Daily Schedule Overview

• We will be holding 2 sessions per day, mainly Q1 and Q2 Tuesday - Friday (U.S. CST Time Zone)

• Tuesday is dedicated for the IEEE 11073 PoCD Working Group Meetings

  • Note: 8 am CST Start Time
• Wednesday - Friday for the HL7 DEV Working Group Meetings
  • Friday focused on Gemini SES and MDI work
  • Note: 9 am CST Start Time

Expanded Daily Schedule - NOTE that the meeting occurs virtually in the United States Central Standard Time Zone

• WebEx Information (Tuesday - Friday, January 18-21, 2022)

  • Meeting link: https://ieeesa.webex.com/ieeesa/j.php?MTID=m4b3e92886b57b6fd96537721a3c64677
  • Meeting number (access code): 2347 376 2262
  • Meeting password: PApgmtdG733

• Recording Attendance:

  Please Log January 2022 HL7 DEVICE and IEEE 11073 WG Attendance here

• Meeting Documents (Link to HL7 DEV Documents Storage Location on Confluence F3 Site)

Agenda:

Abbreviations

IEEE EMB 11073 PoCD WG Meeting

18 Jan 2022

IEEE EMB 11073 PoCD WG Meeting

Tuesday Q1, Q2 (8:00 AM - 12:30 PM, CST)

Recording Attendance:

Please Log January 2022 HL7 DEVICE and IEEE 11073 WG Attendance here

Slides and other resources were uploads/archived in IEEE POCD imeet-central https://ieee-sa.imeetcentral.com/11073pocd/folder/WzIwLDEzNTI0ODc1XQ/

 IEEE11073 POCD WG meeting (September 21, 2021) -Virtual/Draft agenda  (8 to noon US ET -Eastern time))

08:00a | Welcome, Introductions, and Agenda Review [Steve/Kosta] 

08:10a | 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]

08:15a | Agenda Review [Kosta] / Review Previous Minutes and New Members[Kosta] 

8:30-9:00 am | Update regarding PARs & Standards (Tom Thompson, IEEE-SA Liaison) 

IEEE 11073 PARs, Projects, SDOs and Analytics

IEEE reports, dates and stats

09:00-9:45 am  | Update from SDC SG (Martin)

9:45-10:30 am  | Update from the IDCO SG (Craig Reister)

======

Break 10:30-11 AM

======

11:00 am-12:00 pm | Update from the Nomenclature SG (Paul Schluter)

IEEE 11073 Nomenclature

12:00-12:30 |  PoCD WG organization, meetings & wrap-up

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

Logistics next WG meeting, Additional topics for Friday morning?

12:30p Closing [Stefan/Kosta/Steve]

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

Wednesday Q3 + Q4 (No WG meetings)

• Open 

HL7 Devices (DEV) WG Meeting

19 Jan 2022 

Wednesday Q1, 9 AM - 10:30 AM (Central Standard Time - CST U.S.)

Recording Attendance:

Please Log January 2022 HL7 DEVICE and IEEE 11073 WG Attendance here

• 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). 

  • Note:  HL7 International Education on Demand Site for members: https://www.pathlms.com/hl7
    • E.g., "How To" videos on Confluence and Jira
  • HL7 Co-Chair Updates (including new CStdsO / dCImplO, JIRA use, etc.) (Cooper)
  • DEV WG Health Metrics: Working Group Health Files
  • General updates / announcements / ... / <Kosta stuff> / ...
  • Other announcements / updates / suggestions from attendees...

• Housekeeping: Current Versions of WG documents, for discussion (Rhoads)

  • 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) 

  • Download 3 Year Plan (2021-->2024)

  • Download SWOT Analysis (2019-01-17 Document)

  • Download Mission and Charter (2019-01-17 Document)

  • HL7 DEV Working Group 'Health Reports and the Project and Ballot Health Metrics': 2021Sep Final Reports (Rhoads)
    • See links to current "HL7 WG Health" documents at end of this Agenda

• September 2021 WG Meeting Minutes Review / Approval (Garguilo)
• HL7 DEV General WG Updates (HL7 Officers)

  • Projects Review,

    HL7 DEV / Updates & Biz and Work Group documents (Co-Chairs)
    

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

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

Recording Attendance:

Please Log January 2022 HL7 DEVICE and IEEE 11073 WG Attendance here

• DoF Updates 

  • PHD FHIR IG - Current Status ... '22 roadmap including final publication & support for PROs, GHS, etc.

1. • PoCD FHIR IG:  Current & next PSS's

     1. What will it take to get the PoCD FHIR IG Published? 

     2. How will Maturity Level #2 be achieved for the IG and the DeviceMetric resource? 

     3. What (3+) independent implementations might be "encouraged"? 

     4. What testing events in addition to the May FHIR CAT be used to achieve the needed testing?

     5. How will we support device alerting in FHIR IGs?  2nd edition of the PoCD FHIR IG?  A focused PoCD Alerting FHIR IG?

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

• (Duplicated list of items from Last Meeting for review) 

  • At Thursday Q1 joint w/ O&O DEV BRR:  JIRA items related Device, DeviceDefinition & DeviceMetric   (also device Product, Catalog) 

  • NOTE:  For Thursday Q1 Please join using O&O's Zoom Meeting Information - You may use the Whova app in order to join the meeting with OO 

  • (Potential Discussion Topics from prior weekly meetings and O&O recent Mtg Minutes...)

    PRT[Device] 
        We need to review all messages in scope for PRTs and see whether any one may need to map to DeviceUseStatement. 
        We need to look more at the Action Code in PRT-2 and determine how that impacts the creation and/or status of the FHIR resource being mapped to 
        Included comments to address PRT-2 = D.  This needs to be copied to any other message mapping PRT. 
    PRT[Observation-Location] 
        Does it make sense to record the begin and end dates for a location? Is it likely that a location participates for only a portion of the Observation time period (which are themselves typically a point in time)? 
        We agreed not to map at this time.  The time period should be done on the event resource that reflects the activity performed in the location.  While in v2 that may be an OBX with a specific LOINC (or other code), in FHIR that could be a different resource from Observation to capture that event.  
        Looked at an alternate mapping for PRT-5 (based on what we are doing in ORC for ordering provider) that needs to be resolved 
        Agreed to map PRT-5 to PractitionerRole.practitioner. - Done 
        We will add this to the issues list as a general request for feedback. 

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

• Adjourn IHE-DEV Wednesday 

Wednesday Q3 + Q4 (No WG meetings)

• Open 

HL7 Devices (DEV) WG Meeting

20 Jan 2022 

Thursday Q1 (9:00 - 10:30 AM CST)

Recording Attendance:

Please Log January 2022 HL7 DEVICE and IEEE 11073 WG Attendance here

• Welcome and Introductions (new attendees)

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

  • Allocate: 1 Quarter

  • Review project proposal - approved

  • PSS - Review & Approve 

  • Review general project scope & INTERSECTION with other DEV areas (incl. DoF IGs & Gemini SES MD

• Any pre-meeting discussion needed??

• Joint at 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 TCcon Service) in order to join the meeting with FHIR-I

• Joint at O & O (Rhoads + Team)

  • At Thursday Q1 joint w/ O&O DEV BRR:  JIRA items related Device, DeviceDefinition & DeviceMetric   (also device Product, Catalog) 
  • NOTE:  You must use the Whova app in order to join the meeting with OO 
  • Device/Device Definition Mapping
  • (Potential Topics below noted from O&O prior weekly meetings and discussions...)
    PRT[Device]
    • We need to review all messages in scope for PRTs and see whether any one may need to map to DeviceUseStatement.
    • We need to look more at the Action Code in PRT-2 and determine how that impacts the creation and/or status of the FHIR resource being mapped to
    • Included comments to address PRT-2 = D.  This needs to be copied to any other message mapping PRT.

PRT[Observation-Location]

• • • Does it make sense to record the begin and end dates for a location? Is it likely that a location participates for only a portion of the Observation time period (which are themselves typically a point in time)?
    • We agreed not to map at this time.  The time period should be done on the event resource that reflects the activity performed in the location.  While in v2 that may be an OBX with a specific LOINC (or other code), in FHIR that could be a different resource from Observation to capture that event.  
    • Looked at an alternate mapping for PRT-5 (based on what we are doing in ORC for ordering provider) that needs to be resolved
    • Agreed to map PRT-5 to PractitionerRole.practitioner. - Done
    • We will add this to the issues list as a general request for feedback. 

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

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

Recording Attendance:

Please Log January 2022 HL7 DEVICE and IEEE 11073 WG Attendance here

• Quote of the Day:

  • (From Sept 2021)

     John Halamka on Hospital @ Home - Mayo Style

    During last week's ONC Tech Forum panel session ...

    Speaking about the interoperability of remote patient monitoring solutions, Halamka said that unfortunately, many devices that are on the market today don't follow widely accepted standards. “You have the challenge of getting these high-velocity continuous signals from the home into a standard form and then transmitting them robustly into the social platform. Mayo Clinic is working with Medically Home, a Boston-based technology-enabled services company, as its implementation partner. He said Mayo seamlessly and bidirectionally integrated Epic with the platform for selected data elements, “so that there was not a lot of having to hunt in two different places and having to manually re-key information.”

    (Source:  Healthcare innovation article, 202.09.20)

• (NIST) Tooling & Testing (Faughn, Garguilo)

  • RTMMS version 2 status update (Faughn)
  • V2+ Project / Tooling Update
  • Michael's thoughts on complexities, hurdles, and advantages of tooling technologies...(Faughn, Cooper)

NOTE:  Gemini SES MDI related CA & Tooling to be provided in the Friday discussion

• 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)
  • New PSS "Unique Mobile Health App Identifier" (Datta)
  • Prior Topics:  Possible connection between JHU/APL MDIRA / Gemini MDIRA Profile & HL7 mHealth Standards?  (Cooper / Datta)
  • Others...

Thursday Q3 + Q4 (No WG meetings)

• No Meetings / Open if needed 

Friday Q1/2  (9:00 AM - 12:30 PM AM EST)

Recording Attendance:

Please Log January 2022 HL7 DEVICE and IEEE 11073 WG Attendance here

21 Jan 2022 

• Note: Members welcomed to join Joint O&O and FHIR-I WG Sessions in Q1

  • O&O Agenda

• 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). 

• Update on TC215 & JWG7 Related Projects (PHN-A & DTx & SES MDI) (Todd Cooper)

• Gemini SES MDI Update 

  • <normal roadmap update>

  • Incl. MDIRA Update

  • Ecosystem Pathway update

  • RI+MC-RR Update (incl. MBSE / SysML 2.0)

  • Catalyst Study Report Out 

• Perspective:  ISO/TC 215 WG11 Personalized Digital Health Informatics (w/ DTx & PHN ...)  

• ISO/IEEE 11073 "MDC" 2.0 - Update discussion (Cooper)

• Gemini SDC/SDPi Confluence Pages Review ("upon request") (Cooper)
  

  • •  Gemini SES MDI Confluence Pages of Interest

      Topics from the Wednesday Q3 Gemini SES MDI using SDC / SDPi+FHIR update ...

      1. Library with EVERYTHING you ever wanted to know ... (https://confluence.hl7.org/x/aojGBg)
      2. RI-TF-CA Coordinated Focus (https://confluence.hl7.org/x/KA7xB)
         1. Requirements Interoperability Pilot (… https://confluence.hl7.org/x/oJGHBg)
         2. MBSE / SysML / Cameo Pilot (https://confluence.hl7.org/x/YAZxBg)
         3. FDA ASCA & IHE CA Pilot (https://confluence.hl7.org/x/VouHBg)
      3. Topics of Interest continue to expand (https://confluence.hl7.org/x/0yPxB)
      4. Device Specializations home (https://confluence.hl7.org/x/wZqfBg)
      5. IHE SDC/SDPi PAT events (https://confluence.hl7.org/x/09R7BQ) 
         1. Python Reference Provider Test PAT #4
         2. Reference Provider/Consumer Specification 
      6. HL7 FHIR CAT “Isolation PoC” events (https://confluence.hl7.org/x/m2PPBQ)
      7. MDIRA Profile home (https://confluence.hl7.org/x/4Y_HBg)

      NOTE:  Remember these confluence pages are ALL a work-in-progress ... messiness expected!

      
      

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

  • OO

    • From OO Agenda for Friday Q1
    • FHIR Device Resource & related d discussions

  • FHIR-I

    • Topics for discussion...

• 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

  • FDA (Konstantinos Makrodimitris) Meetings - Planning 2022-2023

    • considerations about a March 2022 Meeting (Virtual) hosted by FDA

  • Regulatory map/coordination on interoperability 

• Planning May 9-13 '22 WGM (Co-Chairs)

  • HL7 announced it will again be Virtual

  • Feedback from these/Sept '21 meetings

  • Objectives / Core Topics for May '22 (incl. joint sessions)

  • HL7 (Virtual) Room Reservation for May 2021 Meetings (Garguilo)

• Action Items overview going forward from January 2022(HL7/IEEE/ISO) and coordination with other SDOs

  • Action Item Review

  • HL7 PSS "Action Plan" 

• Meeting Adjournment (Co-Chairs)

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