Unintended effects associated with clinical interventions.

Data Element
Adverse Event
Description

An adverse event is any undesirable experience associated with the use of a medical product in a patient.
Submitted By: Mitra Rocca / Food and Drug Administration
Data Element Information
Data Element Description An adverse event is any undesirable experience associated with the use of a medical product in a patient.
A serious adverse event or reaction is any untoward medical occurrence that at any dose resulting in:
Death
Life-threatening
Hospitalization (initial or prolonged)
Disability or Permanent Damage
Congenital Anomaly/Birth Defects
Other Serious or Important Medical Events
Required Intervention to Prevent Permanent Impairment/Damage
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
  • Improving patient experience of care (quality and/or satisfaction)
  • Improving the health of populations
  • Improving provider experience of care
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.
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 1 - Use cases apply to several care settings or specialties.

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Fig 4 The "File Upload" section permits users to attach supporting documentation that supplements their written comments.

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Fig 6 The review screen allows users to verify comment content and make any necessary modifications before final submission.

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