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

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

Copyright 2011 by IEEE 3 Background: Why was the ISO/IEEE 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 already formed and active l ISO/IEEE 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

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

Copyright 2011 by IEEE 5 Completed Standards (17) l IEEE Std Dev specialization – Pulse oximeter l IEEE Std Dev specialization – Basic ECG l IEEE Std Dev specialization – Blood pressure monitor l IEEE Std Dev specialization – Thermometer l IEEE Std Dev specialization – Weighing scale l IEEE Std Dev specialization – Glucose meter + Revision l IEEE Std Dev specialization – INR (blood coagulation) l IEEE Std Dev specialization – Body composition analyzer l IEEE Std Dev specialization – Peak flow l IEEE Std Dev specialization – Cardiovascular + Revision l IEEE Std Dev specialization – Strength l IEEE Std Dev specialization – Activity hub l IEEE Std Dev specialization – Medication monitor l IEEE Std Optimized exchange protocol + Amendment l IEEE Std Guide for Health informatics - Personal health device communication - Overview

Copyright 2011 by IEEE 6 Projects Underway (16) l Other work being drafted l IEEE Std Optimized exchange protocol (Revision) l IEEE P Dev specialization – Pulse oximeter (Revision) l IEEE P Dev specialization – Respiration rate l IEEE P Dev specialization – Insulin pump l IEEE P Dev specialization – Urine analyzer l IEEE P Dev specialization – Sleep Quality Monitor l IEEE P Dev specialization – Sleep Aponea Breathing Therapy Equipment l IEEE P Dev specialization – Continuous Glucose Meter l IEEE P a Dev specialization – Glucose meter (Amendment) l IEEE P a Dev specialization – Basic ECG (Amendment) l IEEE P a Dev specialization – AI Living Hub (Amendment) l IEEE P Dev specialization – Blood Pressure Monitor (Corrigendum) l IEEE P Dev specialization – Thermometer (Corrigendum) l IEEE P Dev specialization – Weighing Scale (Corrigendum) l IEEE P Dev specialization – Body composition analyzer (Corrigendum) l IEEE P Dev specialization – INR monitor (Corrigendum)

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 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

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

Copyright 2011 by IEEE Newly Approved PARs (Blood Pressure Monitor) (Thermometer ) (Weighing Scale ) (Body composition analyzer) (INR monitor )

Copyright 2011 by IEEE Completed Initial Ballots l Initial Ballots already completed l (Insulin Pump) – 24 voters l (Urine Analyzer) – 20 voters l (CGM) – 39 voters

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

Copyright 2011 by IEEE Topics and News l Consensus reached to initiate ballot process. l Command & Control is under discussion. Current proposal is based on the Control Package in PHD members are struggling to understand the relevant content in The provided text description in is not sufficiently informative. l PHD-Nom-Code-List verified (all the published PHD standards). l Wondering the ISO publication status of l Oct 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

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