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  1. Status of JIRA items for changes in the FHIR core documentation of Device, DeviceDescription, and related resources - are they there yet and in good order?
  2. The upcoming Working Group Meeting (WGM)
    1. Agenda items suggested so far

Attendees

Todd Cooper, John Dyer, Martin Hurrell, Stefan Karl, Tom Kowalczyk, Filip Manevski, Koichiro Matsumoto, Joe Quinn, Brian Reinhold, Elliot Siver, Marti Velezis


Meeting Notes


References

Meeting Notes from May WGM  Meeting Notes: May 2022 Virtual - IEEE 11073 General Committee / IEEE-PoCD WG / HL7 DEV Devices WG

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  1. (Full Q) (Martin Hurrell) Intra-procedural Anesthesia FHIR IG Work (proposed Thursday Q1)
  2. Device Alerting (John Rhoads)
  3. Housekeeping - (proposed Wednesday Q1)
    1. Required Documentations (e.g., SWOT, 3 Year Plan, others )
    2. items such as PHD publication
    3. Review:
      1. See OO joint topics below
      2. Review DEV related Jira tickets 
      3. Identify priority discussion topics for joint OO sessions (communicate to OO)
  4. (FHIR Core Resource Changes) - DEV discussion (prior to joint meeting with OO)
  5. PHD Status update/report out (Martin R. + Javier??)
  6. Report Out from IHE-DEV proceedings (from Spring F2F WG meetings week of Apr 26-28, 2022)
  7. Test and Test Tooling Report out (NIST and others...)
    1. RTMMS + "V2+" Ongoing work...
    2. (Paul Schluter) Nomenclature - RTM status update
  8. Co-Chair Report Out
    1. (John Rhoads) Directions of / from HL7 to be aware of...
  9. Joint Sessions:
    1. OO (FHIR Core Resource Changes) - joint with OO (Tuesday Q1 + Friday Q1 - )
      1.   Review: 
        1. Not schedule Tuesday Q1 unless there is something significant to discuss (noting overlap with IEEE)
        2. Thursday Q1 OO has joint meeting time set aside (OO, BRR, DEV)
        3. Friday Q1 (OO, DEV, (BRR, CQI, mHealth) FHIR-I)
        4. Discussion will include review of Jira tickets + device Word document etc. 
    2. MHealth (Thursday Q2)
    3. FHIR-I - see above for Q1 Friday w OO (waiting on FHIR-I Agenda to be formulated??)
  10. Friday Q1/2:
    1. Gemini Approved Project Discussion
    2. Open discussion on New architectures within "regulated personal health space" 
      1. e.g., Digital Therapeutics/Personal Health Navigation Ecosystem - Areas being progressed in ISO/TC-215
      2. How should DEV reposition ourselves given SOMD kinds of regulated devices...
        1. related to new HL7 Organizational direction...
    3. Test Tooling Landscape (Todd Cooper)
  11. Meeting with the Physical Activity Alliance and the American Heart Association regarding project proposal (Q3 Thursday)
  12. Members/Co-Chairs - Please add new topics here (add your name "( @ ... )" so we know who to ask about the topic):
    1. (Todd Cooper )  "What is a 'Device'?"
      1. Review general "heads up" content proposed for the updated Device resource description
      2. Review the content being added to the SDPi 1.0 TF-1 front matter related to the scope of the IHE DEV TF (this will be the first version of the broadened IHE domain (vs. PCD only)
      3. Discuss whether and who and where to include and publish the broader question of "What is a 'Device'?" material 
        1. Consider Martin's work around establishing a metamodel w/ attributes, looking for "clusters" and leveraging that to address some common uses of the term:  device 
        2. Link in the previous material from Paper: What is a device? confluence page
        3. Determine the best place to publish this article - for example as an article in the FHIR space similar to workflow and other topics (and linkable from the device-related resources!)
        4. A previous project proposal (pre PSS) was floated for this topic but never fully advanced .. should it be now?
        5. All in favor of Dr. Martin Hurrell being the Editor-in-Chief, raise your hand!  (you cannot vote, Martin ...)
        6. Is this a Gemini (joint IHE-HL7 article) and should fly under that flag?  Or simply an HL7 internal paper?  (it will be used / leveraged in the IHE DEV TF-1 discussion)
    2. (Todd Cooper )  DeviceAlert project:  
      1. Consider leveraging the "What is a 'Device'?" metamodel mentioned previously to explain what is unique about the alerting devices & DEVAL space but without having to include the whole topic (again, linkable article)
            1. not computable
            2. This is a similar concern to the ISO/IEC JWG7 "SES" concern and is tied in with requirements from 60601-1-8, 11073-10702, and similar standards
            3. Alert management systems (DIS / DAS / cDAS etc.) all include support for configuring in accordance with implementation environment polices, e.g., around escalation BUT ...
            4. Is there value in making this COMPUTABLE (as is the case with security infrastructure) and if so, how?
        1. (Todd Cooper )  MDIRA Project Update (esp. relevance to SDPi + EP group discussions)
      2. Note: DEV can meet w/ OO on Friday Q1 as spillover from Thursday or if additional discussion needed around Device resource
      3. ...
      4. DISCUSS:  (John Donnelly ) Alert Policy 
        1. Should the DeviceAlert project also include something around a care provider's "alert policy"?
        2. By analogy, security experts who see "risk management" as 100% a security issue, always talk about managing security policies 
        3. Medical device alerting includes similar policies; however, they are never formalized (via standards) and are definitely not computable
        4. This is a similar concern to the ISO/IEC JWG7 "SES" concern and is tied in with requirements from 60601-1-8, 11073-10702, and similar standards
        5. Alert management systems (DIS / DAS / cDAS etc.) all include support for configuring in accordance with implementation environment polices, e.g., around escalation BUT ...
        6. Is there value in making this COMPUTABLE (as is the case with security infrastructure) and if so, how?
    3. (Todd Cooper )  MDIRA Project Update (esp. relevance to SDPi + EP group discussions)
  13. Note: DEV can meet w/ OO on Friday Q1 as spillover from Thursday or if additional discussion needed around Device resource
  14. ...

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