HL7 DEV WG / IEEE 11073 WG Joint Working Group Meetings
January 14-18, 2013 @ Pointe Hilton Squaw Peak Resort, Phoenix, AZ
Sunday
Note: Official WG meetings do not begin until Monday Q1
Monday - Q1
Welcome & Introductions

  • John Rhoads - Philips Healthcare -
  • Paul Schluter - GE Healthcare -
  • Tracy Rausch - DocBox -
  • Masaki Hirai - Nihon Kohden -
  • Greg Staudenmaier - VHA -
  • Sungkee Lee - Kyungpook National University -
  • Malcolm Clarke - Brunel University -
  • Stan Wiley - Draeger Medical -
  • Jan Wittenber - Philips Healthcare -
  • Allen Hobbs - Kaiser Permanente -
  • Ken Fuchs - Mindray NA -
  • Todd Cooper - Breakthrough Solutions / WestHealth -

Agenda Review & Approval
Monday - Q2
Minutes & Action Item Review & Approval
· 2012 Sept Baltimore - APPROVED Unanimously
· 2012 Nov La Jolla / San Diego

  • Need to include IHE_PCD_DS_IP_Consolidated_r3_Containment_Baseline_r1
  • APPROVED Unanimously

Review of Action Items
From Baltimore:
10101 new PAR submission language - Kathryn
> Closed - Approved, also created PAR for 10101a
10201 extension request submission - Jan
> Closed - Approved
Leadership telecon re: coordinated messaging from cooperating orgs
> Closed - Reviewed in La Jolla
Prospective meeting roadmap with International Reps - Jan/Kathryn
> Review of MOUs and other coordination docs not done
Completing UL listserv distribution list - Jan/Kathyrn
> Open - GC listserv name changed. Otherwise possibly need a real GC list and a real 11073 Classic list.
> Need to discuss with PHD for coordination of lists
Hold tcon to resolve issues of 802 tutorial content and contributors - Todd/Ken
> Closed - discussions were conducted
From LaJolla:
Work on a Program Plan/Schedule for 11073 based on JW work to date - Ken/Stan
> Closed -
Publish draft agenda for January '13 X73 meetings before 2012.12.25 - Todd
> Closed
Submit 11073-10101 Amendment PAR to add a new set of terms - Todd
> Closed
EU MDD Formal References: Consider revising the presentation for a larger audience (non-11073) and vet with others such as Patty Krantz (ISO TC215 WG2/7), Peter Linders (Philips) and Alpo Vaari (CEN TC251). In other words, those who are currently engaged in both European medical device regulatory discussions, related standards organizations and development, and industry - Melvin
> Open - monitoring the situation
11073-20101
Reframe the MDAP set development around a harmonized / common base set of 11073 profiles (incl. 20601 & 20101) - per the DISCUSSION SLIDES - Jan
> Closed - Jan prepared white paper
Provide for the extensibility for additional protocols like DDS and MQTT, so that these technologies can be utilized within the 11073 MDAP standard set - Tracy
> Closed -
11073-10201
Coordinate with Garguilo on using the DIM Editor for updating the 10201 models editorially, plus kicking off 10202... - Todd
> Closed
Ask Kathryn that we are linked up with their database project. - Todd
> Closed
Talk with Kathryn about their process. Potentially we will just follow MC's suggestion to declare what X73 is going to do ... or TC's suggestion to submit a new PAR around the X73 direction for NesCom to respond
> Closed
11073-20201
Tiger team for CI and the set of transport / LL types to which a profile would connect and the info that would be provided (e.g., 802.x) - Jan/Paul.
> Closed
More fully describe the various use cases and reasons for developing the (primarily) Messaging Ontology. Also has implications on MIB (management information base) for the device. Target to make progress for January WGM. - Jan
> Open
IHE PCD Standards and Tooling
Identify differences between the two databases - John G.
> Closed
Submit -10202 PAR for a computational representation of the DIM - Todd
> Open - needs further discussion this week
Review -10201 revision PAR to update Scope - Todd
> Open - needs further discussion this week
Prepare a revised draft of NIST/IEEE “press release” template for consideration by the group - Paul
> Open - topic for Q5 Tuesday (Phoenix)
11073-10302-1
Draft a diagram that illustrates the relationship of the 11073-103xx standards components and the IHE PCD profile architecture and technical framework - Todd
> Open
Draft diagram to summarize the proposed -103xx document framework - by Dec. 22 - Ken
> Closed
11073-20301
Create a "real world" example of the use of Vattributes - by Jan 7 - Jan
> Closed - mini-white paper generated
Prepare an informative annex based on an ICE Use Case - by Jan 7 - Jan/JR
> Closed
Distribute the 231 draft by Dec. 22 - Todd
> Open - document started, not distributed
11073-20401
Survey of technical solutions. Look at development alternatives. Create a collection of Use Cases and Scenarios. Make progress by Jan 7 - West
> Open
HL7/HCD Status Report
WG Mission & Charter

  • No work needed for Mission / Charter

3 Year Plan + SWOT

  • SWOT should be in good shape

3 Year Plan

  • Need to look at this and address.
  • ++John R. will draft a preliminary PSS for HCD + X (possibly with FHIR)

Monday - Q3
Attendees:

  • -Masaki Hirai
  • -Sungkee Lee
  • Barry Brown - Mortara -
  • John Garguilo - NIST -

IEEE 11073 Status Update from Kathryn

  • Reviewed report from Kathryn Bennett (see documents IEEE-SA_PAR-STD Report (xls) and IEEE/EM/11073 Status Update (ppt))
  • ++IEEE to sign agreement with NIST - Kathryn

IEEE PHD Update

  • Reviewed update provided by Daidi Zhong(see document 2013-01-14-IEEE11073-PHD-Update v0.1.ppt)
  • Malcolm provided some additional information concerning the BLE work.
  • ++Pull together a process summary for harmonization of PHD terms using the RTMMS tool, to be forwarded to the PHD group for discussion - Jan / Paul / John G.

IEEE Committee Schedule

  • Schedule to be discussed and finalized at the weekly Tooling and Coordination Committee meeting (Thursdays at 11 Eastern) before next HL7 WGM - Fuchs / Wiley

IEEE Central Desktop Tool

  • Reviewed a presentation about this tool
  • Will use this tool for the 10101a and the Pump Specialization projects - Jan / Todd

Monday - Q4
ICE Update - Tracy Rausch

  • Will be working on 4 Use Cases
  • Funding continued from DoD
  • Will probably be opening new ASTM project this year

mHeatlh Update - Allen Hobbs

  • General update about mHealth Summit

80001 - Todd Cooper

  • Responsibility Agreement out for NWIP ballot
  • Next JWG is May 3/4 (Before HL7 WGM)

General Updates

  • Barry Brown, Mortara - Trying to respond to FDA request for 24/48 hour full-disclosure ECG data. Current approach in aECG would be too large in xml. Looking to propose a pointer to an external file encoded in a more compact format (ISHNE). In addition need to deal with the annotations which will be done in a similar manner.

Tuesday - Q1
Attendees:

  • John Rhoads - Philips Healthcare -
  • John Garguilo - NIST -
  • Paul Schluter - GE Healthcare -
  • Malcolm Clarke - Brunel University -
  • Tracy Rausch - DocBox -
  • Masaki Hirai - Nihon Kohden -
  • Greg Staudenmaier - VHA -
  • Mike Lardiere - National Council for Behavioral Health -
  • Sungkee Lee - Kyungpook National University -
  • Stan Wiley - Draeger Medical -
  • Jan Wittenber - Philips Healthcare -
  • Allen Hobbs - Kaiser Permanente -
  • Ken Fuchs - Mindray NA -
  • Todd Cooper - Breakthrough Solutions / WestHealth -

Co-Chair Meetings - Update

  • Update from Monday evening co-chair meeting
  • Product Families vs. Product Lines
  • ** Update SAFE status - John R.
  • ** Update project lists to HL7 - John R.
  • 3-yr plan discussion

NIST Tooling review

  • IHE PCD v2 Tooling, RTMMS
  • See presentation "NIST_HL7_IEEE_WG_Update_15_Jan_2013.pdf"
  • Usage Agreement w/ IEEE
  • All signed off!!!

NIST MDDL v2 Update

  • DIM Editor (Art G.)

Tuesday - Q2
Attendees:
- Mike Lardiere
+ Hisao Yoshimura - Nihon Kohden Corp. -
DIM Revision:

  • Proposed Stds Arch / 10201/-10202/-20101
  • Refer to document "FHIR-MDDL-Schema_jw6.pdf"
  • Tooling Support
  • Jan reviewed topics related to converting from MDDL to FHIR

Tuesday - Q3
Attendees

  • John Rhoads - Philips Healthcare -
  • John Garguilo - NIST -
  • Paul Schluter - GE Healthcare -
  • Malcolm Clarke - Brunel University -
  • Tracy Rausch - DocBox -
  • Stan Wiley - Draeger Medical -
  • Jan Wittenber - Philips Healthcare -
  • Allen Hobbs - Kaiser Permanente -
  • Ken Fuchs - Mindray NA -
  • Todd Cooper - Breakthrough Solutions / WestHealth -

ICE Remote Control Use Cases

  • Tracy presented various Use Cases; see presentation "-----"
  • Dave Arney + Tracy Rausch will be primary points-of-contact to work with the X73 team on this
  • Part of the process is to map the available control constructs to meet the high-level ICE requirements + to have the capabilities to ensure that they can be implemented safely & effectively
  • ++ Convene a tiger team to work on this RCOP Appendix, perhaps meeting during the ICE-PAC time slots (Jan, Tracy, ... usual suspects)

VATTR White Paper Review
11073-20301 RCOP Review
PHD Device Controls Update
Tuesday - Q4
+ Martin Hurrell - MJHC Consulting -
+ John Walsh - Partners Healthcare -
+ David Hay - Orionhealth -
- Tracy Rausch
Hosting HL7 Anesthesia WG (GAS)

  • Review Active Projects (projects #513 & #850)
  • #513 - want to put more resources on this and get this done and then address #850
  • BP NIBP Use Case
  • Jan reviewed his white paper on the NIBP Use Case.
  • See document "FHIR-MDDL_Schema_jw6.pdf"
  • See document "GASx73-CDA-DCM-DataTopo-UCs-DCM_d1-jw"
  • John R. reviewed an initial draft of the PSS for a project to develop joint FHIR resources for HCD WG.

Tuesday - Q5
IEEE/NIST Press Release

  • Discussion concerning how to improve the current press release wording led by Paul
  • ++ WG to work with John G. to improve the press release - John G./Paul

Wednesday - Q1
Attendees

  • John Rhoads - Philips Healthcare -
  • John Garguilo - NIST -
  • Paul Schluter - GE Healthcare -
  • Martin Hurrell - MJHC Consulting -
  • Andrew Norton - NHS / Anesthesia SIS -
  • Masaki Hirai - Nihon Kohden -
  • Sadama Takasaka - PMDA -
  • Gary Mills - Hospira -
  • Malcolm Clarke - Brunel University -
  • Tracy Rausch - DocBox -
  • Stan Wiley - Draeger Medical -
  • Jan Wittenber - Philips Healthcare -
  • Allen Hobbs - Kaiser Permanente -
  • Ken Fuchs - Mindray NA -
  • Todd Cooper - Breakthrough Solutions / WestHealth -

11073-10101a Amendment

  • Term Life Cycle + repartitioning
  • 10101a PAR Review
  • Even though the PAR says "no" we are coordinating with ISO and it will be submitted for ISO review and approval.
  • 10101 Review
  • Addendum Contents
  • Process
  • Tooling
  • Term Life Cycle

Wednesday - Q2
Attendees:

  • -Rausch
  • -Hurrell
  • -Masaki
  • -Sadama
  • -Norton

(Get minutes from Jan)
Wednesday - Q3
Attendees

  • John Rhoads - Philips Healthcare -
  • John Garguilo - NIST -
  • Paul Schluter - GE Healthcare -
  • Gary Mills - Hospira -
  • Malcolm Clarke - Brunel University -
  • Tracy Rausch - DocBox -
  • Stan Wiley - Draeger Medical -
  • Jan Wittenber - Philips Healthcare -
  • Allen Hobbs - Kaiser Permanente -
  • Ken Fuchs - Mindray NA -

Please refer to detailed notes from Jan - "10101 Discussion Notes Wednesday Q3"
Wednesday - Q4
Attendees
+ Grahame Grieve - Health Intersections - or
Hosting FHIR
Status Update / 2013 May Ballot

  • DSTU by end of year

X73=> FHIR Tech Approach

  • Recommendation would be to use FHIR for applications which we haven't addressed before, not reinventing the same wheel

PSS for DEV WG FHIR Project
Thursday - Q1
Attendees

  • John Rhoads - Philips Healthcare -
  • John Garguilo - NIST -
  • Paul Schluter - GE Healthcare -
  • Gary Mills - Hospira -
  • Malcolm Clarke - Brunel University -
  • Tracy Rausch - DocBox -
  • Stan Wiley - Draeger Medical -
  • Jan Wittenber - Philips Healthcare -
  • Allen Hobbs - Kaiser Permanente -
  • Ken Fuchs - Mindray NA -
  • Art Griesser (on the phone) - NIST -

JSON Overview

  • See presentation from Art Griesser ("Ease_DIM_Use.ppt"), and JSON file ("metainfo.json")

Telematics Proposal

  • See presentation from Allen Hobbs ("Telematics and Digital Health.pptx")

x73 Terminology Work Plan

  • Paul to pull together terms for review including pump terms. (These are all the MDC terms currently in RTMMS). Other terms will be reviewed in future cycles.
  • PHD to work with John G. to bulk load their terms into RTMMS
  • They will be reviewed at the RTM T-Cons
  • John G. to add columns to RTMMS to track SDO approval

Thursday - Q2
Attendees
+ Sungkee Lee
- Art Griesser
FHIR Update and Work Plan

  • **Grahame will propose some sample FHIR resources based on artifacts that we provided to him.
  • Todd to coordinate with Grahame concerning follow-up timing and venue

Interoperability Pledge Press Release

  • Ken presented press release from Health Safety Summit ("Medical device makers ink interoperability pledge.docx")

Document Architecture

  • Jan discussed specialization document and architecture ("MDS_speczn_10xxx_Defns_jw1.pdf")
  • ** Need to resurrect 10300-1 (Device Specializations - General) - Jan/Todd to initiate PAR

Thursday - Q3
Attendees

  • John Rhoads - Philips Healthcare -
  • John Garguilo - NIST -
  • Paul Schluter - GE Healthcare -
  • Sungkee Lee - - Kyungpook National University -
  • Gary Mills - Hospira -
  • Malcolm Clarke - Brunel University -
  • Tracy Rausch - DocBox -
  • Stan Wiley - Draeger Medical -
  • Jan Wittenber - Philips Healthcare -
  • Allen Hobbs - Kaiser Permanente -
  • Ken Fuchs - Mindray NA -
  • Clem McDonald - NLM -

Infusion Pump

  • Review discussion to date
  • Scope out topics for inclusion in standard
  • Thoughts from Gary Mills:
  • Delivery information / Device status
  • Security
  • Drug library Updates (may need to be vendor specific)
  • Patient Pump association / disassociation
  • Device therapy programming (auto programming)
  • Device metrics / software and hardware version information.
  • Logs and log management
  • Device configuration setup
  • Alarm forwarding
  • Device software update
  • Device location (tracking / location)
  • Remote Alarm Acknowledgement
  • Dose management / predictive and closed loop management – input and output for this.
  • Peer to Peer communication (data and status) hub for communication with low power / limited devices
  • General organization of the standard (outline)
  • Is there general agreement concerning pump modes? Are there any relevant Standards, such as 60601-2-24?
  • What content is migrated from existing draft
  • General question about how standalone the document should be. Todd's opinion is that it should be readable - but not complete enough to support a full implementation without other supporting documentation/standards.

Types of pumps

  • Pumps for drug delivery may be categorized into four subgroups on the basis of the mode of delivery:
  • type 1: continuous infusion;
  • type 2: non-continuous flow only;
  • type 3: discrete delivery of a bolus;
  • type 4: PROFILE PUMP.

Discussion of 11073-10301

  • Need for a self test capability was discussed.
  • Keystroke log with a possible extension to a playback functionality. This would be important to ICE. Dave Arney (ICE Datalogger) this would need to include soft interfaces softkeys and touches on the screen) there is a need to be able to playback this log data to replaced scenarios for investigation purposes.
  • Some discussion about how stand alone these will need to be in their next revision (what can be pulled out into a base document) as well as the other referenced data types (from other documents ASN1 for example)
  • Need to enhance the network utilization/ bandwidth need with respect to library update and data logging (keystroke and event log transfer in bulk)
  • Jan suggested a scheduled type of operational mode. An example of this would be multistep and interchange sequence.
  • Malcolm suggested that the attributes from the base document not be replicated in the more specific documents. Todd’s observation is that these are extended to define new features in the documents where necessary – this is the same as what is done in the baseline ASN1 and DIM.
  • Need to add something that explicitly addresses ICE concerns and add event log examples to the annexes.
  • Discussion on if this should include all infusion (LVP/PCA…) or broken up into different documents for infusion specialized.
  • **Gary to investigate the mapping of modes in 60601-2-24 to see what is used in this document
  • Consider usage of IEEE Central Desktop
  • Will be used for this project

Thursday - Q4
Attendees

  • John Rhoads - Philips Healthcare -
  • Paul Schluter - GE Healthcare -
  • Sungkee Lee - - Kyungpook National University -
  • Malcolm Clarke - Brunel University -
  • Stan Wiley - Draeger Medical -
  • Jan Wittenber - Philips Healthcare -
  • Allen Hobbs - Kaiser Permanente -
  • Ken Fuchs - Mindray NA -
  • Gora Datta - Cal2Cal Corp -
  • Matthew Graham - Mayo Clinic -
  • Andrzej Knafel - Roche Diagnostics International -
  • Greg Staudenmaier - VHA -
  • Vannak Kann - VA -
  • Sasha Bojicre - Canada Health Infoway -
  • Dmytro Rud - Roche Diagnostics -
  • Trish Williams - HL7 Australia -
  • Ann Wrightson - HL7 UK -

Hosting Mobile Health

  • First meeting of WG this week.
  • Trying to understand what the mission will be from a technical standpoint. Doing a gap analysis.
  • Possible areas of work are:
  • Functional model
  • Messaging - use of SMS in developing countries, for example.
  • Services - get apps to talk to each other or to the EMR in an interoperable manner
  • Assisted living project in UK.
  • Long discussion about the definition of the term "Mobile Health" in the context of this HL7 WG.
  • ++HCD to work with Mobile Health on a PSS to come up with use cases and a working definition of Mobile Health, Mobile Devices, etc. - Allen
  • ++HCD to provide MH with relevant background documents - Allen

Friday - Q1 & Q2
Attendees

  • John Rhoads - Philips Healthcare -
  • Paul Schluter - GE Healthcare -
  • Malcolm Clarke - Brunel University -
  • Stan Wiley - Draeger Medical -
  • Jan Wittenber - Philips Healthcare -
  • Allen Hobbs - Kaiser Permanente -
  • Todd Cooper - Breakthrough Solutions -

<at Q2>

  • John Ritter -
  • Nicu Goga - University Groningen -
  • Mike Lardiere - National Council for Behavioral Health -

HL7 WG Matters …

  • FHIR PSS Discussion
  • Reviewed, updated and approved unanimously an initial draft of the PSS
  • ++Forward draft FHIR PSS to Dave Hay (FHIR Liaison to DEV WG), and CC: other key FHIR individuals who have interfaced with the DEV WG - Rhoads
  • SWOT & DMPs
  • Reviewed and approved unanimously WG DMPs without modification
  • Updated SWOT per group discussion and approved unanimously
  • ++ Forward updated SWOT and DMP to the DESD co-chairs, CC: Austin - Rhoads
  • Mission & Charter (w/ SAIF)
  • Reviewed and updated the DEV WG Mission & Charter, unanimously approved
  • NOTE: Rhoads will include a reference supporting SAIF
  • ++ Forward updated Mission & Charter documents to the DESD co-chairs, CC: Austin - Rhoads
  • HL7 DEV WG 3-Year Plan
  • Currently DEV WG has no 3 Year Plan (that we know of)
  • ++ Create an initial 3 Year Plan based on current and anticipated activities - Rhoads
  • NOTE: The WG expressed their thankfulness to John Rhoads for his support in these areas of WG business.

X73 Harmonization Planning