Health Care Devices (DEV) WG MTG 2012-01 San Antonio

Minutes of the meeting of the Health Care Devices WG of HL7 at the HL7 WGM, San Antonio, Texas, January 15-20, joint meeting with ISO/IEEE 11073 Medical Device Communications General Committee

John Rhoads, presiding co-chair, HL7 Health Care Devices WG

Jan Wittenber, chairman of IEEE Upper Layers Committee, chairman pro tem of IEEE 11073 General Committee (so designated by co-chairs Todd Cooper and Melvin Reynolds)

Minutes taken by John Rhoads

Monday, January 15, Q1

Present:

Jan Wittenber, Philips Healthcare
John Rhoads, Philips Healthcare
John Garguilo, NIST
Sandra Martinez, NIST
Carol Macumber, Apelon
Trish Williams, HL7 Australia
Kathryn Bennett, IEEE
Masaaki Hirai, Nihon Kohden
Ken Fuchs, IEEE
Paul Schluter, GE Healthcare
Allen Hobbs, Kaiser Permanente

The number of WG members present constitute a quorum.

Review of Agenda Approval of minutes deferred to a later session Co-chair elections

Review of HL7 HCD Activities

Topics discussed:

joint work with Generation of Anesthesia Standards on CDA representation of device data

HL7 over the spectrum of care - work ongoing on the classical starting environment (acute care), beginning on long term care, HL7 HCD has mostly deferred to IHE PCD, IEEE PHD, and Continua

Status of Work in IEEE 11073 (Bennett presenting) - start

Monday Q2

Present:

Jan Wittenber, Philips Healthcare John Rhoads, Philips Healthcare John Garguilo, NIST Sandra Martinez, NIST Carol Macumber, Apelon (not on WG listserv, so not voting on HL7 HCD matters) Trish Williams, HL7 Australia (not on WG listserv, so not voting on HL7 HCD matters) Kathryn Bennett, IEEE Masaaki Hirai, Nihon Kohden Ken Fuchs, IEEE (not on WG listserv, so not voting on HL7 HCD matters) Paul Schluter, GE Healthcare Allen Hobbs, Kaiser Permanente

The number of WG members present constitute a quorum.

Vote to create additional co-chair position in the HL7 Health Care Devices WG

John Rhoads stepped down temporarily as presiding co-chair in order to make a motion and to participate in discussions in which he could be perceived to have an interest, designating Jan Wittenber as co-chair pro tem presiding over the deliberations and vote on the question. He moved that an additional co-chair position be created, and nominated Alan Hobbs as interim co-chair in the newly created position, pending a regular co-chair election at the next HL7 Working Group meeting.

The voice vote on the motion to add a co-chair position was unanimous in favor.

The paper ballot on the person to be interim co-chair in that position was unanimous for Allen Hobbs.

At this point, John Rhoads resumed as presiding co-chair of HL7 HCD. Discussion of HL7 status resumed

Topics discussed:

Recent publications and work in progress in individual ISO/IEEE 11073 family standards documents

Projected mappings between 11073-10101 nomenclature and other nomenclatures such as LOINC and IHTSDO.

Change in IEEE balloting due to ANSI requirement: ballot group formerly could not be in more than 50% of one category (e.g. vendor). New threshold is no more than 33% of one category.

Monday Q3

Present:

Jan Wittenber, Philips Healthcare John Rhoads, Philips Healthcare John Garguilo, NIST Sandra Martinez, NIST Kathryn Bennett, IEEE Ken Fuchs, IEEE (not on WG listserv, so not voting on HL7 HCD matters) Paul Schluter, GE Healthcare Allen Hobbs, Kaiser Permanente

Topics discussed

Do we need to stop co-locating ISO/IEEE 11072 with HL7 Working Group Meetings. Issue is that ISO has a policy that ISO meetings cannot be where there is a substantial meeting fee, as at HL7. Issue raised by ISO TC 215 secretariat Joe Llewelling (AAMI). Disposition: refer question to 11073 leadership.

Monday Q4

Present:

Jan Wittenber, Philips Healthcare John Rhoads, Philips Healthcare John Garguilo, NIST Sandra Martinez, NIST Kathryn Bennett, IEEE Ken Fuchs, IEEE (not on WG listserv, so not voting on HL7 HCD matters) Paul Schluter, GE Healthcare Allen Hobbs, Kaiser Permanente

Topics discussed

11073 General Committee Co-chair status -- Todd Cooper and Melvin Reynolds do not generally have funding to attend meetings, and they have not been able to attend some recent meetings, including this one. This may create problems having meetings and keeping records in compliance with relevant policies and procedures.

Jan Wittenber will initiate a meeting of all co-chairs and other leadership (Upper Layers, Lower Layers, General Committee, Personal Health Devices, and sponsor) to find out intentions of incumbents, consider adding a co-chair, consider meeting venue issues, and report back.

National Institute of Standards and Technology (NIST) device communications testing

Presented by John Garguilo, Sandra Martinez

Presented results from new "isolated" test tools used in Pre-Connectathon testing by Integrating the Healthcare Enterprise (IHE) Patient Care Device (PCD) domain.

Discussion of imminent (end of January) roll-out of Rosetta Terminology Mapping Management Service (RTMMS) for collaborative terminology management between, initially, IHE PCD and ISO/IEEE 11073-10101 Nomenclature (and eventually, mapping to related terminology items from LOINC and SNOMED). Presented process by which terms will be reviewed.

Have recently added annotated ECG terms, also systematic name, common term, acronym and term description information from the standard.

Garguilo demonstrated new RTMMS capabilities.

See slides associated with this session:

Kathryn Bennett, IEEE N0354_11073 Update 1-16-2012.pptx

John Garguilo, NIST (note yet submitted)

Tuesday Q1

Present:

Alan Hobbs, Kaiser Permanente Paul Schluter, GE Healthcare Martin Entwistle, Palo Alto Medical Foundation Ken Fuchs, Mindray North America Kathlryn Bennett, IEEE Carol Macumber, Apelon Sandra Martinez, NIST John Rhoads, Philips Healthcare, presiding co-chair, HL7 Health Care Devices WG Jan Wittenber, Phlips Healthcare, Chair pro tem of IEEE 11073 General Committee

Topics discussed:

Presentation by Martinez, Garguilo from National Institute of Standards and Technology (NIST) on Test Case Authoring and Management Tool

Tool will be used for HL7 profile conformance testing in Integrating the Healthcare Enterprise Patient Care Device (IHE PCD) domain, and it is proposed for change tracking and maintenance.

Intended scope of:

RTMMS database - should it include unit of measure co-constraints? Enumerations?

Similarly, should the IEEE 11073-10101 standard contain these things?

Lively discussion.

Adjourned at 5:15.

Tuesday Q2

Present:

Alan Hobbs, Kaiser Permanente Paul Schluter, GE Healthcare Martin Entwistle, Palo Alto Medical Foundation Ken Fuchs, Mindray North America Il Kon Kim, Kyongook National University, Korea Kathlryn Bennett, IEEE Catherine Chronaki, HL7 Greece Sandra Martinez, NIST Jay Lyle, Veterans Health Administration John Rhoads, Philips Healthcare, presiding co-chair, HL7 Health Care Devices WG Jan Wittenber, Phlips Healthcare, Chair pro tem of IEEE 11073 General Committee

Discussion of the process of moving currently available forms of the 2004 edition of IEEE 11073-10101 standard and merging with more recent editions to make a new edition.

Consensus to initiate a "tiger team" effort to make a concentrated effort to organize the data needed for this.

Details of life cycle of a term in RTMMS.

Very lengthy discussion of hierarchical containment of metrics, Paul Schluter offering several representations and asserting a close relationship with event representation. No conclusion at this time.

Tuesday Q4

Alan Hobbs, Kaiser Permanente Paul Schluter, GE Healthcare Ken Fuchs, Mindray North America Kathryn Bennett, IEEE Sandra Martinez, NIST John Rhoads, Philips Healthcare, presiding co-chair, HL7 Health Care Devices WG Jan Wittenber, Phlips Healthcare, Chair pro tem of IEEE 11073 General Committee

Continuing the event discussion, Wittenber suggested another "tiger team" with representatives from vendors to collect and collate alarms and events emitted by the devices.

Further discussion of representation of events and attributes.

Displayed and discussed Griesser UML model generated from NIST ICSGenerator XML schema.

Adjourned at 5 pm

HL7 Working Group Meetings, Wednesday, January 17, 2012

Wednesday Q1

Present

Jan Wittenber, Philips Healthcare, chair pro tem of IEEE 11073 General Committee John Rhoads, Philips Healthcare, presiding co-chair, HL7 Health Care Devices WG Terri Monk, Duke University John Walsh, Massachusetts General Hospital Sadami Tabesaba, HL7 Japan Masaaki Hirai, HL7 Japan Carol Macumber, Apelon, for US Veterans Administration Tricia Greim, US Veterans Administration Paul Schluter, GE Healthcare Martin Hurrell, HL7 Generation of Anesthesia WG

Martin Hurrell reported on joint project with Generation of Anesthesia WG (G.A.S) to create a Clinical Documents Architecture R2 compliant representation of device data.

Project Scope Statement` for project approved at Domain Exports Steering Division meeting on Monday. Meeting pointed up the need to study vital signs representations in Patient Care WG. (Later conversations outside the meeting pointed out the need to harmonize with existing Structured Documents work).

A very simple blood pressure example was presented and discussed.

The appropriate use of such a data representation was much discussed.

Wednesday Q2

Present:

Jan Wittenber, Philips Healthcare Paul Schluter, GE Healthcare Alan Hobbs, Kaiser Permanente John Rhoads, Philips Healthcare

The quarter was planned to be a joint telephone conference with domain experts on ventilator terminology, but the cost of using a conference phone was prohibitive, so the session was cancelled.

Wednesday Q3

Present:

Jan Wittenber, Philips Healthcare, chair pro tem of IEEE 11073 General Committee John Rhoads, Philips Healthcare, presiding co-chair, HL7 Health Care Devices WG Tracy Rausch, DocBox John Garguilo, NIST Sandra Martinez, NIST Sadami Tabesaba, HL7 Japan Masaaki Hirai, Nihon Kohden, HL7 Japan Paul Schluter, GE Healthcare

IEEE 11073 Personal Health Device status update

Expected slide deck was not received, so Wittenber and Schluter gave an update based on minutes and tutorial slides.

ASTM Integrated Clinical Environment questions to 11073 (Rausch)

How will 11073 approach security concerns

Demographics need updates to harmonize with, e.g. HITSP

Communications

Patient location

Control

Wednesday Q4

Present:

Jan Wittenber, Philips Healthcare, chair pro tem of IEEE 11073 General Committee John Rhoads, Philips Healthcare, presiding co-chair, HL7 Health Care Devices WG Tracy Rausch, DocBox Sandra Martinez, NIST Allen Hobbs, Kaiser Permanente Sadami Tabesaba, HL7 Japan Masaaki Hirai, Nihon Kohden, HL7 Japan Paul Schluter, GE Healthcare

Continuation of ICE and 11073 harmonization discussion

Simple example of common of significant lack of communication between devices: NIBP cuff placed on same arm as (1) an SpO2 sensor (2) an IV line. ICE proposes a higher level of integration which could assist by displaying or asking the question, is the clinical rule that being followed. Or an ICE supervisor may be able to integrate the information from another source.

Discussion of ICE supervisor and 11073 as layers in a layered system, and the regulatory implications of that.

Including and processing "Quality-of-measurement" data and requirements for use cases.

Requirement to be able to distinguish statically specified or dynamically changing quality of measurements attributes.

Thursday Q1

Present: Paul Schluter, GE Healthcare Tracy Rausch, DocBox Allen Hobbs, Kaiser Permanente, presiding co-chair Sandra Martinez, NIST John Garguilo, NIST John Rhoads, Philips Healthcare Jan Wittenber, Philips Healthcare

Proceedings:

The winners of the co-chair election, Todd Cooper and Allen Hobbs, were announced and congratulated.

John Garguilo made a motion to reconsider a motion passed earlier this week to name Allen Hobbs on an interimmoved that, since Allen Hobbs had won the election to fill the additional co-chair position and also the regular election, the intent of the WG in establishing the extra position was not being met, so

Discussion Topics:

DCM4MD project intends to ballot their document again in the May ballot

Thursday Q2

Vincent McCauley, McCauley Software, HL7 Australia Paul Schluter, GE Healthcare Masaaki Hirai, Nihon Kohden, HL7 Japan Sadami Tabesaba, HL7 Japan Tracy Rausch, DocBox Ilkon Kim, Kyongook National University, HL7 Korea Allen Hobbs, Kaiser Permanente, presiding chair Sandra Martinez, National Institute of Standards and Technology (NIST) John Garguilo, NIST John Rhoads, Philips Healthcare Jan Wittenber, Philips Healthcare

WIttenber presented Revision and Development based on IEEE 11073 standards and revision PARs, but also emphasizing the detailed interdependancies with other standards and profiling groups (Health Level 7, Integrating the Health Enterprise Patient Care Device domain, NIST, International Electrotechnical Commission, International Healthcare Terminology Standards Development Organization, Continua Alliance, International Standards Organization).

Tracy Rausch agreed to work with Wittenber on adding detail to the interdependancy matrix.