PSS - HL7 Clinical Genomics Domain Information Model

1a. Project Name HL7 Clinical Genomics Domain Information Model(s) 1b. Project ID 1050 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 Clinical Genomics 2d. Project Facilitator Robert Freimuth 2e. Other Interested Parties (and roles) 2f. Modeling Facilitator 2g. Publishing Facilitator 2h. Vocabulary Facilitator 2i. Domain Expert Representative 2j. Business Requirements Analyst 2k. Conformance Facilitator 2l. Other Facilitators 2m. Implementers 3a. Project Scope Throughout the past decade, the HL7 Clinical Genomics has been developing various artifacts (e.g., informative, DSTU and normative specifications), domain analysis models, storyboards, etc. The approved/trialed/proposed specifications are of different HL7 flavors, i.e., v3, v2, CDA and recently FHIR. These artifacts share some common view of clinical genomic data, but lack semantic alignment at the modeling level. Therefore, it is crucial to have agreed-upon Clinical Genomics Domain Information Model(s) (CG DIMs), which have the following functions: 1. The CG DIMs reflect the results of the Domain Analysis Model efforts 2. The CG DIMs serve as a single source of semantics with which all standard specifications are aligned 3. The CG DIMs are represented in an HL7 standards-independent format, e.g., plain UML 4. The CG DIMs are Universal and do not mandate binding to specific vocabularies (these bindings could be present in realm-specific versions of the actual standard specifications) Attachments 3b. Project Need The need for this project stems from lack of Clinical Genomics Domain Information Model(s), as well as from lack of alignment across the current HL7 Clinical Genomics specifications. 3c. Security Risk No 3d. External Drivers 3e. Objectives/Deliverables and Target Dates Draft Domain Information Model [2019 07] Comments Only Ballot [2019 09] Normative Ballot [2021 01] 3f. Common Names / Keywords / Aliases: CG IM 3g. Lineage 3h. Project Dependencies 3i. HL7-Managed Project Document Repository URL: http://wiki.hl7.org/index.php?title=Clinical_Genomics_Domain_Information_Model(s)_Project 3j. Backwards Compatibility No 3k. Additional Backwards Compatibility Information (if applicable) 3l. Using Current V3 Data Types? N/A 3l. Reason for not using current V3 data types? 3m. External Vocabularies Yes 3n. List of Vocabularies Relevant domain vocabularies will be provided in the model as examples, but as this is not an implementation specification no formal binding is needed. 3o. Earliest prior release and/or version to which the compatibility applies 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 Create new 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 Comment (aka Comment-Only) 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 The modeling done as part of this project is being coordinated with similar work done by GA4GH. 6b. Content Already Developed 30% 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, Standards Development Organizations (SDOs) 6f. Other Stakeholders 6g. Vendors EHR, PHR, Clinical Decision Support Systems, Lab 6g. Other Vendors 6h. Providers Clinical and Public Health Laboratories 6h. Other Providers 6i. Realm Universal 7d. US Realm Approval Date 7a. Management Group(s) to Review PSS 7b. Sponsoring WG Approval Date May 03, 2016 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 7j. TSC Approval Date