Health Care Devices (DEV) WG MTG 2012-05 Vancouver

Meeting Information

HL7 Health Care Devices (HCD / DEV) and IEEE 11073 Medical Device Communications General Committee Meeting Minutes Location: Junior Ballroom Salon A, Sheraton Vancouver Ball Centre, Vancouver, BC		Date: 2012-04-14 Time: Q1
[mark x if on the conference call, or regrets]	[In this section, list those on the conference call]	[In this section, record attendee affiliation to identify preponderance of influence; indicate those guests that are not members of the WG.]
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Quorum Requirements Met: Yes/No
quorum achieved as defined in the Work Group Decision Making Practices?

Agenda

Agenda Topics

1. Agenda review and approval (Suggestions or additions to and acceptance of agenda)
2. Approve previous meeting minutes
3. (Other topics; e.g. if voting on ballot reconciliation item - see minutes)
4. (If projects or other actions proposed for approval are on the agenda, they can be marked in bold and represented as)
   • Motion:

Supporting Documents

1. List any/all documents to be provided at the meeting, including their URL if applicable. For a WGM, indicate if hardcopies will be supplied or attendees should print off copies themselves

Minutes

Minutes/Conclusions Reached:

1. (Suggestions or additions to and acceptance of agenda)
2. (One efficient method used for meeting minutes is approval by general consent, of non-controversial topics like minutes when there are no corrections: “You have received the minutes. Are there any corrections to the minutes? Hearing none, if there is no objection the minutes are approved as posted.”)
3. (Discussion on agenda topic 3; If voting on ballot reconciliation item:
   Agenda business is ballot reconciliation? Yes / No
   Ballot reconciliation posted to ballot desktop? Yes / No
   If no, where is ballot reconciliation posted? ________________)
   if voting on ballot reconciliation, please indicate the votes are documented elsewhere, and note the item numbers from the spreadsheet, but you may document the actual vote tallies in the ballot reconciliation spreadsheet.
4. Discussion on agenda topic 4; Motion (if amended) can be retyped in bold. Discussion on motion back to regular type. Vote on Motion in bold Identify the vote distribution across affirmative, negative, or abstention; numbers in format “for/against/abstain”, or ‘unanimous’.
5. Discussion on agenda topic 5; if no conclusion reached and issue tabled to next meeting, add to ‘next meeting’ items below. If action items are identified, add to ‘Actions’ below.
6. Adjourned <hh:mm am/pm> <timezone>.

Meeting Outcomes

Actions (Include Owner, Action Item, and due date) .

Next Meeting/Preliminary Agenda Items .

© 2012 Health Level Seven® International. All rights reserved.

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MONDAY - Q1 Reviewed and approved agenda 2012-JAN DEV WG Minutes / Action Items Review All Action Item topics captured with agenda items later this week

HL7 Mission / Charter - 3 Year Plan - SWOT Initial review of current statements / documents Mission statement "enterprise level" - means different things to different people; possibly used by some to "exclude" < what exactly???> ; ACTION: (Hobbs) Provide a proposal for changing the wording of the first line of the Mission statement (starting "To facilitate the integration of health care device information at the enterprise level by ...") CLSI - Is this still an active area of coordination ACTION: (Todd) contact CLSI to get an update w.r.t. their activity in this area

MONDAY - Q2 (Andrez) CLSI POCT RF-ID & 2D Bar code; mechanical optical characteristics + semantic content; new project in CLSI Lab Automation Chapter 13 (HL7) IHE & CLSI working on an analyzer profile within LAB Domain; LAW profile (lab analyizer workflow)

DEV WG Liaison groups - external WHO eHSCG - ACTION: check with Melvin ACTION: Consider adding ASTM F27, AAMI, extend CDRH to include MDICC IHTSDO (ACTION: Christoph to assess) LOINC (NLM/Regenstrief) - ACTION: Christoph to assess ACTION: Follow up w/ Paul Schluter re. LOINC "harmonization" (per Cambridge 2010 Fall meetings) DICOM

HL7 Internal Relationships Consider adding Conformance WG Tooling WG ACTION: Garguilo to coordinate

HL7 DEV WG Charter Reviewed the current items in the Charter statement IDC - Should stay within the Charter of the DEV WG Consider adding: Model driven definitions related to POC / PHD devices DCM4MD (Patient Care ...) ACTION (Rhoads) Check HL7 project for DCM4MD ... Command & Control: <what do I say here if anything???>

SWOT Strengths Weakness Security WG engagement - should there be more engatement Opportunity Mobile Health WG engagement: FIHR WG? Threats

Mobile Health WG Forming Forming - Scope, Mission, Charter etc. Where did this come from? Many questions aimed at HL7 w.r.t mHealth engagement march 16th first TCon to kick off consideration Presentations on HL7 server ... wiki page Agenda: Interim co-chair elections Liaisons (include DEV WG) 3-Year Plan Decision Making Process Charter ID data standards & functional requirements ID & promote terminology for interoperability Coordinate & cooperate with other groups With DEV WG: Clear touch points w/ PHD devices Definition of mHealth? <see definition from glossary - Rhoads provides reference> Specifically "Mobile Health Device" focused ... need to clarify in Scope w.r.t. DEV WG Scope Need to delineate "use cases" to clarify the class of applications that may be the focus of the group Is this mostly a "presentation" application set Where does telehealth fit within HL7 today? Historically? ACTION ?: (Co-Chairs?) Determine whether this mHealth WG would require updating the definition of "health care devices" definition, or does this need to wait until the mHealth group figures out what it's charter is?

DCM4MD General Update Jan provided a general history / origin of the project DCM around ventilator usage, was created and has been taken to ballot - comments being resolved? Thursday Q4 will review specific work in this area

MONDAY - Q3

IEEE 11073 Update (Bennett) <see slides> 11073 PAR approach ACTION: (Wittenber) Open Amendment PAR ACTION: (Wittenber) Modify current Revision PAR to "restructure standard" , consider ... Withdraw current Revision PAR Submit new PAR for an Overview & Arch Document Plan to submit a new PAR for a DB standard - ONCE THE PROCESS IS FINALIZED BY IEEE; Kathryn to report @ September 2012 Baltimore meetings Note: "7x" annual reviews: 4 F2F RevCom/year + 3 TCon meetings 10102 aECG Paul should have a complete draft document around June 7th Ballot Invitees: Harry Solomon (DICOM), Barry Brown (RCRIM), ... HRS? MoU's IHTSDO - Changes in senior management @ both org's stalled renewal ... will be resubmitted soon HL7 - Up for renewal soon ... will confer with HL7 Staff (Karen V.) regarding this process and timing RTMMS: IEEE Senior Management considering making access to RTMMS freely available (!!!) Final decision by 15 June 2012 - possible stakeholder meeting in June at NIST Open questions include governance of who gets to participate in which role Working Group Policies and Procedures need to be checked - should PHD maintain separate ones? TBD ACTION: (Wittenber / Kirwan) to determine if there can be a single harmonized set of working group PnP's, to report back summer 2012 "Ecosystem Mapping Session: Discussion w/ Melvin @ Piscataway in April; 13 action items identified Potential usage of the ISO DB process model Participation @ ITU-WHO Workshop e-Health Standards & Interoperability, Geneva, 26-27 april 2012 ... IEEE participation DICOM Request for nomenclature terms: After 2 years, IEEE processed copyright request for -10101 ecg value sets; -10102 is "on hold" until published AED QoS: Looking at an "AED" (defib) Quality of Service (?) part No current devices support this type of 911 calling (per those in the room who are familiar with these systems) ACTION: (Kathryn) to follow up with 802 contact <name?> to convene a discussion about the possible opportunities in this area EMBS conference in San Diego ... plan on an 11073 presentation? ACTION: (Kathryn) to contact Elliot Sloane to determine if he can Consider whether EMBS is the correct society home for 11073; proposed is "CommSoc" IEEE-SA @ HIMSS 2013 ... will have a booth ? "South by Southwest Interactive 2013" - Should there be an IEEE-SA presence? 11073 session IEEE-SA SASB & Committees: Never been any 11073 representation on these committees

MONDAY - Q4

ICE Update (Rausch) <see slides> General discussion around clarification of points on slides For "Plan Going Forward" ... it will be announced in the next few months exactly what those steps are, which includes a restart of the "formal standards work" General discussion of what will be specified in the ASTM specifications (clinical scenario level, technical implementation level) and how conformance can be tested, also at what point will the deliberations on the standards be visible outside the small working group

IEEE Document Numbering Issue For example, Wittenber is proposing 11073-10301-Gx for various "flavors" of an infusion pump device specialziation ACTION: (Kathryn) Will check for options.

ISO TC215 WG7 Resolutions Report 11073-10422 is STILL AN ACTIVE PROJECT!!! 11073-10417 published, being amended, when amended to be submitted for Fast Track 11073-10418 INR monitor - ISO asks that it be submitted for Fast Track New items to be added to work program -10413, -10419, -10441, -10442, -10443 Daidi Zhong: -10406 should be in this list - K. Bennet: there is a resolution on this in Finland meeting

TC215 WG7 being reorganized back into WG2 (where it formerly was)

IEEE 11073 Personal Health Devices work group update (Daidi Zhong) - see presentation More members and institutions Conference calls changed to Thursday 8:15 Pacific 4 new PARS: Resp Rate, Urine Analysis, Sleep Apnea Breathing.., Sleep Quality Monitor

-20601 revision in progress -10411 in 2nd rev. P11073 -10419 - renewed interest from several members, now going forward P11073-00103 PHD over iew recommended for approval by NesCom New PARs approved -10423 Sleep Quality Monitor - team is clarifying scope, might need to be split into two PARs -10424 Sleep Apnea Breathing Therapy Equipment. -10425 Continuous Glucose Monitor

No progress on P11073-10413 (Respiration) , -10404 (pulse oximeter) currently lacking lead authors

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