22 nd meeting of: iso/tc215 health informatics wg7 devices, jointly with ieee embs 11073, and hosted...

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22 ND MEETING OF: ISO/TC215 — HEALTH INFORMATICS WG7 — DEVICES, Jointly with IEEE EMBS 11073, and hosted by HL7 Health Care Devices (DEV) WG, at the HL7 Working Meetings Kathryn Cush Program Manager, Technical Process Development IEEE-SA 21 August 2009 Atlanta, GA

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Page 1: 22 ND MEETING OF: ISO/TC215 HEALTH INFORMATICS WG7 DEVICES, Jointly with IEEE EMBS 11073, and hosted by HL7 Health Care Devices (DEV) WG, at the HL7 Working

22ND MEETING OF:ISO/TC215 — HEALTH INFORMATICS WG7 — DEVICES, Jointly with IEEE EMBS 11073, and hosted by HL7 Health Care Devices (DEV) WG, at the HL7 Working Meetings

Kathryn CushProgram Manager, Technical Process DevelopmentIEEE-SA 21 August 2009Atlanta, GA

Page 2: 22 ND MEETING OF: ISO/TC215 HEALTH INFORMATICS WG7 DEVICES, Jointly with IEEE EMBS 11073, and hosted by HL7 Health Care Devices (DEV) WG, at the HL7 Working

IEEE Status

Page 3: 22 ND MEETING OF: ISO/TC215 HEALTH INFORMATICS WG7 DEVICES, Jointly with IEEE EMBS 11073, and hosted by HL7 Health Care Devices (DEV) WG, at the HL7 Working

RevCom/NesCom Submittals

• September 2009 – None

• December 2009 - Determine based on 5 year maintenance review this week

Page 4: 22 ND MEETING OF: ISO/TC215 HEALTH INFORMATICS WG7 DEVICES, Jointly with IEEE EMBS 11073, and hosted by HL7 Health Care Devices (DEV) WG, at the HL7 Working

Reaffirmations• 111073-30300-2004 Health informatics —

Point-of-care medical device communication —Part 30300: Transport profile — Infrared wireless (IEEE/ISO)

• Invitation extended to 24 Aug 2009 to balance ballot pool• Pool remains out of balance • Academic=1• General Interest=23 (74.19%)• Gov/Mil=1• Producer=3• User=3• Total = 31

Page 5: 22 ND MEETING OF: ISO/TC215 HEALTH INFORMATICS WG7 DEVICES, Jointly with IEEE EMBS 11073, and hosted by HL7 Health Care Devices (DEV) WG, at the HL7 Working

– 11073-30200-0 Health informatics — Point-of-care medical device communication —Part 30200: Transport profile — Cable connected (IEEE/ISO) Invitation terminated Requires modification

– Invoke IEEE & ISO processes for modification Amend to cope with new capability, retaining

backward compatibility Discussion regarding amendment to be conducted

this week Target IEEE & ISO submissions

***IEEE before 10/19/09***

Reaffirmations Con’t.

Page 6: 22 ND MEETING OF: ISO/TC215 HEALTH INFORMATICS WG7 DEVICES, Jointly with IEEE EMBS 11073, and hosted by HL7 Health Care Devices (DEV) WG, at the HL7 Working

Ballots in Progress– P11073-30400 Standard for Health

Informatics–POC Medical Device Communication–Interface profile-Cable Ethernet (ISO/IEEE) Comment resolution (ballot closed 6 Mar 2008)

– Malcolm Clarke elected LL WG Chair

– P11073-10472 Standard for Health informatics - Personal health device communication -Device specialization – Medication Monitor Comment resolution 1 (ballot closed 30 Jul

2009)

Page 7: 22 ND MEETING OF: ISO/TC215 HEALTH INFORMATICS WG7 DEVICES, Jointly with IEEE EMBS 11073, and hosted by HL7 Health Care Devices (DEV) WG, at the HL7 Working

Ballots in Progress Con’t.P11073-10420 Standard for Health informatics - Personal health device communication - Device specialization - Body composition analyzer– Invitation (closing 10/17/2009)

P11073-10421 Standard for Health informatics - Personal health device communication - Device specialization € Peak expiratory flow monitor (peak flow)– Invitation (closing 10/17/2009)

Page 8: 22 ND MEETING OF: ISO/TC215 HEALTH INFORMATICS WG7 DEVICES, Jointly with IEEE EMBS 11073, and hosted by HL7 Health Care Devices (DEV) WG, at the HL7 Working

ISO Joint Development ProjectsIEEE 11073-10404-2008, Standard for Health Informatics - Personal Health Device Communication - Device Specialization - Pulse Oximeter (sent 12 May 2009)IEEE 11073-10407-2008, Standard for Health Informatics - Personal Health Device Communication - Device Specialization - Blood Pressure Monitor (sent 12 May 2009)IEEE 11073-10408-2008, Standard for Health Informatics - Personal Health Device Communication - Device Specialization – Thermometer (sent 19 Jan 2009)IEEE 11073-10415-2008, Standard for Health Informatics - Personal Health Device Communication - Device Specialization - Weighing Scale (sent 19 Jan 2009)IEEE 11073-10417-2009, Standard for Health Informatics - Personal Health Device Communication - Device Specialization - Glucose Meter (sent 12 May 2009)IEEE 11073-10471-2008, Standard for Health Informatics - Personal Health Device Communication - Device Specialization - Independent Living Activity Hub (sent 19 Jan 2009)IEEE 11073-10472 - Standard for Health informatics - Personal health device communication -Device specialization – Medication Monitor (sent 20 April 2009)IEEE 11073-20601-2008, Standard for Health Informatics - Personal Health Device Communication - Application Profile - Optimized Exchange Protocol (sent 19 Jan 2009)

Page 9: 22 ND MEETING OF: ISO/TC215 HEALTH INFORMATICS WG7 DEVICES, Jointly with IEEE EMBS 11073, and hosted by HL7 Health Care Devices (DEV) WG, at the HL7 Working

ISO Joint Development Projects Submitted for Joint Development under the ISO/IEEE PSDO Cooperation Agreement (these documents are within the scope of ISO TC215)

Discussions with ISO to use combined front matter and IEEE template for content OK in principle; still awaiting final decision from ISO

ISO Joint Development Projects Con’t.

Page 10: 22 ND MEETING OF: ISO/TC215 HEALTH INFORMATICS WG7 DEVICES, Jointly with IEEE EMBS 11073, and hosted by HL7 Health Care Devices (DEV) WG, at the HL7 Working

Sponsor P&Ps– Recommendations From 17 March 2009

AudCom meeting Mentors: Gary Robinson/Chuck Powers Revision must be completed and submitted as

soon as possible FINAL DUE FOR DECEMBER MEETING BY

OCTOBER 19 2009

Page 11: 22 ND MEETING OF: ISO/TC215 HEALTH INFORMATICS WG7 DEVICES, Jointly with IEEE EMBS 11073, and hosted by HL7 Health Care Devices (DEV) WG, at the HL7 Working

Working Group P&Ps

To be completed & approved by December 31, 2010Template including required text availableWG P&Ps template to be reviewed by Sponsor to coinside with Sponsor P&PsDevelopment, submission to AudCom, etc. to be outlined by SponsorStay tuned!

Page 12: 22 ND MEETING OF: ISO/TC215 HEALTH INFORMATICS WG7 DEVICES, Jointly with IEEE EMBS 11073, and hosted by HL7 Health Care Devices (DEV) WG, at the HL7 Working

5 Year Maintenance Items– 11073-60101 NEW– 11073-20301 NEW– 11073-20200 NEW– 11073-10102 NEW– 11073-10103 NEW– 11073-00201 NEW– 11073-10101 REV– 11073-20201 NEW– 11073-10201 REV– 11073-20202 MOD– 11073-20000 NEW– 11073-10104 NEW– 11073-20103 NEW– 11073-30400 MOD – 11073-30503 NEW– 11073-00000 MOD– 11073-30505 NEWl

Page 13: 22 ND MEETING OF: ISO/TC215 HEALTH INFORMATICS WG7 DEVICES, Jointly with IEEE EMBS 11073, and hosted by HL7 Health Care Devices (DEV) WG, at the HL7 Working

Other - ItemsNew S2ESC HITSP Liaison – Dr. Meredith NewmakerNumbering & committee structure update in myProject– Project Leads on PAR (?)– Draft layout approval will be required before actual

changes are implementedDrafts for Sale - Procedure to be included in WG P&PsUsing “plug & play” - MoU procedure to be included in WG P&PsIHTSDO MoU -Pending

Page 14: 22 ND MEETING OF: ISO/TC215 HEALTH INFORMATICS WG7 DEVICES, Jointly with IEEE EMBS 11073, and hosted by HL7 Health Care Devices (DEV) WG, at the HL7 Working

Wireless Technology in Health Care Workshops– Resource issue; May try to do under AAMI or WiFi

Alliance– Better served as a Standard rather than a Guidance

Document– Potential strategy pending

E-Tools– NIST tools– IEEE tools

CAG Overview – Slide Deck available

Other – Items Con’t.

Page 15: 22 ND MEETING OF: ISO/TC215 HEALTH INFORMATICS WG7 DEVICES, Jointly with IEEE EMBS 11073, and hosted by HL7 Health Care Devices (DEV) WG, at the HL7 Working

New EMB Standards Working Group – EEG – Gained AAMI cooperation– On-boarded at ISNR Conference, 4 SEPT 2009,

Indianapolis Corporate membership & balloting model to be utilized

– Contacts John Nash, Behavioral Medicine Assoc, Inc Tom Collura, BrainMaster Technologies Cynthia Kerson, ISNR

– Forming Working Group– Discussing goals, PAR and draft

Other – Items Con’t.