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BR and R FHIR Resource Maintenance

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Basics

BR and R FHIR Resource Maintenance

1702
- Other -


FHIR Profile

Revise Current Standard, Supplement to a Current Standard

Details

This project is an umbrella project for the maintenance and development work to be done on all current and future FHIR Resources. in BRR WG. As of Q1 2021, there are 16 FHIR resources that are in active development. The list and status of each is managed by BRR here: https://confluence.hl7.org/pages/viewpage.action?pageId=97476291

Below is the list of current BRR 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.


This is larger BRR 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.



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





Regulatory Agency, Standards Development Organizations (SDOs), Other (specify in Misc. Notes below),Pharmaceutical; Health Care IT; Lab

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


Medication Definition, Research Resources, BRR Resources

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

N/A


No

This project addresses work originally under Projects 1367, 1416. Other Stakeholders: BRR WG members representing -- FDA, EMA, Health Canada, Vulcan, CODEx, NIH, CDISC, Implementation vendors, others, etc., Pharmacy, OO and CQI WGs
Organization & Realm

Universal

People

BRR CoChairs



Biomedical Research and Regulation Work Group

Clinical Quality Information Work Group; Orders and Observations Work Group; Pharmacy Work Group

Status & Dates

Active

Active Project (Resources assigned to pjt)

04/13/2021

09/01/2033

2033 Sept WGM/Ballot

09/01/2033

2033 Sept WGM/Ballot

Approvals

03/21/2022


Not Needed


All Received




System Info



View Ballot Items (with NIBs)




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