Draft - Updates pending...

• Daily Schedule Overview

  • We will be holding 2 sessions per day, mainly Q1 and Q2 Tuesday - Friday

Daily Schedule - NOTE that the meeting occurs virtually in the United States Eastern Time Zone

• WebEx Information

  • https://ieeesa.webex.com/ieeesa/j.php?MTID=med0e5d8362b2d4caa329de5de988fcd9
  • Meeting number (access code): 2346 569 8933 

  • Meeting password: sjM5xMTXE56

• Recording Attendance:

  Please Log September 2021 HL7 DEVICE and IEEE 11073 WG Attendance here

Agenda:

Abbreviations

HL7 Plenary Meetings

20 Sep 2021 

Monday Q1 & Q2

• Plenary Meeting Agenda: 35th Annual Plenary Meeting
• Note: No IEEE or HL7 DEV meetings
• Monday A.M. - This is the annual HL7 Plenary meeting, so Monday A.M.'s sessions are focused on those sessions (not the DEV WG)
  Note HL7-wide moment of silence for those who have passed in the past year.
  

IEEE EMB 11073 PoCD WG Meeting

Monday Q3 & Q4

• No Meetings

21 Sep 2021

IEEE EMB 11073 PoCD WG Meeting

Tuesday Q1, Q2

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] 

08:05a | 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

08:15a | Agenda Review [Kosta] 

08:25a | Review Previous Minutes and New Members[Kosta] 

08:45a | 11073 SC Update [Ken] 

08:50a | IEEE 11073 PARs, Projects, SDOs and Analytics [Tom, All]

IEEE reports, dates and stats (Tom) 15mins

9:15a | Other SDOs WGs  eg AAMI, LOINC, ISO, IEC, SNOMED, IEEE 11073-PHD, FDA/DSAB, MDEPINET…(ALL) (Ray, Ken, Isabel, Martha)

• • IEEE 11073 PHD Report-out (Ray Krasinski)
  • ACOM (Abstract Content Model) and GHS (Generic Health Sensors) Goals (Ray Krasinski)

9:30a | Update ISO/TC 215 Remote Connected Care - Mobile Health (RCC-MH) project (Ken, Gora)

09:45a | IEEE 11073 SDC Update [Martin K.]

10:30a | Break

10:45a | IEEE 11073 Nomenclature Update [Paul]

11:30a | 11073 Stories/Pilots and Conformity and Regulatory track: IHE, ASCA, NIST/FDA, IMDRF (Kosta, John, Todd)

11:50a | Logistics next WG meeting, Additional topics for Friday morning?

12a Closing [Stefan/Kosta/Steve]

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

HL7 Devices (DEV) WG Meeting

22 Sep 2021 

Wednesday Q1, 9 AM - 10:30 AM (Eastern US)

• Welcome, Introductions, and Agenda Review (HL7 Officers)
  • HL7 DEV Working Group 'Health Reports and the Project and Ballot Health Metrics': 2021Sep Final Reports
  • May 2021 WG Meeting Minutes Review / Approval (Garguilo)
  • Note:  HL7 International Education on Demand Site for members: https://www.pathlms.com/hl7
  • "How To" videos on Confluence and Jira
  • Congrats to Chris Courville - recently elected to another 2-year term as a HL7 DEV Co-chair

• HL7 DEV General WG Updates (HL7 Officers)

  • HL7 DEV / Updates & Biz and Work Group documents
    

  • Anesthesia (Martin Hurrell/John Walsh)

    1. Topics?
    • Previously discussed idea of merging projects version 2 of Intraoperative anesthesia DAM and FHIR Implementation Guide

• V2-to-FHIR Mapping (specifically for ORU) (John Rhoads)

  • • What's changed since May WG Mtgs...

• HL7 PHD and PoCD FHIR DoF - focus 
  • General Updates per the IGs and active projects
    • IHE Devices / PCH (PCHAlliance / Continua) report out + POU profile & BPP's under development (Thom Ericson)
    • IEEE PHD Report-out on ACOM, GHS & relation to DoF work (Brian Reinhold)

Break from 11:10 AM - 11:20 AM EST

Wednesday Q2, 11:20 AM - 12:30 PM (Eastern US)

• MDIRA profile update (Steve Griffiths / Jan Rizzuto / Todd Cooper)

  • General project update (Jan)
  • Current Gemini MDIRA Profile efforts & outlook

• Guest Presentation:  Dr. Maurice Ramirez on AI applied to SAMD & Emergency Care

• Incorporating description - cross-walk to UDI   (John Rhoads)

  • Provide an update per OO & IEEE standards & IHE Profiles >
  • Issues and Challenges...

• Discussion (potential items) before tomorrow/Thursday's Joint O&O Meeting in Q1 (John Rhoads)

  • 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 tomorrow/Thursday's Joint FHIR-I Meeting in Q1 (Chris Courville)

• Adjourn IHE-DEV Wednesday 

Wednesday Q3 + Q4 (No WG meetings)

• Open 

HL7 Devices (DEV) WG Meeting

23 Sep 2021 

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

• Note: No IHE-DEV Mtgs for Q1 - Members welcomed to join Joint O&O and FHIR-I WG Sessions

• 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 
  • (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 EST

Thursday Q2 (11:00 AM - 1:00 PM EST)

• Welcome and Introductions (new attendees)

• A minute of silence for those who passed in 2021 ...

  •  Remembrances During HL7 Annual Business Meeting

    

    

    

• Quote of the Day:

  •  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)

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

  • V2-to-FHIR mapping update (esp. for ORU message semantics)

  • UDI Update (is it actually still ... relevant?  Progressing?)

  • FHIR DeviceDefinition & related device supply chain management discussions

• FHIR-I Report Out from Joint Meeting with DEV in Q1 (Courville + Team)

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

  • RTMMS version 2 status update (Faughn)

  • V2+ Project / Tooling Update

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)
  • Topic:  Possible connection between JHU/APL MDIRA / Gemini MDIRA Profile & HL7 mHealth Standards?  (Cooper / Datta)

• ONC ISA & USCDI Request for Comments (Lead?)

  • Our opportunity to provide devices-related input to this ONC effort

  • Comment period closes September 30th

  • See Interoperability Standards Advisory (ISA) Table of Contents 

  • See U.S. Core Data for Interoperability (USCDI) 

  • USCDI questions? andrew.northup@hhs.gov

• NEWS:  FDA Launching AI/ML-Enabled Devices List

  • Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices ... List ... extensive!

  • Program from the FDA Digital Health Center of Excellence 

• 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)

Thursday Q3 + Q4 (No WG meetings)

• No Meetings / Open if needed 

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

24 Sep 2021 

• Welcome and Daily Agenda Review (Cooper)

• Japan SCOT project (Koichiro)

• Other Potential Topics:  Devices on FHIR (Carried forward From Wednesday Q1)

  • PHD FHIR IG  (rev 0.3.0) - ballot comment resolution and advancement toward publication, and planning + Next Version 

  • PoCD FHIR IG (rev 2.0) - PSS advancement

  • DeviceAlert FHIR Resource - FHIR Resource project proposal review / content review / advance toward first ballot Summer '22 etc. (Jan-Alrik Philipsen)

  • NOTE:  HL7 PMO October PSS submission deadline

  • QUESTION:  Will we/DEV need to meet with FMG or others to review our work plan and get it "approved"?  <Probably a FMG call outside the WGM week>

  • Real-world Implementation Challenges - FHIR Resource & IG Change Management 
    • FHIR Resources NOT managed by HL7 DEV are key elements in DoF IGs (e.g., Patient, Observation, Location) ... change management is VERY important
    • Moving from Universal Realm to a specific National Realm (e.g., Netherlands) - How will this be managed / supported by the PoCD / PHD FHIR IG's
  • Past unresolved (Specific) topics?:
    • Jira Issue:  How to store parameters of a procedure in ServiceRequest in a structure way? 
    • Zulip Discussion:  Device Type vs Kind 

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

• Gemini SES MDI - SDC/SDPi+FHIR Update (Cooper)

  • General Project Update (activities since the May '21 WGM) 

  • Role of Gemini MDIRA Profile 
  • 3-Year Roadmap Overview
  • RI+MC+RR for SDPi 1.0 & Conformity Assessment & Beyond
    

  • Gemini SES/Regulatory Initiative Kick-off

• Toward ISO/IEEE 11073 "MDC" 2.0 (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!

      
      

• 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 2021-2022

    • considerations about a November 2022 in person meeting at FDA

  • Regulatory map/coordination on interoperability 

  • ...

• Planning January  18-21 '22 WGM (Co-Chairs

  • Feedback from these/Sept '21 meetings

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

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

• Action Items overview going forward from Sept. 2021(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