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Day / DateTimeChairScribeNotes 11073 PoCD IEEE WG Meetings

Tuesday

 

Q1/Q2
9:00 AM - 1:00 PM, ET
  • IEEE 11073 SC Leadership:

    CHAIR: KEN FUCHS   

    VICE-CHAIR: DAIDI ZHONG

    SECRETARY: STEVEN DAIN    

    emb-11073-Listserv: emb-11073-sc@LISTSERV.IEEE.ORG

  • IEEE 11073 PoCD WG Leadership:

    CHAIR: STEFAN SCHLICHTING

    VICE-CHAIR: STEVEN DAIN

    SECRETARY: KONSTANTINOS MAKRODIMITRIS

    IEEE-SA Liason to PoCD: TOM THOMPSON

    11073 PoCD Google Group: ieee-11073-pocd@googlegroups.com

MAKRODIMITRIS
/Garguilo

IEEE POCD Meeting minutes(approved) in IMEET-CENTRAL IEEE POCD WEB

IEEE-SA iMeetCentral Folder for: 11073 Point of Care Device Working Group

MEETING NOTES FROM John J. Garguilo

Start Q1

Welcome, Introductions, and Agenda Review [Kosta M./Ken Fuchs]  

Welcome by Konstantinos Makrodimitris (Kosta) and Ken Fuchs (Chair Stefan Schlichting regrets for first part of meeting)

Attendance officially kept by Kosta and IEEE-SA; attendees encouraged to log attendance on HL7 site: Log May 2022 HL7 DEVICE and IEEE 11073 WG Attendance here

Konstantinos Makrodimitris, Ken Fuchs, Tom Thompson, Alpo Varri, Amit Handa, Bjorn Andersen, Danielle Sill (Public Health Institute), David Gregorczyk, John Rhoads, Koichiro Matsumoto, Malcolm Clarke, Martin Hurrell, Martin Kasparick, Martin Rosner, Michael Faughn, Paul Schluter, Peter Gunter, Satoshi Kobayashi, Steven Dain, Javier Espina, Craig Reister, Chris Courville
(23 on Conference)
Non Members (3): Amit Handa, Alpo Varri, Martin Hurrell, Danielle Sill
Total Members (20)

Joined later: Martin Kasparick, Stefan Schlichting (Chair)

Slide sets and meeting materials at IEEE-SA's iMeet Central
https://development.standards.ieee.org/myproject/Public/mytools/mob/slideset.pdf
https://ieee-sa.imeetcentral.com/p2933/folder/WzIwLDEyMTEyODczXQ/WzIsNjY4ODg0NTdd/
Presentations site to upload slides: https://ieee-sa.imeetcentral.com/11073pocd/folder/WzIwLDE1MDMwOTA4XQ/

IEEE Disclosures [Ken]

Call for Potential Essential Patents Holders. Please contact IEEE WG co-chairs with just name and affiliation. 

IEEE Patent Policy - IEEE Patent Policy

IEEE-SA Copyright Policy - IEEE Copyright Policy

IEEE Meeting Conduct – IEEE Code of Conduct

IEEE Ethics Policy - IEEE Code of Ethics

11073 SC Update [Ken Fuchs]

  • Ken noted: No actual standards development in the Standards Committee

    • Documents are started in subgroup or working groups, it may also include outside work  - prior to this stage.  Following that stage the standards committee is required to process and vote (review of WG accomplishing what is set out to be accomplished).
    • Look at Project Authorization Requests (PARs)

09:15a | Agenda Review [Kosta] / Review Previous Minutes and New Members[Kosta] 

Kosta walked through the IEEE-SA site, and showed the structure (tabs) for this PoCD WG.

Kosta reviewed the last meeting minutes taken, asked showed suggested edits to date, and asked for folks to send any other edits.

See IEEE-SA's iMeet site for approved and unapproved Meeting minutes

Motion to approve the meeting minutes from Ken Fuchs, second by Javier Espina, no abstentions, no negative, passes unanimously. (20 Attendees)

Update regarding PARs & Standards (Tom Thompson, IEEE-SA Liaison)

IEEE 11073 PARs, Projects, SDOs and Analytics
IEEE reports, dates and stats

Tom Thompson, IEEE-SA, provided the 11073 Standards update - please see slide set provided on iMeet Central Site: IEEE-SA Liaison Slide Set: Update May 2022

  • Tom noted there are several projects coming to deadlines in 2023 and suggested members have a look to determine what if anything needs to be done for that project.
  • Standards Breakdown presented.
  • Tom provided slide set providing breakout of IEEE 11073 PARs, Projects, SDOs
    • Current Projects Breakdown was provided
              Noted the final submission deadline is 13 Oct 2022
              Paul Schluter requested a PAR extension for 11073-10101b as it will likely be completed in the next Calendar year.
                  Stefan Schlichting ACTION: Schlichting needs to add formal extension to the IEEE site as Chair (no vote needed today)
    • Presently (as of 5 May 2022) for PoCD
              7 Active
              6 Inactive-Reserved - can remain in this status indefinitely, unless requested to withdrawal
                  Malcolm Clarke noted the Inactive-Reserved were agreed upon to keep all in Inactive-Reserved
    • Presently (as of 5 May 2022) for PHD
              Active 18
              Inactive-Reserved - 6 - can remain in this status indefinitely, unless requested to withdrawal
              Expiring at end of  year: 1
         
  • IEEE MOUs in place:
            HL7 - update to agreement being worked on
            LOINC
            NIST - Royalty Free Agreement
            Personal Connected Health Alliance (PCHA)

IEEE reports, dates and stats

  • Schedule and upcoming meetings (e.g., NESCOM):

https://standards.ieee.org/content/dam/ieee-standards/standards/web/governance/sasb/2022calendar.pdf

Update from SDC SG (Martin Kasparick, University of Rostock, Germany; and  Bjorn Andersen)

  • Martin Kasparick (University of Rostock), subcommittee chair, introduced topic and provided information on progress of PKP standards
  • (Bjorn Andersen)  Part 10700: Base PKP + Part  10701: Metric PKP
        Bjorn provided stats on Recirculation-1 (27/77 Comments resolved)
  • Martin K. walked through the "new cathedral diagram"
    Martin noted the 'yellow' part they are waiting on the PKP standards, the other standards are continuously being worked on (every two weeks)
        Note: The plan is for adding the first two PKPs (working draft) by end of year or beginning of 2023… to share w/ international community
        No question on the general progress of the SDC standards family


Reference links for General Project, Issue Tracker, and Draft Document:


PHD Update (Martin Rosner)

Martin Rosner (on behalf of Ray and Daidi - not able to attend) provided brief update

  • ACOM - (Abstract COntent Model) in ballot, closes on Thursday, May 12, 2022
    • Likely last ballot, small number issues remain - before becoming public.
  • Spirometry  Specification - there are comments that likely will lead to re-ballots due to the technical discussion likely leading to some changes.
  • Battery Status - new PAR on battery status reporting (extension based on -10427) - brought forth by Philips

Break 10:35-11 AM

Start Q2

New folks joining call Marc Mar-Yohana OtisHealth, Anantha Bysani

Update from the IDCO SG (Craig Reister)

  • Craig Reister provided update; Craig's IDCO slide set
  • Text from slide):
    IEEE P11073-10103R Implanted Devices Cardiac
    •    Revision of ISO/IEEE 11073-10103:2012 Implanted Devices Cardiac
    •    The nomenclature Word document draft has been completed and approved by the IDCO subgroup with one exception.
    •    The item that remains is to insert the final reference ID table as exported from RTMMS into the nomenclature document
    •    RTMMS output received from Michael Faughn yesterday (ll-May-2022)
    •    Incorporate and verify accuracy this week
    •    This will complete the final draft of the nomenclature
    •    Next step is to submit the draft to PoCD working group for ballot - ASAP
    •    10103 expires 2022, expect to complete revision in 2023
    •    The IDCO SG meets weekly on Fridays at 10:00 AM CT (US).
  • Craig presented work at the recent (May '22) annual Heart Rhythm Society (HRS) Conference, and noted the following contacts from HRS meeting as subject matter experts: Dr. Gerald Serwer, U of Michigan, Division of Pediatric Cardiology, Chair HRS IDCO Interoperability Workgroup, and Dr. David Slotwiner, Weill Cornell Medical College
    • Sarah Bell, from IHE-DEV, can send notices to folks who ask…
    • Focus on P11073-10103R - Implanted Devices Cardiac
    • Kudos to Craig, Paul Schluter and Michael Faughn (NIST) for help and expertise on the terminology development

Update from the Nomenclature SG (Paul Schluter)

IEEE 11073 Nomenclature

  • Paul provided slide set providing status updates regarding P11073-10101b "provisional" term groups
    • "provisional" term groups discussed (Group 1 --> 7)


Text from slide:

  •  IEEE P11073-10101b "provisional" term groups 
        • Group 1: 750+ events and alerts covering devices used in the ICU, CCU, OR and ER as well as NMT, 
        rS02 and other parameters. 
        • Group2:  IHE PCD infusion pump observations, settings, and events and alerts and MEM-DMC 
        terms. Draft pump containment model has been completed by Brian Witkowski and 
        colleagues. 
        • Group3: Hemodialysis (numeric observations, settings, events and alerts, and containment 
        model) that support the Dialysis Machine Data Standard project. 
        • Group4, 5: Additional terms for Getinge/Maquet Ventilator and Anesthesia (observations, settings, 
        events and alerts, and containment model). 
        • Group6: Mapping for Dräger, Getinge and GE ventilator modes to ISO 19223 ventilator mode 
        nomenclature and syntax and to IEEE 11073 REFIDs and numeric codes. 
        • Group7: Terms required for the BPKP (Base Participant Key Purpose) vocabulary for the IEEE 
        PI 1073-10700 SDC ballot, plus other terms. 
        • Group8: New infusion pump terms — possibly more expected! 
            May add nine [mgPEJ UOM_MDC units for phenytoin sodium equivalents (no UOM_UCUM) 
            Plus several remaining GroupZ terms. 

IEEE P11073-10101b (text from slide above)

Other 10101b Additions
    • Systematic names for Partition 2 and Partition 3 terms
    • Last-minute vendor requests for individual terms
    • Additional IHE PCD infusion pump terms (13 new + enums)

Deferred

    • Additional terms for dialysis orders

What's next

    • Terms are already grouped by 10101R table identifiers
    • Paste Excel tables into MS-Word template
      • UOM_MDC and UOM_UCUM will be listed for individual terms in Annex A
        Enumeration Groups, Enum_Values and Enum_Descriptions as individual tables, expandable to support ASN.1 mnemonic(bit#) and OID identifiers as mappings sharing a common enumeration definition
    • Add body text and submit for IEEE MEC... then ballot!



Alpo Varri asked about the process for PHD terminology - Paul Schluter suggested that as we move forward the PHD WGs/Leads work directly with Michael Faughn (NIST).  For example Daidi should now work with Michael to get terms vetted and into RTMMS.


No Action items identified

PoCD WG organization, meetings & wrap-up (Kosta)

Kosta introduced Stefan Schlichting, Chair, who was able to join last part of meeting.

Stefan thanked everyone for work and progress and contributions... and looks forward to continuing & advancing the work.

11073 Stories/Pilots and Conformity and Regulatory track: IHE, ASCA, NIST/FDA, IMDRF (Kosta)

11073 Stories/Pilots and Conformity (Kosta, Stefan, Sajjad, Anil)

• Stefan Schlichting commented on a few issues:
    • Stefan is aware of the need to formally form a ballot group for IDCO
    • Stefan mentioned we've had really good progress on the Standards 
        ○ Includes work on IDCO, OR.Net, PHD, and Nomenclature
    • Ken mentioned, the need for Stefan to file a PAR extension for 10101
    • Stefan will provide a link (post meeting) 
    • https://www.youtube.com/watch?v=HfOVgzf4RskM
• Steven Dain mentioned work on emergency response / ICU / critical care
    • NETCCN
    • Military funded - use cases (e.g., ventilator controlled in Toronto from MDPnP lab in Massachusetts
    • Focus on 10101 and 10201 (DIM - containment model)…
    • https://www.tatrc.org/netccn/index.html
• Malcolm Clark
    • 10206 - Description of data an content of messages
    • One of the activities (a bit off-track) - what was found in PHD 10601 - using Bluetooth SIG (industrial Consortium, there are three levels) and BLE protocol (encouraged  to provide the complete content and adopt -10101 nomenclature - which could then map directly in to FHIR and PCD-01
    • Hope is this will be adopted by small device makers (typically proprietary, thus each has to be integrated one by one)
    • Current version .7 "Generic Health Sensor" so might be some report out in future… currently being review by WG/SIG, and once reviewed by architecture board then be sent to the adopter groups (see early versions of specs and provide comments).  Noted that any work prior to V1 is confidential…
        ○ Perhaps when it gets to version .9 - report out in Sept WG meetings
        ○ End of year hoping to have Specification nearly finalized (at least trajectory presently)…
    • https://www.bluetooth.com/
    • https://www.bluetooth.com/bluetooth-resources/?types=case-study

PoCD WG organization, meetings & wrap-up;    Logistics next WG meeting

  • Next HL7 Meeting / Plenary Sept 17 - Sept 23, 2022
  • Potential to have in parallel PHD session…
  • Hope is in person meeting but continuing to provide Hybrid capabilities…
  • Joint WG meeting at FDA (which was postponed…) update
    •     Kosta mentioned FDA is pointing to a more public meeting
          • Work items for workshop likely would come from WGs, including PoCD, PHD, and other
          • Likely will be a virtual 1/2 day meeting…
          • Kosta mentioned FDA will reach out to individuals 
          • Kosta framed this as a "joint workgroup workshop" not from FDA
          • Goal is to further discussion of how WG coordinate, evaluate the usage of standards
               FDA could have liaison from the regulatory side…
          • FDA is considering conformity efforts 
              ASCA is an example
                  § https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/accreditation-scheme-conformity-assessment-asca
                  § Program Guidance
                  § Basic Safety and Essential Performance standards-specific guidance
    • No Additional topics bought forward for this coming Friday morning Q1 meeting (January 21, 2022)

13:00 pm Closing [Stefan/Kosta/Steve]

Kosta thanked attendees , reminded presenters to post slides.

Martin Rosner motion to adjourn, and second by Ken Fuchs (approved)

  • CHAIR: STEFAN SCHLICHTING, PHD
  • VICE-CHAIR: STEVEN DAIN, MD
  • SECRETARY: KONSTANTINOS MAKRODIMITRIS, PHD

draft IEEE POCD Meeting minutes (unapproved) - 

https://ieee-sa.imeetcentral.com/11073pocd/folder/WzIwLDY2MDkyNDhd/

IEEE POCD Meeting minutes (Approved) - 

https://ieee-sa.imeetcentral.com/11073pocd/folder/WzIwLDY2MDkyNjZd

Q3

Q4



No Meetings


No Meetings
Day / DateTimeChairScribeNotes; HL7 DEV WG Meetings

Wednesday

 

Q1/Q2
9:00  AM - 12:30 PM CST
  • HL7 DEV WG

CO-CHAIR:  TODD COOPER   

CO-CHAIR: CHRIS COURVILLE

CO-CHAIR: JOHN GARGUILO

CO-CHAIR: JOHN RHOADS   

CO-CHAIR: MARTIN HURRELL

CO-CHAIR: JOHN WALSH

CO-CHAIR: MARTIN ROSNER

Garguilo

MEETING NOTES FROM John J. Garguilo

Wednesday Q1, 9 AM - 10:30 AM (Eastern Time - ET U.S.)

Welcome, Introductions, and Agenda Review (HL7 Officers)

    • ANSI Anti-Trust Policy: 

      Professional Associations, such as HL7, which bring together competing entities are subject to strict scrutiny under applicable antitrust laws. HL7 recognizes that the antitrust laws were enacted to promote fairness in competition and, as such, supports laws against monopoly and restraints of trade and their enforcement. Each individual participating in HL7 meetings and conferences, regardless of venue, is responsible for knowing the contents of and adhering to the HL7 Antitrust Policy as stated in §05.01 of the Governance and Operations Manual (GOM). 

  • General updates / announcements 

  • HL7 Poll (per Request from HL7 Board, by Karen Van Hentenryck, Assoc. Executive Director)

We’re already in the process of planning the in-person September Working Group Meeting (WMG) in Baltimore. To plan appropriately, we need to understand how many in our community will be attending this in-person event.

We recently attempted to gather this information via a SurveyMonkey survey but did not receive an adequate number of responses. We are therefore asking co-chairs to conduct an informal poll of their WG during the WGM. Your poll can be conducted any day you wish, but ideally it should be done during a quarter in which you have good attendance. You will need to ask 3 simple questions:

    1. How many of you will attend the in-person September WGM?
    2. How many of you will NOT attend the in-person September WGM?
    3. How many of you are uncertain of your plans?


    • Garguilo walked through the January 2022 WG Meeting Minutes and Notes
    • No further updates/edits/otherwise brought forward by members
    • Motion made "to approve January 2-22 DEV WG meeting minutes" by John Garguilo, second by John Rhoads
      • Motion passes 13-0-0
  • HL7 DEV Working Group 'Health Reports and the Project and Ballot Health Metrics': 2022 January Final Reports (Co-Chairs)

    • See links to current "HL7 WG Health" documents at end of this Agenda
    • DEV has some "stale" JIRA issues, it was suggested to spend further time (as detailed review needed) later in this week, or during the weekly working group meetings.
    • Perhaps triage during this meeting and continue to dedicate one Quarter in future meetings for review of JIRA items.  O&O was referenced, as that WG dedicated several quarters to JIRA tickets.
    • John Rhoads noted that several of the so called stale JIRA tickets relate to devices (e.g., wheel chair) that are not the types of devices DEV considers...
    • John Rhoads also offered to do a "Intro to JIRA" session for DEV attendees in future meetings.
  • Housekeeping: Current Versions of WG documents, for discussion (Rhoads)

    • Review of DEV WG required documents

    • HL7 DEV Confluence Page providing mission and relationships: https://confluence.hl7.org/display/HCD

    • Download HL7 Decision making practices (Default_HL7_WG_DMP_2019_V5.2_Clean) 

      • John Rhoads noted he's updated document to Version 5.3, changes discussed.
      • Motion made by John Garguilo to "Move to and adopt Version 5.3 of the Decision Making Practices", second by John Rhoads
        • Approved 13-0-0
        • See notes below
    • Download 3 Year Plan (2021→2024)

      • Martin Hurrell has take ownership of document, noted some changes have occurred and need to be synched with the PHD group (Martin Rosner)
      • Doc is to be updated and again presented at Sept 2022 WG Meetings (and likely voted upon).
    • Download SWOT Analysis (2019-01-17 Document)

      • John Rhoads noted he started editing document, will first share with Co-chairs, then group for approval in September 2022 WG meetings 
    • Download Mission and Charter (2019-01-17 Document)

      • Discussion on document - it was noted that the document is not expiring any time soon
      • Motion made by John Garguilo "to adopt current version of Mission and Charter", second by Martin Rosner
        • Approved 10-0-0
    • HL7 DEV Working Group 'Health Reports and the Project and Ballot Health Metrics:  (Rhoads)
      • The final WG Health and PBS Metrics reports have been released for the 2022 May cycle: 2022 May Final Reports
      • New WG Health Metric:
        • A new metric has been added to Work Group Health measuring the number stale issues your WG has in JIRA across product families. Since this is new, it is purely informational at this time, but eventually anything in the red zone will result in an increment on your work group health. This metric will be recalculated before each report is released.

      • See links to current "HL7 WG Health" documents at end of this Agenda
        • John Rhoads noted documents to be updated, and discussed at weekly meetings and can be voted upon in the Sept 2022 DEV WG meetings.
    • Co-Chair Elections (All Co-Chair positions, other than Chris Courville, up for nomination)
      • Devices - electing five co-chairs to fill the positions currently held by Todd Cooper, John Garguilo, Martin Hurrell, John Rhoads and Martin Rosner (Interim) (all of whom may be re-elected)
      • The work groups will be conducting co-chair elections for the term beginning 1/1/23.  The nominations period is May 1 through June 15, 2022.
      • AThe above information was conveyed to attendees and encouraged anyone interested to nominate (self or otherwise) 
  • HL7 DEV General WG Updates (HL7 Officers)

    • Projects Review

      HL7 DEV / Updates & Biz and Work Group documents (Co-Chairs)
      •  Notes Review (for Thursday's Q1 mtg with OO):
        1. OO joint topics:
          1. Review DEV related Jira tickets 
          2. Identify priority discussion topics for joint OO sessions (ACTION John Rhoads communicate to OO)
      • ( Notes Review for) Friday Q1 (OO, DEV, (BRR, CQI, mHealth) FHIR-I)
        1. Discussion will include review of Jira tickets + device Word document etc. 
    • Meeting minutes from 2022-04-27 Wednesday DEV WG and DoF Agenda and Minutes
      • Status Update on Project Scope Statements, 
        1. PSS-2005 - Device Alerting (DEVAL) CONSENSUS-REVIEW  Device Alerting, and 
        2. PSS-1980 - Gemini Safe, Effective & Secure Medical Device Interoperability (SES+MDI) CONSENSUS-REVIEW  Gemini Safe, Effective & Secure Medical Device Interoperability (SES+MDI)
      • Open issues related to Device resource & Communicating Devices Word document (in draft)


  • Co-Chair Report Out

    • (John Rhoads) Any directions of / from HL7 to be aware of...(from Co-Chair meetings between WG meetings)
    • No further report out other than Co-Chairs indicating these meetings (Co-Chair) provide valuable information on operation of the WG...

CO-CHAIR:  TODD COOPER   

CO-CHAIR: CHRIS COURVILLE

CO-CHAIR: JOHN GARGUILO

CO-CHAIR: JOHN RHOADS   

CO-CHAIR: MARTIN HURRELL

CO-CHAIR: JOHN WALSH

CO-CHAIR: MARTIN ROSNER

Garguilo

Q2 (14 total Attendees); same as Q1 + Michael Faughn

Wednesday Q2, 11:00 AM - 12:30 PM (ET U.S.)

DoF Updates

  • PHD Status update/report out (Martin Rosner + Javier Espina + Brian Reinhold)
    • 2022-04-25 HCP (Related Mtg Minutes recorded by OO - Marti Velezis)
  • "Communicating Device" - has been discussed
  • John Rhoads mentioned to keep active with Jira items to provide feedback to Healthcare Products Meetings OO - for both DEV calls
  • Recognized Marti Velezis work with DEV
  • Kosta noted that Marti is part of the FDA "data standards committee" - working for FDA (consultant) on standards concern.

Javier summarized the following notes from Healthcare Products Meeting with O&O held on 4/25/2022:

  • Need to finalize discussion with Javier that:
    • Remove Container from both Device and DeviceDefinition relation type
    • Gateway remains applicable to both Device and DeviceDefinition
    • Previous and Replace are only applicable to DeviceDefinition, not Device
    • Connected is currently either covered by Gateway or parent, while any other connections is currently not of interest, but can be addressed when needed as the value set on both Device and DeviceDefinition remains extensible.
    • Marti will create one for the backbone and one for the value set for Device and DeviceDefinition
  • FHIR-36830 - Update Value set for relationType RESOLVED - CHANGE REQUIRED - See JIRA for vote.
  • FHIR-36828 - Change Device.link to Device.gateway RESOLVED - CHANGE REQUIRED - See JIRA for vote
  • FHIR-36195 - Revise operationalStatus to operation APPLIED JD to update build with changes previously voted.
  • PHD FHIR IG - Current Status ... '22 roadmap including final publication & support for PROs, GHS, etc.
    • Martin is on the Agenda of the TSC, DEV has done everything can do to this point…
    • Roadmap:  Need to see what falls out of O&O and assess if a new version of PHD Guide
    • ACOM - and related to GHS (Gateway) mapping to same resources (i.e., technical parts will not change, but when it comes to attributes - GHS doesn't use attributes in the same manner
    • Martin noted Q1/Q2 of 2023 of IG likely would include the decisions from OO
    • Malcolm Clarke asked about 20601 - simplified attributes approach
  • (Martin Rosner) Roadmap: Not looking at Sept NIB, more likely looking at January NIB

PoCD FHIR IG:  Current & next PSS's (John Rhoads, Stefan Karl, others)

Device Alerting (John Rhoads)

https://confluence.hl7.org/display/DOF/Draft+DeviceAlert+element+definitions+mockup

  • John Rhoads walked through the link above… described the "Named" Device Alert items including identifier, status, code, priority, type, subject, Conditions, device, derivedFrom, alarmLabel
    • Michael Faughn asked about those items with "code" - which is assumed to be tied to a value set, but in some cases of the DeviceAlert don't have the value set…
    • Suggested by Michael to provide the value sets, Paul Schluter mentioned there is ample precedence in IHE Alert work…
    • John Rhoads mentioned this work is in the hands of the OO not value set folks
    • If folks are interested in additional use cases, outside of record an alert, there is much to be considered…

Discussion (potential items) from Tuesday's and leading to Friday's (Q1) Joint O&O Meeting (John Rhoads, Others)

  • Device Concepts
  • HCP (Device/DeviceDefinition) JIRA 


Discussion (potential items) before Friday's Joint FHIR-I Meeting in Q1 (Chris Courville, Others)

  • No discussion 

(NIST) Tooling & Testing (Faughn, Garguilo)

  • RTMMS version 2 status update (Faughn)
    • IDCO terms added
    • Vetted with Paul Schluter
    • 54,246 terms
      • Accounts for all the discriminator expansion of all terms (e.g., for every lead term, there are ~200 terms, so above and beyond…)
    • Advanced Search functionality
    • Mike asked attendees to "kick the tires on the system" and is open to UI and functionality suggestions of RTMMS
    • Check Terms - way to upload terms to check (from a CSV file)
    • Working on a user guide… much to be done here…
    • Michael Faughn provide an update on what RTMMS looks like now and plans going forward…
    • RTMMS (new version) is up and running on NIST server - not yet available for public consumption
    • Other updates
    • Paul Schluter, mentioned for the PHD (e.g., Daidi) the "check in" feature would be good ensure correct formatting and proceed in a unified way (including a provisional term)
    • Malcolm Clarke agreed that standard cannot be published until vetted through RTMMS
  • Adjourn HL7 DEV WG for Wednesday 

    • Meeting Adjourned at 12:50 PM ET

Q3

Q4



No Meetings


No Meetings
Day / DateTimeChairScribe

Notes

Thursday

 

Q1/Q2

9:00 AM - 12:30 PM



CO-CHAIR:  TODD COOPER   

CO-CHAIR: CHRIS COURVILLE

CO-CHAIR: JOHN GARGUILO

CO-CHAIR: JOHN RHOADS
(at O&O)   

CO-CHAIR: MARTIN HURRELL

CO-CHAIR: JOHN WALSH

CO-CHAIR: MARTIN ROSNER

Garguilo

Thursday Q1 (9:00 - 10:30 AM ET)

Recording Attendance: May 2022 HL7 DEVICE and IEEE 11073 WG Attendance here   

  • Welcome and Introductions (new attendees)

  • Introductions: 13 Attendees;  new attendees for Q1 Grant Forrest, Dr. Cheryl Lohman, "SV"(?)

Garguilo read ANSI Anti-Trust Policy: 

Professional Associations, such as HL7, which bring together competing entities are subject to strict scrutiny under applicable antitrust laws. HL7 recognizes that the antitrust laws were enacted to promote fairness in competition and, as such, supports laws against monopoly and restraints of trade and their enforcement. Each individual participating in HL7 meetings and conferences, regardless of venue, is responsible for knowing the contents of and adhering to the HL7 Antitrust Policy as stated in §05.01 of the Governance and Operations Manual (GOM). 

Anesthesia WG Topic (Martin Hurrell)

    • Allocated: 1 Quarter

    • Intra-procedural Anesthesia FHIR IG Work

  • Martin Hurrell asked about the need (by HL7) or who qualifies as implementers.
    • Anesthesia IG Guide was flagged:  regarding the Ballot type is 'Informative', not 'STU' and requirement to list implementers…
    • Do organizations have to be included for Informative - and is an intent to gain sufficient participation?
  • Martin showed and Outline Workplan
    • Point-of-Care Device Implementation Guide, FHIR IG Device Information Client Applications (1643)
    • Main resource would be IEEE11073 Nomenclature
    • IOTA + 5K SNOMED terms that are relevant
      • e.g., Anesthesia procedures
    • Which Tooling to use? (future issue to resolve)
    • Targeting 2-years' time…
    • Mapping of Anesthesia DAM logical models to FHIR resources
    • Gap analysis
    • Profiling (anticipated to be mainly constraints, some extensions)
    • Value Sets
    • Production
    • Publication
  • Main FHIR Resources required likely:  Device, Med Amin, Observation, and Procedure for such an encounter
    • Concern these resources are not sufficient (or would need to be "extended")…
    • E.g., "Device Use Statement" - was looking at a single body site… however a device like a catheter needs to record more than one body site…
  • Martin showed the Anesthesia DAM - and the various use cases…
  • Main task on hand is the Mapping
    1. Thus which FHIR resource?
      • Noted that devices may be "non-communicating" such as a Catheter
      • There may  be devices that are "passive" but with complex structures.
  • IOTA Terms - some are crossed referenced to 11073 Common Term
  • Discussion on the future of what might be reported… which requires a means to model the devices and metrics reported…
  • Martin suggested working with Grant Forrest on providing a write up with models and get Paul Schluter to review.
  • Martin also mentioned an automatic tunicate which is an active device with physical characteristics - doing a lot of processing.
  •  Stefan Karl did note that the "Device Resource" has a 'property' element for another way of doing extensions
    • IGs however intent to constrain
    • Goal is to keep the extensions to a minimum


Joint at (hosted by) FHIR-I  (Courville + Team)

  • FHIR-I WG Coordination (Chris C. - overview of future work/items, Publishing IGs/Device Alert; maturity process...??)

      1. At Thursday Q1 joint w/ FHIR-I (Jira Item/Key: FHIR-32557 - Normative Device Attributes)
      2. NOTE:  You must use the Whova app (Zoom TCon Service) in order to join the meeting with FHIR-I

Joint at (hosted by) O&O (Rhoads + Team)
+ J
oint at (hosted by O&O) FHIR-I  (Courville + Team)

Break from 10:30 AM - 11:00 AM ET

CO-CHAIR:  TODD COOPER   

CO-CHAIR: CHRIS COURVILLE

CO-CHAIR: JOHN GARGUILO

CO-CHAIR: JOHN RHOADS   

CO-CHAIR: MARTIN HURRELL

CO-CHAIR: JOHN WALSH

CO-CHAIR: MARTIN ROSNER

Garguilo

Thursday Q2 (11:00 AM - 12:30 PM ET)

(19 Attendees)

New folks joining: Dorothy Egan SME Nurse Clinical Informatics IT Background representing Tata International TCS - Actively participating in Gravity and CDC SDoH. Exploring groups as TCS that is a top IT global firm better known in European market is participating HL7 FHIR and in May Workgroups.  

Marti V. (O&O), Dorothy Egan, Marc Mar-Yohana (OtisHealth) (first time Hl7 attendee), Shriram Viswanathan (first time HL7 attendee)

+John Rhoads, Javier Espina, Malcolm Clarke, Mhealth Co-chairs: Matt Graham, Frank Ploeg, Gora Datta

 Report Out from IHE-DEV proceedings (from Spring F2F WG meetings week of Apr 26-28, 2022) (John Rhoads, Paul Schluter, Others)

    • Held in at BD in San Diego; included a Pump WG () , PCIM WG ()  set of sessions
    • CPs discussed + other business
    • PCD, PHD, DPI Programs
    • John Rhoads reported good work and progress on the following Integration Profiles (using HL7 V2):
      • IHE-DEV Pump Work and Change Proposals involving flushing the pump lines
      • (Patient Care Identity Management) IHE-DEV - PCIM work has been advanced - group is striving to getting documentation in place to meet requirements for upcoming IHE Connectathon (next is September 2022, after that likely January 2023)
    • Paul Schluter provided a few slides on work from IHE-DEV (PCD Program) reported and discussed and IHE-PCD face to face:

Integrating into one report, some of the in-line technical events…
Malcolm noted  lower case for technical event name; Paul indicated this is the norm.
Also noted the containment tree number is unique within a message (but not shown in sample V2 message above (1.1.4.15, 1.1.4.16, 1.1.4.17)

Paul wrote an HL7 V2 validator - could be used in supplement with the NIST V2 tools, or perhaps provide requirements into advancing the NIST tools.

Use IHE Patient ID (PDQ) for prescription transfer and treatment 'run sheet'

O&O Q1 (DEV at OO) report out from Q1 Thursday (John Rhoads)

  • A lot of other topics including:
    • Mentioned Monday 3 pm (Eastern Time) Healthcare products.
    • Device Usage and maintaining a supply chain for maintaining a catalog for devices
    • John asked about perspective on the Device Resource…
    • JIRA tickets were stepped through (a bit outside the scope)… not much time to address DEV items, mote to come in weekly Monday (9AM) and Wednesday (9 AM) meetings - Kudos to Marti Velezis for all the support she has been giving DEV as a liaison to O&O.

Nomenclature - RTM status update (Paul Schluter)

    • See Paul Schluter's Slide set here

Malcolm suggested that perhaps there is an MDC--> UCUM  "indisputable" table/listing (regardless of language, e.g., French vs. English)…

Paul responded that there are a very small amount of items like {unitless} 1

  • Paul noted a problem with the font size (IEEE-SA Publishing) and layout is a problem for enumerations

  • Joint with Mobile Health WG (Matt Graham/Gora Datta/Nathan Botts/Frank Ploeg - Mobile Health Co-Chairs)

    • Welcome & Introductions (Mobile Health WG Agenda

    • General mHealth WG Updates w/ report out and status of on-going projects (Graham/Datta
    • See Matt Graham's / MH Slide Set here.
  • Matt Graham presented (see slide set)
  • cMHAFF
    • ~80 Comments, most addressed
    •  been working on about  5 years
    • STU2 Ballot Reconciliation to be completed May 2022
  • Mobile Health App Data Exchange Project Scope
    • Looking at the variation in FHIR reporting…
  • SHIFT Project
    • Executive Summary near done
  • UMHAI
    • New Mobile Project PSS-1867
    • Still looking at use analysis to see how it will play out
    • Draft USCDI V2
  • New Use Cases (Q3 today, Thursday May 12th)
    • Multiple Medical Device Data Interoperability
    • Single Device  - Multiple User Interoperability
    • VA/DoD/FEHRM - new use cases
  • Javier E. asked about UMHAI project with relation to FHIR Resource
  • Kosta Makrodimitris asked about the use cases being addressed,
  • https://confluence.hl7.org/display/MH/2022+May+WGM+-+Virtual+Mobile+Health+WG

O&O Q1 report out

Gora mentioned another project he's working on: https://get.blockchain.ieee.org/'

PSS Updates (e.g.,  "Unique Mobile Health App Identifier") (Datta)

    • Prior Topics:  Possible connection between JHU/APL MDIRA / Gemini MDIRA Profile & HL7 mHealth Standards?  (Cooper / Datta)
    • Others...
Q3
1:00 - 1:30 PM

CO-CHAIR: JOHN GARGUILO

CO-CHAIR: JOHN RHOADS   

CO-CHAIR: MARTIN HURRELL

Laurie Whitsel,

Maria Isler,

Russell Buchanan,

John Garguilo (DEV)

Thursday Q3 (1:00 - 1:30 PM)

Presenters/Project Sponsors: Russell Buchanan Russ Buchanan (Accenture, russell.buchanan@accenture.com), Laurie Whitsel (Laurie.Whitsel@heart.org), Maria Isler (Maria.Isler@heart.org), 

Attendees: John Garguilo, John Rhoads, Martin Rosner (DEV Co-chairs)
Brooke McSwain (AHA), Javier Espina, Konstantinos Makrodimitris, Malcolm Clarke, Paul Chase (AHA), Paul Schluter, Peter Gunther, Satoshi Kobayashi, Stefan Karl

Meeting Session w/  Physical Activity Alliance and the American Heart Association jump into the HL7 FHIR standards development world

  • Laurie Whitsel (Laurie.Whitsel@heart.org) and Maria Isler (Maria.Isler@heart.org) are the project sponsors. 
    At May WGM they met with certain relevant work groups to talk about their project proposal for an IG defining standards for physical activity measurement and enhancement. 
  • Russell Buchanan (russell.buchanan@accenture.com) will be supporting them at the WGM.  Devices is one of the work groups that seems to have overlap/interest.  
  • Laurie, Maria, and Russ provided an ~20 minute overview/presentation of work and proposal
  • Specifically, the project is looking at being able to capture measures related to physical activity level.  This may well involve leveraging real-time device information such as step counts or heart rate monitor information.

  • Currently looking for sponsors, co-sponsors and interested parties, so please think about if/how the HC Devices work group might like to be involved. 

Also reaching out to PC, FM, OO, MH, CIC, and the Gravity project


John Garguilo asked:

  • What standards are being considered, e.g., HL7 V2?, FHIR? IEEE 11073?
  • Project work statement focuses on HL7 FHIRMeasure as an observation - can background be provided on how the measure interacts with Device Data?
  • How IEEE Standards can come into play?


  • To date - A variety of ways to measure activity such as using: smart watches, various apps, but are not presently common platforms… and support patient activity monitors to provide prompts or interventions are needed…
  • Also not a clear link used to monitor overall public health monitoring… different interventions...
  • Goal is to bring HL7 guidance groups (accelerators such Gravity and DaVinci) to share physical activity levels and to share (quality) data...
  • Assessment tools and observations needed...
  • Use the observations to identify population at risk and further to notify folks in poor health; later on to monitor (evidence based); and much further downstream on is Provider/Insurance Companies
  • Tracking could be at the level of an Rx (Prescription); users "required" to report.

Minutes of Heart Rate (HR) to get to assessment of moderate to excessive exercise levels - many proprietary solutions out there…This effort is looking for result of high level reporting
Comment made about the transport of (quality data) and the algorithms needed to provide "good" data.  (At least) two parts need to be considered:

  1. Data transmission
  2. Algorithmic part

Reality is that the market is another part, and to date this has been somewhat difficult to work with…
Laurie mentioned there has been some research on self-reporting from data accelerometers (e.g., smart watch)
Laurie also noted there is a matter of patient continuum from a couch potato and marathon runner…

Motion made by John Garguilo "to list HL7 DEV as an "interested party/Work Group" to be in a supportive and guidance role on PSS-2069, Physical Activity measurement and remediation", https://jira.hl7.org/browse/PSS-2069.  Second by Martin Rosner, approved 10-0-0

  •  ACTION ITEM:  John J. Garguilo John Garguilo to schedule a quarter on next HL7 DEV September 2022 WG agenda for status updates on this work (and potentially at same time/joint with Mobile Health WG)



No Meetings
  • Q4 (No WG meetings)

    • No Meetings / Open if needed 
DayTimeChairScribeNotes

Friday

 

Q1/Q2
9:00 AM - 12:00 PM

CO-CHAIR:  TODD COOPER   

CO-CHAIR: CHRIS COURVILLE

CO-CHAIR: JOHN GARGUILO

CO-CHAIR: JOHN RHOADS   

CO-CHAIR: MARTIN HURRELL

CO-CHAIR: JOHN WALSH

CO-CHAIR: MARTIN ROSNER

Garguilo/Cooper

to be validated by Todd Cooper

Friday Q1 (9:00 AM - 10:30 AM ET)

NOTE: No Q1 DEV Meeting - Joint at O&O


Recorded Attendance: May 2022 HL7 DEVICE and IEEE 11073 WG Attendance here 

 

Friday

Q2

11:00 AM –1:00 PM

End of Meetings1:00 PM

Friday Q2 (11:00 AM - 1:00 PM ET)

 

Welcome and Daily Agenda Review (Cooper)

ANSI Anti-Trust Policy: 

Professional Associations, such as HL7, which bring together competing entities are subject to strict scrutiny under applicable antitrust laws. HL7 recognizes that the antitrust laws were enacted to promote fairness in competition and, as such, supports laws against monopoly and restraints of trade and their enforcement. Each individual participating in HL7 meetings and conferences, regardless of venue, is responsible for knowing the contents of and adhering to the HL7 Antitrust Policy as stated in §05.01 of the Governance and Operations Manual (GOM). 

OO Report Out from Joint Meeting with DEV in Q1 (Rhoads, Others) 

DEV at O&O (see also O&O Meeting Minutes)

  • From OO Agenda for Friday Q1
    • Suggestion was to, as we move forward, have a dedicated quarter at O&O with DEV

    • Little to no time in Q1 to discuss Alert...

From O&O Friday, May 13, Q2Agenda/Meeting Minutes

    • Device
      • Device Scope/Usage and Boundary and Relationships
        • FHIR-32408 - DeviceMetric resource listed as device related resource, but the Device resource does not reference it
          • That’s because it is an option to refer to from observation
          • Is part of a stack of resources used in the POCD IG
            • Top level device
            • Medical device
            • Channels
            • DeviceMetric is on an observation
          • General guidance is to point from child to parent because if a resource already exists, we don’t want to go to it to update a relationship – should add this explanation to the scope
          • Should we add a search parameter that returns DeviceMetric from device – that would be a separate ticket - @Rob
          • Motion to update the device resource Scope and Boundary section to include stating the relationship with DeviceMetric
            • John Roads, Jose Costa Teixera, no further discussion, against: 0, abstain: 1, in favor: 12
            • Clarification
            • Non-substantive
            • Update as part of https://jira.hl7.org/browse/FHIR-32277
            • Assign to Marti Velezis
    • Suggested and agreed by Hans to arrange the workshop session between OO and DEV
    • JIRAs to do with Device and DeviceDefinition discussed - not directly related to DEV WG or work...
      • John Rhoads asked: how DeviceMetric worked in response to a JIRA asking why Device doesn’t mention DeviceMetric
      • Attendees agreed that the relationship works as it should (pointers going down the containment tree, but no pointers going up), but it should be explained in the Device core resource page (which OO voted to do, as the owners of the Device resource).
    • Many thanks to Marti Velezis  for her efforts for working with DEV on the weekly Wednesday meetings - DEV certainly appreciates these efforts to move our work forward!!

Gemini SES+MDI Update (Todd Cooper)

    • General Project Update (Workstreams + Roadmap)

    • PSS-1980 - Gemini Safe, Effective & Secure Medical Device Interoperability (SES+MDI) CONSENSUS-REVIEW & Joint IHE-HL7 Gemini Projects Update

    • Gemini Accelerator Update & FHIR CAT Considerations

Todd Cooper presented a slide set (Gemini SES+MDI Project Update)

  • IHE Connectathon(Sept '22) both European event and North American Event - will they be synched in any way? TBD
  • Todd review several upcoming events coming including Stretch goal hybrid connection near end of year
  • Todd mentioned the HL7 "Re-envisioning" effort and new positions created including:
    • Chief Standards Development Officer: Dan Vreeman, Deputy Chief: Diego Kaminker
    • Other new TSC members: Jean Duteau (TSC Vice-Chair), Gora Datta, Rich Geimer
  • Discussion on "Accelerator" and HL7's modeling around specification ballots
    • DaVinci (Accelerator) Model is more of a wide scoped "everything" model
    • However, an accelerator can be tailored to a specific community…

Todd Cooper presented update and slides regarding CA & Tooling Strategy 

  • Gemini SES MDI - SES Ecosystem Pathway Update
    • By-weekly meetings every other Tuesday
  • Todd showed and walked through the Gemini Ecosystem Pathway Process
    1. MDI Group
    2. EP Pathway Group
    3. MDIRA Group
  • SDPi BICEPS Extension Namespace
    • Issue has to do with OID naming (and used or exchanged during "unsecured" discovery/mode)
      • Name space noted for BICEP extensions
      • If an OID, we resolved this issue at IHE Spring F2F meeting
        • Codified it - with DEV OID being PCD OID (CP to change from PCD--> DEV  in synch with IHE Domain name (with underlying Programs)


  • Github to profiles.ihe
    • Several repositories:
      • IHE-DEV repo
      • Gemini sdpi-FHIR repo
      • HL7 Dev Alerting repo
      • NIST XDS & Asbestos FHIR Toolkit repo
      • IHE Publications repo

Open Discussion / Topics Arising from this week... (Co-Chairs)

      • IEEE POCD 11073 additional topics
      • Interoperability standards success stories/Pilots and Conformity updates around the globe
      • Joint Standards Workgroup (Konstantinos Makrodimitris) Meetings - Planning 2022-2023
        • considerations about a future 2022 Meeting (Virtual) hosted at FDA
      • Regulatory map/coordination on interoperability 

Planning September 17-23 '22 WGM (Co-Chairs)

  • HL7 announced it will likely be a live event (w hybrid options) in Baltimore Maryland - based on weekly poll taken by each WG
  • Feedback from these/May '22 meetings:
    • Establish joint meeting with O&O (full quarter)
    • Invite Physical Activity Group join DEV during same quarter as Mobile Health
      • Not obvious which, if any, WG Physical Activity Group is with?? (PS-
    • Should there be an in person event:
      • What is the possibility of having a time for an IEEE PHD set of meetings?
      • Issues related to attendees for IEEE-SA meetings but not registered for HL7
        • How should this be handled?
  • Objectives / Core Topics for Sept '22 (incl. joint sessions)
    • NOTE: we have been offered a full Quarter with OO - what day/quarter works best for DEV?
  • HL7 (Virtual) Room Reservation for May 2021 Meetings (Garguilo)
    • John J. Garguilo ACTION: Garguilo will reserve rooms and schedule joint quarters - needs to be completed by next week.
    • To include full Q with O&O and DEV (OO hosting)
  • Action Items overview going forward from May 2022(HL7/IEEE/ISO) and coordination with other SDOs

    • Action Items Reviewed (Garguilo)

    • HL7 PSS "Action Plan" 

      • No further discussion

Meeting Adjournment (Co-Chairs)

  • Many Thanks to our wonderful presenters, attendees, and a VERY Informative work of week!
    • Co Chairs thanked participants and presenters for their engagement, enlightening and very informative sessions throughout the week and contributions to the HL7 DEV WG :-)
    • Attendees reminded to review meeting minutes and post all presentations to DEV's Confluence File Storage Area within Working Group Materials Folder 
  • Motion to "Adjourn Meeting" by John Garguilo, Second by Martin Hurrell
    • Approved 11-0-0
  • Be well and thanks for your attendance and work as we move DEV forward :-)

  • May HL7 DEV Meeting Adjourned at 1:07 PM, Friday May 13, 2022

Current Versions of WG documents, for discussion (To Do: John Rhoads please validate for latest versions...)

https://www.hl7.org/documentcenter/public/wg/healthcaredevices/Default_HL7_WG_DMP_2018.pdf

Default_HL7_WG_DMP_2019_V5.2_Clean.docx

https://www.hl7.org/documentcenter/public/wg/healthcaredevices/HL7 DEVICES - 3-year plan 2021 - 2024.docx

https://www.hl7.org/documentcenter/public/wg/healthcaredevices/HCD_DEV_SWOT_Analysis_2019-01-17.doc

https://www.hl7.org/documentcenter/public/wg/healthcaredevices/HCD_WG_Mission_And_Charter_2019-01_17.docx





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