BRIDG 2020 Update

1a. Project Name BRIDG 2020 Update 1b. Project ID 1574 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 Smita Hastak 2e. Other Interested Parties (and roles) 2f. Modeling Facilitator Wendy Ver Hoef 2g. Publishing Facilitator Myron Finseth 2h. Vocabulary Facilitator Julie James 2i. Domain Expert Representative HL7 BR&R Members, CDISC, NCI and FDA domain experts 2j. Business Requirements Analyst 2k. Conformance Facilitator 2l. Other Facilitators 2m. Implementers 3a. Project Scope Changes are made to the BRIDG model based on work planned by FDA and NCI - we know there will be work, but at this point we are unclear what that will be. It will be similar in scope to that of previous releases. As an illustration BRIDG 5.3 was concerned with adding imaging semantics and updating a mapping; 5.2 was concerned with updates for anatomic pathology and specimen DAM modelling. The full release history is here: https://bridgmodel.nci.nih.gov/bridg-news#bridgrelease5.3.1. Any work of a greater scope than previously seen will be subject to separate approval. Attachments 3b. Project Need The BRIDG model is subject to an annual revision - this PSS covers the revision in 2020 3c. Security Risk No 3d. External Drivers 3e. Objectives/Deliverables and Target Dates Ballot for May 2020 ballot resolution Publish Autumn 2020 3f. Common Names / Keywords / Aliases: BRIDG, BRIDG Model, Biomedical Research Integrated Domain Group Model 3g. Lineage New model version will replace previous model version. 3h. Project Dependencies 3i. HL7-Managed Project Document Repository URL: https://confluence.hl7.org/display/BRR/BRIDG+Model 3j. Backwards Compatibility Yes 3k. Additional Backwards Compatibility Information (if applicable) 3l. Using Current V3 Data Types? Yes 3l. Reason for not using current V3 data types? 3m. External Vocabularies 3n. List of Vocabularies 3o. Earliest prior release and/or version to which the compatibility applies BRIDG 5.3.1 4a. Products Domain Analysis Model (DAM) 4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to? 4c. FHIR Profiles Version 4d. Please define your New Product Definition 4d. Please define your New Product Family 5a. Project Intent Revise 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 BRIDG 5.3.1 5b. Project Ballot Type Informative 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 6c. Content externally developed? No 6d. List Developers of Externally Developed Content 6e. Is this a hosted (externally funded) project? 6f. Stakeholders Regulatory Agency, Standards Development Organizations (SDOs) 6f. Other Stakeholders 6g. Vendors Pharmaceutical, EHR, PHR, Health Care IT, Clinical Decision Support Systems, Lab, HIS, Other 6g. Other Vendors Clinical Research Organisations 6h. Providers 6h. Other Providers 6i. Realm Universal 7d. US Realm Approval Date 7a. Management Group(s) to Review PSS 7b. Sponsoring WG Approval Date Oct 01, 2019 7c. Co-Sponsor Approval Date 7c. Co-Sponsor 2 Approval Date 7c. Co-Sponsor 3 Approval Date 7c. Co-Sponsor 4 Approval Date 7c. Co-Sponsor 5 Approval Date 7c. Co-Sponsor 6 Approval Date 7c. Co-Sponsor 7 Approval Date 7c. Co-Sponsor 8 Approval Date 7c. Co-Sponsor 9 Approval Date 7c. Co-Sponsor 10 Approval Date 7e. CDA MG Approval Date 7f. FMG Approval Date 7g. V2 MG Approval Date 7h. Architecture Review Board Approval Date 7i. Steering Division Approval Date Oct 29, 2019 7j. TSC Approval Date