SDPi+FHIR Device Interoperability

1a. Project Name SDPi+FHIR Device Interoperability 1b. Project ID 1545 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 Health Care Devices 2b. Co-Sponsor WG Mobile Health 2c. Co-Sponsor Level of Involvement Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.) 2d. Project Facilitator Todd Cooper 2e. Other Interested Parties (and roles) Ken Fuchs (...) John Garguilo (...) John Rhoads (...) Stefan Schlichting (...) 2f. Modeling Facilitator 2g. Publishing Facilitator 2h. Vocabulary Facilitator Christoph Gessner 2i. Domain Expert Representative David Gregorcyzk 2j. Business Requirements Analyst 2k. Conformance Facilitator Michael Faughn 2l. Other Facilitators 2m. Implementers Dräger Medical IHE Devices Philips Healthcare OR.NET 3a. Project Scope Application of IEEE 11073 Service-oriented Device Connectivity (SDC) standards with HL7 FHIR to support medical and health device interoperability across multiple use contexts and applications that interact with and consume information from devices. This includes regulated (medical) and non-regulated (health) devices. Software as a Medical Device (SAMD) and health apps are to be supported. Devices on FHIR implementation guides will be created and / or updated, as well as IHE Devices profiles created. Educational and similar materials will also be created as appropriate. Attachments 3b. Project Need Device informatics / interoperability standardization has been progressing in parallel within HL7 Devices, IHE Devices, and IEEE 11073 Standards Committee. Although these efforts are generally well coordinated, there is an increasing need to ensure strong linkages between the specifications, especially between FHIR and IEEE 11073 SDC. The latter is tailored for the most acute, medical grade device connectivity applications (e.g., operating room and ICU), including service-oriented plug-and-play and medical content reporting, alerting and external control (including closed-loop clinical apps/SAMD). FHIR supports interoperability across the broad landscape of health information exchange, including integration of device-sourced content and services. This project ensures the coordinated and cohesive development of FHIR profiles, extensions and implementation guides, as well as SDC-based IHE profiles to enable the next generation of device interoperability standardization. 3c. Security Risk Yes 3d. External Drivers IHE Connectathon events in Europe & North America (2020/2021) 3e. Objectives/Deliverables and Target Dates Kick-off @ 2020 May WGM First Drafts by end 2020 3f. Common Names / Keywords / Aliases: FHIR, SDC, IEEE 11073, device, health software, SAMD, SOA, web services 3g. Lineage Devices on FHIR (PoCD & PHD) IG projects 3h. Project Dependencies None identified. 3i. HL7-Managed Project Document Repository URL: https://confluence.hl7.org/pages/viewpage.action?pageId=66926431#DeviceInteroperabilityusingSDPi+FHIR-SDPi+FHIRDocuments 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 ISO/IEEE 11073-10101 and related (11073-1010x) LOINC SNOMED-CT 3o. Earliest prior release and/or version to which the compatibility applies N/A 4a. Products FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, FHIR Resources, Guidance (e.g. Companion Guide, Cookbook, etc), Non Product Project - (Educ. Marketing, Elec. Services, etc.), White Paper 4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to? R4 4c. FHIR Profiles Version DoF PoCD IG (version 0.4) 4d. Please define your New Product Definition 4d. Please define your New Product Family 5a. Project Intent White Paper, Implementation Guide (IG) will be created/modified 5a. White Paper Type Balloted Informative 5a. Is the project adopting/endorsing an externally developed IG? No 5a. Externally developed IG is to be (select one) Adopted 5a. Specify external organization HL7-IHE Gemini MDI Project IHE Devices IEEE 11073 Standards Committee / PoCD WG 5a. Revising Current Standard Info 5b. Project Ballot Type STU to Normative 5c. Additional Ballot Info 5d. Joint Copyright Yes 5e. I understand I must submit a Joint Copyright Letter of Agreement to the TSC in order for the PSS to receive TSC approval. Yes 6a. External Project Collaboration Materials created in this project will integrate work being advanced in IEEE 11073 standards as well as IHE profiles related to Service-oriented Device Connectivity (SDC), namely Service-oriented Device Point-of-care Interoperability (SDPi) profiles. 6b. Content Already Developed 50% 6c. Content externally developed? No 6d. List Developers of Externally Developed Content Todd Cooper 6e. Is this a hosted (externally funded) project? No 6f. Stakeholders Regulatory Agency, Standards Development Organizations (SDOs) 6f. Other Stakeholders 6g. Vendors EHR, PHR, Equipment, Health Care IT, Clinical Decision Support Systems, Lab, HIS 6g. Other Vendors 6h. Providers Emergency Services, Healthcare Institutions (hospitals, long term care, home care, mental health) 6h. Other Providers 6i. Realm Universal 7d. US Realm Approval Date 7a. Management Group(s) to Review PSS FHIR 7b. Sponsoring WG Approval Date Sep 22, 2020 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