IEEE 11073 Personal Health
Devices work group update
Daidi Zhong, Michael J. Kirwan
Working Group Co-Chair
28th Nov, 2013
Copyright 2011 by IEEE
Membership
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319 members
206 organizations
Weekly conference calls (Thursday 8:15 AM Pacific)
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Last for 90 min
Face to face meetings planned every 4 – 5
months
International
involvement in
the Work Group
52.9 % North America
25.8 % Europe
21.3 % Far East
Copyright 2011 by IEEE
Background: Why was the ISO/IEEE
11073 group selected?
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Respected standards body with open participation
Harmonized with ISO for International Standards
Also harmonized with NCCLS/CLSI, HL7, CEN TC251,
ISO TC215, IHE, FDA, and NIST
ISO/IEEE 11073 already formed and active
ISO/IEEE 11073 Charter contains health care devices
Able to support Disease Management, Health and
Fitness, and Independent Living
Standards structured to be transport portable
Low cost for membership and access to standards
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Copyright 2011 by IEEE
Background: IEEE Structure
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IEEE Engineering in Medicine and Biology Society
(EMB)
 IEEE 11073 (EMB/11073 Elliot Sloane)
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IEEE 11073 Clinical/General Committee WG (Todd Cooper)
IEEE 11073 Upper Layer WG (Jan Wittenber)
IEEE 11073 Lower Layer (Malcolm Clarke)
IEEE 11073 Personal Health Device WG (Michael Kirwan
& Daidi Zhong)
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See following 2 slides for list of standards
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Copyright 2011 by IEEE
Completed Standards (17)
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IEEE Std 11073-10404 Dev specialization – Pulse oximeter
IEEE Std 11073-10406 Dev specialization – Basic ECG
IEEE Std 11073-10407 Dev specialization – Blood pressure monitor
IEEE Std 11073-10408 Dev specialization – Thermometer
IEEE Std 11073-10415 Dev specialization – Weighing scale
IEEE Std 11073-10417 Dev specialization – Glucose meter + Revision
IEEE Std 11073-10418 Dev specialization – INR (blood coagulation)
IEEE Std 11073-10420 Dev specialization – Body composition analyzer
IEEE Std 11073-10421 Dev specialization – Peak flow
IEEE Std 11073-10441 Dev specialization – Cardiovascular + Revision
IEEE Std 11073-10442 Dev specialization – Strength
IEEE Std 11073-10471 Dev specialization – Activity hub
IEEE Std 11073-10472 Dev specialization – Medication monitor
IEEE Std 11073-20601 Optimized exchange protocol + Amendment
IEEE Std 11073-00103 Guide for Health informatics - Personal health
device communication - Overview
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Copyright 2011 by IEEE
Projects Underway (16)
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Other work being drafted
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IEEE Std 11073-20601 Optimized exchange protocol (Revision)
IEEE P11073-10404 Dev specialization – Pulse oximeter (Revision)
IEEE P11073-10413 Dev specialization – Respiration rate
IEEE P11073-10419 Dev specialization – Insulin pump
IEEE P11073-10422 Dev specialization – Urine analyzer
IEEE P11073-10423 Dev specialization – Sleep Quality Monitor
IEEE P11073-10424 Dev specialization – Sleep Aponea Breathing Therapy
Equipment
IEEE P11073-10425 Dev specialization – Continuous Glucose Meter
IEEE P11073-10417a Dev specialization – Glucose meter (Amendment)
IEEE P11073-10406a Dev specialization – Basic ECG (Amendment)
IEEE P11073-10471a Dev specialization – AI Living Hub (Amendment)
IEEE P11073-10407 Dev specialization – Blood Pressure Monitor (Corrigendum)
IEEE P11073-10408 Dev specialization – Thermometer (Corrigendum)
IEEE P11073-10415 Dev specialization – Weighing Scale (Corrigendum)
IEEE P11073-10420 Dev specialization – Body composition analyzer
(Corrigendum)
IEEE P11073-10418
6 Dev specialization – INR monitor (Corrigendum)
Copyright 2011 by IEEE
Step by Step
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Membership: PHD WG, IEEE-SA, IEEE
Engagement (use case, tiger team)
Draft the (Project Authorization Request) PAR
PAR Submission (NesCom) -- 3~4 opportunities per year
Draft the standard
Forming the Ballot Group -- ≥30 days
MEC Review -- 30 days
Initial Ballot -- ≥30 days
Recirculations (0 .... *) -- ≥10 days
RevCom Submission -- 3~4 submission deadlines per year
RevCom Approval
IEEE editorial process -- 2 – 3 months
Published
Total: 12 – 20 months (typical)
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Copyright 2011 by IEEE
Progress of each standard
ISO Pub
ISO Approve
ISO Submitted
IEEE Pub
RevCom
Balloting
Drafting
NesCom
Drafts underway
Approved and published IEEE stds
Approved and published international standards
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 )
Copyright 2011 by IEEE
Completed Initial Ballots
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Initial Ballots already completed
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Copyright 2011 by IEEE
11073-10419 (Insulin Pump) – 24 voters
11073-10422 (Urine Analyzer) – 20 voters
11073-10425 (CGM) – 39 voters
Progress as normal
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11073-10423 (Sleep Quality Monitor)
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11073-10424 (Sleep Aponea Equipment)
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major progress expected in Oct. F2F
Forming ballot group
Almost ready for initial ballot
Pending for harmonization
IEEE P11073-10404 (Pulse Oximeter)
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Copyright 2011 by IEEE
decided to change it to Amendment
Topics and News
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Consensus reached to initiate 20601 ballot process.
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.
PHD-Nom-Code-List verified (all the published PHD standards).
Wondering the ISO publication status of 10442
Oct 28-30th, F2F at Geneva, co-located with ITU.
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.
Coordination and harmonization around 10424.
Copyright 2011 by IEEE
Thank You !
Copyright 2011 by IEEE