Data Element

Information from the submission form
Serious Adverse Events
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

Submitted By: Mitra Rocca / Food and Drug Administration
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.
Estimated number of stakeholders capturing, accessing using or exchanging 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
Number of organizations/individuals with which this data element has been electronically exchanged 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.
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 Level 1 - Used by many, but not most, patients, providers or events requiring its use

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