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1a. Project Name

FHIR Implementation Guide: Migrate from Structured Product Labeling V3 to a FHIR-based submission

1b. Project ID

1704

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

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

Jean Duteau

2e. Other Interested Parties (and roles)

Vocabulary WG
Structured Documents WG
Clinical Decision Support WG

2f. Modeling Facilitator

2g. Publishing Facilitator

Jean Duteau

2h. Vocabulary Facilitator

2i. Domain Expert Representative

2j. Business Requirements Analyst

2k. Conformance Facilitator

Jean Duteau

2l. Other Facilitators

2m. Implementers

IBM
FDA

3a. Project Scope

IBM and FDA are partnering to produce a FHIR Implementation Guide that will allow stakeholders to migrate from the current Structured Product Labeling (SPL) V3 document architecture to a FHIR-based submission architecture. The Implementation Guide will provide profiles on FHIR resources as well as a mapping to and from the existing SPL V3 specification. Additionally, it will document an initial FHIR-based architecture for handling existing FDA SPL use cases in parallel with the current SPL-based architecture.
The initial scope will be focused on the pharmaceutical submissions along with the associated SPL use cases that are needed for those label submissions. As the project goes on, we will look at expanding beyond the pharmaceutical use case.
Since this is a US Realm project, we have analyzed US-Core and there is no overlap with the profiles and use cases covered by US-Core. Therefore there is no dependency on US-Core by this project.

Attachments

3b. Project Need

The existing SPL submission process at FDA uses the existing V3 models. As part of a project that is looking at how the V3 submission could be enhanced or replaced with a FHIR-based submission, this Implementation Guide is needed to provide the guidance on how to use the FHIR artifacts.

3c. Security Risk

No

3d. External Drivers

3e. Objectives/Deliverables and Target Dates

Connectathon: September 2021
Initial ballot: January 2022
Publishing May 2022

3f. Common Names / Keywords / Aliases:

3g. Lineage

3h. Project Dependencies

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/BRR/FHIR+IG+Project+Space%3A+Migrate+from+SPL+V3+to+a+FHIR-based+submission

3j. Backwards Compatibility

No

3k. Additional Backwards Compatibility Information (if applicable)

We are mapping from the existing V3 SPL standard into FHIR and are trying to remain as backwards-compatible in terms of the data elements needed, although obviously not their representation.

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

This is a FHIR Implementation Guide.

3m. External Vocabularies

Yes

3n. List of Vocabularies

NCI Thesaurus contains a number of terminologies used in the current SPL submission process and we will be reusing these in our implementation guide.

3o. Earliest prior release and/or version to which the compatibility applies

4a. Products

FHIR Implementation Guide

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

FHIR R4B, FHIR R5

4c. FHIR Profiles Version

4d. Please define your New Product Definition

4d. Please define your New Product Family

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. White Paper Type

5a. Is the project adopting/endorsing an externally developed IG?

No

5a. Externally developed IG is to be (select one)

5a. Specify external organization

5a. Revising Current Standard Info

5b. Project Ballot Type

STU to Normative

5c. Additional Ballot Info

5d. Joint Copyright

No

5e. I understand I must submit a Joint Copyright Letter of Agreement to the TSC in order for the PSS to receive TSC approval.

no

6a. External Project Collaboration

6b. Content Already Developed

0%

6c. Content externally developed?

6d. List Developers of Externally Developed Content

6e. Is this a hosted (externally funded) project?

6f. Stakeholders

Regulatory Agency

6f. Other Stakeholders

6g. Vendors

Pharmaceutical

6g. Other Vendors

6h. Providers

6h. Other Providers

6i. Realm

U.S. Realm Specific

7d. US Realm Approval Date

Dec 01, 2020

7a. Management Group(s) to Review PSS

FHIR

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

Nov 25, 2020

7g. V2 MG Approval Date

7h. Architecture Review Board Approval Date

7i. Steering Division Approval Date

Apr 19, 2021

7j. TSC Approval Date

Apr 26, 2021


Version

9

Modifier

Anne Wizauer

Modify Date

May 07, 2021 20:45

1a. Project Name

FHIR Implementation Guide: Migrate from Structured Product Labeling V3 to a FHIR-based submission

1b. Project ID

1704

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

2a. Primary/Sponsor WG

Biomedical Research & Regulation

2d. Project Facilitator

Jean Duteau

2e. Other Interested Parties (and roles)

Vocabulary WG
Structured Documents WG
Clinical Decision Support WG

2g. Publishing Facilitator

Jean Duteau

2k. Conformance Facilitator

Jean Duteau

2m. Implementers

IBM
FDA

3a. Project Scope

IBM and FDA are partnering to produce a FHIR Implementation Guide that will allow stakeholders to migrate from the current Structured Product Labeling (SPL) V3 document architecture to a FHIR-based submission architecture. The Implementation Guide will provide profiles on FHIR resources as well as a mapping to and from the existing SPL V3 specification. Additionally, it will document an initial FHIR-based architecture for handling existing FDA SPL use cases in parallel with the current SPL-based architecture.
The initial scope will be focused on the pharmaceutical submissions along with the associated SPL use cases that are needed for those label submissions. As the project goes on, we will look at expanding beyond the pharmaceutical use case.
Since this is a US Realm project, we have analyzed US-Core and there is no overlap with the profiles and use cases covered by US-Core. Therefore there is no dependency on US-Core by this project.

3b. Project Need

The existing SPL submission process at FDA uses the existing V3 models. As part of a project that is looking at how the V3 submission could be enhanced or replaced with a FHIR-based submission, this Implementation Guide is needed to provide the guidance on how to use the FHIR artifacts.

3c. Security Risk

No

3e. Objectives/Deliverables and Target Dates

Connectathon: September 2021
Initial ballot: January 2022
Publishing May 2022

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/BRR/FHIR+IG+Project+Space%3A+Migrate+from+SPL+V3+to+a+FHIR-based+submission

3j. Backwards Compatibility

No

3k. Additional Backwards Compatibility Information (if applicable)

We are mapping from the existing V3 SPL standard into FHIR and are trying to remain as backwards-compatible in terms of the data elements needed, although obviously not their representation.

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

This is a FHIR Implementation Guide.

3m. External Vocabularies

Yes

3n. List of Vocabularies

NCI Thesaurus contains a number of terminologies used in the current SPL submission process and we will be reusing these in our implementation guide.

4a. Products

FHIR Implementation Guide

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

FHIR R4B, FHIR R5

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

No

6b. Content Already Developed

0%

6f. Stakeholders

Regulatory Agency

6g. Vendors

Pharmaceutical

6i. Realm

U.S. Realm Specific

7a. Management Group(s) to Review PSS

FHIR

7b. Sponsoring WG Approval Date

Nov 24, 2020

7d. US Realm Approval Date

Dec 01, 2020

7f. FMG Approval Date

Nov 25, 2020

7i. Steering Division Approval Date

Apr 19, 2021

7j. TSC Approval Date

Apr 26, 2021

Version

8

Modifier

Dave Hamill

Modify Date

Apr 20, 2021 22:17

1a. Project Name

FHIR Implementation Guide: Migrate from Structured Product Labeling V3 to a FHIR-based submission

1b. Project ID

1704

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

2a. Primary/Sponsor WG

Biomedical Research & Regulation

2d. Project Facilitator

Jean Duteau

2e. Other Interested Parties (and roles)

Vocabulary WG
Structured Documents WG
Clinical Decision Support WG

2g. Publishing Facilitator

Jean Duteau

2k. Conformance Facilitator

Jean Duteau

2m. Implementers

IBM
FDA

3a. Project Scope

IBM and FDA are partnering to produce a FHIR Implementation Guide that will allow stakeholders to migrate from the current Structured Product Labeling (SPL) V3 document architecture to a FHIR-based submission architecture. The Implementation Guide will provide profiles on FHIR resources as well as a mapping to and from the existing SPL V3 specification. Additionally, it will document an initial FHIR-based architecture for handling existing FDA SPL use cases in parallel with the current SPL-based architecture.
The initial scope will be focused on the pharmaceutical submissions along with the associated SPL use cases that are needed for those label submissions. As the project goes on, we will look at expanding beyond the pharmaceutical use case.
Since this is a US Realm project, we have analyzed US-Core and there is no overlap with the profiles and use cases covered by US-Core. Therefore there is no dependency on US-Core by this project.

3b. Project Need

The existing SPL submission process at FDA uses the existing V3 models. As part of a project that is looking at how the V3 submission could be enhanced or replaced with a FHIR-based submission, this Implementation Guide is needed to provide the guidance on how to use the FHIR artifacts.

3c. Security Risk

No

3e. Objectives/Deliverables and Target Dates

Connectathon: September 2021
Initial ballot: January 2022
Publishing May 2022

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/BRR/FHIR+IG+Project+Space%3A+Migrate+from+SPL+V3+to+a+FHIR-based+submission

3j. Backwards Compatibility

No

3k. Additional Backwards Compatibility Information (if applicable)

We are mapping from the existing V3 SPL standard into FHIR and are trying to remain as backwards-compatible in terms of the data elements needed, although obviously not their representation.

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

This is a FHIR Implementation Guide.

3m. External Vocabularies

Yes

3n. List of Vocabularies

NCI Thesaurus contains a number of terminologies used in the current SPL submission process and we will be reusing these in our implementation guide.

4a. Products

FHIR Implementation Guide

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

FHIR R4B, FHIR R5

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

No

6b. Content Already Developed

0%

6f. Stakeholders

Regulatory Agency

6g. Vendors

Pharmaceutical

6i. Realm

U.S. Realm Specific

7a. Management Group(s) to Review PSS

FHIR

7b. Sponsoring WG Approval Date

Nov 24, 2020

7d. US Realm Approval Date

Dec 01, 2020

7f. FMG Approval Date

Nov 25, 2020

7i. Steering Division Approval Date

Apr 19, 2021

Version

7

Modifier

Anne Wizauer

Modify Date

Apr 20, 2021 20:48

1a. Project Name

FHIR Implementation Guide: Migrate from Structured Product Labeling V3 to a FHIR-based submission

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

2a. Primary/Sponsor WG

Biomedical Research & Regulation

2d. Project Facilitator

Jean Duteau

2e. Other Interested Parties (and roles)

Vocabulary WG
Structured Documents WG
Clinical Decision Support WG

2g. Publishing Facilitator

Jean Duteau

2k. Conformance Facilitator

Jean Duteau

2m. Implementers

IBM
FDA

3a. Project Scope

IBM and FDA are partnering to produce a FHIR Implementation Guide that will allow stakeholders to migrate from the current Structured Product Labeling (SPL) V3 document architecture to a FHIR-based submission architecture. The Implementation Guide will provide profiles on FHIR resources as well as a mapping to and from the existing SPL V3 specification. Additionally, it will document an initial FHIR-based architecture for handling existing FDA SPL use cases in parallel with the current SPL-based architecture.
The initial scope will be focused on the pharmaceutical submissions along with the associated SPL use cases that are needed for those label submissions. As the project goes on, we will look at expanding beyond the pharmaceutical use case.
Since this is a US Realm project, we have analyzed US-Core and there is no overlap with the profiles and use cases covered by US-Core. Therefore there is no dependency on US-Core by this project.

3b. Project Need

The existing SPL submission process at FDA uses the existing V3 models. As part of a project that is looking at how the V3 submission could be enhanced or replaced with a FHIR-based submission, this Implementation Guide is needed to provide the guidance on how to use the FHIR artifacts.

3c. Security Risk

No

3e. Objectives/Deliverables and Target Dates

Connectathon: September 2021
Initial ballot: January 2022
Publishing May 2022

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/BRR/FHIR+IG+Project+Space%3A+Migrate+from+SPL+V3+to+a+FHIR-based+submission

3j. Backwards Compatibility

No

3k. Additional Backwards Compatibility Information (if applicable)

We are mapping from the existing V3 SPL standard into FHIR and are trying to remain as backwards-compatible in terms of the data elements needed, although obviously not their representation.

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

This is a FHIR Implementation Guide.

3m. External Vocabularies

Yes

3n. List of Vocabularies

NCI Thesaurus contains a number of terminologies used in the current SPL submission process and we will be reusing these in our implementation guide.

4a. Products

FHIR Implementation Guide

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

FHIR R4B, FHIR R5

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

No

6b. Content Already Developed

0%

6f. Stakeholders

Regulatory Agency

6g. Vendors

Pharmaceutical

6i. Realm

U.S. Realm Specific

7a. Management Group(s) to Review PSS

FHIR

7b. Sponsoring WG Approval Date

Nov 24, 2020

7d. US Realm Approval Date

Dec 01, 2020

7f. FMG Approval Date

Nov 25, 2020

7i. Steering Division Approval Date

Apr 19, 2021

Version

6

Modifier

Jean Duteau

Modify Date

Dec 01, 2020 18:17

1a. Project Name

FHIR Implementation Guide: Migrate from Structured Product Labeling V3 to a FHIR-based submission

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

2a. Primary/Sponsor WG

Biomedical Research & Regulation

2d. Project Facilitator

Jean Duteau

2e. Other Interested Parties (and roles)

Vocabulary WG
Structured Documents WG
Clinical Decision Support WG

2g. Publishing Facilitator

Jean Duteau

2k. Conformance Facilitator

Jean Duteau

2m. Implementers

IBM
FDA

3a. Project Scope

IBM and FDA are partnering to produce a FHIR Implementation Guide that will allow stakeholders to migrate from the current Structured Product Labeling (SPL) V3 document architecture to a FHIR-based submission architecture. The Implementation Guide will provide profiles on FHIR resources as well as a mapping to and from the existing SPL V3 specification. Additionally, it will document an initial FHIR-based architecture for handling existing FDA SPL use cases in parallel with the current SPL-based architecture.
The initial scope will be focused on the pharmaceutical submissions along with the associated SPL use cases that are needed for those label submissions. As the project goes on, we will look at expanding beyond the pharmaceutical use case.
Since this is a US Realm project, we have analyzed US-Core and there is no overlap with the profiles and use cases covered by US-Core. Therefore there is no dependency on US-Core by this project.

3b. Project Need

The existing SPL submission process at FDA uses the existing V3 models. As part of a project that is looking at how the V3 submission could be enhanced or replaced with a FHIR-based submission, this Implementation Guide is needed to provide the guidance on how to use the FHIR artifacts.

3c. Security Risk

No

3e. Objectives/Deliverables and Target Dates

Connectathon: September 2021
Initial ballot: January 2022
Publishing May 2022

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/BRR/FHIR+IG+Project+Space%3A+Migrate+from+SPL+V3+to+a+FHIR-based+submission

3j. Backwards Compatibility

No

3k. Additional Backwards Compatibility Information (if applicable)

We are mapping from the existing V3 SPL standard into FHIR and are trying to remain as backwards-compatible in terms of the data elements needed, although obviously not their representation.

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

This is a FHIR Implementation Guide.

3m. External Vocabularies

Yes

3n. List of Vocabularies

NCI Thesaurus contains a number of terminologies used in the current SPL submission process and we will be reusing these in our implementation guide.

4a. Products

FHIR Implementation Guide

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

FHIR R4B, FHIR R5

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

No

6b. Content Already Developed

0%

6f. Stakeholders

Regulatory Agency

6g. Vendors

Pharmaceutical

6i. Realm

U.S. Realm Specific

7a. Management Group(s) to Review PSS

FHIR

7b. Sponsoring WG Approval Date

Nov 24, 2020

7d. US Realm Approval Date

Dec 01, 2020

7f. FMG Approval Date

Nov 25, 2020

Version

5

Modifier

Jean Duteau

Modify Date

Dec 01, 2020 18:16

1a. Project Name

FHIR Implementation Guide: Migrate from Structured Product Labeling V3 to a FHIR-based submission

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

2a. Primary/Sponsor WG

Biomedical Research & Regulation

2d. Project Facilitator

Jean Duteau

2e. Other Interested Parties (and roles)

Vocabulary WG
Structured Documents WG
Clinical Decision Support WG

2g. Publishing Facilitator

Jean Duteau

2k. Conformance Facilitator

Jean Duteau

2m. Implementers

IBM
FDA

3a. Project Scope

IBM and FDA are partnering to produce a FHIR Implementation Guide that will allow stakeholders to migrate from the current Structured Product Labeling (SPL) V3 document architecture to a FHIR-based submission architecture. The Implementation Guide will provide profiles on FHIR resources as well as a mapping to and from the existing SPL V3 specification. Additionally, it will document an initial FHIR-based architecture for handling existing FDA SPL use cases in parallel with the current SPL-based architecture.
The initial scope will be focused on the pharmaceutical submissions along with the associated SPL use cases that are needed for those label submissions. As the project goes on, we will look at expanding beyond the pharmaceutical use case.
Since this is a US Realm project, we have analyzed US-Core and there is no overlap with the profiles and use cases covered by US-Core. Therefore there is no dependency on US-Core by this project.

3b. Project Need

The existing SPL submission process at FDA uses the existing V3 models. As part of a project that is looking at how the V3 submission could be enhanced or replaced with a FHIR-based submission, this Implementation Guide is needed to provide the guidance on how to use the FHIR artifacts.

3c. Security Risk

No

3e. Objectives/Deliverables and Target Dates

Connectathon: September 2021
Initial ballot: January 2022
Publishing May 2022

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/BRR/FHIR+IG+Project+Space%3A+Migrate+from+SPL+V3+to+a+FHIR-based+submission

3j. Backwards Compatibility

No

3k. Additional Backwards Compatibility Information (if applicable)

We are mapping from the existing V3 SPL standard into FHIR and are trying to remain as backwards-compatible in terms of the data elements needed, although obviously not their representation.

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

This is a FHIR Implementation Guide.

3m. External Vocabularies

Yes

3n. List of Vocabularies

NCI Thesaurus contains a number of terminologies used in the current SPL submission process and we will be reusing these in our implementation guide.

4a. Products

FHIR Implementation Guide

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

FHIR R4B, FHIR R5

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

No

6b. Content Already Developed

0%

6f. Stakeholders

Regulatory Agency

6g. Vendors

Pharmaceutical

6i. Realm

U.S. Realm Specific

7a. Management Group(s) to Review PSS

FHIR

7b. Sponsoring WG Approval Date

Nov 24, 2020

Version

4

Modifier

Jean Duteau

Modify Date

Nov 24, 2020 21:57

1a. Project Name

FHIR Implementation Guide: Migrate from Structured Product Labeling V3 to a FHIR-based submission

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

2a. Primary/Sponsor WG

Biomedical Research & Regulation

2d. Project Facilitator

Jean Duteau

2e. Other Interested Parties (and roles)

Vocabulary WG
Structured Documents WG
Clinical Decision Support WG

2g. Publishing Facilitator

Jean Duteau

2k. Conformance Facilitator

Jean Duteau

2m. Implementers

IBM
FDA

3a. Project Scope

IBM and FDA are partnering to produce a FHIR Implementation Guide that will allow stakeholders to migrate from the current Structured Product Labeling (SPL) V3 document architecture to a FHIR-based submission architecture. The Implementation Guide will provide profiles on FHIR resources as well as a mapping to and from the existing SPL V3 specification. Additionally, it will document an initial FHIR-based architecture for handling existing FDA SPL use cases in parallel with the current SPL-based architecture.
The initial scope will be focused on the pharmaceutical submissions along with the associated SPL use cases that are needed for those label submissions. As the project goes on, we will look at expanding beyond the pharmaceutical use case.

3b. Project Need

The existing SPL submission process at FDA uses the existing V3 models. As part of a project that is looking at how the V3 submission could be enhanced or replaced with a FHIR-based submission, this Implementation Guide is needed to provide the guidance on how to use the FHIR artifacts.

3c. Security Risk

No

3e. Objectives/Deliverables and Target Dates

Connectathon: September 2021
Initial ballot: January 2022
Publishing May 2022

3h. Project Dependencies

US-Core

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/BRR/FHIR+IG+Project+Space%3A+Migrate+from+SPL+V3+to+a+FHIR-based+submission

3j. Backwards Compatibility

Yes

3k. Additional Backwards Compatibility Information (if applicable)

We are mapping from the existing V3 SPL standard into FHIR and are trying to remain as backwards-compatible in terms of the data elements needed, although obviously not their representation.

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

This is a FHIR Implementation Guide.

3m. External Vocabularies

Yes

3n. List of Vocabularies

NCI Thesaurus contains a number of terminologies used in the current SPL submission process and we will be reusing these in our implementation guide.

4a. Products

FHIR Implementation Guide

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

FHIR R4B, FHIR R5

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

No

6b. Content Already Developed

0%

6f. Stakeholders

Regulatory Agency

6g. Vendors

Pharmaceutical

6i. Realm

U.S. Realm Specific

7a. Management Group(s) to Review PSS

FHIR

7b. Sponsoring WG Approval Date

Nov 24, 2020

Version

3

Modifier

Jean Duteau

Modify Date

Nov 24, 2020 21:40

1a. Project Name

FHIR Implementation Guide: Migrate from Structured Product Labeling V3 to a FHIR-based submission

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

2a. Primary/Sponsor WG

Biomedical Research & Regulation

2d. Project Facilitator

Jean Duteau

2e. Other Interested Parties (and roles)

Vocabulary WG
Clinical Decision Support WG

2g. Publishing Facilitator

Jean Duteau

2k. Conformance Facilitator

Jean Duteau

2m. Implementers

IBM
FDA

3a. Project Scope

IBM and FDA are partnering to produce a FHIR Implementation Guide that will allow stakeholders to migrate from the current Structured Product Labeling (SPL) V3 document architecture to a FHIR-based submission architecture. The Implementation Guide will provide profiles on FHIR resources as well as a mapping to and from the existing SPL V3 specification. Additionally, it will document an initial FHIR-based architecture for handling existing FDA SPL use cases in parallel with the current SPL-based architecture.
The initial scope will be focused on the pharmaceutical submissions along with the associated SPL use cases that are needed for those label submissions. As the project goes on, we may expand beyond the pharmaceutical use case.

3b. Project Need

The existing SPL submission process at FDA uses the existing V3 models. As part of a project that is looking at how the V3 submission could be enhanced or replaced with a FHIR-based submission, this Implementation Guide is needed to provide the guidance on how to use the FHIR artifacts.

3c. Security Risk

No

3e. Objectives/Deliverables and Target Dates

Connectathon: September 2021
Initial ballot: January 2022
Publishing May 2022

3h. Project Dependencies

US-Core

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/BRR/FHIR+IG+Project+Space%3A+Migrate+from+SPL+V3+to+a+FHIR-based+submission

3j. Backwards Compatibility

Yes

3k. Additional Backwards Compatibility Information (if applicable)

We are mapping from the existing V3 SPL standard into FHIR and are trying to remain as backwards-compatible in terms of the data elements needed, although obviously not their representation.

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

This is a FHIR Implementation Guide.

3m. External Vocabularies

Yes

3n. List of Vocabularies

NCI Thesaurus contains a number of terminologies used in the current SPL submission process and we will be reusing these in our implementation guide.

4a. Products

FHIR Implementation Guide

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

FHIR R4B, FHIR R5

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

No

6b. Content Already Developed

0%

6f. Stakeholders

Regulatory Agency

6g. Vendors

Pharmaceutical

6i. Realm

U.S. Realm Specific

7a. Management Group(s) to Review PSS

FHIR

Version

2

Modifier

Jean Duteau

Modify Date

Nov 23, 2020 18:05

1a. Project Name

FHIR Implementation Guide: Migrate from Structured Product Labeling V3 to a FHIR-based submission

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

2a. Primary/Sponsor WG

Biomedical Research & Regulation

2d. Project Facilitator

Jean Duteau

2e. Other Interested Parties (and roles)

Vocabulary WG
Clinical Decision Support WG

2g. Publishing Facilitator

Jean Duteau

2k. Conformance Facilitator

Jean Duteau

2m. Implementers

IBM
FDA

3a. Project Scope

IBM and FDA are partnering to produce a FHIR Implementation Guide that will allow stakeholders to migrate from the current Structured Product Labeling (SPL) V3 document architecture to a FHIR-based submission architecture. The Implementation Guide will provide profiles on FHIR resources as well as a mapping to and from the existing SPL V3 specification. Additionally, it will document an initial FHIR-based architecture for handling existing FDA SPL use cases in parallel with the current SPL-based architecture.

3b. Project Need

The existing SPL submission process at FDA uses the existing V3 models. As part of a project that is looking at how the V3 submission could be enhanced or replaced with a FHIR-based submission, this Implementation Guide is needed to provide the guidance on how to use the FHIR artifacts.

3c. Security Risk

No

3e. Objectives/Deliverables and Target Dates

Connectathon: September 2021
Initial ballot: January 2022
Publishing May 2022

3h. Project Dependencies

US-Core

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/BRR/FHIR+IG+Project+Space%3A+Migrate+from+SPL+V3+to+a+FHIR-based+submission

3j. Backwards Compatibility

Yes

3k. Additional Backwards Compatibility Information (if applicable)

We are mapping from the existing V3 SPL standard into FHIR and are trying to remain as backwards-compatible in terms of the data elements needed, although obviously not their representation.

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

This is a FHIR Implementation Guide.

3m. External Vocabularies

Yes

3n. List of Vocabularies

NCI Thesaurus contains a number of terminologies used in the current SPL submission process and we will be reusing these in our implementation guide.

4a. Products

FHIR Implementation Guide

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

FHIR R4B, FHIR R5

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

No

6b. Content Already Developed

0%

6f. Stakeholders

Regulatory Agency

6g. Vendors

Pharmaceutical

6i. Realm

U.S. Realm Specific

7a. Management Group(s) to Review PSS

FHIR

Version

1

Modifier

Jean Duteau

Modify Date

Nov 23, 2020 18:02

1a. Project Name

FHIR Implementation Guide: Migrate from Structured Product Labeling V3 to a FHIR-based submission

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

2a. Primary/Sponsor WG

Biomedical Research & Regulation

2d. Project Facilitator

Jean Duteau

2e. Other Interested Parties (and roles)

Vocabulary WG
Clinical Decision Support WG

2g. Publishing Facilitator

Jean Duteau

2k. Conformance Facilitator

Jean Duteau

2m. Implementers

IBM
FDA

3a. Project Scope

IBM and FDA are partnering to produce a FHIR Implementation Guide that will allow stakeholders to migrate from the current Structured Product Labeling (SPL) V3 document architecture to a FHIR-based submission architecture. The Implementation Guide will provide profiles on FHIR resources as well as a mapping to and from the existing SPL V3 specification. Additionally, it will document an initial FHIR-based architecture for handling existing FDA SPL use cases in parallel with the current SPL-based architecture.

3b. Project Need

The existing SPL submission process at FDA uses the existing V3 models. As part of a project that is looking at how the V3 submission could be enhanced or replaced with a FHIR-based submission, this Implementation Guide is needed to provide the guidance on how to use the FHIR artifacts.

3c. Security Risk

No

3e. Objectives/Deliverables and Target Dates

Connectathon: September 2021
Initial ballot: January 2022
Publishing May 2022

3h. Project Dependencies

US-Core

3j. Backwards Compatibility

Yes

3k. Additional Backwards Compatibility Information (if applicable)

We are mapping from the existing V3 SPL standard into FHIR and are trying to remain as backwards-compatible in terms of the data elements needed, although obviously not their representation.

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

This is a FHIR Implementation Guide.

3m. External Vocabularies

Yes

3n. List of Vocabularies

NCI Thesaurus contains a number of terminologies used in the current SPL submission process and we will be reusing these in our implementation guide.

4a. Products

FHIR Implementation Guide

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

FHIR R4B, FHIR R5

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

No

6b. Content Already Developed

0%

6f. Stakeholders

Regulatory Agency

6g. Vendors

Pharmaceutical

6i. Realm

U.S. Realm Specific

7a. Management Group(s) to Review PSS

FHIR