Submit Adverse Event Report from an Electronic Health Record to Drug Safety Regulators

Type	Standard / Implementation Specification	Standards Process Maturity	Implementation Maturity	Adoption Level	Federally required	Cost	Test Tool Availability
Standard	International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Medical Dictionary for Regulatory Activities (MedDRA)	Final	Production		Yes	$	N/A
Implementation Specification	IHE-RFD (Retrieve Form for Data Capture)	Final	Production	Feedback Requested	No	Free	N/A
Implementation Specification	HL7® FHIR® Implementation Guide: Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting	Balloted Draft	Pilot		No	Free	No
Implementation Specification	IHE-DSC (Drug Safety Content)	Balloted Draft	Pilot	Feedback Requested	No	Free	N/A
Implementation Specification	IHE-CPRC (Clinical Research Process Content)	Balloted Draft	Pilot	Feedback Requested	No	Free	N/A
Emerging Standard	HL7 FHIR Adverse Event Resource	In Development	Feedback requested	Feedback Requested	No	Free	No
Emerging Standard	HL7 FHIR Adverse Event Resource	In Development	Feedback requested	Feedback Requested	No	Free	No

Limitations, Dependencies, and Preconditions for Consideration	Applicable Security Patterns for Consideration
MedDRA was created to manage clinical information about pharmaceuticals, biologics, vaccines and drug-device combinations for the entire lifespan of products.	Feedback requested.

Comment

Submitted by shellyspiro on 2018-10-01

Pharmacy HIT Collaborative's Comments on ONC's Proposed 2018 ISA

The Pharmacy HIT Collaborative supports the use of IHE-RFD (Retrieve From for Data Capture) and balloted drafts of IHE-DSC (Drug Safety Content) and IHE-CPRC (Clinical Research Process Content).

Submitted by vojtech_huser on 2017-10-31

PRM model

remove this entry from the table. PRM is not closely related to adverse event submission.