Reaffirm HL7 Version 3 Standard: Implantable Device Cardiac - Follow-up Device Summary, Release 2

1a. Project Name Reaffirm HL7 Version 3 Standard: Implantable Device Cardiac - Follow-up Device Summary, Release 2 1b. Project ID 1362 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 Oct 23, 2019 1f. Name of standard being reaffirmed HL7 Version 3 Standard: Implantable Device Cardiac - Follow-up Device Summary, Release 2 1g. Project Artifact Information A project artifact is balloting Normative (no STU) (this includes reaffirmations) 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 Orders & Observations 2b. Co-Sponsor WG Health Care Devices 2d. Project Facilitator Lorraine Constable 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 The therapeutic devices domain comprises the models, messages, and other artifacts that are needed to support messaging related to therapy delivery and observations made by a medical device. Currently, the scope has been focused only on implantable cardiac devices (pacemakers, defibrillators, etc.). This message is related to the follow-up of an Implantable Cardiac Device (pacemaker, defibrillator, etc.) that will contain a subset of device observations, current device therapy settings and device diagnostic information. Attachments 3b. Project Need To enable a standardized device report format to be used across the (Implantable Device Cardiac) IDC sector. Users: IDC industry and cardiologists/cardiac technicians. 3c. Security Risk 3d. External Drivers 3e. Objectives/Deliverables and Target Dates The earliest ballot cycle the TSC will allow - either Feb2020 or May 2020 3f. Common Names / Keywords / Aliases: 3g. Lineage 3h. Project Dependencies 3i. HL7-Managed Project Document Repository URL: http://www.hl7.org/implement/standards/product_brief.cfm?product_id=41 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 Yes 3n. List of Vocabularies Uses IEEE 11073-10103 standardised IDC terminology 3o. Earliest prior release and/or version to which the compatibility applies 4a. Products V2 Messages - Clinical, 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 reaffirmation 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 6f. Other Stakeholders 6g. Vendors Health Care IT 6g. Other Vendors 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 24, 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 Nov 07, 2019 7j. TSC Approval Date