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Page 1:  · Web viewChicago, Illinois See meeting documents posted @  Monday – Q3 September 1 5, 2014 Recurring Participants John Garguilo (NIST) john.garguilo@nist.gov

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) [email protected] John Rhoads (Philips) [email protected] Stan Wiley (Draeger) [email protected] Paul Schluter (GE) [email protected] Jan Wittenber (Center for Medical Interoperability) [email protected] Todd Cooper (Center for Medical Interoperability) [email protected] Ken Fuchs (Center for Medical Interoperability) [email protected] Masato Tanaka (Nihon Kohden) [email protected]

Q3-Specific Participants

Catherine Chronaki (HL7 Foundation) [email protected] Geoff Emory (Graphy) [email protected] Stefan Schlichting (Draeger) [email protected] Stephan Poehlsen (Draeger) [email protected] Scott Brown (GS1 US) [email protected] Recurring participants

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

Gora Datta (Cal2Cal) [email protected] Kathryn Bennett (IEEE) [email protected] Leslie Tompkins (FDA CDRH UDI) [email protected] John Walsh (Partners Healthcare) [email protected] Paul Knapp (ITS , Chair of UDI Task Force) [email protected] Chi Tran (Center for Medical Interoperability) [email protected] Michael Faughn (Prometheus Computing) [email protected] Joe Good (Center for Medical Interoperability) [email protected] Darryl Mellott (Center for Medical Interoperability) [email protected] Paul Spadafora (Center for Medical Interoperability) [email protected] Greg Staudenmaier (VA) [email protected] David Hay (FMG) [email protected] Christian Hay (GS1) [email protected] Tracy Rausch (DocBox/MDPnP) [email protected] Steven Foglietta (DocBox) [email protected] Kai Hassing (Philips) [email protected] Sadamu Takasaka (HL7 Japan) [email protected] Masaaki Hirai (Nihon Kohden) [email protected] Ioana Singureanu (VA/Eversolve) [email protected] Alan Lippitt (IHE/HL7) [email protected] Clem McDonald (NLM) [email protected]

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Tim McKay(Kaiser Permanente) [email protected] Lori Dieterle (Kaiser Permanente) [email protected] Shannon Gray (Softarex Technologies) [email protected] Brian Reinhold, (Lamprey Networks/Continua) [email protected] Ewout Kramer (Furore) [email protected] Geoff Emory (Graph 8) [email protected] Mike Henderson (OSEHRA) [email protected] Dave Shaver (Corepoint) [email protected] Brad Arndt (Cerner) [email protected] Doug Pratt (Siemens) [email protected] Havar Edidin (Edidin Group) [email protected] Chris Doss (North Carolina A&T) [email protected] Matt Graham (Mayo Clinic) [email protected] Harry Rhodes (AHIMA) [email protected] Evelyn Gallege (ONC) [email protected] Rob Snelick (NIST) [email protected] Sandra Martinez (NIST) [email protected] Norman Jones (ISO TC 121/SC4) [email protected]

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, Work-plan, Projects - Cross-border support for electronic exchange of patient data sets; Anti-lope 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

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Q4-Specific Participants

Recurring Participants from Q3 on Monday Chi Tran Paul Spadafora Ioana Singureanu Stefan Schlichting Stephan Poehlsen

Minutes for Q4

DEV Projectso #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 Updateso 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

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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 SAFo New look and feel for HL7 Web-site, effective Sep.23o HL7 Terminology Authority (HTA)o Consolidated PSS for FHIR – going forwardo mHealth group considering medication administration projecto US Realm Task Force: US affiliate for HL7 projects – centralized control of projectso 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

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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

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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 2015o Stephen Foglietta to replace Tracy as representative from DocBox for 11073o 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) [email protected] Kathryn Bennett Michael Faughn Greg Staudenmaier Masaaki Hirai Sadamu Takasaka Stefan Schlichting Stephan Poehlsen

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Tracy Rausch Steven Foglietta Lori Dieterle Tim McKay Geoff Emory

Minutes from Q3

OpenSDC Update General update (Stefan Schlichting)

o Technical Overviewo Clarification of current downloadso Beta04 to be released at end of Oct. 2014o BICEPs adaptation of the DIM over the last two monthso 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 2015o 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 Roadmapo 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 Schlichtingo Action: Creation of TG under UL WG to drive OpenSDC standard – Action: Jan Wittenber

Tuesday – Q4

Q4-Specific Participants

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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

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Doug Pratt

Minutes from Q1

IP / Patent Policy ReviewWelcome & 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.

New introductions were made.

FHIR Prep / Update from PHX activities Presentation from Chi Tran (C4MI)

o Proposed new resources for device configuration Two approaches (resources v profile) for modeling MDS, VMD, Channel and Metric

o Extended the observation resource to include traceability infoo Profiles is new (alertlist profie profile)o Collaboration between DM, Ewat, Graham and C4MI on proposalo Current DeviceObservationReport resource in current DSTU will be removed – results from work.o DM and EPIC will do prototyping with C4MIo Re-designed Device Alert

New resource for DeviceAlert evidentiaryData v relatedObservation

o Creation of alert report simulator

FDA UDI Discussion

Update @HL7 v2.8.2 (Todd Cooper)o Change Request proposal submitted to HL7 Orders & Observations Work Group; will go to ballot

in Oct. 2014, targeting version 2.8.2o PRT segment in Chapt. 7 and adds UDI content in PRT-10 field.o Adding PRT fields 16 – 21 for discrete values if field 10 is not available.o Discussion on implementation guidance documento IHE PCD already using PRT 10 for device identifier. More detailed presentation @ IHE PCD F2F

in Boca Raton, FL in Oct. 2014o Looking at reducing the number of parseable fields.

GS1 UDI Formatting (Christian Hay)o NOTE: This discussion addressed an issue raised by Stephan Poehlsen (Draeger) regarding

contradictions in the draft UDI formatting specifications, especially from GS1.o GS1 human readable format uses parentheses;o Parentheses have been replaced with braces.o Creating change request to remove parentheses throughout GS1,

IEEE EUI 64 (Todd Cooper/Christian Hay/Paul Knapp/Leslie Tompkins)o NOTE: The question of using an IEEE EUI-64 identifier as a type of UDI was raised recently at a

GS1 conference in Europe, and has particularly been a point of discussion in IEEE and the PHD group.

o UDI has been in discussion for more than 10 years.o Medical devices often use EUI-64 as an instance identifier

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o This is included in the ISO/IEEE 11073 specifications (especially PHD devices), it is called out in the IHE PCD TF-2 specification, and is also specified as an HL7 data type.

o EUI-64 identifies an ‘instance’ of a device on the network; UDI identifies the device at the model/version level

EUI-64 vs UDI – they are applied at different levels of granularity EUI-64 is an electronic address and represents only one aspect of a medical device Could EUI-64 be viewed as a production identifier (PI) and included in the barcode??

EUI-64 may change during the lifecycle of the device.o There is an industry need/use case to connect the network identifier (IEEE/EUI-64) to the DI/UDI

There could conceivably be 1,000’s or more of EUI-64 per UDI, for any given device; EUI-64/MAC address can be changed during the lifecycle (MAC is a type of EUI …

typically a 40-bit identifier); UDI/GUDID represent static device information. While the use case is compelling, UDI/GUDID is not a good solution. Temporary solution: HL7 V2 2.8.2 – PRT10 will be used to capture both UDI and EUI-

64 identifiers; they can be transmitted together in the same message.o UDI is addressing a Supply Chain issue. There is/was a variety of identification solutions – and

there is still a number of “non-identified” devices, which at the end puts patient safety at risk.o UDI requires 3 elements, one of them being the capacity to read a semantically formatted

identification from a data carrier (currently a bar code, but that could evolve to RFID for example).

o UDI requires devices to be identified regardless to their particular characteristics. A bandage, a hip implant and an electronic implantable device has to be identified by using the same schema / pattern.

o There are devices that are to be identified by class (product identification, or batch identification), and others that are to be identified by instance (electronic implantable devices, for example).

o Therefore regarding the question raised about the pertinence to use EUI-64 to identify an electronic device in the context of UDI, this does not correspond to UDI’s scope (which is supply chain), and as well does not correspond to GUDID capacities (which is to record classes and not instances). But it is worth considering GUDID including a boolean information letting know if the device has an IUE64 or not.

o NOTE: Users databases (SUDID) might include the IUE64 information. But this is out of UDI regulation.

Wednesday – Q2

Q2-specific Participants

Recurring attendees from Q3 on Monday Kathryn Bennett Michael Faughn Stefan Schlichting Stephan Poehlsen Chi Tran Masato Tanaka Brian Reinhold Ewout Kramer Doug Pratt Mike Henderson Dave Shaver Brad Arndt Ioana Singureanu Geoff Emory Havar Edidin

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Minutes from Q2

Hosting FHIR Status Update / Ballot Resolution

o Chi Tran’s presentation review Feedback on 2 new resources: if MDS, VMD, Channel, and Metric are always collected

in a hierarchy, then recommendation is not to make all of them a resource, and instead to embrace approach 2 where these are MDS, VMD, and channels are profiles, while Metric is a resource. Need use cases to help drive decision.

Feedback on new observation profile: Feedback on new resource Device Alert: Feedback on new AlertList profile: Next steps for FHIR WG support Need input to FHIR WG by 29 Sept. 2014 Follow-up webexs for model reportings and expanded prototyping

X73=> FHIR Update (incl. Connectathon)o Not covered

Wednesday – Q3

Q3-specific Participants

Recurring attendees from Q3 on Monday Kathryn Bennett Michael Faughn Stefan Schlichting Stephan Poehlsen Chi Tran Masato Tanaka Brian Reinhold Paul Spadafora Kai Hassing (remote) Joe Good Darryl Mellott (remote) Doug Pratt

Minutes from Q3

Standards Prototyping Update Center4MI PIM Project update (Paul Spadafora)

o Prototyping efforts around 11073 and IHE PCDo PIM – Protocol Interoperability Manager

A software framework that provides a simple API for software developer integration Supports multiple standards-based communication protocol modules Provides a simple transport layer interface Intended for medical device manufacturer use of several libraries: MDIP, Protocol, Discovery

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PIM will be released as open source – seek 1st public demonstration at HIMSS (4/2015) – New Directions in HIMSS showcase.

Terminology Preview (P. Schluter) Resp/Vent Nomenclature – modeling dynamic variables (IEEE 11073-ISO SC4 19223-IHE PCD RTM JWG

D3F Agreement from a Synergy perspective. 65 pages in draft IEEE 10101a

Wednesday – Q4

Q4-specific Participants

Recurring attendees from Q3 on Monday Kathryn Bennett Michael Faughn Stefan Schlichting Stephan Poehlsen Brian Reinhold Doug Pratt Leslie Tompkins Chris Doss Matt Graham Harry Rhodes Gora Datta Evelyn Gallege

Minutes from Q4

Hosting Mobile Health Update

o Working on projects with FHIR

Presentation from North Carolina A&To Overall vision

Mobile health interoperabilkity Focus on home environment and others outside of hospital Devices/Aggregation/EH R/HIS

o Faculty (6)o Lab Overview

Patient Data Simulation Advanced Geri Manikin Pronk Technologies SimCube

Mobile Platforms Medical Devices HIS

o Projects (Application development focus) Normalized Data for EHR Systems Integrating FHIR with .NET

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Captured Standardized Medical data Compilation Integrating FHIR with OpenMRS Context-Aware Remote FHIR Frame

mFHAST: mobile Framework for SMS Technologies within rural health an LMIC healthcare settingso clinical reminderso community health mobilizationo health educationo public health and emergency notificationso surveillance and tracking

Patient Medication Managemento Use of FHIR to support patient medication managemento Initial use cases: patient reminder to refill of medication Rx; patient reminder to renew Medication

Rx; Patient management of oral medications; patient reminder to take medications

Review mHealth use cases needing MD Interop.o Will place use cases from India and from US on wiki and solicit feedback from HCD

Thursday – Q1 September 18, 2014

Q1-Specific Attendees

P. Schluter J. Rhoads J. Garguilo J. Wittenber S. Wiley T. Cooper M. Faughn S. Brown M. Tanaka S. Schlichting S. Poehlsen D. Pratt

Minutes from Q1

IP / Patent Policy Review

Welcome & Introductions & Announcements John Garguilo was re-elected as HL7 Co-chair Use of new HL7 room scheduling tool Plan for San Antonio meeting Mon. Q1 to Thursday Q4 Proposing meeting with GAS on Wednesday Q3

NIST Tooling (John Garguilo): IHE PCD v2 Tooling, RTMMS

o Nicolas and John on HL7; Michael on DIM

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o HL7 V2 (2.6) IHE-PCD Validation Tools Pre-Connectathon Tools

IHE cycle 9 updates RTMMS

Awaiting for 10101a upates IGAMT – Authoring Tool (Rob Snelick)

Placed on hold; will re-start to address conformance profiles Test case authoring tools to deliver consistent requirements

DIM Overview Well vetted model for the DIM and easily updateable. Can generate documentation from models to automatically generate the standard

– provided to IEEE for feedback Japanese Connectathon under way this week IEEE/NIST Royalty Free Agreement IHE Fall F2F (Oct 20-24) Boca Raton UDI is targeted for IHE Vol. 3 – future CP discussion in Boca Raton RTMMS

50 contributing organizations, increasing. DIM Tooling Update and Demo (Michael Faughn)

o The UML model is the standardo Historical review of DIM tooling evolutiono Review of current MyDevice capabilityo Near-Term Goals

Improved user friendliness Connect MyDevice to RTMSS Import/Export of device profiles Alert user when and where a device profile is not in compliance with the DM and/or

nomenclature Will add Model Manager and Standards Document Manager Facilitate user and group level access to individual device profiles in MyDevice Produce Conformance statements Produce much improved pdf of DIM

o Detailed Tool demo

Thursday – Q2

Q2-Specific Attendees

K. Fuchs P. Schluter J. Rhoads J. Garguilo J. Wittenber S. Wiley T. Cooper S. Martinez S. Brown M. Faughn M. Tanaka S. Schlichting

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S. Poehlsen D. Pratt R. Snelick K. Bennett

Minutes from Q2

Revised HL Decision-Making Rules Relationship to HL7 Consensus voting (66%) Ballot Group Balance Rationale for Recording of Meeting Motion: to adopt new decision-making rules: by Todd ; Garguilo 2nd ; no opposition or abstentions;

NIST Tooling – IGAMT Goal – facilitating the preparation of the implementation guides Currently covers HL7 V2 Test Case Management Tool (TCAMT) takes IGAMT output and produces test cases Has been used to produce Meaningful Use artifacts Demo

DIM Revision: Overview

o Growing demand on DIM due to IHE PCD, OpenSDC, OpenICE, FHIR, 11073 PHDo Need principals to freeze assumptions of what is in common; what is not; what is critical in the

near-term. o Decision to prepare strategy for DIM content update prior to next meeting

Pump Update: Overview of Infusion Pump Sematics

o Summary of Key Proposed Changes Add source label, channel mode, active channel Remove or constrain use of Pump mode Expect alignment at the Boca Raton IHE PCD Meeting

Impact on 10101A – to be considered after on day 1 of the IHE PCD F2F meeting in October.

Thursday – Q3

Q3-Specific Attendees

K. Fuchs P. Schluter J. Rhoads J. Garguilo J. Wittenber S. Wiley K. Bennett

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M. Tanaka S. Schlichting S. Poehlsen C. Tran E. Kramer M. Faughn

Minutes from Q3

HL7 FHIR Collaboration Continuation: Discussion on trade-offs for Approach 1 and Approach 2 Initial preference for Approach 1 (Containment) Need a consider definition of VMO (6.3.1 and 7.3.3.1) C. Tran and S. Schlichting to collaborate in the development of additional HL7 HCD pilot resources.

Thursday – Q4

Q4-Specific Attendees

K. Fuchs P. Schluter J. Rhoads J. Garguilo J. Wittenber S. Wiley S. Schlichting S. Poehlsen M. Faughn M. Tanaka K. Bennett N. Jones (Remote)

Minutes from Q4

Terminology: 11073-10101a Amendment

o Review Statuso Have mappings from ISO CD 19233o Resp/Vent/Anesth – 97 terms (Near Comp)o Other Parameters – 57 terms (Comp)o ACM Attrs & Enums RTM and ACM Compo WCM Attrs &Enums Define new SCADA attr or use aECG?o Infusion Terms In process using NIST RTMMSo Units RTM and NIST RTMMS ready to publisho MDS/VMD/Chan List compiled; awa final pump terms

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o PHD Include new PHD MDC_PART_DIM and MDC_Part_SCADA termso Goal: draft standard ready by end of Oct, 2014

Remaining Actionso Add final BTSD breath rateo Merge in infusion pump section if readyo Add new WCM waveform attributeso Any new MDS/VMD/Chan identifiers from IHE PCDo Incorporate other recommendations

Detailed draft standard review

Friday – Q1 September 19, 2014

Q1- Specific Attendees

K. Fuchs P. Schluter J. Rhoads J. Garguilo J. Wittenber S. Wiley S. Schlichting S. Poehlsen

Minutes from Q1

IP / Patent Policy Review

Welcome & Introductions

Possible New Standards Work: Optimized Association

o This is in the 20101 base standard; proposing to modify this content in this standard (Jan Wittenber). Change the encoding methodology.

o WSTF has been discussing profiling IEEE 802.11.

SW Connect Indicationo RS232 IrDA profiles supports a connect indication. Seek vendors to place this capability

back into legacy devices via software.o This feature could be included in 30200 as an addendum or in the proposed CNS

standard.o Need a protocol data unit to support connect indication.o In OpenSDC, the transport is aware of the connection via UDP multicast discovery

message to perform this function. WSDS.o May need to submit a PAR for this depending on membership interest.

CNS Convergence/OpenSDCo 3 layer protocol call services in OpenSDC that do not easily map into CNS

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o CNS was conceived to be mostly transport with a common API to the upper layers. o Attempting to find commonality between OpenSDC and PHD for upper layers API.o This is different from the PMI project at C4MI. This project is interfacing a manager and

agent with multiple direct data links. Possibility for this API to become a candidate for a future standard.

o For San Antonio meeting update of OpenSDC, will have presentation on risk control measures embedded within the protocol.

802.3, 802.11, etc. profiles

Specializationso No active standards work here, tooling work is in process to create specialized models.o This is also being pursued in IHE PCD.o Relevant to containment tree content.o 11073-103xx series of standards…would need capabilities to support remote controls ….

current elements to support remote control include draft 20301, content in the DIM, etc.o Need NIST containment model working to support this effort.

Othero PHD devices models in the containment treeo Proposed Project Preferences

High OpenSDC based Standards Optimized Association(modify 20101) Pump and other specializations

Medium Optimized Association Remote Control

Low CNS 802.3, 802.11, etc. SW Connect Indication for legacy RS232

Standards Roadmap Planning: HL7 HCD 3 Year Plan

o FHIR Supporto Joint Projects with Anesthesia and mHealtho HL7 v2.9 Message Model (O&O)o #595 – removed

IEEE 11073 Plano See Q3 work preference ordering

Open itemsNone

Adjourn Meeting

Motion advanced by Garguilo, seconded by Schluter; no absentions or objections.

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