Unintended effects associated with clinical interventions.

Exclusions: This data class does not include patient safety analyses, internal risk management documentation, or patient safety work product as defined under the Patient Safety and Quality Improvement Act of 2005 (42 U.S.C. 299b 21 et seq.) and implementing regulations (42 CFR part 3). It is not intended to define data elements for the exchange of Patient Safety Organization (PSO) investigations, safety reviews, or facility level reporting activities.

Data Element
Medication Adverse Event
Submitted By: Mitra Rocca / Food and Drug Administration
Data Element Information
Data Element Description Type of the event itself in relation to the subject
Use Case Description(s)
Use Case Description Extracting adverse event for FDA regulated medical products from EHRs
Estimate the breadth of applicability of the use case(s) for this data element 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
Extent of exchange 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.
ASTP Evaluation Details
Each submitted Data Element has been evaluated based on the following 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
Criterion #1
Maturity - Current Standards		 Level 2 - Data element is represented by a terminology standard or SDO-balloted technical specification or implementation guide.
Criterion #2
Maturity - Current Use 		Level 1 - Data element is captured, stored, or accessed in at least one production EHR or HIT module.
Criterion #3
Maturity - Current Exchange		 Level 1 - Data element is electronically exchanged between two production EHRs or other HIT modules using available interoperability standards.
Criterion #4
Use Case(s) - Breadth of Applicability		 Level 0 - Use cases apply to a limited number of care settings or specialties, or data element represents a specialization of other, more general data elements.

Comment

Submitted by barbee.whitaker on

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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