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    • Resolution: Done
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      Medical devices often generate alert / alarm conditions as a result of risk analysis (including probability and severity of harm to the patient and their surroundings).  These alert conditions are both:

      1. The subject of numerous international standards, such as IEC 60601-1-8 and IEEE 11073 device informatics family, as well as profiles such as IHE Devices "Alert Communication Management" (which leverages both IEEE 11073 semantics and HL7 V2 messaging);
      2. The subject of public / government regulatory agency oversight that has jurisdiction where the device is placed into use 

      These unique characteristics of an established multi-SDO pedigree for device alerting coupled with the potential for severe risk (including patient death) and regulatory agency oversight, necessitates consistent and coherent support in HL7 FHIR, including the specification of a carefully crafted resource and associated implementation guide, that can fully meet the requirements of the medical device community.

       

      Show
      Medical devices often generate alert / alarm conditions as a result of risk analysis (including probability and severity of harm to the patient and their surroundings).  These alert conditions are both: The subject of numerous international standards, such as IEC 60601-1-8 and IEEE 11073 device informatics family, as well as profiles such as IHE Devices "Alert Communication Management" (which leverages both IEEE 11073 semantics and HL7 V2 messaging); The subject of public / government regulatory agency oversight that has jurisdiction where the device is placed into use  These unique characteristics of an established multi-SDO pedigree for device alerting coupled with the potential for severe risk (including patient death) and regulatory agency oversight, necessitates consistent and coherent support in HL7 FHIR, including the specification of a carefully crafted resource and associated implementation guide, that can fully meet the requirements of the medical device community.  
    • Devices
    • Clinical Decision Support
      Orders & Observations
      Patient Care
    • Hide
      Pharmacy WG (for any medication related questions)
      IHE DEV / Devices on FHIR team members, especially those working on the FHIR PoCD IG (2nd Edition).
      IHE-HL7 Gemini SES+MDI team members

      Todd Cooper, John Rhoads, Brian Reinhold, Martin Rosner, Stefan Karl
      Show
      Pharmacy WG (for any medication related questions) IHE DEV / Devices on FHIR team members, especially those working on the FHIR PoCD IG (2nd Edition). IHE-HL7 Gemini SES+MDI team members Todd Cooper, John Rhoads, Brian Reinhold, Martin Rosner, Stefan Karl
    • Hide
      Medtronic, Philips, Dräger,
      Brian Reinhold
      Show
      Medtronic, Philips, Dräger, Brian Reinhold
    • 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.
    • Product Family Product Project Intent Lineage Ballot Type Target Cycle Actions
      1
      FHIR
      Resource
      Create New R1 Standard
       
      STU
      January 2023
      2
      FHIR
      Implementation Guide
      Create New R1 Standard
       
      STU
      January 2023
    • DEVAL
    • None
    • Yes
    • Hide
      Joint IHE-HL7 Gemini Device Interoperability program (a.k.a. SDC/SDPi+FHIR)
      ISO/IEEE 11073 device communication standards, including 11073-10702 Alert Participant Key Purposes standard (in development)
      Show
      Joint IHE-HL7 Gemini Device Interoperability program (a.k.a. SDC/SDPi+FHIR) ISO/IEEE 11073 device communication standards, including 11073-10702 Alert Participant Key Purposes standard (in development)
    • N/A
    • 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

    Description

      Medical devices generally support alert annunciation and management, both from a user interface on the device, as well as communicated to a remote system, such as an ICU Central Station. The Device Alerting project addresses how to represent this information within FHIR, as well as supporting some key use cases such as using analytics to better manage the environment of care. Distributed alert information systems ("DIS") for remote annunciation of device alerts, as well as "dashboards" will also be considered.

      Anticipated deliverables include definition of a FHIR resource - DeviceAlert - and associated implementation guide and educational materials.

      NOTE: This work has been progressing under the PSS-1660 Devices on FHIR - Point-of-Care Device Implementation Guide (2nd Edition) project, but is now being broken out into an independent, more focused project. This will help streamline the more general PoCD IG 2nd edition work, as well as enable the device alert team to concentrate on this subject area. It is also part of the joint IHE-HL7 Gemini Device Interoperability project (PSS-1615), transitioning to PSS-1980), which will continue to leverage the work from this new project.  Finally, this project will also factor in and harmonize with related standards work such as the IHE Devices / Patient Care Devices (PCD) Alert Communication Management (ACM) profile that utilizes the same ISO/IEEE 11073 device alerting semantic base being considered for this PSS, but communicated using HL7 V2 messaging for alert distribution information systems (DIS).

       

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            jrhoads John Rhoads
            todd.cooper Todd Cooper
            John Rhoads John Rhoads
            Martin Rosner Martin Rosner
            Christof Gessner Christof Gessner
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              Created:
              Updated:
              Resolved: