Submitted By: Mitra Rocca / Food and Drug Administration | |
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Data Element Information | |
Rationale for Separate Consideration | These specific outcomes are not currently present. |
Use Case Description(s) | |
Use Case Description | Capture serious adverse events outcomes from EHR systems. |
Estimate the breadth of applicability of the use case(s) for this data element | Any healthcare provider |
Link to use case project page | https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event |
Healthcare Aims |
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Maturity of Use and Technical Specifications for Data Element | |
Applicable Standard(s) | SNOMED CT (e.g., Life-threatening severity) snomed.org |
Additional Specifications | HL7 FHIR Release 5.0 |
Current Use | In limited use in test environments only |
Extent of exchange | 2-3 |
Supporting Artifacts |
Comment Level – used only in connect-a-thons of small pilots Tested at the IHE Connectathon |
Potential Challenges | |
Restrictions on Standardization (e.g. proprietary code) | none |
Restrictions on Use (e.g. licensing, user fees) | none |
Privacy and Security Concerns | none |
Estimate of Overall Burden | It might be captured in clinical notes with an EHR system. |
Data Element |
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Serious Adverse Events
Description
An adverse event is any undesirable experience associated with the use of a medical product in a patient. |
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Comment