Reaffirm HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 1: The Framework for Adverse Event Reporting, R2
1b. Project ID
1663
1c. Is Your Project an Investigative Project (aka PSS-Lite)?
No
1d. Is your Project Artifact being Reaffirmed or proceeding to Normative directly after being either Informative or STU?
No
1e. Today's Date
1f. Name of standard being reaffirmed
HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 1: The Framework for Adverse Event Reporting, R2
1g. Project Artifact Information
1h. ISO/IEC Standard to Adopt
1i. Does the standard include excerpted text from one or more ISO, IEC or ISO/IEC standards, but is not an identical or modified adoption?
1j. Unit of Measure
2a. Primary/Sponsor WG
Biomedical Research & Regulation
2d. Project Facilitator
Boris Brodsky
2e. Other Interested Parties (and roles)
2f. Modeling Facilitator
2g. Publishing Facilitator
2h. Vocabulary Facilitator
2i. Domain Expert Representative
2j. Business Requirements Analyst
2k. Conformance Facilitator
2l. Other Facilitators
2m. Implementers
3a. Project Scope
The Individual Case Safety Report (ICSR) captures information about adverse events and product problems that are reported to public health, patient safety/quality improvement organizations or regulatory agencies. The ICSR message supports reporting from a variety of sources such as consumers, hospitals, contract research organizations, clinicians or pharmaceutical product and medical device manufacturers.
Attachments
3b. Project Need
Harmonized reporting formats that enable regulated industries that are required by law to submit human drugs, biologics, vaccines and medical device adverse events and product problems to use a single standard. Support implementation of HL7/ISO ICSR.
3k. Additional Backwards Compatibility Information (if applicable)
3l. Using Current V3 Data Types?
3l. Reason for not using current V3 data types?
3m. External Vocabularies
3n. List of Vocabularies
3o. Earliest prior release and/or version to which the compatibility applies
4a. Products
V3 Messages - Clinical
4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?
4c. FHIR Profiles Version
4d. Please define your New Product Definition
4d. Please define your New Product Family
5a. Project Intent
Reaffirmation of a standard
5a. White Paper Type
5a. Is the project adopting/endorsing an externally developed IG?
5a. Externally developed IG is to be (select one)
5a. Specify external organization
5a. Revising Current Standard Info
5b. Project Ballot Type
Normative (no STU)
5c. Additional Ballot Info
5d. Joint Copyright
Yes
5e. I understand I must submit a Joint Copyright Letter of Agreement to the TSC in order for the PSS to receive TSC approval.
Yes
6a. External Project Collaboration
Joint Initiative Council for Global Health Informatics Standardization (JIC)
6b. Content Already Developed
Yes
6c. Content externally developed?
Yes
6d. List Developers of Externally Developed Content
JIC
6e. Is this a hosted (externally funded) project?
6f. Stakeholders
Regulatory Agency
6f. Other Stakeholders
6g. Vendors
6g. Other Vendors
6h. Providers
6h. Other Providers
6i. Realm
Universal
7d. US Realm Approval Date
7a. Management Group(s) to Review PSS
7b. Sponsoring WG Approval Date
Nov 24, 2020
7c. Co-Sponsor Approval Date
7c. Co-Sponsor 2 Approval Date
7c. Co-Sponsor 3 Approval Date
7c. Co-Sponsor 4 Approval Date
7c. Co-Sponsor 5 Approval Date
7c. Co-Sponsor 6 Approval Date
7c. Co-Sponsor 7 Approval Date
7c. Co-Sponsor 8 Approval Date
7c. Co-Sponsor 9 Approval Date
7c. Co-Sponsor 10 Approval Date
7e. CDA MG Approval Date
7f. FMG Approval Date
7g. V2 MG Approval Date
7h. Architecture Review Board Approval Date
7i. Steering Division Approval Date
Apr 19, 2021
7j. TSC Approval Date
 Show Changes
Version
6
Modifier
Anne Wizauer
Modify Date
Apr 20, 2021 20:56
1a. Project Name
Reaffirm HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 1: The Framework for Adverse Event Reporting, R2
1b. Project ID
1663
1c. Is Your Project an Investigative Project (aka PSS-Lite)?
No
1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?
No
1f. Name of standard being reaffirmed
HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 1: The Framework for Adverse Event Reporting, R2
2a. Primary/Sponsor WG
Biomedical Research & Regulation
2d. Project Facilitator
Boris Brodsky
3a. Project Scope
The Individual Case Safety Report (ICSR) captures information about adverse events and product problems that are reported to public health, patient safety/quality improvement organizations or regulatory agencies. The ICSR message supports reporting from a variety of sources such as consumers, hospitals, contract research organizations, clinicians or pharmaceutical product and medical device manufacturers.
3b. Project Need
Harmonized reporting formats that enable regulated industries that are required by law to submit human drugs, biologics, vaccines and medical device adverse events and product problems to use a single standard. Support implementation of HL7/ISO ICSR.
5e. I understand I must submit a Joint Copyright Letter of Agreement to the TSC in order for the PSS to receive TSC approval.
Yes
6a. External Project Collaboration
Joint Initiative Council for Global Health Informatics Standardization (JIC)
6b. Content Already Developed
Yes
6c. Content externally developed?
Yes
6d. List Developers of Externally Developed Content
JIC
6f. Stakeholders
Regulatory Agency
6i. Realm
Universal
7b. Sponsoring WG Approval Date
Nov 24, 2020
7i. Steering Division Approval Date
Apr 19, 2021
Version
5
Modifier
Boris Brodsky
Modify Date
Mar 15, 2021 12:54
1a. Project Name
Reaffirm HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 1: The Framework for Adverse Event Reporting, R2
1b. Project ID
1663
1c. Is Your Project an Investigative Project (aka PSS-Lite)?
No
1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?
No
1f. Name of standard being reaffirmed
HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 1: The Framework for Adverse Event Reporting, R2
2a. Primary/Sponsor WG
Biomedical Research & Regulation
2d. Project Facilitator
Boris Brodsky
3a. Project Scope
The Individual Case Safety Report (ICSR) captures information about adverse events and product problems that are reported to public health, patient safety/quality improvement organizations or regulatory agencies. The ICSR message supports reporting from a variety of sources such as consumers, hospitals, contract research organizations, clinicians or pharmaceutical product and medical device manufacturers.
3b. Project Need
Harmonized reporting formats that enable regulated industries that are required by law to submit human drugs, biologics, vaccines and medical device adverse events and product problems to use a single standard. Support implementation of HL7/ISO ICSR.
5e. I understand I must submit a Joint Copyright Letter of Agreement to the TSC in order for the PSS to receive TSC approval.
Yes
6a. External Project Collaboration
Joint Initiative Council for Global Health Informatics Standardization (JIC)
6b. Content Already Developed
Yes
6c. Content externally developed?
Yes
6d. List Developers of Externally Developed Content
JIC
6f. Stakeholders
Regulatory Agency
6i. Realm
Universal
7b. Sponsoring WG Approval Date
Nov 24, 2020
Version
4
Modifier
Boris Brodsky
Modify Date
Mar 12, 2021 21:37
1a. Project Name
Reaffirm HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 1: The Framework for Adverse Event Reporting, R2
1b. Project ID
1663
1c. Is Your Project an Investigative Project (aka PSS-Lite)?
No
1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?
No
1f. Name of standard being reaffirmed
HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 1: The Framework for Adverse Event Reporting, R2
2a. Primary/Sponsor WG
Biomedical Research & Regulation
2d. Project Facilitator
Boris Brodsky
3a. Project Scope
The Individual Case Safety Report (ICSR) captures information about adverse events and product problems that are reported to public health, patient safety/quality improvement organizations or regulatory agencies. The ICSR message supports reporting from a variety of sources such as consumers, hospitals, contract research organizations, clinicians or pharmaceutical product and medical device manufacturers.
3b. Project Need
Harmonized reporting formats that enable regulated industries that are required by law to submit human drugs, biologics, vaccines and medical device adverse events and product problems to use a single standard. Support implementation of HL7/ISO ICSR.
5e. I understand I must submit a Joint Copyright Letter of Agreement to the TSC in order for the PSS to receive TSC approval.
Yes
6a. External Project Collaboration
Joint Initiative Council for Global Health Informatics Standardization (JIC)
6b. Content Already Developed
Yes
6c. Content externally developed?
Yes
6d. List Developers of Externally Developed Content
JIC
6f. Stakeholders
Regulatory Agency
6i. Realm
Universal
7b. Sponsoring WG Approval Date
Nov 24, 2020
Version
3
Modifier
Boris Brodsky
Modify Date
Mar 12, 2021 21:33
1a. Project Name
Reaffirm HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 1: The Framework for Adverse Event Reporting, R2
1b. Project ID
1663
1c. Is Your Project an Investigative Project (aka PSS-Lite)?
No
1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?
No
1f. Name of standard being reaffirmed
HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 1: The Framework for Adverse Event Reporting, R2
2a. Primary/Sponsor WG
Biomedical Research & Regulation
2d. Project Facilitator
Boris Brodsky
3a. Project Scope
The Individual Case Safety Report (ICSR) captures information about adverse events and product problems that are reported to public health, patient safety/quality improvement organizations or regulatory agencies. The ICSR message supports reporting from a variety of sources such as consumers, hospitals, contract research organizations, clinicians or pharmaceutical product and medical device manufacturers.
3b. Project Need
Harmonized reporting formats that enable regulated industries that are required by law to submit human drugs, biologics, vaccines and medical device adverse events and product problems to use a single standard. Support implementation of HL7/ISO ICSR.
5e. I understand I must submit a Joint Copyright Letter of Agreement to the TSC in order for the PSS to receive TSC approval.
Yes
6a. External Project Collaboration
Joint Initiative Council for Global Health Informatics Standardization (JIC)
6b. Content Already Developed
Yes
6c. Content externally developed?
Yes
6d. List Developers of Externally Developed Content
JIC
6f. Stakeholders
Regulatory Agency
6i. Realm
Universal
7b. Sponsoring WG Approval Date
Nov 24, 2020
Version
2
Modifier
Boris Brodsky
Modify Date
Mar 12, 2021 21:28
1a. Project Name
Reaffirm HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 1: The Framework for Adverse Event Reporting, R2
1b. Project ID
1663
1c. Is Your Project an Investigative Project (aka PSS-Lite)?
No
1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?
No
1f. Name of standard being reaffirmed
HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 1: The Framework for Adverse Event Reporting, R2
2a. Primary/Sponsor WG
Biomedical Research & Regulation
2d. Project Facilitator
Boris Brodsky
3a. Project Scope
The Individual Case Safety Report (ICSR) captures information about adverse events and product problems that are reported to public health, patient safety/quality improvement organizations or regulatory agencies. The ICSR message supports reporting from a variety of sources such as consumers, hospitals, contract research organizations, clinicians or pharmaceutical product and medical device manufacturers.
3b. Project Need
Harmonized reporting formats that enable regulated industries that are required by law to submit human drugs, biologics, vaccines and medical device adverse events and product problems to use a single standard. Support implementation of HL7/ISO ICSR.
5e. I understand I must submit a Joint Copyright Letter of Agreement to the TSC in order for the PSS to receive TSC approval.
Yes
6a. External Project Collaboration
JIC
6b. Content Already Developed
Yes
6c. Content externally developed?
Yes
6f. Stakeholders
Regulatory Agency
6i. Realm
Universal
7b. Sponsoring WG Approval Date
Nov 24, 2020
Version
1
Modifier
Boris Brodsky
Modify Date
Mar 12, 2021 17:43
1a. Project Name
Reaffirm HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 1: The Framework for Adverse Event Reporting, R2
1b. Project ID
1663
1c. Is Your Project an Investigative Project (aka PSS-Lite)?
No
1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?
No
1f. Name of standard being reaffirmed
HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 1: The Framework for Adverse Event Reporting, R2
2a. Primary/Sponsor WG
Biomedical Research & Regulation
2d. Project Facilitator
Boris Brodsky
3a. Project Scope
The Individual Case Safety Report (ICSR) captures information about adverse events and product problems that are reported to public health, patient safety/quality improvement organizations or regulatory agencies. The ICSR message supports reporting from a variety of sources such as consumers, hospitals, contract research organizations, clinicians or pharmaceutical product and medical device manufacturers.
3b. Project Need
Harmonized reporting formats that enable regulated industries that are required by law to submit human drugs, biologics, vaccines and medical device adverse events and product problems to use a single standard.
