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  1. Project Scope Statements/Proposals
  2. PSS-1980

Gemini Safe, Effective & Secure Medical Device Interoperability (SES+MDI)

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    • Icon: Project Scope Statement Project Scope Statement
    • Resolution: Done
    • Icon: Medium Medium
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      Device informatics / interoperability standardization has been progressing in parallel within HL7 Devices, IHE Devices, and IEEE 11073 standards committees. 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 (Service-oriented Device Connectivity), which provides a service-oriented device-to-device plug-and-trust architecture. The latter is tailored for the most acute, medical grade device connectivity applications (e.g., operating room and ICU), incorporating  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. The project will include the development of HL7 V2 "gateway" profiles / implementation guides such as the IHE DEV Device-Enterprise Communication (DEC) profile and the Alert Communication (ACM) profile.  This project ensures the coordinated and cohesive development of FHIR profiles, extensions and implementation guides, as well as IEEE 11073 SDC-based IHE profiles to enable the next generation of device interoperability standardization.

      Show
      Device informatics / interoperability standardization has been progressing in parallel within HL7 Devices, IHE Devices, and IEEE 11073 standards committees. 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 (Service-oriented Device Connectivity), which provides a service-oriented device-to-device plug-and-trust architecture. The latter is tailored for the most acute, medical grade device connectivity applications (e.g., operating room and ICU), incorporating  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. The project will include the development of HL7 V2 "gateway" profiles / implementation guides such as the IHE DEV Device-Enterprise Communication (DEC) profile and the Alert Communication (ACM) profile.  This project ensures the coordinated and cohesive development of FHIR profiles, extensions and implementation guides, as well as IEEE 11073 SDC-based IHE profiles to enable the next generation of device interoperability standardization.
    • Devices
    • Orders & Observations
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      IHE-HL7 Gemini SES+MDI team members
      HL7 DEV / Devices on FHIR team members

      John Rhoads, Martin Rosner, Peter Kranich, Andy Iverson, Javier Espina Perez, David Gregorczyk, Ken Fuchs
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      IHE-HL7 Gemini SES+MDI team members HL7 DEV / Devices on FHIR team members John Rhoads, Martin Rosner, Peter Kranich, Andy Iverson, Javier Espina Perez, David Gregorczyk, Ken Fuchs
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      OR.NET (Germany-based consortium)
      Dräger Medical
      Philips Healthcare
      Medtronic
      Others active in the HL7 & IHE Devices WGs
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      OR.NET (Germany-based consortium) Dräger Medical Philips Healthcare Medtronic Others active in the HL7 & IHE Devices WGs
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      National recommendation for support of safe, effective & secure interoperable medical devices (e.g., Germany, U.S.).
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      National recommendation for support of safe, effective & secure interoperable medical devices (e.g., Germany, U.S.).
    • Filter by
      Product Family Product Project Intent Lineage Ballot Type Target Cycle Actions
      1
      FHIR
      Implementation Guide
      Create New R1 Standard
       
      STU
      January 2023
      2
      V2
      Implementation Guide
      Create New R1 Standard
       
      STU
      January 2024
      3
      Other
      White Paper/Guidance
      Other
       
      Informative
      May 2023
    • SES+MDI
    • Hide
      Coordination with IHE Devices (SDPi Supplement)
      Coordination with IEEE 11073 SDC standards
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      Coordination with IHE Devices (SDPi Supplement) Coordination with IEEE 11073 SDC standards
    • Yes
    • Yes
    • Hide
      IHE Devices (this is a Gemini project approved by the steering committee May 2020)

      IHE Devices Domain Device Point-of-Care Interoperability (IHE DEV/DPI) Program
      IEEE 11073 Point-of-Care Device (PoCD) Working Group
      ISO TC215/WG 2 Health Informatics / Systems & Device Interoperability
      ISO/TC215 & IEC/SC62A Joint Working Group 7 (JWG7) Health software and health IT systems safety, effectiveness and security

      Materials created in this project will integrate work being advanced in IEEE 11073 standards as well as IHE profiles related to SDC connectivity, namely Service-oriented Device Point-of-care Interoperability (SDPi) profiles.
      Show
      IHE Devices (this is a Gemini project approved by the steering committee May 2020) IHE Devices Domain Device Point-of-Care Interoperability (IHE DEV/DPI) Program IEEE 11073 Point-of-Care Device (PoCD) Working Group ISO TC215/WG 2 Health Informatics / Systems & Device Interoperability ISO/TC215 & IEC/SC62A Joint Working Group 7 (JWG7) Health software and health IT systems safety, effectiveness and security Materials created in this project will integrate work being advanced in IEEE 11073 standards as well as IHE profiles related to SDC connectivity, namely Service-oriented Device Point-of-care Interoperability (SDPi) profiles.
    • Yes
    • IHE Devices / DPI Program Group (as part of the Gemini Device Interoperability project since early 2020).
    • Academic/Research, Association/Goverment Agency, Consultant, Healthcare IT Vendors, Healthcare Provider/user, Patients, Providers, Regulatory Agency, Standards Development Organizations (SDOs), Vendor/Manufacturer
    • N/A
    • Universal

      The Gemini "SES+MDI" project is a joint effort between IHE Devices and HL7 Devices working groups for the application of ISO/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 (DoF) 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, including technical reports / white papers that explore specific topic areas within the scope of the project.

      The primary objective of the project is to enable an ecosystem of "plug-and-trust" (safe & secure, SOA based, device-to-device connectivity) medical technology solutions that are optimized for high acuity points of care.

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            Unassigned Unassigned
            todd.cooper Todd Cooper
            Todd Cooper Todd Cooper
            Martin Rosner Martin Rosner
            Christof Gessner Christof Gessner
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              Updated:
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