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Gemini Safe, Effective & Secure Medical Device Interoperability (SES+MDI) (Jira PSS-1980)

Basics

Gemini Safe, Effective & Secure Medical Device Interoperability (SES+MDI) (Jira PSS-1980)

1767
Ballot - STU


FHIR Implementation Guide; FHIR Resources; White Paper

Create New Standard

STU
Details

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.


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. 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.



FHIR IG R1 - Target: STU Ballot 2023 January V2 IG R1 - Target: STU Ballot 2024 January White Paper- Target: Informative Ballot May 2023


https://github.com/IHE/sdpi-fhir PSS: https://jira.hl7.org/browse/PSS-1980?src=confmacro

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.

Coordination with IHE Devices (SDPi Supplement) Coordination with IEEE 11073 SDC standards

N/A

OR.NET (Germany-based consortium) Dräger Medical Philips Healthcare Medtronic Others active in the HL7 & IHE Devices WGs

National recommendation for use of Devices on FHIR implementation guides (e.g., Germany). Need to have a FHIR-based technology specification for this class of medical device informatics.

SES+MDI


N/A


Yes

2025 December: TSC approved an STU Publication Request for HL7-IHE Gemini Standard: Service-oriented Device Point-of-care Interoperability (SDPi) Technical Framework, Edition 1 for 1 year
Organization & Realm

Universal

People

Todd Cooper



Devices Work Group

Orders and Observations Work Group

Status & Dates

Active

STU - Test Period/Accepting Comments

04/20/2022

05/01/2027

2027 May WGM/Ballot

01/01/2027

2027 Jan WGM/Ballot

2026 May Ballot Cycle Info: STU Ballot Results: Met basic vote requirements. 0 negatives to reconcile. Document Name: HL7/IHE Specification: Service-oriented Device Point-of-care Interoperability (SDPi) Technical Framework, Edition 2 2025 Jan Ballot Cycle Info: STU Ballot results: Met basic vote requirements. 0 Negatives to reconcile Document Name: HL7/IHE Specification: Service-oriented Device Point-of-care Interoperability (SDPi) Technical Framework, Edition 1 2024 May Ballot Cycle Info: STU Ballot results: Met basic vote requirements. 1 Negatives to reconcile Document Name: HL7/IHE Specification: Service-oriented Device Point-of-care Interoperability (SDPi) Technical Framework, Edition 1 2024 Jan Ballot Cycle Info: STU Ballot results: Met basic vote requirements. 6 Negatives to reconcile Document Name: HL7/IHE Specification: Service-oriented Device Point-of-care Interoperability (SDPi) Technical Framework, Edition 1
Approvals

04/07/2023


Not Needed


All Received




V2 Management Group -- Agreed -- (PSS-2079)
FHIR Management Group -- Agreed -- (PSS-2080)
System Info

182012

PSS-1980



06/26/2026

Anne Wizauer