Page tree
Skip to end of metadata
Go to start of metadata

Weekly SDPi+FHIR web meetings are recorded below, including participants, high-level issues discussed, links to related Confluence & Jira items, etc.   


Note that the topics of these discussions cover all of the SDPi+FHIR project space.  Details of topics discussed should be primarily integrated in those places (e.g., Quiet Hospital Narratives pages) with linkages included here.


NOTE:  Order newest & future-est to oldest.

.

Gemini 2021-12-03 SDPi Friday

NOTE:  Friday November 26, 2021 Meeting Canceled due to U.S. Thanksgiving Holiday

Gemini 2021-11-19 SDPi Friday 

NOTE:  The notes below may eventually be moved to the Gemini SES MDI Meeting Notes Archives page

Agenda (proposed)

  1. General Updates
  2. Topics of Interest Review
  3. RI+MC+RR Review
  4. SDPi 1.0 Review
  5. Additional Topics

Participants

Todd Cooper   David Gregorczyk   John Rhoads   Tom Kowalczyk   Peter Kranich  Jan Rizzuto  Javier Espina   Okan Yilmaz   Dalibor Pokrajac   

Regrets:  Kenneth Fuchs   + Holiday week for many ("Veterans Day" holiday in the U.S., for example)

Discussion Notes

  1. General Updates
    1. PAT #6 - Now fully virtual due to pandemic resurgence 
    2. PAT #7? - Possibly first week of February (TBD whether it is virtual or hybrid)
    3. IHE International Board Report from IHE Devices
      1. 2021.11.11 John Rhoads & Todd presented the IHE DEV Domain Board Report that was VERY well received 
      2. Gemini + SDPi+FHIR work was very well received
      3. SAMD was a key topic!   "What is a device?" including Health & Medical Device "apps" 
        1. ACTION( Todd Cooper  John Rhoads  ) restart the "What is a device?" discussion & content development 
      4. Also mentioned "Ecosystem Pathway" (regulatory) group work stream being launched 
    4. IHE Catalyst study is progressing - more to report out in December
  2. SDPi Supplement & RI Updates
    1. Todd reaffirmed the SDPi specification direction regarding basic support for "RI" and tooling 
      1. "RI" leveraging Word styles / references / bookmarks that can be used to extract the information that is needed beyond the "document" production
      2. Reaffirmed (showing 2-3 slides  from Michael Faughn ) that leveraging NIST's HL7 V2+ project tooling is still appropriate as the "basic" support starting place
    2. Development work this week included an SES focus ...
      1. TF-1 Appendix B ICS tables for the 11073-10700 bPKP draft standard (the ICS tables for the core SDC standards are already in place) 
      2. ALSO the 80001-1 2nd edition Appendix A that has an (informative) section 
    3. SysML 2.0 Considerations 
      1. SysML 2.0 has matured greatly ... about to be released
        1. Github repo provides both documentation (both the spec + introductory slides) and reference implementation stuff, etc.
      2. Given the intent of ultimately moving toward "MC" single source of truth + the tooling chain reaffirmed in (2.a.ii) above, and given the maturity and "future" use of SysML 2.0
        1. Question:  Should ReqIF still be considered for formalized requirements specifications OR should the now much more robust requirements modeling of SysML 2.0 be used
        2. Question:  Should Gherkin be used for use case formalization and extracted into Feature files and then converted to ReqIF (etc. as proposed early this year) OR should SysML 2.0 use case / constraint language / dynamic behaviour modeling be used in stead?
        3. ANSWERS (at least working answers for now):  Yes to both the OR's above:  Use SysML 2.0 NOW so as to ease more comprehensive MC support later in 2022
  3. Additional Topics
    1. No new topics identified

Action Items / Tasks



Agenda (proposed)

  1. General Updates
  2. Topics of Interest Review
  3. RI+MC+RR Review
  4. SDPi 1.0 Review
  5. Additional Topics

Participants

Todd Cooper  John Rhoads   Jan Rizzuto   Brian Witkowski  Javier Espina   

Regrets:  Peter Kranich   Kenneth Fuchs   + TIME ZONE CHALLENGES! (talking about you, David Gregorczyk )

Discussion Notes

  1. General Updates (only)
    1. RI+MC+RR 
      1. Some progress this week (little but some) at advancing the RI analysis and modeling slide deck
      2. This is the primary focus now, establishing the "basic" RI approach that will then enable completion of the SDPi 1.0 specification
    2. Catalyst Study Update
      1. Webinars have been presented the last two weeks to the Catalyst team re. the Gemini SES MDI SDC/SDPi+FHIR program, both a general overview & technical "deep dive" 
      2. Still on track to complete the study early December and report back to this group what Catalyst-based CA & Tooling looks like for 2022 and beyond
    3. Update on the "Pathway to a Plug-and-Trust Product Ecosystem"
      1. Discussions continue in the forming (definitely still "storming") of a quality / regulatory / risk management focused workgroup within the Gemini SES MDI program 
      2. Working title for the group is "Ecosystem Pathway" which is focused on discussing all the non-technical aspects of developing conformant products that are developed independently ("decoupled") by different companies but are plugged into a network around an acute point of care
      3. Goal is to issue a Call for Participation by the end of November; convene an initial meeting in December and start regular meetings in January 2022
      4. Javier Espina  asked who was participating in these "formation" discussions:  Matthias Marzinko , Kenneth Fuchs   Konstantinos Makrodimitris  Michael Bothe, John J. Garguilo  Monica da Silva and others
      5. Note:  This is a small "formation" group to get the content for the Call for Participation agreed (e.g., charter / scope, meeting cadence, top 10 questions, etc.); it will be an open group like all the other Gemini SES MDI groups once it gets launched; group membership, though, will be non-technical focused, but rather those who have a primary "day job" focus on quality, regulatory & risk management aspects of product development, market clearance, deployment & maintenance.

Action Items / Tasks

  • (Koichiro Matsumoto ) Identify who from Japan might want to participate in these discussions (i.e., from industry quality & regulatory affairs personnel) and the Japan PMDA 
  • (Todd Cooper ) Engage IHE Korea colleagues to see who from the Korea MFDS might want to participate in the discussions



NOTE:  Friday October 29, 2021 Meeting Canceled due to "unhealthy" work loads!  


Agenda (proposed)

  1. General Updates
    1. IHE DE PAT #5 ... #6
    2. IHE DEV Meetings Update
    3. ...
  2. ToI Review
  3. RI Update
  4. SDPi Supplement Drafting Update
  5. Additional Topics

Participants

Todd Cooper  Koichiro Matsumoto   Kenneth Fuchs    Javier Espina   David Gregorczyk   Peter Kranich   John Rhoads   Jan Rizzuto   

Discussion Notes

  1. General Updates
    1. IHE DE PAT #5 ... #6
      1. As reported out during the recent Gemini CA & Tooling meeting, PAT #5 (2021.10.21, item #2) was very successful, including more "real" devices + maturing of the libraries and test tooling
      2. PAT #6 scheduled for December 1-3 ... hybrid with 50% participants at facility in Lübeck in person! 
    2. IHE DEV Meetings Update 
      1. This week (Tuesday through Thursday) was the IHE DEV Fall F2F meetings (hybrid) held at BD in San Diego
      2. Thursday 2021.10.21 Tobias Klotz  provided a live demonstration of an Arcomed syringe pump that had an SDC interface integrated into the firmware! 
        1. Demo was impressive and very well received by meeting participants, which included most of the infusion pump vendors as well 
        2. QUESTIONWhen can ... can we ... get open access to the test "UI" tool?  
          1. One "surprise" answer to the above question was that it was TBD if / when the test tool that Tobias used would be available for use by others.  
          2. Issues include need for support and documentation, etc.  it is an engineering tool and not necessarily ready for "public" consumption 
          3. Though the issues were understood, they were not compelling to those present in the meeting ... (smile)  
          4. ACTION(Todd Cooper )  Sync with Dräger to determine if and when the tool can be made public 
      3. Thursday Todd also provided a general update based on the September 24th slide deck and that included the Word Roadmap document
        1. There was some discussion and questions but mostly for clarification only
        2. Note that the roadmap document was updated Thursday as well and there was considerable interest in how far the infusion pump model will go w.r.t. therapeutic / CLC applications for example
      4. PCIM at SDPi+FHIR?
        1. Major topic at the DEV meetings was the PCIM profile (the related white paper also has some good background information) and how it might be implemented for the '22 HIMSS Showcase that will include ACM+PCIM+MEM demonstration
        2. The PCIM profile has never been formally tested at an IHE Connectathon and the IHE NA CAT '22 has been pushed from late January to later in 2022 (TBD) - so the group focused this week on how to implement the profile for the Showcase
        3. The PCIM profile group has been meeting on Mondays at 1400 Eastern, but will try to find a better time slot in the future to accommodate European participants.
        4. Question:  Should we add PCIM profile to the SDPi+FHIR Roadmap? 
          1. We have had discussions (e.g., at FHIR CAT events) about how we might implement PCIM in an SDC/SDPi+FHIR context, especially with identity management baked into SDC  and the related FHIR support; those discussions were in the context of the Isolation Point-of-Care (IPoC) use case
          2. ACTION( Todd Cooper ) Add PCIM profile to SDPi 3.0 
      5. Topic of V2 in TF & RI+MC+RR Support was also raised
        1. This is an interesting topic, since the current focus is on the supplement document (SDPi 1.0) but eventually the gateway actors for FHIR & V2 and IHE profiles based on those two ... will have to be specified, and eventually the SDPi Supplement will be integrated into the IHE DEV TF, including with its support for RI+MC+RR
        2. Question is if and when this support will be added to the existing IHE DEV profiles in the TF?
        3. This has ben an oft repeated topic of discussion, such as looking at the NIST "roadmap" model related to the RTMMS 2.0 work.  
        4. Though the current work needs to stay focused, namely on SDPi 1.0, it should also extend to thee rest of the IHE DEV TF at some point
        5. Related to this topic is the discussion around content creation / editing (will we use Word forever?), and how much we will utilize the "Model Centric" part (but not make everyone become modelers!), and whether we want to craft a content editor akin to the ISO OSD (Online Standards Development) platform for creating standards documents ... many many questions
      6. For the IHE International "Townhall" session, the key takeaway was the value of hybrid CAT events and the desire to continue them in the future, especially if the financial bar can be lowered and more participants accommodated 
    3. Catalyst Study 
      1. Work is proceeding and should be completed by early to mid December ... before the end of '21
    4. Gemini SES/"Regulatory" Initiative continues to evolve 
      1. Scope and title still in discussion 
      2. For example, "Pathway to Interoperability Market" or "Quality & Regulatory Trust" or ... 
      3. Challenges for regulatory agency staff to be in the same "room" with vendors and discussing "regulatory" stuff 
  2. ToI Review
    1. Topic: Alert Delegation Chains 
      1. This topic has evolved as far as it can until the related 11073-10702 Alert PKP evolves more
      2. Priority remains "high" but formalizing has been pushed to SDPi 2.0 (vs. 1.0 ), which should align much better with the timeline for the PKP standard
    2. Topic: Connect Time Delay Algorithm 
      1. ACTION( Todd Cooper  ) Finalize and integrate with github & SDPi 1.0 draft; 
    3. Topic: Info exchanged during unsecured discovery 
      1. ACTION( David Gregorczyk  ) Review updated content for detail
      2. ACTION( Todd Cooper  ) Review https://confluence.hl7.org/pages/viewpage.action?pageId=86970698#Topic:Infoexchangedduringunsecureddiscovery-ProductSpecificationTypeCodes  nomenclature (what is supported in BICEPS and PoCD vs. "Continua" Partition); same for equipment label nomenclature and relationship to "What is a Central?" system types
    4. Topic: What is a Central? 
      1. ACTION( Todd Cooper  ) Finalize and integrate with github & SDPi 1.0 draft; add content to TF-1 Appendix C + consider TF-3 "specialization" carve out for these systems 
    5. Topic:  MDIB/MDS Modeling for Device Aggregators 
      1. ACTION( Todd Cooper  ) Finalize and integrate with github & SDPi 1.0 draft;  TF-1 SDPi-P "aggregators" section + TF-3 section ; include (3) key product applications <pump rack, montior w/ connected devices, Gateway (in) 
      2. ACTION( Todd Cooper  ) Open a nested MDS Topic of Interest 
  3. RI Update
    1. Todd reviewed the slides related to the SES components in the SDPi Supplement document, namely identifying that this is where requirements such as those from the PKP standards will be formalized and "linked" in the SDPi supplement specifications.
    2. ACTION( Todd Cooper  ) Move the draft 11073-10700 Base PKP ICS table to the TF-1 Appendix B and add related slides to the RI slide deck in the SES section 
  4. SDPi Supplement Drafting Update
    1. No additional drafting this last week
  5. Additional Topics
    1. None identified

Action Items / Tasks



Agenda (proposed)

  1. General Updates
    1. SES/Regulatory Update
    2. IHE DEV Meetings Update
    3. ...
  2. ToI Review
  3. RI Update
  4. SDPi Supplement Drafting Update
  5. Additional Topics

Participants

Todd Cooper   Javier Espina  John Rhoads   Jan Rizzuto  Kenneth Fuchs  Peter Kranich   John J. Garguilo   Tom Kowalczyk 

Discussion Notes

  1. General Updates                                         
    1. SES/"Regulatory" Update
      1. The proposed SES / "Regulatory" initiative group had an initial meeting of group conveners, including Kenneth Fuchs  Konstantinos Makrodimitris  Matthias Marzinko & Michael Bothe
      2. Discussion began with the kick-off slides from the Gemini SES MDI Update 9/24 and focused on the scope and charter of the group's work as well as the title (using "regulatory" causes generally strong reactions on the part of everyone!)
      3. This group will have a 2nd meeting in two weeks and hopefully be ready to issue a call for participation in early November with first meetings starting later that Month. 
    2. IHE DEV Meetings Update
      1. The IHE Devices domain meetings are scheduled for this coming week, with the primary DPI program / Gemini SES MDI discussions being Thursday morning
      2. The DPI Program / Gemini SES MDI update will include:
        1. Infusion pump demonstration by Tobias Klotz  and Todd Cooper (about an hour)
        2. Updated version of the Gemini report give 9/24 during the HL7 WGM (about 90 mintues)
        3. A review of the current Requirements Interoperability for SDPi 1.0 work (about 90 minutes)
      3. ACTION( Todd Cooper  ) Confirm the Thursday morning IHE DEV meeting agenda
    3. ...
  2. ToI Review - No updates this week
  3. RI Update
    1. Todd provided a detailed review of RI for SDPi 1.0 (basic RI) analysis this week
    2. The slides will be updated and provided as part of the IHE DEV/DPI Update this Thursday as well as the SDPi Fridah call next week
    3. Specific added information that was suggested during this discussion was to integrate the links to Test Plans / Cases, as well as how FHIR and HL7 V2-based profiles will be accommodated.  
  4. SDPi Supplement Drafting Update - Only minor updates to the document ... nothing reviewed
  5. Additional Topics
    1. No additional topics

Action Items / Tasks

  • ( Todd Cooper  ) Confirm the Thursday morning IHE DEV meeting agenda


Agenda 

No proposed agenda.

Participants

Todd Cooper    John Rhoads   Jan Rizzuto  Javier Espina  Kenneth Fuchs   Peter Kranich  Tom Kowalczyk   John J. Garguilo  Brian Witkowski 

Regrets:  David Gregorczyk  

Discussion Notes

  1. General Updates
    1. September 2021 Update Posted to Library
      1. The September 24 SDPi+FHIR update recording and slides have been posted to the Library
      2. Also the Gemini Device Interoperability home page was updated with the slides and better pointers to the Library
    2. PAT #5 completed today!
      1. See PAT #5 confluence pages for updates 
      2. NOTE:  Due to vacations, report out for the PAT will not happen until the   Friday meeting
      3. QUESTION:  Next PAT first week of December?
    3. Unity Value of Device Interoperability White Paper
      1. Stefan Schlichting  / Unity Consulting published a white paper on "The Real Value of Medical Device Interoperability in Hospitals" 
      2. The survey conducted earlier in 2021 identified priority use cases for MDI, with the Silent ICU and Isolation Point-of-Care coming out at the top!
    4. SDC in the News
      1.  Schleswig-Holstein Magazin broadcast that highlights SDC connectivity - 3 minutes ... VERY interesting! 
        1. "The fascination of digitization in hospitals"   (GERMAN ONLY)
        2. https://www.ndr.de/fernsehen/sendungen/schleswig-holstein_magazin/Faszination-Digitalisierung-im-Krankenhaus,shmag87066.html  
        3. "Intensive care medicine is being digitized. Will the ventilator then also be controlled from the home office in the future?" 
      2. Note this will only be Available until October 14, 2021
  2. Roadmap Consolidated Document
    1. Todd reviewed a Word document that consolidated the various SDPi+FHIR 3 Year roadmap documents & slides into a single document
      1. SDPi Versions Features Roadmap 2021.10.06B.pdf 
      2. Primary focus of this review was the sections identified for each year:
        1. Use Case Capabilities
        2. Profiled Standards / Capabilities
        3. Gateway Interfaces
        4. RI+MC+RR Support
    2. This will be detailed per future discussions + inform SDPi 1.0 content & the Basic RI discussion 
  3. RI+MC+RR Update
    1. Todd reviewed updated slides for the RI topic
    2. Establishing a Baseline RR approach for SDPi 1.0 is a primary focus of the supplement development 
    3. Report out with approach scheduled for   meeting
  4. Topics of Interest Update
    1. Kenneth Fuchs  Updated the "What is a Central?" SAMD Platform Participant Overview Table  - this content will be migrated to SDPi 1.0 TF-1 Appendix C + TF-3 
    2. Peter Kranich  updated Topic: Connect Time Delay Algorithm - efined this topic by more clearly describing the difference between a SDC Provider connect delay and SDC Consumer connect delay and how the provider/consumer shall behave

    3. Peter Kranich  updated Topic: Alert Delegation Chains - Added two use cases (1) Actionable Alert Distribution, and (2) Multiple Alert Notifier Distribution 
  5. Additional Items
    1. None identified

Action Items / Tasks

  • (Todd Cooper ) Update ToI with template at top for both What is a Central? and Connect Time Delay items above.  


Agenda (proposed)

  1. General Updates
  2. IEEE/HL7 WGM Follow-up
  3. Topics of Interest Disposition Review
  4. SDPi+FHIR Roadmap & Plan Review 
  5. ...
  6. Additional Topics

Participants

Todd Cooper  John Rhoads   Kenneth Fuchs   Koichiro Matsumoto   Peter Kranich   David Gregorczyk  Jan Rizzuto   Javier Espina  Tom Kowalczyk  John J. Garguilo  

Discussion Notes

  1. General Updates 
    1. PAT #5 
      1. Next Week! 
      2. First 3-day event - regression testing, filling out the interoperability matrix, focus on transactions to SDC messaging, generating JUnit test results
      3. ACTION( David Gregorczyk  Todd Cooper  ) Prep PAT #5 Confluence page (for Tobias)
      4. ACTION( Todd Cooper  ) Send reminder of cancelation to CA & Tooling group for 1st Thursday October call
    2. SDPi+FHIR Update at IEEE-HL7 September '21 WGM 
      1. Recording & PDF to be posted today in the Library with EVERYTHING you ever wanted to know ... & the Gemini Device Interoperability using SDPi+FHIR landing page
      2. The update presentation included a high-level view of the SDPi+FHIR Roadmap workstreams and 2021/2022 objectives + a kickoff for the creation of a Regulatory Initiative & initial discussions around what an 11073 "MDC" nomenclature 2.0 might look like
    3. IHE Catalyst Discussion
      1. Catalyst is looking at a short term "study" project to come up-to-speed on SDC/SDPi technology and testing/CA objectives and then craft a detailed roadmap & plan for how IHE Catalyst can support the SDPi+FHIR program's Gazelle test management tooling + CAT support + product CA support
      2. Study project should complete by mid-November
      3. QUESTION (Garguilo):  More automated integration of validators into Gazelle? 
        1. Todd noted a debrief with Thom E. regarding how support for the DEV/PCH/POU profile tooling was integrated into Gazelle
          1. Phase 1 (only phase completed):  Test Cases + Attaching a PDF report from the POU tool into Gazelle (this took 1 man month)
          2. Phase 2:  Control of the CTT (Continua Test Tool) from Gazelle ... automated invocation & result from the test case level (again a PDF report returned)
          3. Phase 3:  Stepwise control of the CTT from Gazelle 
        2. Catalyst "Gazelle Innovation" project has been mentioned, but what does that mean?  What about the Gazelle API?  Relationship to 24/7 Gazelle testing (Sharazone)?
        3. NIST IGAMT / TCAMT (vor V2) tools support automation but Gazelle integration?  But how will / could that be integrated into Gazelle?
        4. Note a similar discussion with John Donnelly  in the CA & Tooling discussion 2021.09.16
          1. Related question:  Is Gazelle the best long term tool for our test management?  especially with virtualized 24/7 testing / CA support 
            1. Consider the Stella Story & identification of gaps for using Gazelle for formal independent CA purposes 
            2. John took an action item to provide the short list of "gaps" for using Gazelle in support of product CA using ISO 17000
      4. ACTION( Todd Cooper  ) communicate this topic to Alexander for their discussion next week; CC: Garguilo & Donnelly
    4. Discussions about Gemini "accelerator" Program
      1. Discussions continue around the creation of a funded program to accelerate the Gemini SES MDI roadmap work
      2. Example models include IHE Catalyst's Sharazone program and HL7's Accelerators
      3. A general approach should be determined by the end of October ... hopefully ... 
    5. IEEE-HL7 Devices WGM Action Items
      1. There were a number of action items related to this SDC/SDPi+FHIR work from last week that should be reviewed by this group in a future meeting.
  2. Topics of Interest Disposition Review
    1. Peter Kranich  worked on a number of the Topics of Interest and reviewed them with the group
    2. Topic: What is a Central?  
      1. Peter added use case examples and an excellent table (started by Ken Fuchs)
      2. ACTION( Kenneth Fuchs  ) Update the content on the page, especially the table
      3. Ultimately this will go into TF-1 Appendix C for SDPi 1.0
    3. Topic: Connect Time Delay Algorithm   
      1. Peter added content around definition / use of Configurable Priority Groups, which in principle was accepted
      2. Note that some work remains on the Discovery Group Guidelines table which Peter will add per today's discussion
      3. Ultimately this content would go into TF-2 either for the related transaction(s) or in TF-2 Appendix A for the MDPWS functionality
    4. Topic: Info exchanged during unsecured discovery 
      1. Peter added some use case examples + added the concept of an "equipment label" that might be exchanged during discovery; also how the devices connected through a Device Aggregator might function at discovery time
        1. Note:  This is highly related to Topic:  MDIB/MDS Modeling for Device Aggregators 
      2. A key technical issue would be how to integrate something like an "equipment label" into the Scopes property of the WS-Discovery message; not a major technical problem but one that would need to be defined in the SDPi Supplement (TF-2 Appendix A) and then updated to the 11073-20702 standard at some point
      3. Note that the use case content would be added to the TF-1 Appendix C; there are other guidance in TF-1 and TF-3 carved out for how "aggregators" would be handled 
    5. Note that finalization work for all of these remains for each of these items and a few technical points to research; however, in general a decision on which path to take can be made and advanced to the SDPi 1.0 supplement.
  3. SDPi 1.0 - Planning
    1. To begin the near term (Q4 2021) focus on getting SDPi 1.0 "finalized", including basic Requirements Interoperability capabilities, David & Todd looked at the next steps tasks and identified the following STARTER LIST (first draft ... please comment!):
      1. Edit current draft per the 2021 "milestone" features to indicate what is in and what is out in this draft
        • Yellow content will be replaced by text boxes indicating "reserved" sections and their intended content 
        • Insert IEEE copyright where needed / appropriate
        • Group will review / approve that scope limitation 
      2. Craft BASIC RI Chain
        • ReqIF / UML RI metamodel (for what we will encode in the 1.0 document)
        • Word styles per ReqIF metamodel
          • Note ISO's OSD tool / platform may have an integrated requirements metamodel that we could leverage as well
        • Add to SDPi docx with a simple thread (use case to profile to transaction to BICEPS Core requirement to MDPWS message to ReqIF "export"
        • Process using Michael's V2+ tool (or similar)
      3. Resolve ToI for SDPi 1.0 Document
        • And then for each, updating the github issues, linking to the SDPi 1.0 Open / Closed Issues section and adding to the appropriate points in the document
      4. Finalize content
        • Todd will take TF-1 & TF-3; David & Peter (?) and possibly others will focus on TF-2
        • Create 1.0 content ... integrating ToI solutions
      5. Reviews to TI Pub
        • Gemini internal review and approval (by DPI) to forward to IHE DEV for review & public comment publication 
        • Educational materials / workshops etc. to help build reviewer community 
        • IHE DEV Review & Approval
        • Public Comment & Revew & Update
        • Publication as SDPi Supplement 1.0 TI
      6. Continuous improvement as we go into 2022
    2. These steps (and expanded as we get into the details) + the "roadmap" planning identified in last weeks SDPi+FHIR update will be formalized in a tool like SmartSheet in the near future 
  4. Additional Topics 
    1. Note that David Gregorczyk  will be on vacation next two weeks (until

Action Items / Tasks

  • ( Kenneth Fuchs  ) Update the content on the page, especially the table
  • ( Todd Cooper  ) communicate this topic to Alexander for their discussion next week; CC: Garguilo & Donnelly
  • (Todd Cooper  ) Send reminder of cancelation to CA & Tooling group for 1st Thursday October call
  • ( David Gregorczyk  Todd Cooper  ) Prep PAT #5 Confluence page (for Tobias)


Note2021-09-24 Meeting canceled due to IEEE/HL7 Working Group meetings - see the agenda for full details

Agenda (proposed)

  1. General Updates
  2. ...
  3. Additional Topics
    1. Schedule for next meetings

Participants

Todd Cooper  David Gregorczyk   Koichiro Matsumoto   Peter Kranich  John J. Garguilo  Kenneth Fuchs  John Rhoads  Steven Griffiths  Jan Rizzuto  Javier Espina  

Discussion Notes

  1. General Updates
    1. IEEE/HL7 WGM Updated 
      1. The group reviewed the draft agenda linked above and proposed updates
      2. John J. Garguilo  will make the updates today and Todd Cooper  will review 
    2. HIMSS Showcase '22 Topics 
      1. Couldn't advance a Silent ICU due to lack of potential vendor participation 
      2. NOTE:  The HIMSS'22 Showcase + IHE NA CAT '22 will be marked "Tentative" on the roadmap to be presented next week during the WGMs
  2. Topics of Interest Update
    1. General discussion about expectations and how to finalize each prioritized topic
    2. See 2021.09.10, Item 2 discussion notes below
    3. ACTION( Todd Cooper ) Will update the Topic: SDPi-xC with Mixed Device Safety Classes page with an example template that we can use for all the topics
  3. Additional Topics
    1. Schedule for next meetings:  Cancel next Friday for WGM
    2. Next call October 1st

Action Items / Tasks 


Agenda (proposed)

  1. General Updates
  2. ...
  3. Additional Topics 

Participants

Todd Cooper  Kenneth Fuchs  Koichiro Matsumoto  Peter Kranich  Michael Faughn  Javier Espina  Jan Rizzuto  David Gregorczyk  John Rhoads   Okan Yilmaz 

Discussion Notes

  1. General Updates 
    1. Zoom transition immenent ... hopefully completed today 
    2. IEEE 11073-10701 Metric PKP Ballot Group formation active
      1. Sign up by  
      2. Ask Kenneth Fuchs  for more information 
    3. IEEE/HL7 DEV September WGM Planning
      1. Monday is the Plenary & Jan Remembrance
      2. Tuesday will focus on IEEE 11073 meetings
      3. See AGENDA for more information & to contribute ideas / comments 
      4. Discussion re. formal / informal role of IHE concerns in these WGM ...
        1. Javier Espina  asked:  Is it an "IEEE/HL7" joint meeting or "IEEE/IHE/HL7" joint meeting
          1. Ken and John indicated that it had always been only IEEE and HL7, and that though IHE participants and related discussions had always been included, IHE had never been a formal participant in the joint meetings
          2. Is there value in doing that now?  What would it take and what would the value be?
          3. Further, there are plans in 2022 to have at least one independent IEEE only meeting 
        2. Role of Gemini (formal Joint between IHE-HL7 group) 
          1. Todd mentioned that perhaps it would be good to have the meeting include a joint with the Gemini SES MDI program, since that is currently the primary touch point with HL7 and IEEE.
        3. ACTION( co-chairs IHE & HL7 ) Discuss opportunities / challenges / formalities for future meeting coordination 
    4. IHE DEV October F2F Planning
      1. Limited to 20 in person participants ... the rest remote 
      2. Include an SDC/SDPi Briefing (detailed) & (TBD) Demo w/ Infusion Pump 
      3. QUESTION:  When will the SDC/SDPi Briefing w/ BICEPS Infusion Pump Demo be scheduled?  
        1. Probably on Thursday morning (Pacific) but TBD
      4. Draft agenda and meeting information is posted on the IHE DEV meeting wiki page 
        1. Note that this is actually an IHE DEV/PCD Program meeting that has some report outs from the other programs 
        2. The SDC/SDPi+FHIR briefing & demo would be a joint PCD/DPI session OR possibly an all DEV session
    5. HIMSS '22 CAT (January) & Showcase (March)
      1. NA CAT 22 will be primarily in person in Chicago ... TBD whether it will also include remote (i.e., fully hybrid) 
      2. HIMSS'22 Showcase will be in person in Florida Orlando ... may include some remote components 
      3. Showcase Topics "Revealed" 
        1. HIMSS'22 Showcase Early Bird Webinar Slides
          1. HIMSS22 Interop Showcase Early Bird Webinar_September 2021.pdf 
        2. 2021.09.09 Early Bird Webinar Recording 
        3. HIMSS '22 Overview (web page)
      4. QUESTION:  Origins of "Associating Devices with Patients ..." topic?  It is very techie oriented vs. the others that are more care scenario oriented
      5. Note:  None of the other topics clearly lend themselves to storylines integrating medical devices 
    6. PAT #5 & Tooling Updates
      1. Scheduled for 3 days ... Basic info & (coming soon) event page link is here ... NOTE:  Tobias Klotz  will host the meeting
      2. Tool development efforts are continuing ... to be used in PAT / CAT events ... ultimately integrated into Gazelle
    7. Discussions with IHE Catalyst continue, focused on planning support for CAT events, Gazelle tooling & test plan/case integration, and eventually CA support 
  2. Topics of Interest - Drive to Resolve ASAP
    1. Topic of Interest Resolution Process discussion
      1. Topic-specific pages on confluence (e.g., Topic: SDPi-P Compression Option) would be where the active discussion is captured and the proposed resolution posted
        1. We will provide a standard format for these pages that will include the content that is to be "exported" (e.g., clear problem statement, resolution approach)
      2. For each topic, an sdpi-fhir repo "issue" will be created that will link to the confluence page + the confluence page will link back to the Issue
      3. Problem statement & resolution text from the confluence page will be copied to the Issue in the github repository
      4. The github Issue (with link) will be included in the SDPi supplement document Open/Closed Issues section
      5. The resolution detail will be integrated into the specification in the appropriate place, possibly with links back to the closed issue section and the github repository
    2. How to accomplish this resolution and integration in github and the specification document ASAP was the primary topic of discussion for this session:
      1. Todd Cooper  indicated that items (ii) to (v) are relatively straightforward "editorial" tasks
      2. Technical resolutions and detailed content must be provided by the team and managed by the assigned topic lead(s) 
      3. Topic lead(s) are empowered to engage whomever however to achieve closure ASAP 
      4. Friday SDPi web calls will focus on reviewing and confirming the resolutions - but generally not on detailed open discussions (there are too many topics to cover!)
    3. Group reviewed the assigned lead(s) for each high-priority / SDPi 1.0 item on the Topics of Interest page
    4. Topic: SDPi-xC with Mixed Device Safety Classes topic resolution was discussed at more length
      1. It was noted that though this issue was surfaced in the SPDPi+FHIR group, no one currently here can be considered a regulatory SES expert 
      2. Also, it was notied that Stefan Schlichting , Todd Cooper  & Konstantinos Makrodimitris  have been discussing general approaches to establishing a clear regulatory path / strategy that will lead to medical device products being able to include SDC/SDPi+FHIR conformity assessment test reports directly in their regulatory submissions (e.g., FDA 510(k)).  
        1. IOW the pathway to "regulatory submission ready"!
  3. Additional Topics
    1. Given the SDC/SDPi+FHIR focus on supporting not only formal IHE CAT events ... in person and hybrid ... but also virtual CAT events & 24/7 testing ...
    2. QUESTIONBuilding confidence on the part of REGULATORS that they can clear products for market that have been developed in a "regulatorily decoupled" way + have been primarily tested in virtualized PAT / CAT events ... and maybe even CA testing - What level of multi-vendor in-person plug-and-trust "testing" will be required?
    3. Could this level of real-world at-the-physical-bed testing be accomplished in specialized "demo" or even in-hospital "projectathon" pilot projects?  
    4. This will be a topic addressed in the Gemini SES MDI CA & Tooling discussions as well as the Regulatory WG discussions

Action Items / Tasks

  • ( Todd Cooper  & DEV co-chairs IHE & HL7 ) Discuss opportunities / challenges / formalities for future meeting coordination (incl. "Gemini" joint)


Agenda (proposed)

  1. General Updates
  2. SDPi+FHIR Rodamap Review
  3. SDPi Supplement Review
  4. Additional Topics

Participants

Todd Cooper  Koichiro Matsumoto Michael Faughn  John Rhoads  Jan Rizzuto   John J. Garguilo  Kenneth Fuchs  

Regrets:  Peter Kranich  Javier Espina  + U.S. Long Holiday Weekend + Company-wide Holidays!

Discussion Notes

  1. General Updates
    1. ONC Conference Sessions next week - Register Here  
      1. 2021.09.10 Track 2: Advancing Health IT Interoperability in Medical Devices and Laboratory Test Results
        1. Kosta will be presenting a short segment including SDPi+FHIR program work, possibly MDIRA profile too
      2. 2021.09.17 Session: Plenary Session: Standards Coordination in Action: Project US@ 
        1. Wayne Kubick (HL7 CTO) will be part of the panel discussion 
    2. IEEE / IHE / HL7 WGM Agenda - See updates directly to the agenda
    3. Monday PoCD DoF Canceled - U.S. Holiday!  
    4. IHE DEV Updates
      1. Moving to an IHE Zoom possibly by next Friday 2021.09.10
      2. October DEV Meetings -
        1. "Fully Hybrid" at BD (formerly Carefusion / Cardinal / Alaris ...) in San Diego October 19-21 (Tuesday - Thursday)
        2. Related topics include ...
          1. SDPi+FHIR Discussions focused on a BICEPS Infusion Pump w/ (tbd) demo! 
          2. Review of draft SDPi Supplement in preparation for DEV domain review and advancement to TI publication
    5. RI+MC+RR Updates
      1. Focus currently on the RR aspects including general discussions with FDA on the roadmap from here to "regulatory submission ready" to conformant products cleared for market
      2. There will be a report out in WGM both in September and October (HL7 & IHE DEV respectively)
    6. DoF PoCD Update
      1. Current ballot closes September 13th ... COMMENT!!!
    7. SDPi+FHIR Roadmap & Supplement Update
      1. SLOW Progress ... but progress none the less
      2. IHE Catalyst discussions restarting in earnest next week 
    8. HIMSS '22 Proposals - Deadline 2021.09.20 ... SDC/SDPi+FHIR Please!!!
    9. Dräger Press Release for SDC (Cybersecurity focus) 
    10. MDIRA Update
      1. Current APL work is focused on the "virtual hospital", informed by the MDIRA work 
      2. Continuing to promote / inform re. MDIRA work + look for potential future projects that leverage MDIRA 
    11. Topics of Interest Resolution - 
      1. David Gregorczyk and Todd Cooper will be scheduling specific discussion sessions as needed to resolve each of the prioritized topics (including linking into github repo)
      2. Resolutions will be reported out and affirmed during these Friday sessions
  2. ... (detailed topics deferred due to key participants on holiday)
  3. Additional Topics

Action Items / Tasks

No new items identified.


Agenda (proposed)

  1. General Updates 
  2. Roadmap Review / Update
  3. SDPi Supplement Review / Update

Participants

Todd Cooper David Gregorczyk Okan Yilmaz John Rhoads Koichiro Matsumoto Okan Yilmaz Steven Griffiths

Regrets:  Peter Kranich Javier Espina   (and it is "vacation" month August...)

Discussion Notes

  1. General Updates
    1. IHE MDIRA Profile & FDA Regulatory Considerations
      1. The importance of the actors proposed in the IHE MDIRA profile were reiterated in terms of how they might be leveraged to improve the resiliency of a system of decoupled system component products when implemented and used
      2. This profile may help address a set of "backstop" mechanisms (e.g., Supervisor and DataLogger actors) that ensure that shared responsibility for clinical functions and safety are being met and managed in real-time
    2. SDPi+FHIR Roadmap Development 
      1. Work continues, currently focused on prioritizing technical content that needs to be included in the 1.0 version 
      2. See discussion below on Topics of Interest review
    3. IHE Devices Domain October "Fall" Meetings
      1. Proposed agenda includes ...
      2. SDC/SDPi BICEPS Infusion Pump Specialization briefing
      3. SDPi Supplement Review (in anticipation of Public Comment)
    4. IHE DE PAT #5 - Invite should go out today, for a three day event!
    5. IHE NA CAT + HIMSS'22 Showcase Planning Discussions
      1. Now that the HIMSS'21 conference is over (from last week in Las Vegas), concrete discussions should be able to be advanced regarding the early '22 events (January & March) and the role SDPi+FHIR can play / should play
      2. NOTE:  Primary focus is on specification completion & testing, with public demonstrations anticipated and planned for but not critical path, especially given continued pandemic challenges and travel (esp. international) restrictions
  2. Topics of Interest - Review / Prioritization 
    1. See updates on confluence page marked " 8/20Confirmed
    2. NOTE:  At this point, over the last two weeks the group has reviewed the prioritization of the new / high / medium priority topics and now can craft a plan for getting them resolved in September (fingers crossed!)
  3. Additional Topics 
    1. None identified

Action Items / Tasks

No new action items


Agenda (proposed)

  1. General Updates
    1. HIMSS'21 Report-out?
    2. September WGM Agenda Planning Kick-off
    3. October IHE DEV vF2F Agenda Planning
    4. Participants holiday schedule next few weeks 
    5. PAT #5 Planning Update
    6. AAMI eXchange 2022.06.03-06 Proposals due  
    7. ...
  2. Roadmap Review
    1. Updated & synced Milestones/Capabilities
    2. Review of draft project (SmartSheet) roadmap spreadsheet
    3. (tbd) Review of updated Confluence 2021 Roadmap Central page
  3. IHE SDPi Supplement (1.0) Review
    1. Recap document status and organization 
    2. IPoC Use Case - Plan for detailing content 
    3. Review 1.0 capability details vs. capabilities deferred to 1.x or beyond
    4. Review and update Topics of Interest, focus on prioritization and TF Supplement 1.0 inclusion
    5. Review SourceForge tickets (in general) and the BPKP ballot for impact to the SDPi 1.0 supplement
    6. Work Planning for completing SDPi TF Supplement 1.0
  4. Additional Topics
    1. ...

Participants

Todd Cooper Jan Rizzuto Peter Kranich Koichiro Matsumoto Kenneth Fuchs Steven Griffiths John J. Garguilo

Regrets:  Javier Espina David Gregorczyk  John Rhoads 

Discussion Notes

  1. General Updates
    1. HIMSS'21 Report-out?  
      1. Digital offering was very limited ... pre-recorded content only? 
      2. Virtual Interoperability Showcase was supposedly available ... but not able to discover where!
    2. HIMSS'22 Interoperability Showcase Topics (from "Dr. Phil") Call for topics
      1. HIMSS'22 Interoperability Showcase Demonstration Topic Survey sent out end of July - HERE IS THE SURVEY LINK 
      2. ACTIONTodd Cooper + all! ) Respond to call with current planning around SDC/SDPi+FHIR topics
    3. September WGM Agenda Planning Kick-off
      1.  week 
      2. Update for SDPi+FHIR work (Roadmap & supplement 1.0 content, ...)
      3. Report on SCOT Project in Japan (Koichiro Matsumoto) - TBD
      4. Jan Life Celebration 
      5. ...
    4. October IHE DEV vF2F Agenda Planning
      1.   week 
      2. Considering an SDC/SDPi Briefing Day (or 1/2 day)  focused on Infusion Pumps (Monday / Tuesday) 
    5. Participants holiday schedule next few weeks
      1. Regular Friday meetings will continue BUT attendance will be ... challenged!
      2. Peter & Javier will be out next (3) weeks
    6. PAT #5 Planning Update - deferred to next Friday when David G. can be present
    7. AAMI eXchange 2022.06.03-06 Proposals due  
      1. ACTIONTodd Cooper ) Send out virtual query to team for ideas & interest + submit a proposal
  2. Roadmap Review
    1. Actively building out "SmartSheet" planning tool with the roadmap/milestones and detailed planning (see earlier discussion notes)
    2. This will also include updating of the Confluence 2021 Roadmap Central page, hopefully with an "active" dashboard
  3. IHE SDPi Supplement (1.0) Review
    1. Recap document status and organization - restarted document drafting + pulled an August branch from the github repository
    2. IPoC Use Case -
      1. Updated content from the related Narrative: Isolation Bed confluence pages to the draft SDPi supplement TF-1 Appendix C
      2. NEED A STRATEGY for engaging SMEs (e.g., clinicians and especially clinical engineers) around this topic in order to detail Scenarios and Gherkin logic
    3. Review 1.0 capability details vs. capabilities deferred to 1.x or beyond - briefly spoke to this item 
    4. Review and update Topics of Interest, focus on prioritization and TF Supplement 1.0 inclusion
      1. Reviewed items and updated content on the home confluence page
      2. Specific follow-on discussion items:
        1. Topic: Connect Time Delay Algorithm - Peter indicated that David Gregorczyk had a solution that he had tested out ... yes?
        2. Topic: SDPi-P Compression Option  - Peter indicated that this option (MDPWS/Compression) has been tested at PAT events and is working ... David Gregorczyk:  Yes?
        3. Topic:  MDIB/MDS Modeling for Device Aggregators -
          1. The content from this topic is to be included in the TF-3 supplement sections, perhaps linked to the "sensor connector" actor in TF-1
          2. QUESTION:  Does this topic bear any relationship to the Infusion Pump modeling that also includes multiople channels / multiple MDS's
            1. This should be addressed already in Stefan Schlichting's SysML Infusion Pump MBSE/SysML model 
        4. Ensure that Peter Kranich "must address" issues are integrated into the Topics of Interest or other places, including
          1. Optimization of Alert Delegation: the handshaking for the alert delegation is rather extensive especially when there is a large number of devices connected to the network and each device has multiple active alert. According to David (David, please jump in if I quote you wrong) the alert delegation was more theoretically designed without a comprehensive practical validation, and there are room for improvement without losing the safety aspect. Optimization could be the delegation of an entire alarm system or a more granular delegation with a list of alert event handles the consumer takes the responsibility, etc.

          2. Multiple Alarm Integrator: there are use case where alert are delegated to multiple alarm integrator (e.g. a paging system and a cockpit or central station). At the moment, the standard considers only one Responsible Alarm Notifier (RAN). There are some ideas to use the existing delegation confirmation timeout to prioritize the RANs but it is not clear if this is sufficient.

          3. Notification of an inoperable DAS at PoC devices: one optional but highly recommended requirement in the alarm standard is that the alarm source should notify the user when the DAS is fully or partially inoperable (e.g. a relevant pager device cannot be reached) even when there is no active alarm currently. This requires the SDC consumer to inform the SDC provider by this situation.

          4. Presenting and managing alerts from a smart alert system: alerts generated from a smart alert system shall also be presented on the PoC devices and other systems (cockpits, central stations, pager). In order to prevent alarm fatigue, the alerts shall only presented on one device in the patient room according to its priority or in the case of an actionable alert only at the device(s) involved in the action.

          5. There are a couple of open ticket which relate to changes in the core standards. Maybe it make sense to review them and come up with an assessment whether we have to resolve it before we continue with profiling.

          6. Moving from SOAP to gRPC: David can probably elaborate more on that but the current transport layer is a little bit outdated and the performance could significantly improved when moving to different transport technology.

          7. PKP OIDs: the Glue standard defines some ids. Do we need more for special PKPs?

          8. And finally, as you mentioned there is the Topics of Interest list we may need to review again if there is a need for a change of the standard to resolve the issue.

      3. Test linkages from ToI to gihub issues to supplement Word document 
    5. Review SourceForge tickets (in general) and the BPKP ballot for impact to the SDPi 1.0 supplement
      1. Note that this topic will be added to the Tuesday IEEE 11073 SDC sessions for discussion, specifically
        1. Are there any major items that must resolved for SDPi Supplement 1.0 or 1.x or 2.0 or ... ?
        2. Are there any that we can address 1st in the supplement specification and then backfill into the existing & emerging 11073 SDC standards?
    6. Work Planning for completing SDPi TF Supplement 1.0 - Deferred to next Friday
  4. Additional Topics
    1. No additional topics 

Action Items / Tasks

  • Todd Cooper + all! ) Respond to call with current planning around SDC/SDPi+FHIR topics
  • Todd Cooper ) Send out virtual query to team for ideas & interest + submit a proposal


Agenda (proposed)

  1. General Updates
  2. IHE DE PAT #4 Report Out 
  3. SDPi 1.0 Subsetting Discussion -
  4. Additional Topics

Participants

Todd Cooper David Gregorczyk Javier Espina Kenneth Fuchs Koichiro Matsumoto Michael Faughn Peter Kranich Steven Griffiths  Jan Rizzuto John Rhoads 

Discussion Notes

  1. General Updates
    1. SDPi+FHIR Roadmap Planning Update
      1. Next week will include a focus on crafting a SmartSheet-based roadmap that ...
        1. Incorporates the milestones discussed   
        2. Incorporates the use case mapping "capabilities" identified   
        3. Incorporates a phased approach to the RI+MC+RR pilot projects
        4. Incorporates the various related work streams and events 
    2. IHE Catalyst Engagement & IHE T&T Updates
      1. Though August is a "holiday month" for many in Europe, where IHE Catalyst is based, work will proceed to define the scope of activities for an IHE SDPi+FHIR Program; goal is to have that finalized by end of September
      2. For the IHE Testing & Tools (T&T) monthly meeting, an SDC/SDPi+FHIR standing agenda item has been added
        1. NOTE:  The T&T meeting is open to any IHE members who are interested in advancing the testing side of the profile support
    3. Devices on FHIR Update
      1. Primary focus is on a successful ballot of the PoCD FHIR IG ...
        1. Recent feedback from the FHIR FMG included a significant checklist of items previously unknown need to run down the process failure in notifying how that happened
        2. 20 IGs are facing the same challenge of addressing the checklist requirements ... BY SUNDAY!  
        3. This is consuming significant resources at this time ...
      2. The September FHIR CAT will not include a DoF track this year due to resource constraints (per the ballot effort above)
      3. Note:  The usual November FHIR DevDays event has been canceled as Firely focuses on supporting a "100% hybrid", internationalized event.
        1. See Firely annoucement "The Future of FHIR DevDays:  Becoming an International and Hybrid Event"
        2. The 2022 event will be the week of June 6, 2022 in Cleveland, Ohio, U.S.
    4. IHE DEV Update
      1. October Meeting
        1. Hybrid domain meeting being planned for October 19-22, in San Diego at BD 
      2. DEV Domain Support 
        1. As noteed, the DEV TPM Paul Sherman retired fully end of June; at that same time Michael Kirwan decided to focus on other non-DEV projects, leaving the DEV domain without program management support
        2. As of August 1st, John Rhoads agreed to take on management of the technical program of the domain, with Sarah Bell providing administrative support (e.g., meeting notes, conference calling, web updates, etc.).   CONGRATULATIONS JOHN!!! 
      3. DEV TF 2020/2021 Edition & SDPi 1.0 Supplement Publication
        1. The DEV Technical Framework 2020/2021 edition will be finalized for publication in the coming months
          1. The document will be aligned with the updated Word templates (2020 January edition) 
          2. All outstanding CPs will be incorporated
        2. The most recent TF and supplement publications from ITI are in HTML format and it has been stated that all future IHE TF publications will be in HTML too .. yes?  
          1. Note that the ITI publications are not only posted at the traditional Technical Frameworks page, but also the IHE Profiles web page 
          2. Note that ITI is the only domain currently published on the Profiles web page and is the only domain that has any HTML publications, though others are reportedly working on them (e.g., RAD)
          3. The process used to craft the HTML versions of the TF required considerable hand-crafting by editors directly (hand) editing the HTML content; and this is mostly a rendering / view of the content, somewhat aligned with that used for HL7 FHIR publication
        3. What about the SDPi Supplement?
          1. Yes, that supplement will be published in HTML but the pathway to getting there will be different
          2. The computable artifacts to achieve RI+MC+RR ... especially "regulatory submission ready" test reports ... require a different approach (as detailed in previous presentations)
          3. Supplement content will be crafted in Word; however, a new set of Word styles and other markup will be utilized that is aligned with a formal UML/SysML model of IHE TF specifications and can be used to process additional artifacts (e.g., ReqIF specifications);  NIST tooling will be leveraged for these purposes including that used for the V2plus program
        4. What about the HTML publication of the DEV TF 2021 edition?
          1. The next version of the DEV TF '21 will be published in Word/PDF per above
          2. In parallel, the SDPi Supplement 1.0 will be developed in a way that allows HTML publication + capture of computable artifacts such as ReqIF specifications (RI+MC+RR)
          3. Once the supplement approach has been established, then those Word styles + tooling can be applied to create an aligned HTML version of the DEV TF
          4. NOTE:  The SDPi supplement is also aligned with the latest template, so both documents should be easily integrated down the road
  2. IHE DE PAT #4 Report Out 
    1. David Gregorczyk reported out on the PAT #4 held August 4 & 5
    2. Notes captured on 2021.08.04-05 IHE DE SDC/SDPi PAT #4 
    3. Interoperability matrix PAT #4 shows the general result ...
      1. Regression testing was performed, in which some previously green cells went to yellow - but that is a good thing!  (smile) 
      2. New implementations included the sdcX (C++) from SurgiTAIX) 
      3. Real devices (!!!) were also integrated via Dräger's CC300 converter product (i..e, Dräger Medibus protocol to SDC protocol
    4. Python Reference Provider Test PAT #4 page provided with instructions and sources
    5. SDPi PAT Takeaways ...
      1. Good list provided on this page ... as well as What's Next:
      2. Docker needs to be introduced again
      3. Certificate signing needs to be updated for a non-vendor-specific security certificate source
        1. Note:  IHE Gazelle testing environment supports CA sources for testing of profiles like ATNA
        2. See IHE Gazelle Security Suite for more information
    6. PAT #5 Scheduled for October 6-7 
    7. Discussion:
      1. Go to 3 days? Monthly vs. every other month? to get the needed work done ...
        1. Monthly probably not
        2. 3 days every other month - very possible 
        3. Problem is that more and more is being packed into the PAT events, especially in support of the milestones in the roadmap!
      2. 24/7 testing platform is also very important - this may also be supported by IHE Catalyst and is directly related to pre-CAT testing 
  3. SDPi 1.0 Subsetting Discussion - Allocation of Use Case Scenarios per Roadmap Milestones
    1. Reviewed the related discussion notes from 2021.07.23 below
    2. Discussion:
      1. Regarding the 2.0 version question:  "+ FHIR(out) gateway (vital signs reporting) + (alert reporting for logging?)"
        1. Alert looging for reporting can be supported in the PoCD FHIR IG currently under ballot
        2. The DeviceAlert resource is also under development and should be available in 2022 in time to leverage in the 2.0 version of the SDPi supplement
      2. A "stretch goal" may be added to the 1.0  capabilities to support the FHIR(in) for patient demographics utilizing the well established ITI PDQm and PIXm profiles; this would add the SDC PatientContext to the capabilitiy mix
  4. Additional Topics
    1. Note:  Focus for meetings going forward will be aligned with the roadmap plan + SDPi 1.0 + DoF + CA & Tooling (incl. RI+MC+RR)

Action Items / Tasks

No new action items identified.


Note2021-07-30 Meeting canceled due to holidays / vacations.

Agenda (proposed)

  1. General Updates
  2. Roadmap - Use Case/Scenario Mapping
  3. Additional Topics

Participants

Kenneth FuchsPeter Kranich Koichiro Matsumoto Javier EspinaWouter Peeters

Discussion Notes

  1. General Updates
    1. None
  2. Roadmap - Use Case/Scenario Mapping
    1. 2021 SDPi 1.0
      1. Basic Silent ICU is DAS (i.e. alert reporting and alert delegation to single participant)
      2. With basic SDC functions - discovery, secure connection, context 
      3. Also for reporting vital signs, including waveforms
      4. “Regulatory Submission Ready” CA Foundation
      5. SDPi Supplement use case mapping: 
        1. C.2 Standalone OR Dashboard (SORD)
        2. C.5 Silent PoC Alert distribution (SpoC) - without remote acknowledgement
        3. C.6 Silent ICU Alert Distribution (SICU) - without remote acknowledgement
    2. 2022 SDPi 2.0
      1. Comprehensive Silent ICU is CDAS (i.e. with user confirmation and alert delegation to multiple participants)
      2. Remote control (e.g. of alarm limits or ventilator mode).
      3. + FHIR(out) gateway (vital signs reporting) + (alert reporting for logging?)
      4. + DEC gateway (vital signs reporting)
      5. "IHE RR CA for SDPi Products Established"
      6. SDPi Supplement use case mapping: 
        1. C.3 Standalone OR Cockpit (SORC)
        2. C.4 ICU Isolation PoC Use Case (IIPoC)
        3. C.5 Silent PoC Alert distribution (SpoC) - with remote acknowledgement
        4. C.6 Silent ICU Alert Distribution (SICU) - with remote acknowledgement
        5. C.7 Feature: Remote Alert Management (RAM)
    3. 2023 SDPi 3.0
      1. Closed-Loop (E.g. pump controlled by ventilator and/or patient monitor)
      2. Smart Alerting (Combination of limit alarms from single devices to more actionable alarms across devices. E.g. for deterioration detection)
      3. FHIR(in) gateway (e.g. ingest data from EMR/PDMS such as labs, meds)
      4. ACM gateway (need /purpose less clear today...)
      5. SDPi Supplement use case mapping: 
        1. C.8 Smart Alerting System (SAS)
  3. Additional Topics
    1. Next week's meeting (Jul 30): Agreed to cancel / skip.

Action Items / Tasks

<tbd>


Agenda (proposed)

  1. General Updates
  2. Review SDPi+FHIR Roadmap 
  3. ...
  4. Additional Topics
    1. Finalize Friday meetings through July & August

Participants

Todd Cooper Okan Yilmaz Javier Espina Jan Rizzuto John J. Garguilo Koichiro Matsumoto  David Gregorczyk Kenneth Fuchs  Peter Kranich  John Rhoads

Discussion Notes

  1. General Updates
    1. SDPi Test Cases - Moving Forward!
      1. Discussions yesterday in the CA & Tooling group call resulted in a focused effort to begin leveraging the work accomplished in the PAT events to begin crafting test cases that will ultimately be integrated into the Gazelle test platform; a new confluence space is being created for this development activity:  SDPi CA: Gazelle Test Cases
      2. IHE Catalyst discussions with the Gemini SES MDI Program began in earnest recently (after the IHE EU CAT & conference was completed a few weeks ago):
        1. For more information on IHE Catalyst, see the related session in the IHE EU Experience conference "IHE Catalyst: Its value for users, governments and vendors "
        2. Among other areas, IHE Catalyst manages (and owns) the Gazelle test platform and integration of the related tool sets; it also supports IHE connectathons especially in Europe and the U.S.;  
        3. For SDPi, IHE Catalyst will be the primary tooling and CA support organization, including RR CA product testing
        4. Discussions were very productive and will be ongoing over the coming months
      3. Virtual CAT events for specific profiles - like SDPi - were seen as very doable by the IHE Catalyst leadership, given their experience in 2020 and now 2021, as well as their support for IVD (LAB) profiles.  It was also seen as a way of reducing the cost barrier for many smaller companies or profiles that are targeting emerging markets
    2. PAT #4 Update
      1. Scheduled for August 4-5 ... participation looks like it will be sufficient to be productive ... even in August!!!
      2. Focus of the PAT #4 will be on advancing the test scenarios / cases related to specific SDPi Transaction / MDPWS Message mappings
      3. The PAT #3 Recap video (by David Gregorczyk) was finally posted in the CA & Tooling - RI-MC-RR section; also Stefan Schlichting's tour of the MBSE/SysML/Cameo BICEPS Infusion Pump Model is now "public" (making it viewable!)
    3. "SCOT" Architecture Information 
      1. Information requested by Koichiro Matsumoto but is in Japanese (of course!)
      2. Koichiro Matsumoto will create some briefing slides in English and hopefully be able to show in August or September sometime 
  2. SDPi+FHIR Roadmap Preview
    1. Todd showed an initial draft of a 3 year roadmap that is being developed for the Gemini SES MDI program
      1. Gemini 3 Year Roadmap Overview Slide 2021-07-16A.pdf
    2. Discussion
      1. What is the difference between "Basic" and "Comprehensive" Silent ICU focus area?
        1. (PK)
          1. Basic (a) meets the requirements of 60601-1-8 alarm manager (e.g., in a Central Station); (b) simple alert delegation; (c) basic confirmation
          2. Comprehensive (a) full alarm delegation (including alert delegation "chains"); (b) ability to remotely change alarm limt settings
        2. (All) There were many other "devil in the details" questions that resulted
      2. DECISION:  Review the extensive alarm related use cases / scenarios in TF-1 Appendix C and identify which apply to which milestone year
        1. ACTIONPeter KranichKenneth Fuchs ) Lead a discussion of the use cases over the next two SDPi Friday web meetings   and  
      3. What does "FHIR(in) mean ... specifically? 
        1. Lab data 
        2. Medications history
        3. Invoking remote services (e.g., sepsis evaluation)
      4. Consider "Basic" FHIR(in)  in '22? 
        1. Not just FHIR(out) as currently on the roadmap for 2022 SDPi 2.0
        2. Would include patient context (SDC) information?  (e.g., using the IHE FHIR-based profiles such as mPDQ)
      5. FHIR (Out)? 
        1. Both server and messaging based
        2. Metrics (all)
        3. Device configuration & use info.
        4. Alerting? (alert log available for analytics / quality improvement systems)
      6. Status of Devices onFHIR DeviceAlert resource?
        1. Group is currently (these days ... not months!) focused on the PoCD FHIR IG Ballot package for September that includes the SDC mapping 
        2. Device Alert work continues and will resume after the ballot package has been submitted
        3. Note that in recent discussions with FHIR leadership, there was a generally positive response to defining a DeviceAlert resource; hopefully the path forward can be more efficient and deliberate than in previous years (... to date)
      7. Why support DEC or ACM? 
        1. A perhaps "controversial" but relevant question given the wide use of the V2 message pofiles to integrate at the enterprise level
        2. Though the priority of this support is not as high as the other core SDPi+FHIR capabilities, given their use in various production systems (server to enterprise) it is guessed that supporting these gateway actors (that are already part of the SDPi actor models) would make commercial sense
      8. SAMD in the roadmap?
        1. It was noted that the "hot topic" of SAMD or medical / clinical "apps" was absent from the roadmap - Oversight or irrelevant or ... ???
        2. Given the increasingly frequent use of SAMD and "apps" in the MedTech space, there may be value in explicitly including it in the roadmap
        3. BUT as pointed out by David G., it isn't clear what the differences would be between a physical device (SIMD) and a virtualized device (SAMD) that would operate on a eneral purpose computing platform
        4. Note that SAMD and app platforms are explicitly called out in the SDPi and MDIRA profiles ... so there is precedence and relevance ... question is the precise differentiation
        5. DECISION:  To be discussed further ... but later
  3. CA & Tooling Updates to github repo
    1. David and Tobias have started working with a developer on some of the tooling that will be used for upcoming PAT and CAT events, and that includes utilizing the https://github.com/IHE/sdpi-fhir/tree/master/Tooling folder for the various tools (and configurations).  
    2. This repo and the process around it (e.g., CI/CD Actions) will be advanced in the coming weeks - especially during the CA & Tooling Thursday meetings
  4. SDPi Supplement 1.0 Subsetting
    1. Given roadmap objectives (see above) what capabilities must / should be included in version 1.0 of the SDPi Supplement?
    2. Discussion
      1. As decided above, the next step will be to nail down exactly which use cases & scenarios will be supported by which SDPi release; 
      2. With this mapping in place, determining the needed features / capabilities should be relatively straightforward
    3. Approach for next draft of supplement (in August!)
      1. Identify what is in / out including editorial notes indicating what is deferred for future versions
      2. Craft Word styles per the RI effort -base on initial UML model in Cameo
      3. Start with use case / scenario <allocated to 1.0>
  5. Additional Topics
    1. Finalize meetings through August ...
    2. Next 2 meeting will focus on evaluation of alert use cases (primarily ) to the SDPi releases
      1. This will be led by Kenneth FuchsPeter Kranich during the normal Friday web meetings
    3. Next general meeting   will pick up with updating the SDPi 1.0 version with the needed subset of constructs

Action Items / Tasks

  • Peter KranichKenneth Fuchs ) Lead a discussion of the use cases over the next two SDPi Friday web meetings   and  


Agenda (proposed)

  1. General Updates
  2. SDPi+FHIR Program Roadmap Review
  3. SDPi Transactions to SDC/WS* Message Sequence Mapping
  4. RI-MC-RR Pilots Update
  5. Additional Topics

Participants

Todd Cooper  Jan Rizzuto Javier Espina John J. Garguilo  John Rhoads Okan Yilmaz  Peter Kranich Kenneth Fuchs

Regrets:  David Gregorczyk

Discussion Notes

  1. General Updates
    1. PAT Update Recording "re-recorded" - to be posted ASAP + piloting a YouTube channel via OR.NET
    2. SDPi+FHIR Roadmap Update
      1. Work begun using SmartSheet project management tool that will capture an initial set of milestones 
      2. Detailed review on the July 16 Friday session
    3. IHE EU Experience Sessions Posted 
      1. All sessions available on this IHE EU Experience '21 web page 
      2. Sessions of particular interest include:
        1. IHE & IHE Catalyst: Advancing Interoperable MedTec Solutions with "Regulatory Submission Ready" Conformity Assessment (PDF slides too)
        2. IHE Catalyst: Its value for users, governments and vendors
        3. All you want to know on the IHE Testing Continuum
        4. Introducing IHE SHARAZONE. A new testing service complementing Connectathons (PDF slides too)
    4. IHE Catalyst direct discussions start next week
    5. Architectural Info on Japan's SCOT program?  (see meeting notes below) - Koichiro Matsumoto not able to make today's meeting for this update
    6. MBSE / SysML / Cameo Pilot Update - Tool Testing!
      1. John RhoadsTodd Cooper are working on establishing the ability to update and share the base model from Stefan Schlichting 
      2. Note:  John and Todd have different configurations of 3DS tooling software - Cameo 19 vs. 2021x ... problem?!  
    7. MDIRA Profile Update - Monthly meeting next week (pushed out an hour)
    8. FDA ASCA Pilot - No activity this week, but some discussions next week
    9. Test Tool Development & Github folders
      1. Work continues to try and get an SDC "lite" test tool ready for the next PAT and that can be used in connectathon testing; David Gregorczyk is working to get at least a Python developer on the task, though Java would be preferred; this effort and etails are captured in the notes posted on the Conformity Assessment & Tooling page.
      2. Note that there is already an SDPi+FHIR Github repo folder for Tooling that can be the home for this and other tool sets
    10. DoF PoCD FHIR IG - September Ballot Plans
      1. This version will include SDC-to-FHIR MAPPING + v2 to FHIR mappings 
      2. This content will directly inform the SDPi-P actors for FHIR and v2 messaging interfaces, as well as IHE DEV/PCD V2-based profiles (e.g., DEC, ACM, IPEC, etc.)
      3. NOTE:  Not to be confused with the HL7 V2_to_FHIR project which is a separate, non-device specific mapping project
    11. Transferring "11073" domains 
      1. Transfer of the "11073" domains is underway to at least ensure their namespace is retained!
      2. Note that related domains such as "ieee11073" are not reserved at this point
  2. ISO/TC 215 "Personalized Health Navigation - Reference Architecture" Work Item Proposal Review
    1. Todd provided an overview of a new work item proposal that is going out to ballot (in days) within ISO/TC 215 Health Informatics ...
    2. "Personalized Health Navigation - Reference Architecture" (PHN-RA) is based on research originating at the University of California, Irvine's Institute for Future Health (UCI/IFH)
    3. In addition to reviewing the table of contents for the draft outline being circulated with ballot documents, Todd showed the following graphics that provide a glimpse of the work underway ...
  3. Additional Topics
    1. SDPi Meetings July 19 through August 3rd:  Cancel or Convene?

Action Items / Tasks

None identified.


Agenda (proposed)

  1. General Updates
  2. SDPi+FHIR Program Roadmap Review
  3. SDPi Transactions to SDC/WS* Message Sequence Mapping
    1. Review confluence mapping page
    2. Discuss formalization in the SDPi Supplement + MBSE/SysML Model
    3. ...
  4. "Reference Consumer" testing strategy
  5. ...
  6. Additional Topics
    1. TC215 PHN-Ref Arch - Review Discussion

Participants

Todd Cooper Okan Yilmaz Wouter Peeters Peter Kranich Koichiro Matsumoto Javier Espina  Kenneth Fuchs  

Regrets:  David Gregorczyk 

Discussion Notes

  1. General Updates
    1. MDIRA Profile & Project
      1. Key focus this week has been finalizing numerous of the MDRIA profile confluence pages
      2. See related notes on the Specifications: MDIRA / ICE Profile confluence page
    2. Recording Library update:  
      1. Videos updated to the Library with EVERYTHING you ever wanted to know ... page, especially for MDIRA profile
      2. Completing edit & upload of David G's PAT review from two weeks ago
      3. Determining if an OR.NET YouTube channel can be used for these videos instead of Todd's personal channel - it is looking very promising
    3. SDPi+FHIR Program Roadmap Review -
      1. Detailing a 3+ year roadmap for the SDC/SDPi+FHIR work ... should be able to review initial proposal in the coming week or two
      2. Intend to formalize in SmartSheet then update the 2021 Roadmap Central confluence page
    4. Cameo tooling in process
      1. John Rhoads  & Todd Cooper  & Wouter Peeters  are working to get 3DS Cameo (or similar) products configured for the "model centric" MBSE/SysML project
      2. Goal is to be able to all (3) load and update and share the infusion pump model that SSch crafted and then use that as the basis for adding the IHE TF / SDPi & MDIRA constructs
    5. DoF PoCD IG Notice for Intent to Ballot 
      1. HL7 DoF PoCD group, led by John Rhoads approved an NIB (notice of intent to ballot) submission for the PoCD FHIR IG for the next September 2021 ballot round
      2. This draft will include the SDC mapping and possibly updated/more complete V2 mapping 
      3. NOTE:  the SDPi FHIR Gateway actor will leverage this PoCD IG BUT may not be prioritized for the SDPi 1.0 draft; that draft will at a minimum, though, include a reference to the IG 
  2.  SDPi Transactions to SDC/WS* Message Sequence Mapping TOPIC DEFERRED
    1. Review confluence mapping page
    2. Discuss formalization in the SDPi Supplement + MBSE/SysML Model
  3. "Reference Consumer" testing strategy (review Thursday CA & Tooling Discussion)
    1. Reviewed notes and graphics from yesterday's Gemini CA & Tooling meeting notes 
    2. Peter Kranich reiterated that if you had a general SDC network monitor, the issues would be pretty straightforward and more complex "ensembles" would be addressed 
    3. Note that security in such an environment is a key challenge, but has been addressed in similar IHE tooling, such as for XDS.b secure exchanges
  4. Additional Topics
    1. SDC / DDS Comparison Charts?
      1. Todd Cooper asked group if they had these slides from a previous presentation by Stefan Schlichting ... but no one had a clear idea of where they were at
      2. ACTIONBjoern Andersen Stefan Schlichting) Locate and provide to the group a copy of these slides from a previous presentation.
    2. TC215 PHN-Ref Arch - Review Discussion
      1. This Personalized Health Navigation - Reference Architecture new work item proposal (NWIP) will be finalized this coming Tuesday   and submitted for TC215 ballot 
      2. A general update to the SDPi+FHIR community can be planned for a future meeting
    3. Japan "SCOT" Program 
      1. A Japanese (domestic) research program was discussed:  Smart Cyber Operating Theater (SCOT)
      2. From a high level, it appears to be highly relevant to the SDC / SDPi+FHIR, MDIRA and IEEE P2733 clinical IoT programs, but little architectural or technical information is available
      3. ACTIONKoichiro Matsumoto ) Provide general architectural and technical information that can be used by this group to understand the research project better and possibly provide a briefing in a future Gemini SES MDI meeting

Action Items / Tasks

  • Bjoern Andersen Stefan Schlichting) Locate and provide to the group a copy of these slides from a previous presentation.
  • Koichiro Matsumoto ) Provide general architectural and technical information that can be used by this group to understand the research project better and possibly provide a briefing in a future Gemini SES MDI meeting



Older meeting notes are available on Gemini SES MDI Meeting Notes Archives

DescriptionDue dateAssigneeTask appears on
  • Todd Cooper  Craft PlantUML models for high level transactions that would be in TF-1; including updating of actor names per AMS'19 Sessions (Git Task)
10 Jul 2020Todd CooperGemini SES MDI Meeting Notes Archives
  • Peter Kranich  Provide summary of Philips-internal QH/SH use cases for consideration
14 Jul 2020Peter KranichGemini SES MDI Meeting Notes Archives
  • Michael Faughn   Include Gherkin modeling conventions (e.g., Actor:Patient) into the mapping to ReqIF modeling 
16 Jul 2020Michael FaughnGemini SES MDI Meeting Notes Archives
  • Todd Cooper   Add use case ideas above to the draft supplement doc (to be pushed to the Github repo today)
09 Oct 2020Todd CooperGemini SES MDI Meeting Notes Archives
  • Kenneth Fuchs Peter Kranich   Review the various sources of MDI use cases and provide content for the related SDPi Supplement sections.
16 Oct 2020Kenneth FuchsGemini SES MDI Meeting Notes Archives
  • Todd Cooper Create a strawman SDPi Roadmap for consideration next Friday's meeting
13 Nov 2020Todd CooperGemini SES MDI Meeting Notes Archives
24 Nov 2020Peter KranichGemini SES MDI Meeting Notes Archives
  • ( Todd Cooper  ) Post   MDIRA WGM Recording to library page
11 Jun 2021Todd CooperGemini SES MDI Meeting Notes Archives
  • Peter KranichKenneth Fuchs ) Lead a discussion of the use cases over the next two SDPi Friday web meetings   and  
23 Jul 2021Peter KranichMeeting Logs & Notes
  • (Todd Cooper ) Update the task list so that the top level page can aggregate from the "discussion notes" subpages
Todd CooperGemini 2021-11-19 SDPi Friday
  • (David Gregorczyk ) Add the two new Topics of Interest to the table and initiate the discussion pages
David GregorczykGemini 2021-11-19 SDPi Friday
  • ( IEEE & HL7 DEV leadership) Meet on crafting version 1.0 of the agenda
Gemini SES MDI Meeting Notes Archives
  • (Todd Cooper) Circulate draft ISO/TC 215 Form 4 (New Work Item Proposal) "Personalized Health Navigation - Reference Architecture:" to group for informational purposes & feedback
Todd CooperGemini SES MDI Meeting Notes Archives
Todd CooperGemini SES MDI Meeting Notes Archives
  • (Todd Cooper Okan Yilmaz) Provide an overview of the SDPi connector / gateway actors to inform further specification
Todd CooperGemini SES MDI Meeting Notes Archives
  •  Todd Cooper  ) Try loading on Youtube, Vimeo, IHE Google Drive, "Box", DropBox, OneDrive etc.
Todd CooperGemini SES MDI Meeting Notes Archives
  • Todd Cooper ) Craft the initial PAT home page with the above information
Todd CooperGemini SES MDI Meeting Notes Archives
  • Todd Cooper ) Update confluence sub pages for new Topics of Interest
Todd CooperGemini SES MDI Meeting Notes Archives
Todd CooperGemini SES MDI Meeting Notes Archives
  • Todd Cooper Engage IHE Catalyst (aka IHE Services (Europe)) to see if they are using GITB/TDL or their status for developing an open Gazelle API 
Todd CooperGemini SES MDI Meeting Notes Archives