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1a. Project Name

BR&R FHIR Resource Maintenance

1b. Project ID

1702

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

2b. Co-Sponsor WG

Orders & Observations

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor Update Periods

WGMs

2b. Co-Sponsor WG 2

Pharmacy

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor 2 Update Periods

WGMs

2d. Project Facilitator

BR&R Co-chairs

2e. Other Interested Parties (and roles)

CQI WG

2f. Modeling Facilitator

BR&R WG Members

2g. Publishing Facilitator

Rik Smithes, Hugh Glover, TBD

2h. Vocabulary Facilitator

2i. Domain Expert Representative

BR&R WG Members

2j. Business Requirements Analyst

BR&R WG Members

2k. Conformance Facilitator

N/A

2l. Other Facilitators

2m. Implementers

For Medication Definition Resources -- EMA, FDA, Health Canada, Others
For Research related Resources - US National Institute of Health (NIH), FDA, Vulcan projects, Software vendors, others

3a. Project Scope

This is an umbrella project for the maintenance and development work to be done on all current and future FHIR Resources in the BR&R WG. As of Q1 2021, there are 16 FHIR resources that are in active development. The list and status of each is managed by BR&R here: https://confluence.hl7.org/pages/viewpage.action?pageId=97476291
Below is the list of current BR&R Resources -
Two (2) in Clinical Research:
ResearchStudy,
ResearchSubject

Fourteen (14) in Medication Definition: MedicinalProductDefinition, AdministrableProductDefinition, ClinicalUseIssue, Ingredient, ManufacturedItemDefinition, PackagedProductDefinition, RegulatedAuthorization, Substance, SubstanceDefinition, SubstanceNucleicAcid, SubstancePolymer, SubstanceProtein, SubstanceReferenceInformation, SubstanceSourceMaterial

The above list of resources may grow as BR&R explores and begins to further use cases associated with our scope of Biomedical Research and Regulation.

Attachments

3b. Project Need

This is larger BR&R FHIR Resource development project and not specific to any one particular project use case or implementation needs. The larger need is to support development of FHIR specifications for research and regulatory driven use cases.

3c. Security Risk

No

3d. External Drivers

Regulatory entities -- EMA, US FDA, Health Canada; HL7 Accelerators -- Vulcan, CODEx; Pharmaceutical Manufacturers and Vendors; Other Research entities: US NIH

3e. Objectives/Deliverables and Target Dates

Objectives:
1. Develop FHIR Resources and related artifacts in support of research and regulatory requirements for data exchange.
2. Maintain the FHIR Resources
3. Support the FHIR Resources thru each balloting process

3f. Common Names / Keywords / Aliases:

Medication Definition, Research Resources, BR&R Resources

3g. Lineage

Partial lineage of Medication Definition resources -- Project # 1367, #1416

3h. Project Dependencies

None

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/pages/viewpage.action?pageId=97476291

3j. Backwards Compatibility

No

3k. Additional Backwards Compatibility Information (if applicable)

3l. Using Current V3 Data Types?

No

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

Using FHIR data types

3m. External Vocabularies

N/A

3n. List of Vocabularies

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

None

4a. Products

FHIR Extensions, FHIR Profiles, FHIR Resources

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

This project will not build FHIR IGs. It is an umbrella project to manage and maintain all BR&R FHIR Resources.

4c. FHIR Profiles Version

N/A

4d. Please define your New Product Definition

4d. Please define your New Product Family

5a. Project Intent

Revise current standard, Supplement to a current 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

8 of the 16 BR&R FHIR resources were balloted in R4B in March/April 2021. These are the Medication definition resources. 2 more resources (ResearchStudy and ResearchSubject) were balloted in the May 2021 R5 ballot.

5b. Project Ballot Type

N/A (project won’t go through ballot)

5c. Additional Ballot Info

This project will not go thru ballot as such, sets of resources that fall under this project will be balloted over the next few years.

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

70%

6c. Content externally developed?

No

6d. List Developers of Externally Developed Content

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

No

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

BR&R WG members representing -- FDA, EMA, Health Canada, Vulcan, CODEx, NIH, CDISC, Implementation vendors, others, etc.
Pharmacy, O&O and CQI WGs

6g. Vendors

Pharmaceutical, EHR, PHR, Equipment, Health Care IT, Clinical Decision Support Systems, Lab, HIS, Other

6g. Other Vendors

6h. Providers

N/A

6h. Other Providers

6i. Realm

Universal

7d. US Realm Approval Date

7a. Management Group(s) to Review PSS

FHIR

7b. Sponsoring WG Approval Date

Apr 13, 2021

7c. Co-Sponsor Approval Date

Mar 10, 2022

7c. Co-Sponsor 2 Approval Date

Apr 26, 2021

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

Mar 09, 2022

7g. V2 MG Approval Date

7h. Architecture Review Board Approval Date

7i. Steering Division Approval Date

7j. TSC Approval Date



Version

16

Modifier

Anne Wizauer

Modify Date

Mar 15, 2022 18:53

1a. Project Name

BR&R FHIR Resource Maintenance

1b. Project ID

1702

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

2b. Co-Sponsor WG

Orders & Observations

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor Update Periods

WGMs

2b. Co-Sponsor WG 2

Pharmacy

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor 2 Update Periods

WGMs

2d. Project Facilitator

BR&R Co-chairs

2e. Other Interested Parties (and roles)

CQI WG

2f. Modeling Facilitator

BR&R WG Members

2g. Publishing Facilitator

Rik Smithes, Hugh Glover, TBD

2i. Domain Expert Representative

BR&R WG Members

2j. Business Requirements Analyst

BR&R WG Members

2k. Conformance Facilitator

N/A

2m. Implementers

For Medication Definition Resources -- EMA, FDA, Health Canada, Others
For Research related Resources - US National Institute of Health (NIH), FDA, Vulcan projects, Software vendors, others

3a. Project Scope

This is an umbrella project for the maintenance and development work to be done on all current and future FHIR Resources in the BR&R WG. As of Q1 2021, there are 16 FHIR resources that are in active development. The list and status of each is managed by BR&R here: https://confluence.hl7.org/pages/viewpage.action?pageId=97476291
Below is the list of current BR&R Resources -
Two (2) in Clinical Research:
ResearchStudy,
ResearchSubject

Fourteen (14) in Medication Definition: MedicinalProductDefinition, AdministrableProductDefinition, ClinicalUseIssue, Ingredient, ManufacturedItemDefinition, PackagedProductDefinition, RegulatedAuthorization, Substance, SubstanceDefinition, SubstanceNucleicAcid, SubstancePolymer, SubstanceProtein, SubstanceReferenceInformation, SubstanceSourceMaterial

The above list of resources may grow as BR&R explores and begins to further use cases associated with our scope of Biomedical Research and Regulation.

3b. Project Need

This is larger BR&R FHIR Resource development project and not specific to any one particular project use case or implementation needs. The larger need is to support development of FHIR specifications for research and regulatory driven use cases.

3c. Security Risk

No

3d. External Drivers

Regulatory entities -- EMA, US FDA, Health Canada; HL7 Accelerators -- Vulcan, CODEx; Pharmaceutical Manufacturers and Vendors; Other Research entities: US NIH

3e. Objectives/Deliverables and Target Dates

Objectives:
1. Develop FHIR Resources and related artifacts in support of research and regulatory requirements for data exchange.
2. Maintain the FHIR Resources
3. Support the FHIR Resources thru each balloting process

3f. Common Names / Keywords / Aliases:

Medication Definition, Research Resources, BR&R Resources

3g. Lineage

Partial lineage of Medication Definition resources -- Project # 1367, #1416

3h. Project Dependencies

None

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/pages/viewpage.action?pageId=97476291

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

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

Using FHIR data types

3m. External Vocabularies

N/A

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

None

4a. Products

FHIR Extensions, FHIR Profiles, FHIR Resources

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

This project will not build FHIR IGs. It is an umbrella project to manage and maintain all BR&R FHIR Resources.

4c. FHIR Profiles Version

N/A

5a. Project Intent

Revise current standard, Supplement to a current standard

5a. Revising Current Standard Info

8 of the 16 BR&R FHIR resources were balloted in R4B in March/April 2021. These are the Medication definition resources. 2 more resources (ResearchStudy and ResearchSubject) were balloted in the May 2021 R5 ballot.

5b. Project Ballot Type

N/A (project won’t go through ballot)

5c. Additional Ballot Info

This project will not go thru ballot as such, sets of resources that fall under this project will be balloted over the next few years.

5d. Joint Copyright

No

6b. Content Already Developed

70%

6c. Content externally developed?

No

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

No

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

BR&R WG members representing -- FDA, EMA, Health Canada, Vulcan, CODEx, NIH, CDISC, Implementation vendors, others, etc.
Pharmacy, O&O and CQI WGs

6g. Vendors

Pharmaceutical, EHR, PHR, Equipment, Health Care IT, Clinical Decision Support Systems, Lab, HIS, Other

6h. Providers

N/A

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

7b. Sponsoring WG Approval Date

Apr 13, 2021

7c. Co-Sponsor Approval Date

Mar 10, 2022

7c. Co-Sponsor 2 Approval Date

Apr 26, 2021

7f. FMG Approval Date

Mar 09, 2022

Version

15

Modifier

Smita Hastak

Modify Date

Mar 14, 2022 17:01

1a. Project Name

BR&R FHIR Resource Maintenance

1b. Project ID

1702

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

2b. Co-Sponsor WG

Orders & Observations

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor Update Periods

WGMs

2b. Co-Sponsor WG 2

Pharmacy

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor 2 Update Periods

WGMs

2d. Project Facilitator

BR&R Co-chairs

2e. Other Interested Parties (and roles)

CQI WG

2f. Modeling Facilitator

BR&R WG Members

2g. Publishing Facilitator

Rik Smithes, Hugh Glover, TBD

2i. Domain Expert Representative

BR&R WG Members

2j. Business Requirements Analyst

BR&R WG Members

2k. Conformance Facilitator

N/A

2m. Implementers

For Medication Definition Resources -- EMA, FDA, Health Canada, Others
For Research related Resources - US National Institute of Health (NIH), FDA, Vulcan projects, Software vendors, others

3a. Project Scope

This is an umbrella project for the maintenance and development work to be done on all current and future FHIR Resources in the BR&R WG. As of Q1 2021, there are 16 FHIR resources that are in active development. The list and status of each is managed by BR&R here: https://confluence.hl7.org/pages/viewpage.action?pageId=97476291
Below is the list of current BR&R Resources -
Two (2) in Clinical Research:
ResearchStudy,
ResearchSubject

Fourteen (14) in Medication Definition: MedicinalProductDefinition, AdministrableProductDefinition, ClinicalUseIssue, Ingredient, ManufacturedItemDefinition, PackagedProductDefinition, RegulatedAuthorization, Substance, SubstanceDefinition, SubstanceNucleicAcid, SubstancePolymer, SubstanceProtein, SubstanceReferenceInformation, SubstanceSourceMaterial

The above list of resources may grow as BR&R explores and begins to further use cases associated with our scope of Biomedical Research and Regulation.

3b. Project Need

This is larger BR&R FHIR Resource development project and not specific to any one particular project use case or implementation needs. The larger need is to support development of FHIR specifications for research and regulatory driven use cases.

3c. Security Risk

No

3d. External Drivers

Regulatory entities -- EMA, US FDA, Health Canada; HL7 Accelerators -- Vulcan, CODEx; Pharmaceutical Manufacturers and Vendors; Other Research entities: US NIH

3e. Objectives/Deliverables and Target Dates

Objectives:
1. Develop FHIR Resources and related artifacts in support of research and regulatory requirements for data exchange.
2. Maintain the FHIR Resources
3. Support the FHIR Resources thru each balloting process

3f. Common Names / Keywords / Aliases:

Medication Definition, Research Resources, BR&R Resources

3g. Lineage

Partial lineage of Medication Definition resources -- Project # 1367, #1416

3h. Project Dependencies

None

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/pages/viewpage.action?pageId=97476291

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

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

Using FHIR data types

3m. External Vocabularies

N/A

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

None

4a. Products

FHIR Extensions, FHIR Profiles, FHIR Resources

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

This project will not build FHIR IGs. It is an umbrella project to manage and maintain all BR&R FHIR Resources.

4c. FHIR Profiles Version

N/A

5a. Project Intent

Revise current standard, Supplement to a current standard

5a. Revising Current Standard Info

8 of the 16 BR&R FHIR resources were balloted in R4B in March/April 2021. These are the Medication definition resources. 2 more resources (ResearchStudy and ResearchSubject) were balloted in the May 2021 R5 ballot.

5b. Project Ballot Type

N/A (project won’t go through ballot)

5c. Additional Ballot Info

This project will not go thru ballot as such, sets of resources that fall under this project will be balloted over the next few years.

5d. Joint Copyright

No

6b. Content Already Developed

70%

6c. Content externally developed?

No

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

No

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

BR&R WG members representing -- FDA, EMA, Health Canada, Vulcan, CODEx, NIH, CDISC, Implementation vendors, others, etc.
Pharmacy, O&O and CQI WGs

6g. Vendors

Pharmaceutical, EHR, PHR, Equipment, Health Care IT, Clinical Decision Support Systems, Lab, HIS, Other

6h. Providers

N/A

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

7b. Sponsoring WG Approval Date

Apr 13, 2021

7c. Co-Sponsor Approval Date

Mar 10, 2022

7c. Co-Sponsor 2 Approval Date

Apr 26, 2021

Version

14

Modifier

Ulrike Merrick

Modify Date

Mar 10, 2022 23:29

1a. Project Name

BR&R FHIR Resource Maintenance

1b. Project ID

1702

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

2b. Co-Sponsor WG

Orders & Observations

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor Update Periods

WGMs

2b. Co-Sponsor WG 2

Pharmacy

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor 2 Update Periods

WGMs

2d. Project Facilitator

BR&R Co-chairs

2e. Other Interested Parties (and roles)

CQI WG

2f. Modeling Facilitator

BR&R WG Members

2g. Publishing Facilitator

Rik Smithes, Hugh Glover, TBD

2i. Domain Expert Representative

BR&R WG Members

2j. Business Requirements Analyst

BR&R WG Members

2k. Conformance Facilitator

N/A

2m. Implementers

For Medication Definition Resources -- EMA, FDA, Health Canada, Others
For Research related Resources - US National Institute of Health (NIH), FDA, Vulcan projects, Software vendors, others

3a. Project Scope

This is an umbrella project for the maintenance and development work to be done on all current and future FHIR Resources in the BR&R WG. As of Q1 2021, there are 16 FHIR resources that are in active development. The list and status of each is managed by BR&R here: https://confluence.hl7.org/pages/viewpage.action?pageId=97476291
Below is the list of current BR&R Resources -
Two (2) in Clinical Research:
ResearchStudy,
ResearchSubject

Fourteen (14) in Medication Definition: MedicinalProductDefinition, AdministrableProductDefinition, ClinicalUseIssue, Ingredient, ManufacturedItemDefinition, PackagedProductDefinition, RegulatedAuthorization, Substance, SubstanceDefinition, SubstanceNucleicAcid, SubstancePolymer, SubstanceProtein, SubstanceReferenceInformation, SubstanceSourceMaterial

The above list of resources may grow as BR&R explores and begins to further use cases associated with our scope of Biomedical Research and Regulation.

3b. Project Need

This is larger BR&R FHIR Resource development project and not specific to any one particular project use case or implementation needs. The larger need is to support development of FHIR specifications for research and regulatory driven use cases.

3c. Security Risk

No

3d. External Drivers

Regulatory entities -- EMA, US FDA, Health Canada; HL7 Accelerators -- Vulcan, CODEx; Pharmaceutical Manufacturers and Vendors; Other Research entities: US NIH

3e. Objectives/Deliverables and Target Dates

Objectives:
1. Develop FHIR Resources and related artifacts in support of research and regulatory requirements for data exchange.
2. Maintain the FHIR Resources
3. Support the FHIR Resources thru each balloting process

3f. Common Names / Keywords / Aliases:

Medication Definition, Research Resources, BR&R Resources

3g. Lineage

Partial lineage of Medication Definition resources -- Project # 1367, #1416

3h. Project Dependencies

None

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/pages/viewpage.action?pageId=97476291

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

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

Using FHIR data types

3m. External Vocabularies

N/A

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

None

4a. Products

FHIR Extensions, FHIR Profiles, FHIR Resources

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

This project will not build FHIR IGs. It is an umbrella project to manage and maintain all BR&R FHIR Resources.

4c. FHIR Profiles Version

N/A

5a. Project Intent

Revise current standard, Supplement to a current standard

5a. Revising Current Standard Info

8 of the 16 BR&R FHIR resources are being balloted in R4B in March/April 2021. These are the Medication definition resources. 2 more resources (ResearchStudy and ResearchSubject) are planned to balloted in the May 2021 R5 ballot.

5b. Project Ballot Type

N/A (project won’t go through ballot)

5c. Additional Ballot Info

This project will not go thru ballot as such, sets of resources that fall under this project will be balloted over the next few years.

5d. Joint Copyright

No

6b. Content Already Developed

70%

6c. Content externally developed?

No

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

No

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

BR&R WG members representing -- FDA, EMA, Health Canada, Vulcan, CODEx, NIH, CDISC, Implementation vendors, others, etc.
Pharmacy, O&O and CQI WGs

6g. Vendors

Pharmaceutical, EHR, PHR, Equipment, Health Care IT, Clinical Decision Support Systems, Lab, HIS, Other

6h. Providers

N/A

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

7b. Sponsoring WG Approval Date

Apr 13, 2021

7c. Co-Sponsor Approval Date

Mar 10, 2022

7c. Co-Sponsor 2 Approval Date

Apr 26, 2021

Version

13

Modifier

Jean Duteau

Modify Date

Apr 26, 2021 20:16

1a. Project Name

BR&R FHIR Resource Maintenance

1b. Project ID

1702

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

2b. Co-Sponsor WG

Orders & Observations

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor Update Periods

WGMs

2b. Co-Sponsor WG 2

Pharmacy

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor 2 Update Periods

WGMs

2d. Project Facilitator

BR&R Co-chairs

2e. Other Interested Parties (and roles)

CQI WG

2f. Modeling Facilitator

BR&R WG Members

2g. Publishing Facilitator

Rik Smithes, Hugh Glover, TBD

2i. Domain Expert Representative

BR&R WG Members

2j. Business Requirements Analyst

BR&R WG Members

2k. Conformance Facilitator

N/A

2m. Implementers

For Medication Definition Resources -- EMA, FDA, Health Canada, Others
For Research related Resources - US National Institute of Health (NIH), FDA, Vulcan projects, Software vendors, others

3a. Project Scope

This is an umbrella project for the maintenance and development work to be done on all current and future FHIR Resources in the BR&R WG. As of Q1 2021, there are 16 FHIR resources that are in active development. The list and status of each is managed by BR&R here: https://confluence.hl7.org/pages/viewpage.action?pageId=97476291
Below is the list of current BR&R Resources -
Two (2) in Clinical Research:
ResearchStudy,
ResearchSubject

Fourteen (14) in Medication Definition: MedicinalProductDefinition, AdministrableProductDefinition, ClinicalUseIssue, Ingredient, ManufacturedItemDefinition, PackagedProductDefinition, RegulatedAuthorization, Substance, SubstanceDefinition, SubstanceNucleicAcid, SubstancePolymer, SubstanceProtein, SubstanceReferenceInformation, SubstanceSourceMaterial

The above list of resources may grow as BR&R explores and begins to further use cases associated with our scope of Biomedical Research and Regulation.

3b. Project Need

This is larger BR&R FHIR Resource development project and not specific to any one particular project use case or implementation needs. The larger need is to support development of FHIR specifications for research and regulatory driven use cases.

3c. Security Risk

No

3d. External Drivers

Regulatory entities -- EMA, US FDA, Health Canada; HL7 Accelerators -- Vulcan, CODEx; Pharmaceutical Manufacturers and Vendors; Other Research entities: US NIH

3e. Objectives/Deliverables and Target Dates

Objectives:
1. Develop FHIR Resources and related artifacts in support of research and regulatory requirements for data exchange.
2. Maintain the FHIR Resources
3. Support the FHIR Resources thru each balloting process

3f. Common Names / Keywords / Aliases:

Medication Definition, Research Resources, BR&R Resources

3g. Lineage

Partial lineage of Medication Definition resources -- Project # 1367, #1416

3h. Project Dependencies

None

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/pages/viewpage.action?pageId=97476291

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

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

Using FHIR data types

3m. External Vocabularies

N/A

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

None

4a. Products

FHIR Extensions, FHIR Profiles, FHIR Resources

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

This project will not build FHIR IGs. It is an umbrella project to manage and maintain all BR&R FHIR Resources.

4c. FHIR Profiles Version

N/A

5a. Project Intent

Revise current standard, Supplement to a current standard

5a. Revising Current Standard Info

8 of the 16 BR&R FHIR resources are being balloted in R4B in March/April 2021. These are the Medication definition resources. 2 more resources (ResearchStudy and ResearchSubject) are planned to balloted in the May 2021 R5 ballot.

5b. Project Ballot Type

N/A (project won’t go through ballot)

5c. Additional Ballot Info

This project will not go thru ballot as such, sets of resources that fall under this project will be balloted over the next few years.

5d. Joint Copyright

No

6b. Content Already Developed

70%

6c. Content externally developed?

No

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

No

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

BR&R WG members representing -- FDA, EMA, Health Canada, Vulcan, CODEx, NIH, CDISC, Implementation vendors, others, etc.
Pharmacy, O&O and CQI WGs

6g. Vendors

Pharmaceutical, EHR, PHR, Equipment, Health Care IT, Clinical Decision Support Systems, Lab, HIS, Other

6h. Providers

N/A

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

7b. Sponsoring WG Approval Date

Apr 13, 2021

7c. Co-Sponsor 2 Approval Date

Apr 26, 2021

Version

12

Modifier

Smita Hastak

Modify Date

Apr 21, 2021 21:05

1a. Project Name

BR&R FHIR Resource Maintenance

1b. Project ID

1702

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

2b. Co-Sponsor WG

Orders & Observations

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor Update Periods

WGMs

2b. Co-Sponsor WG 2

Pharmacy

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor 2 Update Periods

WGMs

2d. Project Facilitator

BR&R Co-chairs

2e. Other Interested Parties (and roles)

CQI WG

2f. Modeling Facilitator

BR&R WG Members

2g. Publishing Facilitator

Rik Smithes, Hugh Glover, TBD

2i. Domain Expert Representative

BR&R WG Members

2j. Business Requirements Analyst

BR&R WG Members

2k. Conformance Facilitator

N/A

2m. Implementers

For Medication Definition Resources -- EMA, FDA, Health Canada, Others
For Research related Resources - US National Institute of Health (NIH), FDA, Vulcan projects, Software vendors, others

3a. Project Scope

This is an umbrella project for the maintenance and development work to be done on all current and future FHIR Resources in the BR&R WG. As of Q1 2021, there are 16 FHIR resources that are in active development. The list and status of each is managed by BR&R here: https://confluence.hl7.org/pages/viewpage.action?pageId=97476291
Below is the list of current BR&R Resources -
Two (2) in Clinical Research:
ResearchStudy,
ResearchSubject

Fourteen (14) in Medication Definition: MedicinalProductDefinition, AdministrableProductDefinition, ClinicalUseIssue, Ingredient, ManufacturedItemDefinition, PackagedProductDefinition, RegulatedAuthorization, Substance, SubstanceDefinition, SubstanceNucleicAcid, SubstancePolymer, SubstanceProtein, SubstanceReferenceInformation, SubstanceSourceMaterial

The above list of resources may grow as BR&R explores and begins to further use cases associated with our scope of Biomedical Research and Regulation.

3b. Project Need

This is larger BR&R FHIR Resource development project and not specific to any one particular project use case or implementation needs. The larger need is to support development of FHIR specifications for research and regulatory driven use cases.

3c. Security Risk

No

3d. External Drivers

Regulatory entities -- EMA, US FDA, Health Canada; HL7 Accelerators -- Vulcan, CODEx; Pharmaceutical Manufacturers and Vendors; Other Research entities: US NIH

3e. Objectives/Deliverables and Target Dates

Objectives:
1. Develop FHIR Resources and related artifacts in support of research and regulatory requirements for data exchange.
2. Maintain the FHIR Resources
3. Support the FHIR Resources thru each balloting process

3f. Common Names / Keywords / Aliases:

Medication Definition, Research Resources, BR&R Resources

3g. Lineage

Partial lineage of Medication Definition resources -- Project # 1367, #1416

3h. Project Dependencies

None

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/pages/viewpage.action?pageId=97476291

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

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

Using FHIR data types

3m. External Vocabularies

N/A

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

None

4a. Products

FHIR Extensions, FHIR Profiles, FHIR Resources

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

This project will not build FHIR IGs. It is an umbrella project to manage and maintain all BR&R FHIR Resources.

4c. FHIR Profiles Version

N/A

5a. Project Intent

Revise current standard, Supplement to a current standard

5a. Revising Current Standard Info

8 of the 16 BR&R FHIR resources are being balloted in R4B in March/April 2021. These are the Medication definition resources. 2 more resources (ResearchStudy and ResearchSubject) are planned to balloted in the May 2021 R5 ballot.

5b. Project Ballot Type

N/A (project won’t go through ballot)

5c. Additional Ballot Info

This project will not go thru ballot as such, sets of resources that fall under this project will be balloted over the next few years.

5d. Joint Copyright

No

6b. Content Already Developed

70%

6c. Content externally developed?

No

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

No

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

BR&R WG members representing -- FDA, EMA, Health Canada, Vulcan, CODEx, NIH, CDISC, Implementation vendors, others, etc.
Pharmacy, O&O and CQI WGs

6g. Vendors

Pharmaceutical, EHR, PHR, Equipment, Health Care IT, Clinical Decision Support Systems, Lab, HIS, Other

6h. Providers

N/A

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

7b. Sponsoring WG Approval Date

Apr 13, 2021

Version

11

Modifier

Smita Hastak

Modify Date

Apr 19, 2021 20:56

1a. Project Name

BR&R FHIR Resource Maintenance

1b. Project ID

1702

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

2b. Co-Sponsor WG

Orders & Observations

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor Update Periods

WGMs

2b. Co-Sponsor WG 2

Pharmacy

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor 2 Update Periods

WGMs

2d. Project Facilitator

BR&R Co-chairs

2e. Other Interested Parties (and roles)

CQI WG

2f. Modeling Facilitator

BR&R WG Members

2g. Publishing Facilitator

Rik Smithes, Hugh Glover, TBD

2i. Domain Expert Representative

BR&R WG Members

2j. Business Requirements Analyst

BR&R WG Members

2k. Conformance Facilitator

N/A

2m. Implementers

For Medication Definition Resources -- EMA, FDA, Health Canada, Others
For Research related Resources - NIH, FDA, Vulcan projects, Software vendors, others

3a. Project Scope

This is an umbrella project for the maintenance and development work to be done on all current and future FHIR Resources in the BR&R WG. As of Q1 2021, there are 16 FHIR resources that are in active development. The list and status of each is managed by BR&R here: https://confluence.hl7.org/pages/viewpage.action?pageId=97476291
Below is the list of current BR&R Resources -
Two (2) in Clinical Research:
ResearchStudy,
ResearchSubject

Fourteen (14) in Medication Definition: MedicinalProductDefinition, AdministrableProductDefinition, ClinicalUseIssue, Ingredient, ManufacturedItemDefinition, PackagedProductDefinition, RegulatedAuthorization, Substance, SubstanceDefinition, SubstanceNucleicAcid, SubstancePolymer, SubstanceProtein, SubstanceReferenceInformation, SubstanceSourceMaterial

The above list of resources may grow as BR&R explores and begins to further use cases associated with our scope of Biomedical Research and Regulation.

3b. Project Need

This is larger BR&R FHIR Resource development project and not specific to any one particular project use case or implementation needs. The larger need is to support development of FHIR specifications for research and regulatory driven use cases.

3c. Security Risk

No

3d. External Drivers

Regulatory entities -- EMA, US FDA, Health Canada; HL7 Accelerators -- Vulcan, CODEx; Pharmaceutical Manufacturers and Vendors; Other Research entities: US NIH

3e. Objectives/Deliverables and Target Dates

Objectives:
1. Develop FHIR Resources and related artifacts in support of research and regulatory requirements for data exchange.
2. Maintain the FHIR Resources
3. Support the FHIR Resources thru each balloting process

3f. Common Names / Keywords / Aliases:

Medication Definition, Research Resources, BR&R Resources

3g. Lineage

Partial lineage of Medication Definition resources -- Project # 1367, #1416

3h. Project Dependencies

None

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/pages/viewpage.action?pageId=97476291

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

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

Using FHIR data types

3m. External Vocabularies

N/A

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

None

4a. Products

FHIR Extensions, FHIR Profiles, FHIR Resources

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

This project will not build FHIR IGs. It is an umbrella project to manage and maintain all BR&R FHIR Resources.

4c. FHIR Profiles Version

N/A

5a. Project Intent

Revise current standard, Supplement to a current standard

5a. Revising Current Standard Info

8 of the 16 BR&R FHIR resources are being balloted in R4B in March/April 2021. These are the Medication definition resources. 2 more resources (ResearchStudy and ResearchSubject) are planned to balloted in the May 2021 R5 ballot.

5b. Project Ballot Type

N/A (project won’t go through ballot)

5c. Additional Ballot Info

This project will not go thru ballot as such, sets of resources that fall under this project will be balloted over the next few years.

5d. Joint Copyright

No

6b. Content Already Developed

70%

6c. Content externally developed?

No

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

No

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

BR&R WG members representing -- FDA, EMA, Health Canada, Vulcan, CODEx, NIH, CDISC, Implementation vendors, others, etc.
Pharmacy, O&O and CQI WGs

6g. Vendors

Pharmaceutical, EHR, PHR, Equipment, Health Care IT, Clinical Decision Support Systems, Lab, HIS, Other

6h. Providers

N/A

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

7b. Sponsoring WG Approval Date

Apr 13, 2021

Version

10

Modifier

Hugh Glover

Modify Date

Apr 13, 2021 20:34

1a. Project Name

BR&R FHIR Resource Maintenance

1b. Project ID

1702

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

2b. Co-Sponsor WG

Orders & Observations

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor Update Periods

WGMs

2b. Co-Sponsor WG 2

Pharmacy

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor 2 Update Periods

WGMs

2d. Project Facilitator

BR&R Co-chairs

2e. Other Interested Parties (and roles)

CQI WG

2f. Modeling Facilitator

BR&R WG Members

2g. Publishing Facilitator

Rik Smithes, Hugh Glover, TBD

2i. Domain Expert Representative

BR&R WG Members

2j. Business Requirements Analyst

BR&R WG Members

2k. Conformance Facilitator

N/A

2m. Implementers

For Medication Definition Resources -- EMA, FDA, Health Canada
For Research related Resources - NIH, FDA, Vulcan projects, Others

3a. Project Scope

This is an umbrella project for the maintenance and development work to be done on all current and future FHIR Resources in the BR&R WG. As of Q1 2021, there are 16 FHIR resources that are in active development. The list and status of each is managed by BR&R here: https://confluence.hl7.org/pages/viewpage.action?pageId=97476291
Below is the list of current BR&R Resources -
Two (2) in Clinical Research:
ResearchStudy,
ResearchSubject

Fourteen (14) in Medication Definition: MedicinalProductDefinition, AdministrableProductDefinition, ClinicalUseIssue, Ingredient, ManufacturedItemDefinition, PackagedProductDefinition, RegulatedAuthorization, Substance, SubstanceDefinition, SubstanceNucleicAcid, SubstancePolymer, SubstanceProtein, SubstanceReferenceInformation, SubstanceSourceMaterial

The above list of resources may grow as BR&R explores and begins to further use cases associated with our scope of Biomedical Research and Regulation.

3b. Project Need

This is larger BR&R FHIR Resource development project and not specific to any one particular project use case or implementation needs. The larger need is to support development of FHIR specifications for research and regulatory driven use cases.

3c. Security Risk

No

3d. External Drivers

Regulatory entities -- EMA, US FDA, Health Canada; HL7 Accelerators -- Vulcan, CODEx; Pharmaceutical Manufacturers and Vendors; Other Research entities: US NIH

3e. Objectives/Deliverables and Target Dates

Objectives:
1. Develop FHIR Resources and related artifacts in support of research and regulatory requirements for data exchange.
2. Maintain the FHIR Resources
3. Support the FHIR Resources thru each balloting process

3f. Common Names / Keywords / Aliases:

Medication Definition, Research Resources, BR&R Resources

3g. Lineage

Partial lineage of Medication Definition resources -- Project # 1367, #1416

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/pages/viewpage.action?pageId=97476291

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

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

Using FHIR data types

3m. External Vocabularies

N/A

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

None

4a. Products

FHIR Extensions, FHIR Profiles, FHIR Resources

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

This project will not build FHIR IGs. It is an umbrella project to manage and maintain all BR&R FHIR Resources.

4c. FHIR Profiles Version

N/A

5a. Project Intent

Revise current standard, Supplement to a current standard

5a. Revising Current Standard Info

8 of the 16 BR&R FHIR resources are being balloted in R4B in March/April 2021. These are the Medication definition resources. 2 more resources (ResearchStudy and ResearchSubject) are planned to balloted in the May 2021 R5 ballot.

5b. Project Ballot Type

N/A (project won’t go through ballot)

5c. Additional Ballot Info

This project will not go thru ballot as such, sets of resources that fall under this project will be balloted over the next few years.

5d. Joint Copyright

No

6b. Content Already Developed

70%

6c. Content externally developed?

No

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

No

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

BR&R WG members representing -- FDA, EMA, Health Canada, Vulcan, CODEx, NIH, CDISC, Implementation vendors, others, etc.
Pharmacy, O&O and CQI WGs

6g. Vendors

Pharmaceutical, EHR, PHR, Equipment, Health Care IT, Clinical Decision Support Systems, Lab, HIS, Other

6h. Providers

N/A

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

7b. Sponsoring WG Approval Date

Apr 13, 2021

Version

9

Modifier

Hugh Glover

Modify Date

Apr 13, 2021 20:24

1a. Project Name

BR&R FHIR Resource Maintenance

1b. Project ID

1702

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

2b. Co-Sponsor WG

Orders & Observations

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor Update Periods

WGMs

2b. Co-Sponsor WG 2

Pharmacy

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor 2 Update Periods

WGMs

2d. Project Facilitator

BR&R Co-chairs

2e. Other Interested Parties (and roles)

CQI WG

2f. Modeling Facilitator

BR&R WG Members

2g. Publishing Facilitator

Rik Smithes, Hugh Glover, TBD

2i. Domain Expert Representative

BR&R WG Members

2j. Business Requirements Analyst

BR&R WG Members

2k. Conformance Facilitator

N/A

2m. Implementers

For Medication Definition Resources -- EMA, FDA, Health Canada
For Research related Resources - NIH, FDA, Vulcan projects, Others

3a. Project Scope

This is an umbrella project for the maintenance and development work to be done on all current and future FHIR Resources in the BR&R WG. As of Q1 2021, there are 16 FHIR resources that are in active development. The list and status of each is managed by BR&R here: https://confluence.hl7.org/pages/viewpage.action?pageId=97476291
Below is the list of current BR&R Resources -
Two (2) in Clinical Research:
ResearchStudy,
ResearchSubject

Fourteen (14) in Medication Definition: MedicinalProductDefinition, AdministrableProductDefinition, ClinicalUseIssue, Ingredient, ManufacturedItemDefinition, PackagedProductDefinition, RegulatedAuthorization, Substance, SubstanceDefinition, SubstanceNucleicAcid, SubstancePolymer, SubstanceProtein, SubstanceReferenceInformation, SubstanceSourceMaterial

The above list of resources may grow as BR&R explores and begins to further use cases associated with our scope of Biomedical Research and Regulation.

3b. Project Need

This is larger BR&R FHIR Resource development project and not specific to any one particular project use case or implementation needs. The larger need is to support development of FHIR specifications for research and regulatory driven use cases.

3c. Security Risk

No

3d. External Drivers

Regulatory entities -- EMA, US FDA, Health Canada; HL7 Accelerators -- Vulcan, CODEx; Pharmaceutical Manufacturers and Vendors; Other Research entities: US NIH

3e. Objectives/Deliverables and Target Dates

Objectives:
1. Develop FHIR Resources and related artifacts in support of research and regulatory requirements for data exchange.
2. Maintain the FHIR Resources
3. Support the FHIR Resources thru each balloting process

3f. Common Names / Keywords / Aliases:

Medication Definition, Research Resources, BR&R Resources

3g. Lineage

Partial lineage of Medication Definition resources -- Project # 1367, #1416

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

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

Using FHIR data types

3m. External Vocabularies

N/A

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

None

4a. Products

FHIR Extensions, FHIR Profiles, FHIR Resources

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

This project will not build FHIR IGs. It is an umbrella project to manage and maintain all BR&R FHIR Resources.

4c. FHIR Profiles Version

N/A

5a. Project Intent

Revise current standard, Supplement to a current standard

5a. Revising Current Standard Info

8 of the 16 BR&R FHIR resources are being balloted in R4B in March/April 2021. These are the Medication definition resources. 2 more resources (ResearchStudy and ResearchSubject) are planned to balloted in the May 2021 R5 ballot.

5b. Project Ballot Type

N/A (project won’t go through ballot)

5c. Additional Ballot Info

This project will not go thru ballot as such, sets of resources that fall under this project will be balloted over the next few years.

5d. Joint Copyright

No

6b. Content Already Developed

70%

6c. Content externally developed?

No

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

No

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

BR&R WG members representing -- FDA, EMA, Health Canada, Vulcan, CODEx, NIH, CDISC, Implementation vendors, others, etc.
Pharmacy, O&O and CQI WGs

6g. Vendors

Pharmaceutical, EHR, PHR, Equipment, Health Care IT, Clinical Decision Support Systems, Lab, HIS, Other

6h. Providers

N/A

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

Version

8

Modifier

Hugh Glover

Modify Date

Apr 13, 2021 20:22

1a. Project Name

BR&R FHIR Resource Maintenance

1b. Project ID

1702

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

2b. Co-Sponsor WG

Orders & Observations

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor Update Periods

WGMs

2b. Co-Sponsor WG 2

Pharmacy

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor 2 Update Periods

WGMs

2d. Project Facilitator

BR&R Co-chairs

2e. Other Interested Parties (and roles)

CQI WG

2f. Modeling Facilitator

BR&R WG Members

2g. Publishing Facilitator

Rik Smithes, Hugh Glover, TBD

2i. Domain Expert Representative

BR&R WG Members

2j. Business Requirements Analyst

BR&R WG Members

2k. Conformance Facilitator

N/A

2m. Implementers

For Medication Definition Resources -- EMA, FDA, Health Canada
For Research related Resources - NIH, FDA, Vulcan projects, Others

3a. Project Scope

This is an umbrella project for the maintenance and development work to be done on all current and future FHIR Resources in the BR&R WG. As of Q1 2021, there are 16 FHIR resources that are in active development. The list and status of each is managed by BR&R here: https://confluence.hl7.org/pages/viewpage.action?pageId=97476291
Below is the list of current BR&R Resources -
Two (2) in Clinical Research:
ResearchStudy,
ResearchSubject

Fourteen (14) in Medication Definition: MedicinalProductDefinition, AdministrableProductDefinition, ClinicalUseIssue, Ingredient, ManufacturedItemDefinition, PackagedProductDefinition, RegulatedAuthorization, Substance, SubstanceDefinition, SubstanceNucleicAcid, SubstancePolymer, SubstanceProtein, SubstanceReferenceInformation, SubstanceSourceMaterial

The above list of resources may grow as BR&R explores and begins to further use cases associated with our scope of Biomedical Research and Regulation.

3b. Project Need

This is larger BR&R FHIR Resource development project and not specific to any one particular project use case or implementation needs. The larger need is to support development of FHIR specifications for research and regulatory driven use cases.

3c. Security Risk

No

3d. External Drivers

Regulatory entities -- EMA, US FDA, Health Canada; HL7 Accelerators -- Vulcan, CODEx; Pharmaceutical Manufacturers and Vendors; Other Research entities: US NIH

3e. Objectives/Deliverables and Target Dates

Objectives:
1. Develop FHIR Resources and related artifacts in support of research and regulatory requirements for data exchange.
2. Maintain the FHIR Resources
3. Support the FHIR Resources thru each balloting process

3f. Common Names / Keywords / Aliases:

Medication Definition, Research Resources, BR&R Resources

3g. Lineage

Partial lineage of Medication Definition resources -- Project # 1367, #1416

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

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

Using FHIR data types

3m. External Vocabularies

N/A

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

None

4a. Products

FHIR Extensions, FHIR Profiles, FHIR Resources

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

This project will not build FHIR IGs. It is an umbrella project to manage and maintain all BR&R FHIR Resources.

4c. FHIR Profiles Version

N/A

5a. Project Intent

Revise current standard, Supplement to a current standard

5a. Revising Current Standard Info

8 of the 16 BR&R FHIR resources are being balloted in R4B in March/April 2021. These are the Medication definition resources. 2 more resources (ResearchStudy and ResearchSubject) are planned to balloted in the May 2021 R5 ballot.

5b. Project Ballot Type

N/A (project won’t go through ballot)

5c. Additional Ballot Info

This project will not go thru ballot as such, sets of resources that fall under this project will be balloted over the next few years.

5d. Joint Copyright

No

6b. Content Already Developed

70%

6c. Content externally developed?

No

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

No

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

BR&R WG members representing -- FDA, EMA, Health Canada, Vulcan, CODEx, NIH, CDISC, Implementation vendors, others, etc.
Pharmacy, O&O and CQI WGs

6g. Vendors

Pharmaceutical, EHR, PHR, Health Care IT, Lab, Other

6h. Providers

N/A

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

Version

7

Modifier

Smita Hastak

Modify Date

Apr 08, 2021 21:40

1a. Project Name

BR&R FHIR Resource Maintenance

1b. Project ID

1702

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

2b. Co-Sponsor WG

Orders & Observations

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor Update Periods

WGMs

2b. Co-Sponsor WG 2

Pharmacy

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor 2 Update Periods

WGMs

2d. Project Facilitator

BR&R Co-chairs

2e. Other Interested Parties (and roles)

CQI WG

2f. Modeling Facilitator

BR&R WG Members

2g. Publishing Facilitator

Rik Smithes, Hugh Glover, TBD

2i. Domain Expert Representative

BR&R WG Members

2j. Business Requirements Analyst

BR&R WG Members

2k. Conformance Facilitator

N/A

2m. Implementers

For Medication Definition Resources -- EMA, FDA, Health Canada
For Research related Resources - NIH, FDA, Vulcan projects, Others

3a. Project Scope

This is an umbrella project for the maintenance and development work to be done on all current and future FHIR Resources in the BR&R WG. As of Q1 2021, there are 16 FHIR resources that are in active development. The list and status of each is managed by BR&R here: https://confluence.hl7.org/pages/viewpage.action?pageId=97476291
Below is the list of current BR&R Resources -
Two (2) in Clinical Research:
ResearchStudy,
ResearchSubject

Fourteen (14) in Medication Definition: MedicinalProductDefinition, AdministrableProductDefinition, ClinicalUseIssue, Ingredient, ManufacturedItemDefinition, PackagedProductDefinition, RegulatedAuthorization, Substance, SubstanceDefinition, SubstanceNucleicAcid, SubstancePolymer, SubstanceProtein, SubstanceReferenceInformation, SubstanceSourceMaterial

The above list of resources may grow as BR&R explores and begins to support translation research use cases.

3b. Project Need

This is larger BR&R FHIR Resource development project and not specific to any one particular project use case or implementation needs. The larger need is to support development of FHIR specifications for research and regulatory driven use cases.

3c. Security Risk

No

3d. External Drivers

Regulatory entities -- EMA, US FDA, Health Canada; HL7 Accelerators -- Vulcan, CODEx; Other Research entities: US NIH

3e. Objectives/Deliverables and Target Dates

Objectives:
1. Develop FHIR Resources and related artifacts in support of research and regulatory requirements for data exchange.
2. Maintain the FHIR Resources
3. Support the FHIR Resources thru the balloting process

3f. Common Names / Keywords / Aliases:

Medication Definition, Research Resources, BR&R Resources

3g. Lineage

Partial lineage of Medication Definition resources -- Project # 1367, 1416

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

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

Using FHIR data types

3m. External Vocabularies

N/A

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

None

4a. Products

FHIR Extensions, FHIR Profiles, FHIR Resources

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

This project will not build FHIR IGs. It is an umbrella project to manage and maintain all BR&R FHIR Resources.

4c. FHIR Profiles Version

N/A

5a. Project Intent

Revise current standard, Supplement to a current standard

5a. Revising Current Standard Info

8 of the 16 BR&R FHIR resources are being balloted in R4B in March/April 2021. These are the Medication definition resources. 2 more resources (ResearchStudy and ResearchSubject) are planned to balloted in the May 2021 R5 ballot.

5b. Project Ballot Type

N/A (project won’t go through ballot)

5c. Additional Ballot Info

This project will not go thru ballot as such, sets of resources that fall under this project will be balloted over the next few years.

5d. Joint Copyright

No

6b. Content Already Developed

70%

6c. Content externally developed?

No

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

No

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

BR&R WG members representing -- FDA, EMA, Health Canada, Vulcan, CODEx, NIH, CDISC, Implementation vendors, others, etc.
Pharmacy, O&O and CQI WGs

6g. Vendors

Pharmaceutical, Health Care IT, Lab, Other

6h. Providers

N/A

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

Version

6

Modifier

Dave Hamill

Modify Date

Apr 08, 2021 15:55

1a. Project Name

BR&R FHIR Resource Maintenance

1b. Project ID

1702

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

2b. Co-Sponsor WG

Orders & Observations

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor Update Periods

WGMs

2b. Co-Sponsor WG 2

Pharmacy

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor 2 Update Periods

WGMs

2d. Project Facilitator

BR&R Co-chairs

2e. Other Interested Parties (and roles)

CQI WG

2i. Domain Expert Representative

BR&R WG Members

2j. Business Requirements Analyst

BR&R WG Members

2m. Implementers

For Medication Definition Resources -- EMA, FDA, Health Canada
For Research related Resources - NIH, FDA, Vulcan projects, Others

3a. Project Scope

This project is an umbrella project for the maintenance and development work to be done on all current and future FHIR Resources. in BR&R WG. As of Q1 2021, there are 16 FHIR resources that are in active development. The list and status of each is managed by BR&R here: https://confluence.hl7.org/pages/viewpage.action?pageId=97476291
Below is the list of current BR&R Resources -
Two (2) in Clinical Research:
ResearchStudy,
ResearchSubject

Fourteen (14) in Medication Definition: MedicinalProductDefinition, AdministrableProductDefinition, ClinicalUseIssue, Ingredient, ManufacturedItemDefinition, PackagedProductDefinition, RegulatedAuthorization, Substance, SubstanceDefinition, SubstanceNucleicAcid, SubstancePolymer, SubstanceProtein, SubstanceReferenceInformation, SubstanceSourceMaterial

The above list of resources may grow as BR&R explores and begins to support translation research use cases.

3b. Project Need

This is larger BR&R FHIR Resource development project and not specific to any one particular project use case or implementation needs. The larger need is to support development of FHIR specifications for research and regulatory driven use cases.

3c. Security Risk

No

3d. External Drivers

Regulatory entities -- EMA, US FDA, Health Canada; HL7 Accelerators -- Vulcan, CODEx; Other Research entities: US NIH

3e. Objectives/Deliverables and Target Dates

Objectives:
1. Develop FHIR Resources and related artifacts in support of research and regulatory requirements for data exchange.
2. Maintain the FHIR Resources
3. Support the FHIR Resources thru the balloting process

3f. Common Names / Keywords / Aliases:

Medication Definition, Research Resources, BR&R Resources

3g. Lineage

Partial lineage of Medication Definition resources -- Project # 1367, 1416

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

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

Using FHIR data types

3m. External Vocabularies

N/A

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

None

4a. Products

FHIR Extensions, FHIR Profiles, FHIR Resources

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

This project will not build FHIR IGs. It is an umbrella project to manage ad maintain all BR&R FHIR Resources.

4c. FHIR Profiles Version

N/A

5a. Project Intent

Revise current standard, Supplement to a current standard

5a. Revising Current Standard Info

8 of the 16 BR&R FHIR resources are being balloted in R4B in March/April 2021.

5b. Project Ballot Type

N/A (project won’t go through ballot)

5c. Additional Ballot Info

This project will not go thru ballot as such, sets of resources that fall under this project will be balloted over the next few years.

5d. Joint Copyright

No

6b. Content Already Developed

70%

6c. Content externally developed?

No

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

No

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

BR&R WG members representing -- FDA, EMA, Health Canada, Vulcan, CODEx, NIH, CDISC, Implementation vendors, others, etc.
Pharmacy, O&O and CQI WGs

6g. Vendors

Pharmaceutical, Health Care IT, Lab, Other

6h. Providers

N/A

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

Version

5

Modifier

Smita Hastak

Modify Date

Apr 07, 2021 14:49

1a. Project Name

BR&R FHIR Resource Maintenance

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

2b. Co-Sponsor WG

Orders & Observations

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor Update Periods

WGMs

2b. Co-Sponsor WG 2

Pharmacy

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor 2 Update Periods

WGMs

2d. Project Facilitator

BR&R Co-chairs

2e. Other Interested Parties (and roles)

CQI WG

2i. Domain Expert Representative

BR&R WG Members

2j. Business Requirements Analyst

BR&R WG Members

2m. Implementers

For Medication Definition Resources -- EMA, FDA, Health Canada
For Research related Resources - NIH, FDA, Vulcan projects, Others

3a. Project Scope

This project is an umbrella project for the maintenance and development work to be done on all current and future FHIR Resources. in BR&R WG. As of Q1 2021, there are 16 FHIR resources that are in active development. The list and status of each is managed by BR&R here: https://confluence.hl7.org/pages/viewpage.action?pageId=97476291
Below is the list of current BR&R Resources -
Two (2) in Clinical Research:
ResearchStudy,
ResearchSubject

Fourteen (14) in Medication Definition: MedicinalProductDefinition, AdministrableProductDefinition, ClinicalUseIssue, Ingredient, ManufacturedItemDefinition, PackagedProductDefinition, RegulatedAuthorization, Substance, SubstanceDefinition, SubstanceNucleicAcid, SubstancePolymer, SubstanceProtein, SubstanceReferenceInformation, SubstanceSourceMaterial

The above list of resources may grow as BR&R explores and begins to support translation research use cases.

3b. Project Need

This is larger BR&R FHIR Resource development project and not specific to any one particular project use case or implementation needs. The larger need is to support development of FHIR specifications for research and regulatory driven use cases.

3c. Security Risk

No

3d. External Drivers

Regulatory entities -- EMA, US FDA, Health Canada; HL7 Accelerators -- Vulcan, CODEx; Other Research entities: US NIH

3e. Objectives/Deliverables and Target Dates

Objectives:
1. Develop FHIR Resources and related artifacts in support of research and regulatory requirements for data exchange.
2. Maintain the FHIR Resources
3. Support the FHIR Resources thru the balloting process

3f. Common Names / Keywords / Aliases:

Medication Definition, Research Resources, BR&R Resources

3g. Lineage

Partial lineage of Medication Definition resources -- Project # 1367, 1416

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

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

Using FHIR data types

3m. External Vocabularies

N/A

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

None

4a. Products

FHIR Extensions, FHIR Profiles, FHIR Resources

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

This project will not build FHIR IGs. It is an umbrella project to manage ad maintain all BR&R FHIR Resources.

4c. FHIR Profiles Version

N/A

5a. Project Intent

Revise current standard, Supplement to a current standard

5a. Revising Current Standard Info

8 of the 16 BR&R FHIR resources are being balloted in R4B in March/April 2021.

5b. Project Ballot Type

N/A (project won’t go through ballot)

5c. Additional Ballot Info

This project will not go thru ballot as such, sets of resources that fall under this project will be balloted over the next few years.

5d. Joint Copyright

No

6b. Content Already Developed

70%

6c. Content externally developed?

No

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

No

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

BR&R WG members representing -- FDA, EMA, Health Canada, Vulcan, CODEx, NIH, CDISC, Implementation vendors, others, etc.
Pharmacy, O&O and CQI WGs

6g. Vendors

Pharmaceutical, Health Care IT, Lab, Other

6h. Providers

N/A

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

Version

4

Modifier

Smita Hastak

Modify Date

Apr 06, 2021 14:10

1a. Project Name

BR&R FHIR Resource Maintenance

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

2b. Co-Sponsor WG

Orders & Observations

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor Update Periods

WGMs

2b. Co-Sponsor WG 2

Pharmacy

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor 2 Update Periods

WGMs

2d. Project Facilitator

BR&R Co-chairs

2e. Other Interested Parties (and roles)

CQI WG

2i. Domain Expert Representative

BR&R WG Members

2j. Business Requirements Analyst

BR&R WG Members

2m. Implementers

For Medication Definition Resources -- EMA, FDA, Health Canada
For Research related Resources - NIH, FDA, Vulcan projects, Others

3a. Project Scope

BR&R has 16 FHIR resources that are in active development. This project is an umbrella project for the maintenance and development work to be done on all 16 resources.The list and status of each is managed by BR&R here: https://confluence.hl7.org/pages/viewpage.action?pageId=97476291

Two in Clinical Research: ResearchStudy, ResearchSubject

Fourteen in Medication Definition: MedicinalProductDefinition, AdministrableProductDefinition, ClinicalUseIssue, Ingredient, ManufacturedItemDefinition, PackagedProductDefinition, RegulatedAuthorization, Substance, SubstanceDefinition, SubstanceNucleicAcid, SubstancePolymer, SubstanceProtein, SubstanceReferenceInformation, SubstanceSourceMaterial

3b. Project Need

This is larger BR&R FHIR Resource development project and not specific to any one particular project use case or implementation needs. The larger need is to support development of FHIR specifications for research and regulatory driven use cases.

3c. Security Risk

No

3d. External Drivers

Regulatory entities -- EMA, US FDA, Health Canada; HL7 Accelerators -- Vulcan, CODEx; Other Research entities: US NIH

3e. Objectives/Deliverables and Target Dates

Objectives:
1. Develop FHIR Resources and related artifacts in support of research and regulatory requirements for data exchange.
2. Maintain the FHIR Resources
3. Support the FHIR Resources thru the balloting process

3f. Common Names / Keywords / Aliases:

Medication Definition, Research Resources, BR&R Resources

3g. Lineage

Partial lineage of Medication Definition resources -- Project # 1367, 1416

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

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

Using FHIR data types

3m. External Vocabularies

N/A

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

None

4a. Products

FHIR Extensions, FHIR Profiles, FHIR Resources

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

This project will not build FHIR IGs. It is an umbrella project to manage ad maintain all BR&R FHIR Resources.

4c. FHIR Profiles Version

N/A

5a. Project Intent

Revise current standard, Supplement to a current standard

5a. Revising Current Standard Info

8 of the 16 BR&R FHIR resources are being balloted in R4B in March/April 2021.

5b. Project Ballot Type

N/A (project won’t go through ballot)

5c. Additional Ballot Info

This project will not go thru ballot as such, sets of resources that fall under this project will be balloted over the next few years.

5d. Joint Copyright

No

6b. Content Already Developed

70%

6c. Content externally developed?

No

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

No

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

BR&R WG members representing -- FDA, EMA, Health Canada, Vulcan, CODEx, NIH, CDISC, Implementation vendors, others, etc.
Pharmacy, O&O and CQI WGs

6g. Vendors

Pharmaceutical, Health Care IT, Lab, Other

6h. Providers

N/A

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

Version

3

Modifier

Smita Hastak

Modify Date

Apr 06, 2021 14:06

1a. Project Name

BR&R FHIR Resource Maintenance

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

2b. Co-Sponsor WG

Orders & Observations

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor Update Periods

WGMs

2b. Co-Sponsor WG 2

Pharmacy

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor 2 Update Periods

WGMs

2d. Project Facilitator

BR&R Co-chairs

2e. Other Interested Parties (and roles)

CQI WG

2i. Domain Expert Representative

BR&R WG Members

2j. Business Requirements Analyst

BR&R WG Members

2m. Implementers

For Medication Definition Resources -- EMA, FDA, Health Canada
For Research related Resources - NIH, FDA, Vulcan projects, Others

3a. Project Scope

BR&R has 16 FHIR resources that are in active development. This project is an umbrella project for the maintenance and development work to be done on all 16 resources.The list and status of each is managed by BR&R here: https://confluence.hl7.org/pages/viewpage.action?pageId=97476291

Two in Clinical Research: ResearchStudy, ResearchSubject

Fourteen in Medication Definition: MedicinalProductDefinition, AdministrableProductDefinition, ClinicalUseIssue, Ingredient, ManufacturedItemDefinition, PackagedProductDefinition, RegulatedAuthorization, Substance, SubstanceDefinition, SubstanceNucleicAcid, SubstancePolymer, SubstanceProtein, SubstanceReferenceInformation, SubstanceSourceMaterial

3b. Project Need

This is larger BR&R FHIR Resource development project and not specific to any one particular project use case or implementation needs. The larger need is to support development of FHIR specifications for research and regulatory driven use cases.

3c. Security Risk

No

3d. External Drivers

Regulatory entities -- EMA, FDA, Health Canada; HL7 Acclerators -- Vulcan, CODEx

3e. Objectives/Deliverables and Target Dates

Objectives:
1. Develop FHIR Resources and related artifacts in support of research and regulatory requirements for data exchange.
2. Maintain the FHIR Resources
3. Support the FHIR Resources thru the balloting process

3f. Common Names / Keywords / Aliases:

Medication Definition, Research Resources, BR&R Resources

3g. Lineage

Partial lineage of Medication Definition resources -- Project # 1367, 1416

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

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

Using FHIR data types

3m. External Vocabularies

N/A

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

None

4a. Products

FHIR Extensions, FHIR Profiles, FHIR Resources

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

This project will not build FHIR IGs. It is an umbrella project to manage ad maintain all BR&R FHIR Resources.

4c. FHIR Profiles Version

N/A

5a. Project Intent

Revise current standard, Supplement to a current standard

5a. Revising Current Standard Info

8 of the 16 BR&R FHIR resources are being balloted in R4B in March/April 2021.

5b. Project Ballot Type

N/A (project won’t go through ballot)

5c. Additional Ballot Info

This project will not go thru ballot as such, sets of resources that fall under this project will be balloted over the next few years.

5d. Joint Copyright

No

6b. Content Already Developed

70%

6c. Content externally developed?

No

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

No

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

BR&R WG members representing -- FDA, EMA, Health Canada, Vulcan, CODEx, NIH, CDISC, Implementation vendors, others, etc.
Pharmacy, O&O and CQI WGs

6g. Vendors

Pharmaceutical, Health Care IT, Lab, Other

6h. Providers

N/A

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

Version

2

Modifier

Smita Hastak

Modify Date

Apr 06, 2021 03:22

1a. Project Name

BR&R FHIR Resource Maintenance

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

2b. Co-Sponsor WG

Orders & Observations

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor Update Periods

WGMs

2b. Co-Sponsor WG 2

Pharmacy

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor 2 Update Periods

WGMs

2d. Project Facilitator

BR&R Co-chairs

2e. Other Interested Parties (and roles)

CQI WG

2h. Vocabulary Facilitator

N/A

2i. Domain Expert Representative

BR&R WG Members

2j. Business Requirements Analyst

BR&R WG Members

2m. Implementers

For Medication Definition Resources -- EMA, FDA, Health Canada
For Research related Resources - FDA, VULCAN projects, Others

3a. Project Scope

BR&R has 16 FHIR resources that are in active development. This project is an umbrella project for the maintenance and development work to be done on all 16 resources.The list and status of each is managed by BR&R here: https://confluence.hl7.org/pages/viewpage.action?pageId=97476291

Two in Clinical Research: ResearchStudy, ResearchSubject

Fourteen in Medication Definition: MedicinalProductDefinition, AdministrableProductDefinition, ClinicalUseIssue, Ingredient, ManufacturedItemDefinition, PackagedProductDefinition, RegulatedAuthorization, Substance, SubstanceDefinition, SubstanceNucleicAcid, SubstancePolymer, SubstanceProtein, SubstanceReferenceInformation, SubstanceSourceMaterial

3b. Project Need

This is larger BR&R FHIR Resource development project and not specific to any one particular project use case or implementation needs. The larger need is to support development of FHIR specifications for research and regulatory driven use cases.

3c. Security Risk

No

3d. External Drivers

Regulatory entities -- EMA, FDA, Health Canada; HL7 Acclerators -- Vulcan, CODEx

3e. Objectives/Deliverables and Target Dates

Objectives:
1. Develop FHIR Resources and related artifacts in support of research and regulatory requirements for data exchange.
2. Maintain the FHIR Resources
3. Support the FHIR Resources thru the balloting process

3f. Common Names / Keywords / Aliases:

Medication Definition, Research Resources, BR&R Resources

3g. Lineage

Partial lineage of Medication Definition resources -- Project # 1367, 1416

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

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

Using FHIR data types

3m. External Vocabularies

N/A

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

None

4a. Products

FHIR Extensions, FHIR Profiles, FHIR Resources

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

This project will not build FHIR IGs. It is an umbrella project to manage ad maintain all BR&R FHIR Resources.

4c. FHIR Profiles Version

N/A

5a. Project Intent

Revise current standard, Supplement to a current standard

5a. Revising Current Standard Info

8 of the 16 BR&R FHIR resources are being balloted in R4B in March/April 2021.

5b. Project Ballot Type

N/A (project won’t go through ballot)

5c. Additional Ballot Info

This project will not go thru ballot as such, sets of resources that fall under this project will be balloted over the next few years.

5d. Joint Copyright

No

6b. Content Already Developed

70%

6c. Content externally developed?

No

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

No

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

BR&R WG members representing -- FDA, EMA, Health Canada, Vulcan, CODEx, NIH, CDISC, Implementation vendors, others, etc.
Pharmacy, O&O and CQI WGs

6g. Vendors

Pharmaceutical, Health Care IT, Lab, Other

6h. Providers

N/A

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

Version

1

Modifier

Smita Hastak

Modify Date

Apr 06, 2021 01:54

1a. Project Name

BR&R FHIR Resource Maintenance

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

2b. Co-Sponsor WG

Orders & Observations

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor Update Periods

WGMs

2b. Co-Sponsor WG 2

Pharmacy

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor 2 Update Periods

WGMs

2d. Project Facilitator

BR&R Co-chairs

2e. Other Interested Parties (and roles)

CQI WG

2h. Vocabulary Facilitator

N/A

2i. Domain Expert Representative

BR&R WG Members

2j. Business Requirements Analyst

BR&R WG Members

2m. Implementers

For Medication Definition Resources -- EMA, FDA, Health Canada
For Research related Resources - FDA, VULCAN projects, Others

3a. Project Scope

BR&R has 16 FHIR resources that are in active development. This project is an umbrella project for the maintenance and development work to be done on all 16 resources.The list and status of each is managed by BR&R here: https://confluence.hl7.org/pages/viewpage.action?pageId=97476291

Two in Clinical Research: ResearchStudy, ResearchSubject

Fourteen in Medication Definition: MedicinalProductDefinition, AdministrableProductDefinition, ClinicalUseIssue, Ingredient, ManufacturedItemDefinition, PackagedProductDefinition, RegulatedAuthorization, Substance, SubstanceDefinition, SubstanceNucleicAcid, SubstancePolymer, SubstanceProtein, SubstanceReferenceInformation, SubstanceSourceMaterial

3b. Project Need

This is larger BR&R FHIR Resource development project and not specific to any one particular project use case or implementation needs. The larger need is to support development of FHIR specifications for research and regulatory driven use cases.

3c. Security Risk

No

3d. External Drivers

Regulatory entities -- EMA, FDA, Health Canada; HL7 Acclerators -- Vulcan, CODEx

3e. Objectives/Deliverables and Target Dates

Objectives:
1. Develop FHIR Resources and related artifacts in support of research and regulatory requirements for data exchange.
2. Maintain the FHIR Resources
3. Support the FHIR Resources thru the balloting process

3f. Common Names / Keywords / Aliases:

Medication Definition, Research Resources, BR&R Resources

3g. Lineage

Partial lineage of Medication Definition resources -- Project # 1367, 1416

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

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

Using FHIR data types

3m. External Vocabularies

N/A

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

None

4a. Products

FHIR Extensions, FHIR Profiles, FHIR Resources

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

This project will not build FHIR IGs. It is an umbrella project to manage ad maintain all BR&R FHIR Resources.

4c. FHIR Profiles Version

N/A

5a. Project Intent

Create new standard

5b. Project Ballot Type

N/A (project won’t go through ballot)

5d. Joint Copyright

No

6b. Content Already Developed

70%

6c. Content externally developed?

No

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

No

6f. Stakeholders

Regulatory Agency, Other

6f. Other Stakeholders

BR&R WG members representing -- FDA, EMA, Health Canada, Vulcan, CODEx, NIH, CDISC, Implementation vendors, others, etc.
Pharmacy, O&O and CQI WGs

6g. Vendors

Pharmaceutical, Health Care IT, Lab, Other

6h. Providers

N/A

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR