1. Copyright 2011 by IEEE IEEE 11073 Personal Health Devices work group update Daidi Zhong, Michael J. Kirwan Working Group Co-Chair 28 th Nov, 2013

2. Copyright 2011 by IEEE Membership l 319 members l 206 organizations l Weekly conference calls (Thursday 8:15 AM Pacific) l Last for 90 min l Face to face meetings planned every 4 – 5 months l International involvement in the Work Group l 52.9 % North America l 25.8 % Europe l 21.3 % Far East

3. Copyright 2011 by IEEE 3 Background: Why was the ISO/IEEE 11073 group selected? l Respected standards body with open participation l Harmonized with ISO for International Standards l Also harmonized with NCCLS/CLSI, HL7, CEN TC251, ISO TC215, IHE, FDA, and NIST l ISO/IEEE 11073 already formed and active l ISO/IEEE 11073 Charter contains health care devices l Able to support Disease Management, Health and Fitness, and Independent Living l Standards structured to be transport portable l Low cost for membership and access to standards

4. Copyright 2011 by IEEE 4 Background: IEEE Structure l IEEE Engineering in Medicine and Biology Society (EMB) l IEEE 11073 (EMB/11073 Elliot Sloane) l IEEE 11073 Clinical/General Committee WG (Todd Cooper) l IEEE 11073 Upper Layer WG (Jan Wittenber) l IEEE 11073 Lower Layer (Malcolm Clarke) l IEEE 11073 Personal Health Device WG (Michael Kirwan & Daidi Zhong) l See following 2 slides for list of standards

5. Copyright 2011 by IEEE 5 Completed Standards (17) l IEEE Std 11073-10404 Dev specialization – Pulse oximeter l IEEE Std 11073-10406 Dev specialization – Basic ECG l IEEE Std 11073-10407 Dev specialization – Blood pressure monitor l IEEE Std 11073-10408 Dev specialization – Thermometer l IEEE Std 11073-10415 Dev specialization – Weighing scale l IEEE Std 11073-10417 Dev specialization – Glucose meter + Revision l IEEE Std 11073-10418 Dev specialization – INR (blood coagulation) l IEEE Std 11073-10420 Dev specialization – Body composition analyzer l IEEE Std 11073-10421 Dev specialization – Peak flow l IEEE Std 11073-10441 Dev specialization – Cardiovascular + Revision l IEEE Std 11073-10442 Dev specialization – Strength l IEEE Std 11073-10471 Dev specialization – Activity hub l IEEE Std 11073-10472 Dev specialization – Medication monitor l IEEE Std 11073-20601 Optimized exchange protocol + Amendment l IEEE Std 11073-00103 Guide for Health informatics - Personal health device communication - Overview

6. Copyright 2011 by IEEE 6 Projects Underway (16) l Other work being drafted l IEEE Std 11073-20601 Optimized exchange protocol (Revision) l IEEE P11073-10404 Dev specialization – Pulse oximeter (Revision) l IEEE P11073-10413 Dev specialization – Respiration rate l IEEE P11073-10419 Dev specialization – Insulin pump l IEEE P11073-10422 Dev specialization – Urine analyzer l IEEE P11073-10423 Dev specialization – Sleep Quality Monitor l IEEE P11073-10424 Dev specialization – Sleep Aponea Breathing Therapy Equipment l IEEE P11073-10425 Dev specialization – Continuous Glucose Meter l IEEE P11073-10417a Dev specialization – Glucose meter (Amendment) l IEEE P11073-10406a Dev specialization – Basic ECG (Amendment) l IEEE P11073-10471a Dev specialization – AI Living Hub (Amendment) l IEEE P11073-10407 Dev specialization – Blood Pressure Monitor (Corrigendum) l IEEE P11073-10408 Dev specialization – Thermometer (Corrigendum) l IEEE P11073-10415 Dev specialization – Weighing Scale (Corrigendum) l IEEE P11073-10420 Dev specialization – Body composition analyzer (Corrigendum) l IEEE P11073-10418 Dev specialization – INR monitor (Corrigendum)

7. Copyright 2011 by IEEE Step by Step l Membership: PHD WG, IEEE-SA, IEEE l Engagement (use case, tiger team) l Draft the (Project Authorization Request) PAR l PAR Submission (NesCom) -- 3~4 opportunities per year l Draft the standard l Forming the Ballot Group -- ≥30 days l MEC Review -- 30 days l Initial Ballot -- ≥30 days l Recirculations (0.... *) -- ≥10 days l RevCom Submission -- 3~4 submission deadlines per year l RevCom Approval l IEEE editorial process -- 2 – 3 months l Published l Total: 12 – 20 months (typical) 7

8. Copyright 2011 by IEEE Progress of each standard Approved and published international standards Approved and published IEEE stds Drafts underway

9. Copyright 2011 by IEEE Newly Approved PARs 11073-10407 (Blood Pressure Monitor) 11073-10408 (Thermometer ) 11073-10415 (Weighing Scale ) 11073-10420 (Body composition analyzer) 11073-10418 (INR monitor )

10. Copyright 2011 by IEEE Completed Initial Ballots l Initial Ballots already completed l 11073-10419 (Insulin Pump) – 24 voters l 11073-10422 (Urine Analyzer) – 20 voters l 11073-10425 (CGM) – 39 voters

11. Copyright 2011 by IEEE Progress as normal l 11073-10423 (Sleep Quality Monitor) l major progress expected in Oct. F2F l 11073-10424 (Sleep Aponea Equipment) l Forming ballot group l Almost ready for initial ballot l Pending for harmonization l IEEE P11073-10404 (Pulse Oximeter) l decided to change it to Amendment

12. Copyright 2011 by IEEE Topics and News l Consensus reached to initiate 20601 ballot process. l Command & Control is under discussion. Current proposal is based on the Control Package in 10201. PHD members are struggling to understand the relevant content in 10201. The provided text description in 10201 is not sufficiently informative. l PHD-Nom-Code-List verified (all the published PHD standards). l Wondering the ISO publication status of 10442 l Oct 28-30 th, F2F at Geneva, co-located with ITU. l Planning a joint F2F with Bluetooth-MED at Beijing, 2014/06. Maybe an opportunity to do a joint marketing with BT SIG and Continua for chinese market. l Coordination and harmonization around 10424.

13. Copyright 2011 by IEEE Thank You !