Date: September 20 thru 24, 2021

Quarters: Q1 Monday - Q2 Friday

Note: Draft Meeting Notes Status:

  1. Tuesday's 9/21/2021 Draft Notes Added/to be verified by attendees
  2. Wednesday's - Friday's  9/22 - 9/24/2021 Draft Notes Added/to be verified by attendees

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Day

Date

Time
ChairScribeNotes
Monday
9:00 AM - 12:30 PMQ1

31st HL7 Plenary
Q2

31st HL7 Plenary
PMQ3

No Meetings
Q4

No Meetings
DayDateTime
ChairScribeNotes 11073 PoCD IEEE WG Meetings
Tuesday
8:00 AM - 12:00 PMQ1/Q2
  • 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

https://ieee-sa.imeetcentral.com/11073pocd/folder/WzIwLDY2MTA4MDNd/

MEETING NOTES FROM John J. Garguilo

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

Kosta and Steven Dain Welcomed attendees (21 Attendees to start, additional joined per morning)

  • Ken Fuchs, Steven Dain, Todd Cooper, Anil Kochhar (FDA), Björn Andersen (Draeger, Lubeck), Chris Courville (Epic/UK Bristol), Dario Wieschebrock, Fabian Baumeister, David Gregorczyk, Javier Espina (Philips), John Garguilo, Malcolm Clarke (BSI Standards Institution), Martin Kasparick (University of Rostock), Martin Rosner, Michael Faughn, Sajjad Syed (Software Dev, alternate on 11073 FDA), Satoshi Kobayashi, Steven Dain, Tom Thompson IEEE SA // additional 10 attendees:  Gora Datta, Ray Krasinski,  Oyvind Aassve, John Rhoads, Koichiro Matsumoto

08:05a | IEEE Disclosures [Ken]

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

IEEE - IEEE Patent Policy, Review of IEEE-SA Copyright Policy - IEEE Copyright Policy

08:15a | Agenda Review [Kosta] 

  • Kosta went through Agenda; no edits or further updates noted by group
  • SDC Update will be done by Martin
  • Kosta asked to post presentations to iMeet Central at IEEE

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

  • New Members who registered: Sean Rocke, Wooter Peeters (Philips), Madhu Mohan
  • PoCD Member Count: 112 Members
  • Meeting Minutes review (from IEEE iMeet Central Unapproved Minutes Folders)

https://ieee-sa.imeetcentral.com/11073pocd/folder/WzIwLDY2MTA4MDNd/

https://ieee-sa.imeetcentral.com/11073pocd/folder/WzIwLDY2MTA4MDNd/

  • Motion made to "approve Meeting Minutes" by Ken Fuchs, second by Martin Rosner. Motion Passes 21-0-0

08:45a | 11073 SC Update [Ken] 

  • Ken provided a quick overview (verbal, no slides)

09:00a | IEEE 11073 PARs, Projects, SDOs and Analytics [Tom, All]

IEEE reports, dates and stats (Tom) 15mins

See Tom's Slides

Comments during session:

  • Cybersecurity Standards although are developed in PHD but are also vetted via PoCD group
  • Noted to think about of developing under the Joint ISO/IEC and IEEE development…
  • Some historical difficulty has been experience with CEN (more requirements and constraints)…
    • Todd Cooper mentioned there has been historical challenges in managing ISO Adoption Status
      • Nomenclature, DIM and Service Oriented Medical Device Exchange
      • Discussion about the relationship between the two entities and historical success (or otherwise) of such a working and sharing relationship
    • Tom showed calendar, mentioned October 18 is deadline for this year's RevComs
    • Tom also showed a spreadsheet of downloads and purchases of standards… (noted this is not a complete picture of all possible downloads and standards used)
    • Tom asked if a semi-joint meeting between the PHD and PoCD at FDA (in November 2022?)? Kosta mentioned this would be discussed… mtg to be deferred to Feb 2022
    • Kosta asked about MOU with LOINC and others, are these available? Tom can follow up for any questions (these are kept internal to IEEE).
      • Kosta would like to see MOU with LOINC and asked Tom if he could provide those details…

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

See Ray's slides

  • Ray mentioned the work on Spirometry (in pre-ballot phase but close to being balloted)
  • ACOM - abstract content model
  • Battery status follow on to existing standard - focused on remaining battery life..
  • Steven Dain mentioned we need to be careful to separate Physical protocols with application
  • ACOM - wherever possible - the observations would be done as a tuple with 10101 nomenclature and if a unit a 10101 code thus one would not need any further requirement between BlueTooth and IEEE standards…
  • Time - Overview
  • Malcolm and Ray set the stage for why this work is being done.
  • Proposing a new way of replacing the way to represent "Time" in 20601 - which might be considered "General Health Time"

9:30a | Update RCC-MH/ISOTC215, Mobile Health project (Ken, Gora)

  • Gora Datta noted the joint project of ISO/TC215, IEEE 11073, IHE International, and HL7
  • Accelerating Remote Connected Care and Mobile Health Solutions
    • Presentation given at HIMSS - focus on pandemic
    • HIMSS reviewers really appreciated the team and how the project came together…
    • G7 Health Ministers
    • Looked into four key scenarios: Hospital, Post Acute, Home , Outpatient Care
    • Emerging areas were noted across Interop and Spectrum of application…
    • Planning
      • Roadmap shown… Technical Report, then Review (Hl7 Nov., ISO afterwards)…
    • Work continues on the Content… which is interesting as there are many organizations involved… Once it hits ISO there would be a call for experts…and wider world to expand the input.  Meet every other week on Tuesday at 4 pm EST, US.
    • There has been internal discussion with FDA
    • https://www.himss.org/sites/hde/files/handout-92FINAL_370.pdf

09:45a | IEEE 11073 SDC Update [David Gregorczyk/Martin Kasparick]

See David and Markin's slides (IEEE iMeet Central)

10:30a | Break

New members joined: Fabian Baumeister, "iqbal", Jan-Alrik Philipsen

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)

  • Vice Chair Steven Dain thanked presenters, Kosta, and attendees.
  • No Action items assigned.
  • John Garguilo motion to close the meeting, Bjorn Andersen second, motion approved 22-0-0

CHAIR: STEFAN SCHLICHTING, PHD (regrets)

VICE-CHAIR: STEVEN DAIN, MD

SECRETARY: KONSTANTINOS MAKRODIMITRIS, PHD

draft IEEE POCD Meeting minutes (unapproved)

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






  • David Gregorczyk - Since last meeting in May, mainly ticket resolving
  • David showed slide set
    • SDC Standards family recap
    • Base PKP status
    • Metric PKP status
    • Alert PKP status
  • -10700 Base PKP initial ballot round 1
    • Ballot makeup was shown
  • David walked through the tickets
  • Metric PKP Ballot Group Forming and MEC (not formal round) - see link below to the SourceForge Page:


  • Martin Kasparick (University of Rostock, Institute of Applied Microelectronics and Computer Engineering) - IEEE 11073 SDC Family of Standards
    • DevSpecs (Device Specializations)
    • Nomenclature --> Semantics
  • PoCSpec project tickets, repository, etc.: https://sourceforge.net/projects/pocspec/ (this is the main page, see “Git” and “Tickets” for documents and discussions)
  • Todd Cooper mentioned having these in Volume 3 of the IHE Draft which would have BICEPs specializations…
    • Martin K. mentioned there is some information on SourceForge
  • SDC Subgroup meets on Tuesdays - but until the new updates are ready, the meetings will be postponed…


See Paul Schluter's slide set (on IEEE iMeet Central)

  • Update on -10101b provisional term groups prior to ballot.
  • Finalized another major set of terms:
  • Text From Slide Above) IEEE P11073-10101b "provisional" term groups
  • Group 1: 630+ 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).
  • Group7:        Terms required for the BPKP (Base Participant Key Purpose) vocabulary for the IEEE P11073-10700 SDC ballot, plus other terms.
  • Group6:        Mapping for Drdger, Getinge and GE ventilator modes to ISO 19223 ventilator mode nomenclature and syntax and to IEEE 11073 REFIDs and numeric codes.
  • The zip files for the two sets of terms (Groups 1-3 and 4-7) have been posted on the IEEE-SA ¡Meet Central site at https://ieee-sa.imeetcentral.com/11073-nomenclature/ . Terms have UoM and Enum_Value co-constraints.
  • All of the terms have unit of measure and co-constraints!!

Curated by NIST/Michael Faughn


  • IEEE P11073-10101b - remaining new content
    • Group Z
    • last-minute vendor requests for individual terms
      • additional IHE PCD infusion pump terms
      • additional terms for dialysis orders (can be deferred)
      • additional completed ventilation mappings to ISO 19223 (mapping performed by vendor and reviewed by ISO 19223 leadership and others)
    • Systematic Names
    • should we continue providing these?
    • does 10101b as an amendment require them?
    • use XML/XSLT to provide context with existing terms


  • PAR for 10101c is already in place…
    • Need to close off 10101b to get it done…
    • Question posed by Paul Schluter: Should we consider continuing to work on Systematic Name - Paul feels using "RefIDs" (programmatic codes) would be sufficient - so would companies/people ok without Systematic Names?  More useful for human, not as much for computations…
      • Noted that you can have containment models to group terms…
      • Todd Cooper noted - the genesis of this was from the mid-90s… We do need some sort of ontological computable representation, so looking at how other nomenclatures are doing it today… If the systematic names are not included in the 10101b ammendment, put it as a note in a box in standard indicating this notion. Also have a per term, or per group for which the term was derived… and for those who want to understand complex context…
        • Paul mentioned he has this in the description in footnotes
      • Michael Faughn believes there is way to make "systematic names" more usable… and given the current status (in RTM/RTMMS) there would be a big effort to clean up the systematic names…
      • Fun fact, there are 3425 unique systematic names.
  • This brings 11073 closer to having a structured ontology (like SNOMED; it was noted LOINC does not have a core Ontology)…
  • Todd noted some countries do not have licenses to use it - like Japan - because they have their own medical terminology that is used extensively in Japan and has an "ontology" that matches those physicians' perspective on semantics being represented
  • Ventilator Mode - highlights (grabbed text from slide below)

Group6: Mapping vendor modes to ISO 19223 ventilator mode nomenclature and syntax and to IEEE 11073 REFIDs  and numeric codes.

  • ISO 19223 strings and REFIDs for Draeger, Getinge and GE Healthcare have been reviewed and approved for inclusion in 10101b.
  • Only vendor-approved mappings will be included in IEEE P11073-10101b; implementers should consult ISO 19223 for additional foundational examples.
  • Consider allowing ISO 19223 to be sent as a 'ST' string without numeric code?
  • All "selectable adjuncts" are sent as Boolean flags; adjuncts "inherent to the mode" can also be included in the ISO 19223 mode.*
  • Auxiliary mode variables/settings and enumerated values completed.
  • Process for incorporating new vendor mappings is largely automated.

Discuss: Are there issues regarding the inclusion of vendor names and modes in the published IEEE and ISO/IEEE standards?

  • Rosetta WG Meetings hosted (by Paul Schluter) on Wednesdays at 12 noon EST


  • Kosta mentioned the originally planned Nov 2021 Meeting will need to be moved to Feb 3-4 2022… would be a panel and workshop to give presentations on success stories - related to Devices on Interoperability efforts…
  • Malcolm Clarke noted that and asked how to manage something that is Industry led and not an open organizations - satisfies Industry demand versus medical demand…
  • What is the value of standards, use, etc.…
  • Martin Rosner mentioned ACOM is quite relevant - remote monitoring devices at home… not just off the shelf but approved at home devices…
  • Kosta asked for folks who have ideas for sessions to send him a note…
  • Brian Reinhold mentioned the vendors are concerned about their sensors… and more recently the focus is on communication of the information, thus a focus the vendors have not addressed in earnest… From the Communication Stds view the realization as these devices (e.g., sensors and wearables) may not be focused on standardized information exchange…
  • Steven Dain noted ISO 4135 Respiratory Care Terminology will be published in the next 3 months… a vocabulary in English, French and German and translated to Portuguese and Russian

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

  • Discussion on a future FDA (Next Fall 2022) have a WG meeting in person at FDA (with other sponsors e.g., AMII, ONC, etc..)
  • Logistics would need to be worked out… some unknown parameters (like pandemic status)
  • Idea would be for a full week

12a Closing [Steven Dain/Kosta Makrodimitris]


Q3

No Meetings
Q4

No Meetings
DayDateTime
ChairScribeNotes; HL7 DEV WG Meetings
Wednesday
9:00  AM - 12:30 PMQ1
  • 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

Welcome, Introductions, and Agenda Review (HL7 Officers)

  • (21 attendees to start) John Garguilo, Ken Fuchs, Todd Cooper, Bjorn Andersen, Brian Reinhold, Chris Courville, Danielle Sill, Jan-Alrik, Javier Espina, John Rhoads, Danielle Sill , Jan-Alrik Philipsen, Javier Espina, John Rhoads, Koichiro Matsumoto, Konstantinos, Malcolm Clarke, Martin Hurrell, Michael Faughn, Oyvind Aassve (Hl7 Lead Norway), Paul Schluter, Satoshi Kobayashi, Stefan Karl, Thom Erickson
  • Joined later Martin Rosner, Raymond Krasinski (both from Philips) (up to 23 participants joining; Note: Ken Fuchs and Malcolm Clarke are non-HL7 members.
  • see attendance

HL7 DEV General WG Updates (HL7 Officers)

  • HL7 DEV Working Group 'Health Reports and the Project and Ballot Health Metrics': 2021Sep Final Reports
    • Gold Star Achieved for September WG Meetings :-)
  • 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 (smile)
  • HL7 DEV / Updates & Biz and Work Group documents

Anesthesia (Co-Chairs Martin Hurrell/John Walsh)

  • Was the Domain Analysis Model? Yes
  • Hl7 Domain Analysis Model (DAM) IG (Informative
  • Martin Hurrell walked through Draft Project Proposal for FHIR IG Document
  • Martin walked through the Draft Project Proposal
    • Martin noted that approximately 5,000 terms in SNOMED CT - aim is to provide detailed term bindings related to classes and fully reference 11073 Nomenclature and develop a FHIR IG…
    • Draft Project Proposal for FHIR IG (Vote in this session possibility/inquiry made by Matin H.)
    • Todd Cooper added a comment about calling out 11073 SDC Biceps standard and its profiling in the IHE SDPi (Volume 3)
    • Malcolm asked if this applies to a real-time or "post" processing information/document-based analysis… good comment and will be considered
    • EMIT Committee of ASA were willing to register their interest, e.g., "external collaboration" and "expression of interest"… Note: external collaboration only defines the nature of resources and what the external collaborator requires… So, if this work was to be pursued, it would be good to have space for external collaboration to provide what resources would be provided…
    • Todd Cooper made motion to approve the proposal to publish the draft Project Proposal 'FHIR IG', second by Brian Reinhold:  motion approved 20-0-0

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

  • What's changed since May WG Mtgs…
  • John Rhoads discussed and briefed the Hl7 Version 2 to FHIR effort - a "heavy lift" effort - beyond the ORU segments - such as prescribing, ordering, and other medical informatics that happens in version 2 and FHIR…
  • Reference: https://build.fhir.org/ig/HL7/v2-to-fhir/
  • John Rhoads showed our core OBX segment to Observation Resource in FHIR
  • Many other Segment Maps being considered and looked at as well… lots of work for reference link above
  • Todd Cooper commented there are some specific segments or fields that are critical to HL7-DEV work - so we need to be aware that all paths are correct
    • Todd asked as there was a proposed ballot earlier in the year, how close is this to ballot? John R. mentioned there will be a formal ballot process that will likely go for a while…  O&O is working on flushing out the detail… Todd asked if there are significant changes to OBX mappings?   John replied no, but the work has not focused on specific use cases…
    • Noted that DEV and IHE-DEV are listed as an interested party… John noted a hard process to "dip into"
    • DEV is co-sponsor (perhaps a topic for IHE-DEV): https://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=1481
    • Malcolm Clarke asked how much implementation around these mappings are going on? John R. mentioned there are the machine readable (XML, Concept map in JSON, TTL, etc.) that go along with the mappings… As FHIR versions, Graeme Grieve attempts to keep up with version changes… (e.g., version 3 --> 4 of FHIR)…and as it moves to FHIR V5…with tooling behind it…


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)
    • Reference Thom's slide set…
    • A few profiles to preview 
      Integrating the Healthcare Enterprise
      New Players > New Value
    • Remote Patient Monitoring as a product has been embraced by technology enthusiasts for the past decade.
    • Driving adoption in the mainstream requires engaging with stakeholders who are driven by a strong sense of practicality.
    • Observation data must become useful information, providing the right data at the right time so that its clinically relevant to symptom management workflows thereby reducing clinical burdens.
  • Environmental Scan Findings
  • The US Department of Health and Human Services recently published a report that concluded, in part, that the promise of Patient-Generated Health Data (PGHD) is tempered by lack of standards, data integration, evidence of use, burden of tracking, suitability of use, …
  • While interest is growing in the practical application of PGHD into the clinical workflow, the report cited a lack of such applications primarily due to lack of workflows designed specifically for PGHD with which to demonstrate value.
    Clinicians must guide system developers on how to support specific clinical applications with evidence of improved outcomes for the patient and care team.
  • Cheryl Ludman works in hospitals and offered to help to explore some specific use cases from "Medapptic" Company - Internet of Medical Things - medication monitors…to enable low risks meds without need to physician/nurse Medication Administration Record/funding from Natl Science Admin
  • RPM/PROM - related standards, asked
  • Danielle Sill offered specific use cases - she could provide - work be done as Fed level (starting at the manufacturers all the way to doing this remotely… SMBP has really moved forward
  • Cheryl commented on payment schedule… which was a question posed by Malcolm
  • erickson@himss.org


IEEE PHD Report-out on ACOM, GHS & relation to DoF work (Brian Reinhold)

  • Reference Brian's Slides
  • Abstract Information Content Model - ACOM background and goals discussed
    • Brian Noted: ACOM is not a protocol - it is a guide of concepts using MDC code
  • Slides shown on System Info, Clock Info, Power Info, Observations, Value Types (Simple numeric being most common; compound numeric; Periodic samples (e.g., ECG); simple enumerated (run, walk); compound Boolean; Human readable String)
  • Abstract Observation Example provided… Simple Numeric SpO2
    • ACOM in a protocol (FHIR)
  • Future: Hoping for a standard will be developed following ACOM guidance…
    • Todd Cooper asked - once a FHIR IG - would there be a ACOM section? Brian responded it is not needed, but he would rather have it to provide the details for mappings… e.g., Bluetooth directly out
  • Generic Health Sensor (GHS) - Bluetooth LE alternative to BT-SIG Health Profiles
    • Goals listed in slides
  • Todd posted chat question (out of time to address): Another question is how we are addressing co-constraints in the ACOM standard ... at least as a mention or "quality" indicator …
  • Time Stamp - contains more than just the time (meta data included - see slide)
  • New Time Service Likely (existing BT-SIG services don't cut it!)
  • Current Status shown (see slide)
  • Brian's meet in Bluetooth at 9 am Tuesday mornings (closed) …+ plus PHD WG on 10 am EST on Thursdays (open)…
Q2

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

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

  • MDIRA 2.1 was released in June 2021 (substantial changes from V1.0)
  • https://Secwww.jhuapl.edu/mdira/
  • Conformance section added
  • MDIRA SDC Reference Implementation status provided (Completed and Future)
  • Major Components: Supervisor, Data Logger, Provider, Consumer, Consumer Provider
  • MDIRA SDC (Draeger Open Source Library) RI Software (slightly altered Library)
    • Goal is to make this open source, as it is not yet…
  • MDIRA DDS Reference Implementation (Built by Mass General Hospital - MGH using OpenICE to implement DDS


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

  • Chief Medical Officer/Chief Scientist for RAIsonance, Inc. Family of Companies
  • See slide set provided by Dr. Ramirez …
  • Typical SaMD Workflow: SaMD from Orders to Results shown
  • Emergency Response
  • Multiple (Six) Workflows presented (see slides)
    • Workflow 6: Feedback Machine Learning from Dx SaMD Customer - reinforcement learning - integrated compatibility layer (including HL7 and FHIR)…


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

  • John provided the landscape on the various focus area (e.g., Implantable reporting of information)
    • Support for providing information is available, ahead of implementation..
    • Active activity within O&O - the relevance for HL7 DEV still have 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. 

Q3

No Meetings
Q4

No Meetings
DayDateTime
ChairScribeNotes
Thursday
9:00 AM - 12:30 PMQ1

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


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. 
Q2

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

Welcome and Introductions (of new Attendees)

(New) Members joining Andrew Northup (ONC), Brittney Boakye, Wand Govan-Jenkins, MHealth Co-chairs: Gorra Datta, Matt Graham

23 Attendees (on WebEx) to start… see attendance

Consolidated "Devices" Meeting Calendar

  • Numerous times this week there has been discussion about meetings related to "devices" in IEEE, IHE, HL7 and even ISO/IEC.  Problem is that there is no central calendar for our weekly & monthly meetings, especially that spans the various organizations.
  • With the IHE transition to Zoom + the recent work that Sarah Bell  has done to consolidate invitee lists and the IHE calendar, this is a good time to craft a single list that everyone can use.
  • NOTE:  HL7 has their calendar, IHE has a calendar (somewhere), Gemini has a Community Engagement calendar page (but it is out-of-date) ... but no Single Source of Truth Devices Calendar!
  • A confluence page either in the HL7 Devices WG space or the joint IHE-HL7 Gemini space would be preferred.
  • ACTION
    • ( co-chairs of above groups) Determine the best location for the calendar, the meetings that should be included, and the level of detail for each (e.g., title, topic, date/time/frequency, primary contact, etc. - but probably not actual Zoom info in the public space).

Remembering …

  • Remembrances During HL7 Annual Business Meeting
  • Moment of silence held by DEV WG in honor of and in remembrance for Jan Wittenber, Bill Majurski, and John Quinn

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

  • John Rhoads reported out
  • Several JIRA Tickets (re-)viewed…
    • Primarily the JIRA item on related to HL7 DEV is the "Version" element

    • More discussion is needed and maybe continued in Friday's O&O WG session(s) (September 24, 2021)
  • Device Type - JIRA item to mention in the text that MDC is another appropriate "value set binding".
    • E.g., there is a small set of SNOMED terms that have to do with devices
    • Also there was a vote on MDC
    • Mentioned that "DeviceType" in PHD would like the mapping to be semantically correct in the FHIR hierarchy
      • PHD defines Device Component to express the device…
    • Item not resolved…
  • Noted: Michael Faughn is a member of newly formed "HL7 terminology management group" - thus a tie to the MDC nomenclature (e.g., using RTMMS as a service)…
    • Noted (by Todd C.) that Ted Klein is retiring at end of this year…
  • Noted: O&O will cover this again on Friday Q1 and further Weekly meetings
    • Brian and Martin Rosner will join as representatives on behalf of HL7 DEV on Friday Q1 (Sept. 24, 2021)…
  • Javier mentioned that O&O had discussions to make normative (from draft) particular fields of the Device Resource at this stage going forward with FHIR R5

John Rhoads John R. will get agendas out to group…regarding every other Wednesday 9 AM WG calls.

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

  • Chris Courville Report Out

In terms of resources the device WG is responsible for that needs more Connectathon testing
- Maturity levels for our resources: DeviceMetric is still level 1, level 2 means Connectathon level implementation (at least three), level 3 (list of QA metrics), level 4 (dependent on implementations across its scope), level 5 is ballotted at least twice, in PRD
- Are expecting any new IGs or new Resources: Alert on the horizon, probably not within a year. Anes IG potentially, will come back if there are concrete plans

  • Basic question regarding the DEV resource owned (DeviceMetric) - does this group need help from Lloyd for connectatons…?
    • What DEV really needs is software/prototypes…
  • Maturity levels for HL7 DEV resources:
    • Level 1...  DeviceMetric presently,
    • Level 2 … Connectathon level implementation (at least three)
    • Level 3... List of QA metrics - i.e.,  maturity metrics are followed
    • Level 4...dependent on implementations across scope
    • Level 5: Balloted at least twice and evidence of production use…
    • https://confluence.hl7.org/display/FHIR/FHIR+Maturity+Model
  • ACTION Chris Courville Chris noted this group perhaps should begin discussing what, when, and how Device related information moves up the maturity level.
  • Question asked in FHIR-I session: Will there be new 'resources' in the upcoming calendar year?
    • "Device Alert" and Anesthesia IG are on our "DEV" horizon
    • Chris mentioned what was communicated
  • ACTION John Rhoads However, if the group wants to more formally move forward, DEV should notify Lloyd/FHIR-I; John Rhoads to take action on this item
  • Dev Tracker Items: 16 stale issues, 15 open items without resolution, 2 resolved but changes not applied
    • Follow up and consistent review suggested (Chris noted DEV not yet on naughty list)

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)
    • Matt Graham provided Slide Set - "2021 September Mobile Health Project Updates"
  • New PSS "Unique Mobile Health App Identifier" (Datta)
  • Topic:  Possible connection between JHU/APL MDIRA / Gemini MDIRA Profile & HL7 mHealth Standards?  (Cooper / Datta)
  • Gora provided an overview of Mobile Health WG's work for week on MH WGAgenda
    • cMHAFF project discussed - performing Ballot resolution: cMHAFF: consumer Mobile Health Application Functional Framework Update
    • SHIFT Project overviewed: SHIFT: School Health Innovation Framework leveraging Technology Update - John Ritter
    • UMHAI: Unique Mobile Health App Identifier Update

Unique Mobile Health Application Identifier (UMHAI) Project (Gorra Datta)

  • Noted that NCPDP Standards group interested in work
  • PSS (JIRA) Unique Mobile Health App Identifier (UMHAI)
  • Gora noted he is hoping DEV can provide comments (as well as having review "across the globe"
  • ACTION Completed: HL7 DEV added as a "Co-Sponsor" WG on this PSS

Jira Space for PSS-1877

  • Gora will send out the FHIR-IG once ready (Keith Boone leading), likely to be several weeks out…
  • Gora's email contact: gora@cal2cal.com
  • Matt Graham provided the project updates Slide Set - "2021 September Mobile Health Project Updates"

ONC ISA & USCDI

(NIST) Tooling & Testing (Faughn, Garguilo)

RTMMS version 2 status update (Faughn)

  • Michael noted need of RTMMS (also tied to other development work, e.g., conformance)
  • RTMMS Version 2 in the works
    • Content was 10101-2020 Version
    • Currently system includes Terminology includes 10102, 10103 (IDCO) from 2012
      • Noted no collisions for CF codes as they are in different partitions…
    • Next - vetting and entering10101b as provisional terms until published and finalized
  • "Download Search Results" button added and working (produces CSV file from Search filtered)
  • ZIP files (a bunch of CSV files) for all partitions, withdrawn, deprecated, etc.
    • Two sets: 1) Terms (manually or appeared in a published IEEE document); and 2) Expanded Term Set
  • ~48,000 terms in total
  • Base Terms around ~13,000
  • Recent Development Slide shown (see Slide set)
    • List of items worked on, completed, and still on "to do" list.
  • Michael showed V2, searched on a deprecated term --> implemented the concept behind a term (e.g., a deprecated term)
    • Leads to "what is a term" - Ref ID + Term Code pair, (even though most folks use Term Code…) : still some ontological thoughts to work through…
  • Weekly Tooling Meetings held Thursdays at 2 PM EST (noted: now Zoom calls)

V2+ Project / Tooling Update

  • Michael also working with IDCO WG on 10103R, V2+, and recently volunteered and became an invited member of the new TSMG group.  Noted that this will help ensure MDC terminology/nomenclature is appropriately handled via HL7 and linked to the RTMMS Service (Royalty Free Agreement in place of NIST and IEEE-SA to provide such nomenclature as a service).

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

ONC ISA & USCDI Request for Comments (Lead?)

NEWS:  FDA Launching AI/ML-Enabled Devices List

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

Noted (in lieu of time), that WG Attendees/members should visit the following and provide any feedback/edits/updates to Co-Chairs (John Rhoads lead):



Q3

No Meetings
Q4

No Meetings
DayDateTime
ChairScribeNotes
Friday
9:00 AM - 12:00 PMQ1/Q2

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

Welcome and Daily Agenda Review (Cooper)

see attendance

Agenda reviewed, no futher edits or suggested topics requested from attendees.

Japan SCOT project (Koichiro)

  • Koi has participated since 2017
  • An overview, roadmap, Background,  was provided (see slides)
    • Includes Intelligent OR, MRI, Devices Packaging, Device network - network of operating rooms804000
  • ORiN (Open Resource)
  • OPeLiNK - information platform that constantly provides data gathered from each equipment in the operating theater
    • Makes it possible for shared data (e.g., for surgeons…) - during (remote access included), before (prior similar cases) and after surgery (investigating the causes of complications from all angles)
    •  Improving the quality of Surgery
    • Conceptual Change of Medical Devices - to a world that co-creates new value with apps
  • Related to OR.NET - device
  • Kosta asked Koi about framework - and asked about this work being based on standards ("beyond the barrier of standards")
    • Koi - AMII UL 2800 and OR.net  - the SCOT project can provide progressive use cases used by others
    • Kosta asked about the scope of project beyond medical devices and if there were any devices cleared and regulatory approved or cleared for use?  Koi noted ORiN is for the factory
  • Noted that there is a lot of commonality of this work - more navigation is likely needed … role of IoT in acute care is certainly an interesting topic…

Other Potential (question) 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?:
  • John Rhoads showed the JIRA project that lists the different ballot definitions out there… and showed 2021-Sep-FHIR IG PoCD R1 STU Point of Care Devices (FHIR) specification
    • Noted that this work is above the 60% threshold to move STU forward, but will need to address the negative comments
    • No quorum requirement for STU (only normative standard versions)
    • John R. showed the reconciliation-1.xls comment file (John mentioned he will post to the HL7 DEV documents site)
    • Chris Courville - noted that Epic comments were around existing transport today and the reality that in the wild with high-throughput messaging necessary from devices into EHRs - endorse the IG and use cases and recognize the utility however…
    • Scheduling discussion was deferred, but comment resolution should be done ASAP - go through each item - yes/no persuasive and what group will do about the items… likely be batched in the Monday WG sessions (Wednesday sessions would perhaps be the voting group for the issue sets vetted).  Process performed through JIRA…
    • John noted work on SDPi content in implementation guide and will increase over time…

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

    • Approval from HL7 FMG to go to publications… then things stopped as there were enough "errors" (partly because the process required changed mid-stream - Brian R. and Martin Rosner are working on this and gotten it to a stable state...
    • Since August '21, there is yet another new version of publisher… so will again will need to be compiled and worked through identified items and get it in front of TSC (which is currently being reformulated, a new chair for example)…
    • See DoF landing page for links and further information…

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

  • Topic ongoing since 2019 and about how to get alerts mapped to DoF
  • Jan-Alrik showed a slide set
  • Use Cases around Alarm Logging, Clinical Decision Support, Alarm Analysis on organization level
    • Persistent alarm data adds to a better understanding of patient's condition.
    • Can also benefit at the organizational level - optimize device settings, staffing, etc…
  • Example shown on Alert Reporting within ACM: (referenced IHE PCD TF Volume 2, 3.4 Report Alert [PCD-04], Dev. 9 December 2019
  • Provided an alternative: to extend existing Resources in FHIR (Pros and Cons given - see slides); Resources discussed:
    • Communication
    • Observation

HL7 PMO October PSS submission deadline

    • Oct 9, 2021 is the deadline for balloting which is two meetings ahead for May 2022
    • Topic to address the plan and dates on the weekly Wed. 9am WG meetings
    • Process for a new resource (e.g., Device Alert) is not exactly "clear"
      • Next steps is to get this group happy with content, easy to understand and address such… as well as back up documentation giving why we want to do this, alternatives, etc.,

No Discussion needed on the topic:  Past unresolved (Specific) topics?:

Real-world Implementation Challenges - FHIR Resource & IG Change Management 

    • Todd Cooper introduced topic - and discussion
    • FHIR Resources NOT managed by HL7 DEV are key elements in DoF IGs (e.g., Patient, Observation, Location)... change management is VERY important
      • John R. noted the FHIR resources we don't manage - are becoming more stable and hopefully change management will be more tolerable…
      • Also need to consider possible use cases for patient locations that we need to create "extensions" for…
    • 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
      • John R. noted there is a lot of work ongoing outside of FHIR  - not sure how develop links and resources to track such efforts and see who DEV can get to help out with this…
      • Oyvind Aassve provided a Norway perspective, want to use International Guides…
        • A framework has been developed and looked at how to do that from a national level - Resources and Extensions - and then the Resources to do that.
        • Important to look at, in general, how International Guides are being adopted in other countries..
        • Posted  video link of presentation given at recent DevDays: https://www.youtube.com/watch?v=8pv-Zztibyg
      • Chris Courville mentioned/noted that approaching in a different way (starting from scratch) and strongly encourage in place of doing site specific extensions as in place of not addressing deficiencies…  so when starting on a new initiative, see existing Guides
        • Todd Cooper noted from a medical space… having an International approach to solving a problem is a business case, but often difficult - normative will help this…as long as the correct things are made normative…  Version control is being addressed to better handle visibility
        • Bjorn Andersen noted with FHIR, everyone can see (more transparent) such localizations better than V2.  Second profiles will only be done locally (such as identifiers) and if this happens (incompatibility like required or not allowed)…  There should be a process how to resolve such differences…
          • Todd asked should we have explicit guidance for national usage and local?…
      • This topic needs to be communicated to new development: use context, how intended ways for adaptations for implementations…

Break 10:55 - 11:10 AM

Report Out from Friday Q1 O&O (Brian Rienhold)

  • Lloyd M. stressed: Combination of Device and Component should never be more than 1:1
    • Resolved and agreed upon
  • Type Field - Brian R. is working indirectly to make an MDC value set
    • Brian understands this was always doable - and will attempt to this…
  • Topic on Device Software

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

  • Todd presented a slide set (see slide set) - recently formed in End of August/ Beginning Sept 2021
  • New WG on "Personalized Digital Health Informatics - PDHI (per a resolution to TC215 in June)
  • WG11 PDHI Update given
  • 3 new work items with WG11
    • Digital Therapeutics Health Software Systems (DTx TR)
    • Personalized Health Navigation - Architecture (PHN-A TS)
    • Personalized Digital Health Framework (PDH-F TS)
    • Monthly web meetings to launch new teams…
    • Slides shown for each of the above giving Project Title, Leaders, Scope, Status
  • ISO/EDC JWG7 - Technical Paper or more to be determined…

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

  • See Todd's Slide Set
  • General Project Update (activities since the May '21 WGM) 
    • Likely the place to build out test cases as well
    • High priority needed for version 1.0
    • Medium, can survive without them but still for 1.0
    • Low --> for Version 1.x and beyond…
    • For each item create a "Topics Resolution" and record a "Detailed Topic Discussion" that would land in GitHub
    • Chain of work: Confluence --> GitHub --> Supplement
    • Hanging Gardens Model referenced
    • Posted in previous WG meetings in HL7-DEV F3 Storage area…
    • Gemini 3-Year Roadmap 1.0 completed
    • IHE German Plug-a-thon's (PAT) #3 and #4 successfully completed, #5 coming in early October 2021
    • IHE Catalyst engaged to help chart detailed plans for SDPi CAT & Product CA Testing
    • RI+MC+RR initiates refined and advanced (esp. in CA-Tooling group + BICEPS Pump SysML Model)
    • IHE Europe Experience Presentation
    • MDIRA Profile Activity
    • Education "Library Section" Expanded…
    • SDPi Topics of Interest captured and given Priority, Leads, and Status
    • Intro Ballot: IEEE 11073-10700 & PoCD


  • Role of Gemini MDIRA Profile (Todd Cooper)
    • E.g., Supervisors as a Single Point of Failure
    • Distributed Data Logger Approach
    • Establishing Conformity with MDIRA
    • Adding established SDPi ensembles to a MDIRA Supervisor starting up
    • And more…!
    • Capabilities directly supporting real-time network health
    • Real-time Supervisor and Data Logger for quality analytics & forensics
    • Core Gemini SES MDI Role - to increase confidence in deployed regulated interoperable plug-n-trust MedTech
    • (Noted this includes TPLM and real world applications)
    •  Once a month meetings
    • All predicated on getting MDIRA 1.0 out and available.
    • Confluence Pages for MDIRA identify areas to consider and address
    • Question considered: What is the role of MDIRA in the overall Gemini SES MDI program?
    • Diagram presented for clarifications…
  • 3-Year Roadmap Overview
    • Functional targets
    • Spec Development & Publication
    • Conformity Assessment (CA) & Tooling
    • Computability / Implementation Support (RI _ MC + RR & open source)
    • Prototyping  / Pilots/ Demonstrations
    • Education & Workshops
    • Foundational Standards Support (PKP's & DoF PoCD IGs)
    • As we approach Q4 what are realistic items to look at… "work in progress"
    • Objective, Roadmap "streams" include
    • Factoring in the IHE Ecosystem & Testing Continuum…
    • Work Streams going forward include:
      • Functionality: Silent ICU + FHIR + DEC
      • Spec Development & Publication
        • SDPi 1.0 (2021) & 2.0 (2022) for TI
        • Integrate basic RI+MC+RR
        • Publish both Word & HTML w/ ReqIF integration
      • Conformity Assessment (CA) & Tooling
        • Gazelle integration (w/ supporting test cases & Gemini-developed tooling)
        • Virtual PAT's (4-6) & Virtual CAT's (2-4) & 24/7 CA Capability
        • IHE NA CAT (tentative) & EU CAT (probable)
        • SES/Regulatory Initiative support toward CA that is "RR" (regulatory ready)
      • Computability / Implementation Support (RI _ MC + RR & open source)
        • RI + MC +RR Basic ('21)
    • Education & Workshops
      • Develop materials
      • Participate in IHE EU (CAT) Experience
      • Conduct Webinars and Workshops
    • Foundational Standards Support (PKP's & DoF PoCD IGs)
      • 11073-1070x PKPs (critical path esp. for "RR")
      • DoF PoCD IG Publication (w/ SDC support 1.0 & Alert Support 2.0)


  • RI+MC+RR for SDPi 1.0 & Conformity Assessment & Beyond
  • Advancing RI + MC+ RR
    • Requirements Interoperability
    • MC - Model Centric
    • RR - Regulatory Ready
  • Todd Cooper Todd referenced OR.NET slides from David G. which will be posted to HL7-DEV F3 documents site
  • Gemini SES/Regulatory Initiative Kick-off
    • Getting to Regulatory Initiative
    • "Regulatory Submission Ready" Conformity Assessment
    • Many challenges to RR and an ecosystem of plug n trust products
  • Toward ISO/IEEE 11073 "MDC" 2.0
    • Discussions topics brought out by Todd…
    • See Todd Cooper's slides
    • Todd posed question of what should MDC 2.0 nomenclature for the 21st century look like?

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

  • See Agenda - for references to Confluence pages

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 

  • February '22 Workshop at FDA coming and participants will be requested for presentations and leading break out groups on DEV-related topics - logistics to be worked out.....
  • Potential five day meeting in November 2022 will be included in Feb '22 meeting
  • ...

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

  • Feedback from these/Sept '21 meetings

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

  • ACTION HL7 (Virtual) Room Reservation for January 2022 Meetings (John J. Garguilo Garguilo)

Action Items overview going forward from Sept. 2021(HL7/IEEE/ISO) and coordination with other SDOs

  • Action Item Review completed (Garguilo)

  • HL7 PSS "Action Plan" - deferred for membership off-line review 

HL7 DEV May 2021 Meeting minutes review and approval

    • Motion to "Approve HL7 DEV meeting minutes from May 2021" made by Martin Hurrell
    • Motion made by Martin Hurrell, second by Todd Cooper
    • Motion passes 12-0-0

Meeting Adjournment (Co-Chairs)

  • Many Thanks to our wonderful presenters, attendees, and a VERY Informative work of week!
  • Be well and thanks for your attendance and work as we move DEV forward :-)
  • Motion made by Bjorn Andersen to "Adjourn September 2021 HL7-DEV WG meetings", second from Kosta Makrodimitris.
  • Motion passes 12-0-0





Q3

No Meetings
Q4

No Meetings



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