Allergies and Intolerances
Represents harmful or undesirable physiological response associated with exposure to a substance.
Data Element
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Adverse Event Causality
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Information on the possible cause of the event
Submitted By: Mitra Rocca
/ Food and Drug Administration
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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
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regulators, researchers, patients and healthcare providers and medical products manufacturers
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Healthcare Aims |
- Improving patient experience of care (quality and/or satisfaction)
- Improving the health of populations
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Maturity of Use and Technical Specifications for Data Element |
Applicable Standard(s) |
adverse events are mapped to MedDRA terminology
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Additional Specifications |
Adverse Event Resource in HL7 FHIR R4 |
Current Use |
Not currently captured or accessed with an organization |
Number of organizations/individuals with which this data element has been electronically exchanged
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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
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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. |
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Comment