Data Element
Adverse Event Suspect Entity
Description

The suspected agent causing the adverse event
Submitted By: Mitra Rocca / Food and Drug Administration
Data Element Information
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 Adverse Event Resource in HL7 FHIR R4
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.

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Data Class and Data Element

Fig 1 The "Data Class" and "Data Element" dropdown menus allow users to specify the exact content they wish to comment on.

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Fig 2 The "Propose a New Data Class or Data Element" button redirects users to the ONDEC Submission System for proposing new data elements not currently available in the system.

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Fig 3 The "Comment on another data element" link enables users to create multiple comments addressing different elements within a single submission.

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Upload Supporting Files

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

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Fig 5 A red triangle with exclamation mark indicator appears next to the “Return to saved Comment” button when draft comments are saved in the system.

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Review and Submit

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

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