MEETING AGENDA

Dated                  13 May 2022

Reference           IEEE 11073 / HL7 DEVICES –  Final Version


Joint meeting of HL7 Devices (DEV) WG + IEEE EMBS 11073 PoCD + PHD WGs, Virtual 

Monday  2022/05/09 – Friday 2022/05/13


HL7 DEV WG Leadership:

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

 

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


todd@trustedsolutionsfoundry.com

ccourvil@epic.com

john.garguilo@nist.gov

johnrhoads@johnrhoads.net

martinjhurrell@gmail.com

jwalsh@partners.org

martin.rosner@philips.com



ken.fuchs@ieee.org  

daidi.zhong@ieee.org

stevendain@gmail.com




Stefan.Schlichting@unity.de

sdain@rogers.com

Konstantinos.Makrodimitris@fda.hhs.gov

thomas.thompson@ieee.org


Location: Virtual (On-line Only)

HL7 Site (May 2022) Working Group Registration and Information:

May 2022 Working Group Meeting (Virtual Event)

Whova App : DEV WG 

(Please note, DEV will NOT be using Whova for meetings, see WebEx link below)

  1. Meetings are held in the U.S. Eastern Time Zone - see below for Daily Schedule in several time zones
  2. There are joint meetings - some of us will join FHIR-I (Q1 Friday) and O&O (on Q1/Tuesday and again Friday) and Mobile Health will join us Q2/Thursday.

Virtual Meetings Scheduled:

   Tuesday(Q1 + Q2, 9 AM ET Start General Overview and 11073 Focus)

   Wednesday 9 AM ET Start (Q1 + Q2   HL7 DEV Focus)

   Thursday 9 AM ET Start (Q2 hosting MHealth WG)

   Friday 9 AM ET Start (Q1 + Q2 Gemini SDC/SDPi)

Please see HL7  Guide for additional meeting information

Host organization:

ANSI - HL7 international - please register in advance on the web site

(see  HL7 Registration (May 2022 Working Group Meeting)) for details).

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). 


Host:

ANSI - HL7 international
http://www.hl7.org

Daily Schedule Overview

  • We will be holding 2 sessions per day, mainly Q1 and Q2 Tuesday - Friday (U.S. Eastern Daylight Time (EST) Time Zone)
  • Tuesday is dedicated for the IEEE 11073 PoCD Working Group Meetings

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

US Eastern

US Central

US West

Central European Time

UTC-time

Q1

9:00 am

8:00 am

6:00 am

15:00 pm

13:00:00

Q2

11:00 am

10:00 am

8:00 am

17:00 pm

15:00:00

Q3

1:30 pm

12:30 pm

10:30 am

19:30 pm

17:30:00

Q4

3:30 pm

2:30 pm

12:30 pm

21:30 pm

29:30:00

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

QuarterUS Eastern Time
West Coast US Time
-3 Hours

US Central Standard Time -1 Hour

UTC
+4 Hours

Central Europe Time
+6 Hours
Japan Time (JST)
+13 Hours
Australia (Sidney) Time
+14 Hours

General
Session

8:30 - 9:00 AMHL7 General Session and Announcements
Tuesday Thru Friday
5:30 - 6:00 AM7:30 - 8:00 AM



Q1

 

9:00 - 10:30 PM

Thursday Q1 OO Agenda - joint at/ O&O w DEV, BRR (Thursday Q1 Only)

6:00 - 7:30 AM

8:00 - 9:30 AM

1:00 - 2:30 PM3:00 - 4:30 PM10:00 PM - 11:30 PM11:00 PM - 12:30 AM

Q1

 

9:00 - 10:30 AM

Joint w/ O&O WG Session (O&O, DEV, FHIR-I) (Friday Q1 Only)

Joint w/ FHIR-I WG Session (Friday Only)

6:00 - 7:30 AM

8:00 - 9:30 AM

1:00 - 2:30 PM3:00 - 4:30 PM10:00 PM - 11:30 PM11:00 PM - 12:30 AM

Q1/Q2 IEEE PoCD WG Tuesday

 

9:00 AM – 1:00 PM

IEEE 11073 PoCD WG Meeting Sessions (Tuesday Only)

6:00 - 10:00 AM

8:00 AM – 12:00 PM

1:00 - 5:00 PM3:00 - 7:00 PM10:00 PM - 2:00 AM11:00 PM - 3:00 AM

Q1
HL7 DEV WG

,  

9:00 – 10:30 AM

HL7 DEV WG Meeting Sessions
(Wednesday Thru Friday)

6:00 - 7:30 AM

8:00 – 9:30 AM

1:00 - 2:30 PM3:00 - 4:30 PM10:00 PM - 11:30 PM11:00 PM - 12:30 AM


10:30 - 11:00 AM

Break

7:30 - 8:00 AM 

9:30  AM - 10:00 AM

2:30 - 3:00 PM4:30 - 5:00 PM11:30 PM - 12:00 AM12:30 - 1:00 AM

Q2
HL7 DEV WG

,

11:00 AM – 12:30 PM

HL7 DEV WG Meeting Sessions
(Wednesday Thru Friday)

8:00 - 9:30 AM

10:00 PM – 11:30 AM

3:00 - 4:30 PM5:00 - 6:30 PM12:00 AM - 1:30 AM1:00 - 2:30 AM


12:30 - 1:00 PM 

Lunch Break (if going to Q3)

10:30 - 11:00 AM

11:30 AM - 12:00 PM 

4:30 - 5:00 PM6:30 - 7:00 PM1:30 - 2:00 AM2:30 - 3:00 AM

Q3

MTG w/ Physical Activity Alliance

 

1:00 – 2:00 PM

Meeting Session w/  Physical Activity Alliance and the American Heart Association jump into the HL7 FHIR standards development world
(Thursday Q3 Only)

10:00 - 11:00 AM

12:00 – 11:00 PM

5:00 - 6:00 PM7:00 - 8:00 PM2:00 - 3:00 AM3:00 - 4:00 AM

Q3/Q4

 

12:30 PM...

Additional meeting after Q2 (Open, if needed)
(Wednesday Thru Friday)

9:30 AM ...11:30 AM...4:30 PM...6:30 AM ...1:30 AM2:30 AM ...

WebEx Information (Tuesday - Friday, May 10-13, 2022)

Recording Attendance:

Agenda:

Abbreviations

AbbreviationDefinition
RIRequirements Interoperability
MCModel-Centric (rather than document-centric)
RRRegulatory (submission) - Ready
PoCDPoint-of-Care Device
PHDPersonal Health Device
SDPiService-oriented Device Point-of-Care Interoperability
MDIMedical device interoperability  
SESSafety, Effectiveness & Security
EPEcosystem Pathway



IEEE EMB 11073 PoCD WG Meeting 

 

Tuesday, ET

Q1, Q2

9:00 AM –1:00 PM

Break10:45  - 11:00 AM
Q211:00 AM - 1:00 PM

IEEE EMB 11073 PoCD WG Meeting

Tuesday Q1, Q2 (9:00 AM - 1:00 PM, ET)

Recording Attendance
Please Log May 2022 HL7 DEVICE and IEEE 11073 WG Attendance here   

IEEE-SA 11073 PoCD iMeetCentral site - Presentation, Resource, and other resources for uploaded/archived information:
https://ieee-sa.imeetcentral.com/11073pocd/folder/WzIwLDY2MDkyMzld/


IEEE 11073 PoCD WG meeting (May 10, 2022) -Virtual/Draft agenda  (9 AM to 1:00 PM US ET -Eastern Time))

09:00a | Welcome, Introductions, and Agenda Review [Stefan/Kosta] 

09:10a | 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]

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

9:30-10:00 am | Update regarding PARs & Standards (Tom Thompson, IEEE-SA Liaison

IEEE 11073 PARs, Projects, SDOs and Analytics

IEEE reports, dates and stats

10:00-10:30 am  | Update from SDC SG (Martin K.)

10:30- 10:45 am | PHD Update (Daidi, Ray, Isabel)

======

Break 10:45-11 AM

======

11:00-11:30 am  | Update from the IDCO SG (Craig Reister)  

11:30 am-12:00 pm | Update from the Nomenclature SG (Paul Schluter)

IEEE 11073 Nomenclature

12:00-12:30 |  11073 Stories/Pilots and Conformity (Kosta, Stefan, Sajjad, Anil)

12:30-13:00 |  PoCD WG organization, meetings & wrap-up

Logistics next WG meeting

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

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

Tuesday Q3 + Q4 (No WG meetings)

  • Open 


HL7 Devices (DEV) WG Meeting

 

Wednesday, ET

Q1

9:00–10:30 AM

Break10:30  - 11:00 AM
Q211:00 AM - 12:30 PM

 

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

Recording Attendance:

Please Log May 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). 

  • 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?
    4. Co-Chairs: please record the results at the following Confluence page:  https://confluence.hl7.org/display/WGB/Co-Chair+Survey+on+Sept+WGM+Attendance
  • January 2022 WG Meeting Minutes Review / Approval (Garguilo)



  • 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.


  • 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)

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

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

Recording Attendance:

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

  • DoF Updates 

    • PHD Status update/report out (Martin Rosner + Javier Espina+ Brian Reinhold)


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



      • Questions to consider(carried forward from January '22 Agenda):
      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? 

        1. Need for trial implementations and prototypes, preferably 3 or more...
      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?

        1. FHIR Connectathons (casual events for snippets of code for Resources...)
      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)

    • Device Concepts
    • HCP (Device/DeviceDefinition) JIRA 


  • (Duplicated list of items from Prior WG Meetings for review) 

    • At Thursday Q1 joint w/ O&O DEV BR&R:  JIRA items (e.g., 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)

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

    • RTMMS version 2 status update (Faughn)
    • V2 Tooling Update

NOTE:  Gemini SES MDI related CA & Tooling to be provided in the Friday Q1/2 discussion

  • Adjourn IHE-DEV Wednesday 

Wednesday Q3 + Q4 (No WG meetings)

  • Open 


HL7 Devices (DEV) WG Meeting

 

Thursday, ET

Q1

9:00 - 10:30 AM

Break10:30  - 11:00 AM
Q211:00 AM - 12:30 PM

 

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

Recording Attendance:

Please Log May 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

    • Intra-procedural Anesthesia FHIR IG Work

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

  • Any pre-meeting discussion needed??
  • (FHIR Core Resource Changes) - DEV discussion (prior to joint meeting with Thursday Q1 FHIR-I meeting)
  • https://jira.hl7.org/browse/PSS-2069 (Issue noted from Lloyd McKenzie)
    • (From Email Lloyd's email exchange) - Note: See DEV schedule below - Scheduled to also get a briefing and provide feedback with HL7 DEV WG : for Q3 Thursday (1 - 1:30 PM)
      • Accenture (my new employer) has a contract to help support the Physical Activity Alliance and the American Heart Association jump into the HL7 FHIR standards development world.  Laurie and Maria (cced) are the project sponsors.  They will be coming to the May WGM and are hoping to meet with certain relevant work groups to talk about their project proposal for an IG defining standards for physical activity measurement and enhancement.  Russ Buchanan, who some of you may know, will be supporting them at the WGM.  Devices is one of the work groups that seems to have overlap/interest.  

      • 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.

      • Is there any chance of them getting 10 minutes or so of agenda time at the WGM to give a short 5-6 minute presentation on who they are and what they're up to and answer any questions you might have?  If there's no room to squeeze them in, time on an upcoming call would also be a possibility.

  • 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)

    • Thursday Q1 OO Agenda - (a few DEV representatives) joint at/ O&O w DEV, BRR; OO has joint meeting time set aside
      • At Thursday Q1 joint w/ O&O DEV BRR:  JIRA items related Device, DeviceDefinition & DeviceMetric   (also device Product, Catalog) 
      • NOTE:  You may need to use the Whova app in order to join the meeting with OO 
    • Device/Device Definition Mapping (FHIR Release Draft Ballot - Resource Device Content, v4.6.0)
    • (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 ET


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

Recording Attendance:

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

  • Quote of the Day:

    • (From April 2022)

      The National Institutes of Health website is a good place to start for reliable health information. As a rule, health websites sponsored by Federal Government agencies are good sources of information. You can reach all Federal websites by visiting www.usa.gov.

      (Source: www.usa.gov)

  • 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


  • Nomenclature - RTM status update (Paul Schluter)

    • Note: If additional presentation/update from IEEE PoCD portion of meetings (held on Tuesday)


  • 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)
    • 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...

Thursday Q3 (1:00 - 1:30 PM)

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. 
    They will be coming to the May WGM and are hoping to meet 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 to provide an ~10 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

Q4 (No WG meetings)

  • No Meetings / Open if needed 

Friday Q1 (9:00 AM - 10:30 AM ET)

Recording Attendance:

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

 

Friday

Q1 at O&O

9:00 AM –10:30 AM

Break10:30 - 11:00 AM

 

Note: Joint DEV at O&O (Joint) - Members welcomed to join Joint O&O and FHIR-I WG Sessions in Q1
(No DEV Meeting)

    • O&O Zoom meeting
    • Friday Q1 (OO, DEV, (BRR, CQI, mHealth) FHIR-I)
      • NOTE: joint meeting with O&O included FHIR-I WG 
    • O&O Agenda
    • R5 Plans
      • Device alerting
      • Discuss Physical Activity Alliance and the American Heart Association, project proposal (after all have had briefing)
      • If time left HCP (Device/DeviceDefinition) JIRAs
      • Discussion may include review of Jira tickets + device Word document etc.

Friday Q2  (11:00 AM - 1:00 PM ET)

Recording Attendance:

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

 

Friday

Q2

11:00 AM –1:00 PM

End of Meetings1:00 PM

 

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). 


  • Gemini SES+MDI Update 

    • General Project Update (Workstreams + Roadmap)

    • PSS-1980 - Getting issue details... STATUS & Joint IHE-HL7 Gemini Projects Update

    • Gemini Accelerator Update & FHIR CAT Considerations
  • HL7 DEV Open Discussion:  How should emerging technologies such as DTx & PHN be addressed? (Cooper) 

    • Especially in the regulated SAMD space

    • Inclusion of AI/ML components
    • Conversations elsewhere in HL7 - should DEV be included?  How to position DEV to be a "go to" for these topics?
  • OO Report Out from Joint Meeting with DEV (+FHIR-I) 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
    • Joint Standards Workgroup (Konstantinos Makrodimitris) Meetings - Planning 2022-2023
      • considerations about a future 2022 Meeting (Virtual) hosted by FDA
    • Regulatory map/coordination on interoperability 
    • HL7 DEV Topics?


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

    • HL7 announced it will likely be a live event (w hybrid options) in Baltimore Maryland

    • Feedback from these/May '22 meetings

    • 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 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



Topics Development Items (used to formulate Agenda)

May 2022 IEEE-11073 Point of Care Device (PocD) WG Topics for consideration:

  1. Add new topic here (which will be added below to schedule by IEEE PoCD Co-chairs/Secretary)


May 2022 HL7 DEV WG Topics for consideration
(Note1: Strikethrough items have been placed in HL7 DEV Agenda below)
(Note2: This section will be deleted once verification of all items placed in agenda)

  1. (Full Q) (Martin Hurrell) Intra-procedural Anesthesia FHIR IG Work (proposed Thursday Q1)
  2. Device Alerting (John Rhoads)
  3. Housekeeping - (proposed Wednesday Q1)
    1. Required Documentations (e.g., SWOT, 3 Year Plan, others )
    2. items such as PHD publication
    3. Review:
      1. See OO joint topics below
      2. Review DEV related Jira tickets 
      3. Identify priority discussion topics for joint OO sessions (communicate to OO)
  4. (FHIR Core Resource Changes) - DEV discussion (prior to joint meeting with OO)
  5. PHD Status update/report out (Martin R. + Javier??)
  6. Report Out from IHE-DEV proceedings (from Spring F2F WG meetings week of Apr 26-28, 2022)
  7. Test and Test Tooling Report out (NIST and others...)
    1. RTMMS + "V2+" Ongoing work...
    2. (Paul Schluter) Nomenclature - RTM status update
  8. Co-Chair Report Out
    1. (John Rhoads) Directions of / from HL7 to be aware of...
  9. Joint Sessions:
    1. OO (FHIR Core Resource Changes) - joint with OO (Tuesday Q1 + Friday Q1 - )
      1.   Review: 
        1. Not schedule Tuesday Q1 unless there is something significant to discuss (noting overlap with IEEE)
        2. Thursday Q1 OO has joint meeting time set aside (OO, BRR, DEV)
        3. Friday Q1 (OO, DEV, (BRR, CQI, mHealth) FHIR-I)
        4. Discussion will include review of Jira tickets + device Word document etc. 
    2. MHealth (Thursday Q2)
    3. FHIR-I - see above for Q1 Friday w OO (waiting on FHIR-I Agenda to be formulated??)
  10. Friday Q1/2:
    1. Gemini Approved Project Discussion
    2. Open discussion on New architectures within "regulated personal health space" 
      1. e.g., Digital Therapeutics/Personal Health Navigation Ecosystem - Areas being progressed in ISO/TC-215
      2. How should DEV reposition ourselves given SOMD kinds of regulated devices...
        1. related to new HL7 Organizational direction...
    3. Test Tooling Landscape (Todd Cooper)
  11. Meeting with the Physical Activity Alliance and the American Heart Association regarding project proposal (Q3 Thursday)
  12. Members/Co-Chairs - Please add new topics here
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