification
Maturity - Current Use Level 1 - Used in limited production environments, 1 or 2 different systems
Maturity - Current Exchange Level 1 - Demonstrates exchange between 2 or 3 organizations with different EHR/HIT systems
Breadth of Applicability - # Stakeholders Impacted Comment Level - Used by few stakeholders, or for narrowly defined conditions or events

Comment

Submitted by barbee.whitaker on 2021-04-15

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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