PSS - Regulated Product Submission R2 (Reaffirmation)

1a. Project Name Regulated Product Submission R2 (Reaffirmation) 1b. Project ID 1577 1c. Is Your Project an Investigative Project (aka PSS-Lite)? No 1d. Is your Project Artifact being Reaffirmed or proceeding to Normative directly after being either Informative or STU? No 1e. Today's Date 1f. Name of standard being reaffirmed HL7 Version 3 Standard: Regulated Studies; Regulated Product Submissions (RPS), Release 2 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 Clinical Decision Support 2d. Project Facilitator Mark Gray 2e. Other Interested Parties (and roles) ICH M8 - eCTD Regulatory and Industry Parties 2f. Modeling Facilitator Marti Velezis 2g. Publishing Facilitator Marti Velezis 2h. Vocabulary Facilitator 2i. Domain Expert Representative Mark Gray 2j. Business Requirements Analyst Marti Velezis 2k. Conformance Facilitator 2l. Other Facilitators 2m. Implementers 3a. Project Scope Reaffirmation Ballot - no changes to standard Attachments 3b. Project Need Reaffirmation of the standard 3c. Security Risk No 3d. External Drivers 3e. Objectives/Deliverables and Target Dates No changes to ballot content. submit for reaffirmation May 2020 Ballot reconciliation at the May WGM and publishing thereafter 3f. Common Names / Keywords / Aliases: RPS, Regulated Product Submission 3g. Lineage 3h. Project Dependencies 3i. HL7-Managed Project Document Repository URL: https://confluence.hl7.org/pages/viewpage.action?pageId=66923135 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 No 3n. List of Vocabularies 3o. Earliest prior release and/or version to which the compatibility applies 4a. Products V3 Messages - Clinical 4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to? 4c. FHIR Profiles Version 4d. Please define your New Product Definition 4d. Please define your New Product Family 5a. Project Intent Reaffirmation of a standard 5a. White Paper Type 5a. Is the project adopting/endorsing an externally developed IG? 5a. Externally developed IG is to be (select one) 5a. Specify external organization 5a. Revising Current Standard Info 5b. Project Ballot Type Normative (no STU) 5c. Additional Ballot Info 5d. Joint Copyright 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? 6d. List Developers of Externally Developed Content 6e. Is this a hosted (externally funded) project? 6f. Stakeholders Clinical and Public Health Laboratories, Regulatory Agency 6f. Other Stakeholders 6g. Vendors Pharmaceutical, Other 6g. Other Vendors Other Regulated Products (e.g., devices, foods, etc) 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 14, 2019 7j. TSC Approval Date