Date: 04-07 February 2020

Quarters: Q1 Tuesday - Q4 Friday

Prior Meeting Minutes (Approved on 02/04/2020) as recorded & presented (motion made by John Garguilo, 2nd by Michael Faughn; approved 12-0-0); refer to Meeting Minutes (September 2019, Atlanta ).

These minutes reviewed and approved by on an announced Conference Call of the Health Care Devices (DEV) WG on 2020-02-26


Set goals, objectives or some context for this meeting.

Discussion items


Tuesday, Q1

Welcome, Introductions, Rules

  • IEEE Patent Policy
  • IEEE SA Copyright Policy
  • Review of Previous Meeting Minutes and Action Items 


Ken Fuchs (IEEE 11073 Chair)

(John Rhoads - IEEE PoCD Chair)

Tom Thompson (IEEE-SA Liaison)

John Garguilo (IEEE PoCD Secretary)

Welcome, Introductions, Rules

  • Welcome by John Rhoads, Ken Fuchs, and John Garguilo
  • (IEEE PoCD Chair - Rhoads) Introduction to meeting & Introduction by attendees (and on-line)
  • Ken Fuchs presented (slides from Tom Thompson (IEEE-SA)) provided IEEE Patent and Copyright Policies 
    • IEEE SA Copyright Policy Slides presented: 
    • No patent issues mentioned by attendees in room and on Teleconference
  • Agenda review (Garguilo) - IEEE portion (Tuesday Wednesday, 04-05 February 2020
    • Note of use of Confluence and HL7 HCD Confluence pages 
    • Noted that there are three primary pages on Confluence for Sydney meetings: Agenda, Attendance and Meeting Notes (see Sydney WG Meetings
    • Group going forward is to use Confluence for attendance, meeting agenda and meeting minutes/notes.  Encouraged attendees to get an account.
    • IEEE 11073 PoCD Agenda edited based on meeting attendees
      • Note of schedule change: HCD/IEEE WG will meet joint with O&O on Wednesday Q1
    • Motion to approve IEEE 11073 portion of Agenda (February 2020) meeting minutes. 
      Motion by John J. Garguilo , Second by Michael Faughn 
      • Motion accepted 12-0-0 (positive-negative-abstain)
  • IEEE (portion) of last IEEE PoCD WG Meeting Minutes Reviewed (Garguilo)
    • Motion to approve Atlanta (September 2019) meeting minutes. 
      Motion by John J. Garguilo , Second by Michael Faughn 
      • Motion accepted 12-0-0 (positive-negative-abstain)

No Action Items for Q1

Tuesday, Q2

  • 11073 PHD Status / PAR Report
  • 11073 PoCD Status / PAR Report
  • 11073 SC and PoCD P&Ps
  • Round-up of related standards-related efforts:
    • AAMI (ICE Data Log, UL 2800, 2900, etc)
    • IEEE EMBS Standards Projects & Coordination
      • EMBC Montreal
    • CMI Update

Tom Thompson / Ken Fuchs / (from Daidi Zhong of PHD group)

Ken Fuchs / Tom Thompson

IEEE-SA Report Out

  • Tom Thompson (IEEE-SA) presented slide set (11073 Update_February 2020_final.pptx)  providing status updates.
    • No present issues (refer to dates in slide set on various standards/status)
    • Note:   P11073-10316 - Dialysis Device, has an upcoming expiration date of 31 December 2020
  • Ken Fuchs mentioned his involvement with AAMI ICE  (Data Log) - which provides the interactions, data, and technical exchanges on the "ICE network"... 
  • ICE document mentions several attributes/items such as:
    • Number of days of data capture
    • How Co-located on network?
      • Ken Fuchs described spoke wheel architecture (central data controller) 
      • Also noted that a for a peer-to-peer network there is much more work to record data via a logger
  • Committee Draft (AMII 2700-2-1 Data Logger) is forthcoming (perhaps April 2020?)
  • UL 2800 - no new information since last report out in September 2019
  • UL2900 - Cyber-security -  considered under the UL umbrella of standards
  • IEEE 2733 Project - Medical TIPS (Trust, Identity, Privacy, Safety) - eight subgroups created...
    • Ken Fuchs is Co-chair of the "use case" sub-committee
    • Artificial Intelligence, Blockchain, and other related projects as well as a number of groups in IEEE which have emerged...
  • IEEE Web Site
    • Tom Tompson suggested having IEEE pages on an IEEE Web Site and "owned" by IEEE Leadership role person

CMI Report Out

  • CMI (Center for Medical Interoperability,  Nashville, Tennessee, USA) update (by Paul Schluter) 
    • No updates / report from Paul regarding CMI from last meeting
    • Paul noted ventilator terms still actively being worked on...

No Action items Q2 ...

Tuesday, Q3

  • Terminology Update (for Clem McDonald)
  • Nomenclature Modeling Discussion

Paul Schluter

Michael Faughn

Brief Terminology Report Out 

Paul Schluter, CMI

Note: Paul Schluter provided a status update on terminology efforts (mainly for NLM's Clem McDonald - who had limited time available in the HCD WG session).

Nomenclature Modeling Discussion

Michael Faughn (Prometheus Computing, NIST Contractor)

Michael provided an overview of some thoughts, ideas, and a proposal(?) on potential approaches to improve some terminology which have some "inconsistencies" or areas that are difficult to interpret  based on his tool development and modeling efforts ...

Michael systematically lead everyone to the difficulties encountered in some issues, such as handling attribution around synonyms or homonyms. 

The following slide capture is the introduction of the topic discussed and presented:

  • Engaged discussion, group will continue to move forward and consider Michael's suggestions...
  • More discussion moving forward likely in the weekly WG Teleconferences and future WG meetings noted.

No action items identified for Q3.  

Tuesday, Q4

  • "DiGAV" (German regulation) draft discussion
  • PoCD Cybersecurity:
    •   11073 PHD Cybersecurity
    •   AAMI TIR57, SW96, TIR97,
    •   UL2900
    •   Security topics from JWG7

Bjoern Anderson/Martin Kasparnick 

John Rhoads / Schlichting 

"DiGAV" (German regulation) draft discussion

Bjoern Andersen Björn Andersen provided background on a new German regulation regarding regulations to 'register' "Apps" between 'App' and 'Device'.  The draft regulation mentions requirement of using IEEE 11073.  Björn and Martin Kasparick Martin Kasparnick (both from University in Lübeck, Germany) mentioned that comments are due in the very near term and were looking to get feedback from this HCD WG expertise to potentially submit comments.  

PoCD Cybersecurity

John Rhoads

John noted that documents appear to look at governance versus the typical implementation details...

John provided briefings and updates on the following standards:

  • 11073 PHD Cybersecurity
  • AAMI TIR57,
  • SW96, TIR97,
  • UL2900-1
    • New release just out...
    • Series that talks about general environments, 2900 is general and there is also a UL standard(s) for specific medical devices...

Security topics from ISO TC215, JWG7

Topic discussed regarding Safety and security of health Apps - for health Apps, now looking at software as a medical device...

Trish Williams (Flinders University, Adelaide, AustraliaProfessor Trish Williams) Noted that Australia is looking at IoT (Internet of Things) Security - and attempting to identify what is a device, what is not...

No Action Items for Q4

Wednesday Q1

  • Joint w/ O&O

Meeting minutes recorded by O&O

Wednesday Q2

  • Welcome, Introductions, Rules

  • 11073 SDC:
    • General Update
    • SDC related PARs
      • 1070x Key Purpose Standards
      • 10107 Control Nomenclature
      • 1072x Device Specialisations
        • 10725 Pump renaming discussion:
          Surgical, irrigation, suction, ...
    • OR.NET
  • Click to add a new task...

Rhoads, IEEE Staff

Martin Kasparick & 

Welcome, IEEE rules, and introductions

11073 SDC

General Update

Björn Anderson (University in Lübeck, Germany)  

  • Björn provided overview and within discussion of Road-mapping, addressed "what should be done first?" 
    • Note refer to snippet of "Cathedral Diagram" below
    • Key purpose standards will first be addressed; mainly P11073-10700, -10701, -10702, -10703 (green standards in diagram below)
      • Green standards define roles and responsibilities - e.g., you have to understand the semantic meaning of target, device, and enable the risk management of the "participants"
    • Yellow (see below) parts of standard (-10721, 22, 23, 24, 25) are the device specializations
      • ModSpecs are reusable and a consistent structure is assumed across the devices

"Cathedral Diagram" snippet:

  • Björn noted goal and striving for 'Modular Specifications' - Example provided (gas supply, work in progress, see below):

SDC related PARs

1070x Key Purpose Standards

10107 Control Nomenclature

1072x Device Specialisations

10725 Pump renaming discussion:
Surgical, irrigation, suction, ...

  • Capabilities Model was shown
  • Diagrams shown for "suction and irrigation pumps"
  • Action Item: Martin Kasparick  is to update the PAR via IEEE,  then vote would go to WG, then to NesCom (which would go onto the next NesCom) agenda...


  • Association is still active, now hoping to get some funding for new standards (e.g., SDC standards with security).   Goal would be to make it as easy as possible and usable for small companies.  Will be searching for funding over the next year or so (some marketing efforts happening in some German conferences)
  • OR.NET conformity is important.
  • Started doing "plug-fests"; 3rd meeting of open source libraries and use of these libraries were tried and tested to ensure interoperability and where there are shortcomings or issues.

1 Action Item Assigned

Wednesday Q3

  • "Service-oriented Device Point-of-Care Interoperability (SDPi)" White Paper (out for Public Comment)
    • CAT Roadmapping
  • MDI Standards "Families" - Intro.
    • U.S. Army MRDC MDIRA Project 
    • IHE SDPi Use Cases
    • IHE PCD 2.0 Considerations
    • X73 PoCD/PHD "Scoping" Open Discussion
  • Roadmap for PoCD WG
  • Planning for May Meeting (San Antonio)
  • Review IEEE Portion of Meeting
  • Adjourn IEEE PoCD WG

Todd Cooper


Note: Todd Cooper was not in attendance, however he provided the HU/APL MIDIRA Architecture.  This document is in public comment status and is available per request (contact Todd Cooper via email request).

  • Other topics were not discussed or updated, please refer last meeting (Atlanta) for prior status update.

Roadmap for PoCD WG

John Rhoads

  • Plans are in place to roll PCHA with PHD under IHE as one sub domain (formally IHE-PCD) along with SDPi and proposed new domain name (change) to "IHE-Device".

Planning for Next HL7 HCD WG (May 2020) Meeting (San Antonio)

John Rhoads

  • Noted that several individuals from the group here in Sydney plan on attending ... more details as WG gets closer to May 2020
  • Attendees and WG participants encouraged to submit Agenda topics as soon as possible.
  • Attendees and WG participants encouraged to review Sydney meeting minutes and either edit or contact John Garguilo and Co-Chairs to make edits (include corrections, typos, and elaboration/detail on topics and subjects addressed).

Review IEEE Portion of Meeting

  • IEEE PoCD Secretary John Garguilo led review along with IEEE 11073 Chair Ken Fuchs and PocD Chair John Rhoads.
  • Ken Fuchs noted more forthcoming regarding new officer roles and descriptions...

Motion made to close the IEEE PoCD portion of WG meetings

  • Motion approved 8-0-0 (For-Against-Abstain)

  • Adjourn IEEE 11073 PoCD WG Meeting
  • Type your task here, using "@" to assign to a user and "//" to select a due date

Wednesday, Q4

  • Type your task here, using "@" to assign to a user and "//" to select a due date

No Meeting in Q4

Thursday, Q1

  • Welcome and Introductions
  • Intellectual Property Policy
  • DEV WG Agenda Review
  • Report out from Clinical Steering Division & HL7 Co-chair mtgs.
  • NIST Tooling
  • HL7 V2 + V3 relevance to Device Standards
    • Any official relationship of Devices to V3?
  • Type your task here, using "@" to assign to a user and "//" to select a due date

Co-Chairs (Rhoads, Garguilo)

Regrets: Cooper, Courville


Start of HL7 Healthcare Device Working Group Meetings

Welcome and Introductions

Intellectual Property Policy

John Rhoads


Report out of Co-chair steering Division Meeting

John Rhoads and John Garguilo

  • HL7 continues to move and demand (all WGs use) toward Confluence and JIRA 
  • Harmonization project is going away for Co-Chairs... will now be done electronically on Confluence by Vocabulary WG.  May 2020 reconciliation of terminology is proposed to happen in May 2020.  Vocabulary WG Chair (Ted Klein) calling for "pilot" participants.

NIST Tooling Updates
(Michael Faughn, Prometheus Computing/NIST Contractor, see slides here)

  • Tooling Roadmap presented.

  • Goal is to have a high-quality collection of device terminology (including 10101R)
  • Functional goal to produce any format out of RTMMS II
    • Power users can also take output to perform verification with existing "tools/spreadsheets/etc." (e.g., Paul Schluter)
  • RTMMS V2 - will provide two distinct interfaces - 1) for management/curation/sheppard from inception to ballot and 2) for users to get at collection of terminology
  • 11073-10201 DIM-(Domain Information Model) DPE (Device Profile Editor)
    • Michael has figured out a way to make profiles based on UML models; to enable this it will require enough of a change to refactor DPE to some levels
    • Also a -10207 DPE, which will work on same framework - which is in place today! (and thus be leveraged and used for re-work of -10201)
      • Re-work will enable "plug-ins"
  • Management and Governance of RTMMS
    • This does not preclude a way to get terms through standardization and adoption process...

  • 11073-10201 Device Profile to V2 IG and testing (integrated into NIST Testing and Development Framework)
  • Present NIST Framework - V2 - centric...
  • Michael discussed prior projects and where we are at going forward...

Above: There will be a device profiling tool editor in RTMMS - shown as feeding into "Device Profile Tools"

  • Given the model (see snippet above) - the tool should be device "agnostic"
    • Enables modeling and mapping regarding of the differences (-10201 vs. -20601) which captures all the attributes that "make the device the device"
  • Device Profile to FHIR IG (gives a head start on a FHIR IG)
    • Note: there are other  FHIR IG producing tools (e.g., Forge) - still looking at the boundaries and integration potential...  (e.g., Latana, Trifolia, Fire-I)
    • Related to all the 'resources' from FHIR site...
      • Key "resources" defined (4.0.1 of specification is compatible with IGs): - Device, DeviceMetric, Observation, and Patient
      • Logistics, catalogs, moving patients around the hospital

NIST V2 Tooling Status Update (Garguilo)

  • John Garguilo provided a general overview of NIST test program, V2 Framework and relationship to IEEE family of standards work (semantic content)
  • Discussion on "mappings" of 11073 DIMs, including SDC.
    • Conceptual maps are achievable - achieving specifics is/would be the hard development effort...
    • E.g., device to device vs device to enterprise (having a "common model")...
    • Devices through a gateway to a common interface (including difference  DIMs)  ?? versus device to device...
  • Note: a diagram was shown on "levels of Interoperability" - similar conceptual interoperability Model (see Turnista, 
  • Action: John G. to post both Michael Faugh's and his meeting slides...

Thursday, Q2

  • Terminology:
    • 10101 to LOINC mapping updates
    • 10101 / LOINC review panel plan
    • IEEE P11073-10101b
      • parameters (NMT, TPTD-CCO, infusion?
      • event and alert nomenclature
      • additional body and measurement sites
    • IEEE -10103 IDCO
    • Harmonized Rosetta (hRTM2a) updates
  • Type your task here, using "@" to assign to a user and "//" to select a due date

Terminology (Paul Schluter)

See slide set here

Paul has the (see slide above) asks...

  • Focus on new terms in green below (all above the "New Parameters")

  • Paul presented the following three questions:

Action items from this session (outside of continued work and addressing the items mentioned by Paul (three slide snippets above):

Action items: 

  • Paul Schluter Paul Schluter  intends and has an ask (review by others) to have a provisional term set (by End of February, ref id + code + descriptions)  
  • Paul Schluter Paul also intends to address ability to generate additional test strings (with help of review from others!?)

Thursday, Q3

  • LOINC Mappings

  • HL7 V2 + V3 relevance to Device Standards
    • Any official relationship of Devices to V3?

  • Mobile Health Update
    • Verification of Nomenclature to be used

  • FHIR  Projects Update
  • Devices on FHIR :
  • Joint with FHIR (@HCD)

    • Welcome and Introductions
      • “Devices on FHIR” IG Roadmaps, R5, Resource Maturity, ...
      • DoF:  Alerting Strategies (incl. DeviceAlert)
      • DoF:  Server Performance re. Scaling for Patient Monitored data (e.g., SDC)
      • FHIR "Localization"
      • FHIR support for non-time-based sample arrays
      • Device Static vs. Dynamic Data in FHIR
      • HCD / FHIR Planning
      • SDC to FHIR Topic

Sara Armson (Regenstrief)

Konstantinos Makrodimitris (FDA)

Matthew Graham

John Rhoads

LOINC Mappings Discussion

Sara Armson, Regenstrief (proxy for Swapna Abanyankar)

  • Action Item (HCD/All) Sara asked HCD for review and provide feedback regarding concept map from WG members

FDA Discussion

Konstantinos Makrodimitris

  • Kosta hosted a discussion, which included folks from American Dental Association, around if and what projects involve other HL7 standards including V2, V3, and FHIR
  • Dental Device focus
  • American Dental Association (ADA) folks in attendance include: Philip Wilford, Sharon Stanford, Gregory Zeller
    • SNOMED for Dentistry terminology
    • SNOMED-GD (General Dentistry) 

  • Images are typically exchanges Using DICOM
    • Imaging 
  • CDA Implementation with DoD and Private 
  • Dental to Medical, CCDA
  • Dentist to Dentist CCDA → working on FHIR
  • Patient provider Information Exchange (PIE)
    • Co-sponsor from Patient Care
    • Sharon and Philip Wilford are working through ISO Dental Group TC216
  • Sharon mentioned that anything on Dental (any projects with Dental - likely has a home for the work)
  • Group is open - There is both a National and International umbrella for all such projects
    • These cross between informatics and materials
    • Part of ANSI process...
  • Kosta asked (see following slide snippet) about what projects are in V3 and CDA?

  • HL7 Version 3 Standard:  Implantable Device Cardiac - Follow-up Summary, Release 2
    • Question posed by Kostas if this should go away (V3)
    • Paul Schluter mentioned that IHE IDCO group is focused on V2
    • Action Item: Should this be removed from V3 space...
      • Suggestion is to revisit with Hans and then the IHE-PCD IDCO group (Craig?)
      • General statement that most V3 items are being removed

Mobile Health Discussion

  • Matt asked (and with HCD) verified terminology being consistent with what HCD is actively undertaking
  •  See Matt's slide set updating the projects here


  • Covers use cases but is at the point fairly bare-bones
  • Following HL7 Publisher process - which is a bit of a moving target
    • JIRA project is established identifying the steps needed...given SDC Consideration
  • Devices On FHIR



Thursday, Q4

  • Action Item review from HCD Atlanta Meetings (Sept 2019)
  • IHE PCD Update
    • San Antonio Agenda Review
    • PCD "Reorganization" Proposals Update
    • Alerting:  ACM CPs for timing diag. and fatigue
    • SDPi Public Comment
    • DEC FHIR Option
  • NIST V2 Tool Update & Infrastructure
  • Review of Projects, Status
  • HL7 DEV General Roadmap and Planning
  • Carry-over DEV topics 
  • Click to add a new task...



PCD "Reorganization" Proposals Update

IHE-PCD is joining as the 'DEV-domain' with PHD

  • Details are still being worked out on how the two join and operate as sub-domains
  • More details to come
  • DEV Domain is notional 
  • This also is to include SDPi as part of the "DPI" Subdomain

ACM CPs for timing diag.

  • Two CPS added to the IHE-PCD Technical Framework Document (Volume 2) and more resultant CPs are forethcoming
  • New work was tested at 2020 NA Connectathon and will be demonstrated at HIMSS20 in March (Orlando)

SDPi Public Comment
  • Public Comment Period closed
  • Comment resolution completed
  • Published and now available (published November 2019)


  • POU - Personal Health Observation Upload
  • PCH subdomain, submitted profile supplement for Trial Implementation - was accepted by IHE-PCD
  • Comment period ended 5 January 2020
  • Comment resolution ongoing...

NIST V2 Tool Update & Infrastructure

John Garguilo, NIST

  • IHE-PCD validation tools (V2) used at IHE NA Connectathon in January 2020 were resultant of the NIST Test Framework
  • IHE-Japan is adopting the framework and working with NIST to update their test tools for the October 2020
    • Under development and targeting next (Oct 20) IHE Connectathon

Review of Projects, Status


  • 3-year plan now no longer needed 
  • Projects reviewed from HCD HL7 Projects wiki page
    • 1568: no update (HCD is Co-Sponsor)
    • 1351: To be deleted from Project List (3 year plan no longer needed)
    • 1335: On-going (HCD is Co-Sponsor), owe an update to Project Insight (ballot item)
    • 1277: Need to update the PSS for the steering division (and update dates)
    • 1153: HCD is working with Anesthesia WG to get two groups revised, then Anesthesia WG has to complete DAM 
    • 898: Now at the next stage of usability (no needs for HCD from lead) - success!
    • 897: Now at the next stage of usability (no needs from HCD from lead) - success!
    • 850: Dependent on the DAM finishing
    • 513: HCD has asked to remove, still shows up 

HL7 DEV General Roadmap and Planning

  • Mainly FHIR IGs work, in addition to Anesthesia WG items tied to DAM
  • FHIR Connectathon here in Sydney, John Rhoads caucused with the FHIR Shorthand Group - a domain specific effort to make it less difficult to profile IGs with a simple language in the draft.
  • John R. suggested to - Google "FHIR Shorthand" which provides links to a compiler and other information...
  • John R. was successful in short time at building on basic FHIR resources, appeared to work, was simple and straightforward...much easier than using extensions and cardinality  in raw XML..

Carry-over DEV topics

  • No carry-over topics 

Motion to adjourn HL7 HCD WG

  • Motion by Michael Faughn, second by Matthew Graham
  • Motion approved  8-0-0

Sydney HL7 HCD WG Meeting Adjourned by Co-Chairs

Action items