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1a. Project Name

Reaffirm HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 2: Human Pharmaceutical Reporting Requirements for ICSR, R2

1b. Project ID

1665

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 2: Human Pharmaceutical Reporting Requirements for ICSR, 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.

3c. Security Risk

3d. External Drivers

ISO 27953

3e. Objectives/Deliverables and Target Dates

September 2021 Ballot

3f. Common Names / Keywords / Aliases:

3g. Lineage

3h. Project Dependencies

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/BRR/HL7+V3+ICSR+Storyboards

3j. Backwards Compatibility

No

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 16, 2021

7j. TSC Approval Date



Version

4

Modifier

Anne Wizauer

Modify Date

Apr 20, 2021 20:55

1a. Project Name

Reaffirm HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 2: Human Pharmaceutical Reporting Requirements for ICSR, R2

1b. Project ID

1665

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 2: Human Pharmaceutical Reporting Requirements for ICSR, 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.

3d. External Drivers

ISO 27953

3e. Objectives/Deliverables and Target Dates

September 2021 Ballot

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/BRR/HL7+V3+ICSR+Storyboards

3j. Backwards Compatibility

No

4a. Products

V3 Messages - Clinical

5a. Project Intent

Reaffirmation of a standard

5b. Project Ballot Type

Normative (no STU)

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

6f. Stakeholders

Regulatory Agency

6i. Realm

Universal

7b. Sponsoring WG Approval Date

Nov 24, 2020

7i. Steering Division Approval Date

Apr 16, 2021

Version

3

Modifier

Boris Brodsky

Modify Date

Mar 15, 2021 12:54

1a. Project Name

Reaffirm HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 2: Human Pharmaceutical Reporting Requirements for ICSR, R2

1b. Project ID

1665

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 2: Human Pharmaceutical Reporting Requirements for ICSR, 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.

3d. External Drivers

ISO 27953

3e. Objectives/Deliverables and Target Dates

September 2021 Ballot

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/BRR/HL7+V3+ICSR+Storyboards

3j. Backwards Compatibility

No

4a. Products

V3 Messages - Clinical

5a. Project Intent

Reaffirmation of a standard

5b. Project Ballot Type

Normative (no STU)

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

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 21:39

1a. Project Name

Reaffirm HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 2: Human Pharmaceutical Reporting Requirements for ICSR, R2

1b. Project ID

1665

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 2: Human Pharmaceutical Reporting Requirements for ICSR, 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.

3d. External Drivers

ISO 27953

3e. Objectives/Deliverables and Target Dates

May 2021 Ballot

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/BRR/HL7+V3+ICSR+Storyboards

3j. Backwards Compatibility

No

4a. Products

V3 Messages - Clinical

5a. Project Intent

Reaffirmation of a standard

5b. Project Ballot Type

Normative (no STU)

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

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 17:47

1a. Project Name

Reaffirm HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 2: Human Pharmaceutical Reporting Requirements for ICSR, R2

1b. Project ID

1665

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 2: Human Pharmaceutical Reporting Requirements for ICSR, 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.

3e. Objectives/Deliverables and Target Dates

May 2021 Ballot

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/BRR/HL7+V3+ICSR+Storyboards

3j. Backwards Compatibility

No

5a. Project Intent

Reaffirmation of a standard

5b. Project Ballot Type

Normative (no STU)

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

6f. Stakeholders

Regulatory Agency

6i. Realm

Universal

7b. Sponsoring WG Approval Date

Nov 24, 2020