HL7 Healthcare Devices/IEEE 11073 Working Group Meetings

HL7 Healthcare Devices/IEEE 11073 Working Group Meetings

2014.09.15 – 2014.09.19 – Chicago, Illinois

See meeting documents posted @ http://www.hl7.org/Special/committees/healthcaredevices/docs.cfm?

Monday – Q3 September 15, 2014

Recurring Participants

• John Garguilo (NIST)
• John Rhoads (Philips)
• Stan Wiley (Draeger)

·  Paul Schluter (GE)

• Jan Wittenber (Center for Medical Interoperability)
• Todd Cooper (Center for Medical Interoperability)
• Ken Fuchs (Center for Medical Interoperability)

·  Masato Tanaka (Nihon Kohden)

Q3-Specific Participants

·  Catherine Chronaki (HL7 Foundation)

·  Geoff Emory (Graphy)

·  Stefan Schlichting (Draeger)

·  Stephan Poehlsen (Draeger)

·  Scott Brown (GS1 US)

·  Recurring participants

Other Participants Pool (note – use for future Qs if present)

• Gora Datta (Cal2Cal)
• Kathryn Bennett (IEEE)

·  Leslie Tompkins (FDA CDRH UDI)

·  John Walsh (Partners Healthcare)

·  Paul Knapp (ITS , Chair of UDI Task Force)

·  Chi Tran (Center for Medical Interoperability)

·  Michael Faughn (Prometheus Computing)

·  Joe Good (Center for Medical Interoperability)

·  Darryl Mellott (Center for Medical Interoperability)

·  Paul Spadafora (Center for Medical Interoperability)

·  Greg Staudenmaier (VA)

·  David Hay (FMG)

·  Christian Hay (GS1)

·  Tracy Rausch (DocBox/MDPnP)

·  Steven Foglietta (DocBox)

·  Kai Hassing (Philips)

·  Sadamu Takasaka (HL7 Japan)

·  Masaaki Hirai (Nihon Kohden)

·  Ioana Singureanu (VA/Eversolve)

·  Alan Lippitt (IHE/HL7)

·  Clem McDonald (NLM)

·  Tim McKay(Kaiser Permanente)

·  Lori Dieterle (Kaiser Permanente)

·  Shannon Gray (Softarex Technologies)

·  Brian Reinhold, (Lamprey Networks/Continua)

·  Ewout Kramer (Furore)

·  Geoff Emory (Graph 8)

·  Mike Henderson (OSEHRA)

·  Dave Shaver (Corepoint)

·  Brad Arndt (Cerner)

·  Doug Pratt (Siemens)

·  Havar Edidin (Edidin Group)

·  Chris Doss (North Carolina A&T)

·  Matt Graham (Mayo Clinic)

·  Harry Rhodes (AHIMA)

·  Evelyn Gallege (ONC)

·  Rob Snelick (NIST)

·  Sandra Martinez (NIST)

·  Norman Jones (ISO TC 121/SC4)

Minutes for Q3

• Patent policy and Anti-Trust statements of IEEE were presented and reviewed.
• Attendee introductions were made. See attached list of attendees.
• IEEE service recognition for Todd Cooper, Melvin Reynolds, and Malcom Clarke was noted.
• Agenda revision 1.8 was reviewed. Motion by Wiley (seconded by Cooper) to approve the revised agenda. Motion was unanimously approved.
• Minutes and action items from the May 2014 Committee Meeting were reviewed and accepted as presented.
• HL7/HCD Status Report

o  HL7 Elections

·  Open position to replace A. Hobbs. C. Courville from EPIC was placed into nomination. Motion by Cooper (seconded by Rhoads) to appoint C. Courville as interim-Co-Chair until January 2015 meeting, then stand for formal election – approved unanimously.

·  John Garguilo is standing for re-election as HL7 co-chair.

·  Role of Todd Cooper with HL7 and IHE (all domains) – HL7-IHE Coordinating Committee; to be the formal home of FHIR resources.

o  HL7 Europe

• Catherine Chronaki provided an overview of Overview of HL7 Europe: Mission, Workplan, Projects - Cross-border support for electronic exchange of patient data sets; Antilope Thematic Network; Trillium Bridge - bridging patient summaries across the Atlantic Meaningful Use to epsos (CCD, CDA); also covered eHealth Governance Initiative and SemanticHealthNet. See HL7.eu website for more details.

o  HL7 Work Group Meeting – May 2015, Paris, France

• Todd Cooper made a call for focused agenda items for this special Work Group Meeting – Action item was assigned to membership to provide input for the creation of this agenda.
• Stefan Schlichting noted that there would be engagement of representatives from OR.NET at this meeting.

Monday – Q4

Q4-Specific Participants

·  Recurring Participants from Q3 on Monday

·  Chi Tran

·  Paul Spadafora

·  Ioana Singureanu

·  Stefan Schlichting

·  Stephan Poehlsen

Minutes for Q4

• DEV Projects

o  #850 IG CDAr3 Vital Signs X73 Representation (proposed for discontinuation to enable resource availability for FHIR resource project development – to be discussed in joint HCD-GAS meeting)

o  #595 IG HCD Comm. Messaging – to be discussed in joint HCD-mHealth meeting; Action item assigned to John Rhoads to investigate removal of this project from the HCD roadmap.

o  #1103 FHIR Resources – to be discussed in joint HCD-FHIR meeting

• Other Standards Updates

o  ONC/FCC/FDA

§  At ISO level, there is an initiative to address issues relating to standards that are provided by the originating SDO free of charge.

• For example, since HL7 v2.5 was balloted as an ISO standard, it is now provided for free by HL7, challenging the ISO business model of selling standards.
• This is the same with standards from CDISC, DICOM, IHE, etc.
• TC 215 looking at an approach to create meta-standard specifications that include normative references to these standards; providing a creative approach to getting an ISO P-member approval without going through the re-publishing activity
• This approach will be discussed in the upcoming Berlin meetings (October 6 week) and hopefully will be in place in less than a year.

§  Final report from FDA on FDASIA; FDA strongly considering HL7 and IHE as next round of recognized standards. Trying to allocate resources to participate in IEEE 11073 and IHE.

o  ISO TC215 JWG7

§  No update presented.

o  SNOMED-CT

§  VA has interagency agreement with NLM…mapping ~ IEEE 11073 670 codes to LOINC and SNOMED-CT

§  NLM MoU between VA

§  Meaningful use approved nomenclatures (LOINC and SNOMED)

§  Clarifications were provided on the scope of IEEE 11073 10101 Nomenclature and on the level of adoption of IEEE 11073 10101

§  Allan Lippitt and Ioana Singureanu solicited any reference/contacts regarding anesthesia work harmonizing IEEE 11073 and SNOMED in the past

§  List of the high-priority 100+ concepts from IEEE 11073 to be mapped to LOINC/SNOMED

Tuesday – Q1 September 16, 2014

Q1-Specific Participants

·  Recurring Participants from Q3 on Monday

·  Chi Tran

·  Paul Spadafora

·  Ioana Singureanu

·  Stefan Schlichting

·  Stephan Poehlsen

·  Scott Brown

·  Kathryn Bennett

·  Michael Faughn

·  Greg Staudenmaier

·  Masaaki Hirai

·  Sadamu Takasaka

Minutes from Q1

·  The Patent Policy, IP Policy, and the Anti-Trust Policy of the IEEE were reviewed with attendees.

·  HL7 Co-Chairs Meeting (T. Cooper/J. Rhoads/J. Garguilo)

o  Governance group for SAF

o  New look and feel for HL7 Web-site, effective Sep.23

o  HL7 Terminology Authority (HTA)

o  Consolidated PSS for FHIR – going forward

o  mHealth group considering medication administration project

o  US Realm Task Force: US affiliate for HL7 projects – centralized control of projects

o  Improved Help Desk

§  Glossary Management Session: www.skmtglossary.org

·  IEEE Updates (K. Bennett)

o  IEEE Update

§  PAR Statistics – 5 PARs due to expire in 2014; 24 open PARs

§  Ballot Highlights for P10101a

§  PAR Maintenance Recommendations

·  Extend 10101:

·  Administrative withdrawal for 10201; recommending appealing even though project is over 8 years old; Motion to withdraw and submit new PAR (Jan/Todd) 1 abstention; 15 for – motion approved.

·  Extend 20101

·  Extend 10413

·  Extend 10419

§  SASB Actions – 3 draft standards approved: 10424, 10425, 20601a

§  ISO TC 215 Update

·  4 published by ISO 10103, 10102, 10418, 10417

·  2 in Proof Review

·  2 requiring edits

·  2 to be submitted to ISO

·  K. Bennett to attend Oct. 2014 meetings in Berlin

o  IEEE P&P Discussion

§  Current sponsor P&P expires 12/31/2014 – Ken to create electronic ballot for membership to approve draft sponsor P&P.

§  Also need WG P&Ps – Ken working with Daidi to prepare

o  IEEE SASB Policy Change

§  Public Review via IEEE (aligns with WTO) – no impact to overall timeline for standard approval – FAQ webinar Q4 2014

o  Agreements

§  IEEE/HL7 SoU – renewal underway

§  IHE MoU – auto-renewal in August

§  IHTSDO MoU – currently being considered by IHTSDO

§  NIST Royalty Free Agreement – Addendum submitted to NIST for execution

§  Continua Collaboration Agreement - executed

§  Action: Kathryn to take action to contact Joe Lewelling/Hae Choe wrt creation of formal MoU (1702, 2800)

o  2014/2015 Meetings and Conferences

o  Alternative Publications

§  10101 Nomenclature

·  IEEE standards in database format proposal

§  10201 DIM

·  Digital Content

·  .pdf files from Prometheus

·  XML – IEEE

o  eHealth Strategy

§  Standards education

§  UDI Registry

§  RTLS- new development work (driven by VA); conceptual system model; info model – Action: Contact Monroe Patillo wrt IHE PCD MEM LS

o  Sponsorship – not reviewed

o  Elections for GC Vice-Chair; GC Treasurer; UL Secretary (Discussion)

Tuesday – Q2

Q2-Specific Participants

·  Recurring Participants from Q3 on Monday

·  Scott Brown

·  Kathryn Bennett

·  Michael Faughn

·  Greg Staudenmaier

·  Masaaki Hirai

·  Sadamu Takasaka

·  Tracy Rausch

·  Steven Foglietta

·  Kai Hassing (remote)

·  Clem McDonald

·  Stefan Schlichting

·  Stephan Poehlsen

Minutes from Q2

IEEE Updates

·  IEEE P&P Discussion (Ken Fuchs)

o  What is a P&P?

§  IEEE template

§  Need to submit update of General Committee P&P

§  Challenges for UL WG: Ken, Paul, and Jan to propose workable content - Action

o  Key Decisions

§  Leadership Structure: Chair/Vice-Chair and Secretary

§  Selection of Officers: All elected

§  Voting Rights/Membership: 2 consecutive rule

§  Sponsor meeting rules

§  Quorum:

§  Voting: majority rules; individual voting

o  Recommend email ballot to approve P&P: Action - Kathryn

·  Elections for GC Vice-Chair; GC Treasurer; UL Secretary (Discussion) – propose to hold after P&P approve. Decision is to enable Secretary to serve as Treasurer when need occurs. Action – Ken to run election for GC Vice-Chair.

ICE / OpenICE Update

·  General update (Tracy Rausch)

o  Device model being prototyped and tested – expect documentation to be released by Q1 2015

o  Stephen Foglietta to replace Tracy as representative from DocBox for 11073

o  Clinical implementations occurring in 2 different locations over the next 4 months

·  Review of discussions during DPI calls – not discussed

Other Standards Updates

·  AAMI/UL 2800 (Stan/Jan)

o  Overview of standards family to be reviewed during the Dec. 2014 F2F.

o  Implications to IEEE 11073 WG – follow-up during roadmap discussion

·  AAMI WSTF (Ken)

o  Overview of wireless strategy task force – focus on wireless coexistence of medical devices.

Tuesday – Q3

Q3-Specific Participants

·  Recurring Participants from Q3 on Monday

·  Scott Brown (GS1 US)

·  Kathryn Bennett

·  Michael Faughn

·  Greg Staudenmaier

·  Masaaki Hirai

·  Sadamu Takasaka

·  Stefan Schlichting

·  Stephan Poehlsen

·  Tracy Rausch

·  Steven Foglietta

·  Lori Dieterle

·  Tim McKay

·  Geoff Emory

Minutes from Q3

OpenSDC Update

·  General update (Stefan Schlichting)

o  Technical Overview

o  Clarification of current downloads

o  Beta04 to be released at end of Oct. 2014

o  BICEPs adaptation of the DIM over the last two months

o  Standardization Artifacts

§  DKE WG Standard 1000.8.03 meeting on Sep. 12, 2014

§  SDC – communication service profile

§  BICEPS – message information model

§  MDPWS – communication protocol specification

o  Standardization Proposal ( 3 separate PARs)

§  BICEPS MIM & Services 10207

§  Service Oriented Medical Device Exchange Architecture & Protocol 20701

§  Medical Device Profile for Web Services 20702

o  Propose Timeline (DKE WG prepared to develop standardization artifacts) – missing forming a ballot group (at least 4 weeks)

§  PAR 1st Draft Jan. 2015

§  Ballot Ready Draft May 2015

§  Draft Standard for Approval Ready Dec. 2015

o  Demonstrator at Paris HL7 Meeting 2015

o  Need 1 PAR for each document; S. Schlichting volunteers to begin preparation of these draft PARs

·  Review of discussions during DPI calls

o  Unclear if we are proceeding with a CNS project…

o  Stefan Schlichting appointed TG Chair.

·  Standardization Roadmap

o  A proposed roadmap has been embedded in the Draeger presentation content.

o  Further discussion on Friday for the roadmap planning session.

Open ICE/OpenSDC CNS Convergence Update – not discussed

o  Motion: Stefan is asked to prepare PARs as appropriate with respect to the OpenSDC – submit to IEEE SA by 10/20 (offered by Jan; seconded by John Rhoads): 2 abstentions ; 15 approved; 0 disapproved – motion passes.

o  Action: How does OpenSDC see revisions in the DIM – Action: Stefan Schlichting

o  Action: Creation of TG under UL WG to drive OpenSDC standard – Action: Jan Wittenber

Tuesday – Q4

Q4-Specific Participants

·  Recurring Participants from Q3 on Monday

·  Kathryn Bennett

·  Michael Faughn

·  Greg Staudenmaier

·  John Walsh

·  Shannon Gray

·  Ioana Singureanu

Minutes from Q4

Hosting HL7 Anesthesia WG (GAS)

·  Joint GAS-HCD Projects (John Walsh)

o  Preparing new PSS to split current work (#513) in 2 phases: Domain Analysis Model (DAM) and Implementation Guide

·  #513 CDA Anesthesia Record (John Walsh)

o  Project was kicked off in 2005; project needs to be re-constituted . HCD listed as co-sponsor in old project.

·  #850 VS in CDA (John Rhoads)

o  Sponsored by HCD. Status is that HCD getting resources to work on project. Is related to DAM.

·  #661 DCM4MD update (Ioana Singureanu)

o  Detailed Clinical Model

·  Motion from Ioana to permit enhanced model for DCM candidate attributes to be derived from standard terminology (SNOMED CT and IEEE 11073-10101) (seconded Todd Cooper); abstain - 3, disapprove - 0, approve - 9.

Wednesday – Q1 May 7, 2014

Q1-Specific Participants

·  Recurring attendees from Q3 on Monday

·  Kathryn Bennett

·  Michael Faughn

·  Greg Staudenmaier

·  Stefan Schlichting

·  Stephan Poehlsen

·  Chi Tran

·  Paul Knapp

·  David Hay

·  Masato Tanaka

·  Scott Brown

·  Leslie Tompkins

·  Ioana Singureanu

·  Laurie Deiterly

·  Brian Reinhold

·  Christian Hay

·  Doug Pratt

Minutes from Q1

IP / Patent Policy Review

Welcome & Introductions

·  Todd Cooper chaired pre-meeting and provided overview and a rationale for this session – FHIR for alert communications and FHIR for some level of remote of control.