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

IEEE Status

RevCom/NesCom Submittals September 2009 – None December Determine based on 5 year maintenance review this week

Reaffirmations 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

– 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 Cont.

Ballots in Progress –P 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 –P Standard for Health informatics - Personal health device communication -Device specialization – Medication Monitor Comment resolution 1 (ballot closed 30 Jul 2009)

Ballots in Progress Cont. P Standard for Health informatics - Personal health device communication - Device specialization - Body composition analyzer –Invitation (closing 10/17/2009) P Standard for Health informatics - Personal health device communication - Device specialization Peak expiratory flow monitor (peak flow) –Invitation (closing 10/17/2009)

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

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 Cont.

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

Working Group P&Ps To be completed & approved by December 31, 2010 Template including required text available WG P&Ps template to be reviewed by Sponsor to coinside with Sponsor P&Ps Development, submission to AudCom, etc. to be outlined by Sponsor Stay tuned!

5 Year Maintenance Items – NEW – NEW – NEW – NEW – NEW – NEW – REV – NEW – REV – MOD – NEW – NEW – NEW – MOD – NEW – MOD – NEWl

Other - Items New S2ESC HITSP Liaison – Dr. Meredith Newmaker Numbering & committee structure update in myProject –Project Leads on PAR (?) –Draft layout approval will be required before actual changes are implemented Drafts for Sale - Procedure to be included in WG P&Ps Using plug & play - MoU procedure to be included in WG P&Ps IHTSDO MoU -Pending

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 Cont.

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 Cont.