IEEEEMB11073 Status Report for Combined Working Group Meeting

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IEEE/EMB/11073 Status Report for Combined Working Group Meeting, Chicago, 16 May 2014 Kathryn Bennett,

IEEE/EMB/11073 Status Report for Combined Working Group Meeting, Chicago, 16 May 2014 Kathryn Bennett, Staff Liaison, Standards Technical Community

PAR Statistics v 24 PARs open v 21 Drafts in pre-ballot development v 3

PAR Statistics v 24 PARs open v 21 Drafts in pre-ballot development v 3 Drafts in ballot v 5 PARs due to expire 12/31/2014 v 27 active standards 2

Ballot Highlights v P 10101 a Nomenclature Amendment (Newly formed Pre. Ballot/Invitation Stage) closed

Ballot Highlights v P 10101 a Nomenclature Amendment (Newly formed Pre. Ballot/Invitation Stage) closed 27 May § Close to MEC & Initial ballot? v P 10419 Device specialization - Insulin pump {Comment Resolution since Sept 2013} § Another stall? v P 10422 - Device specialization - Urine analyzer {Comment Resolution since July 2013} 3

PAR Maintenance Recommendations (Expiring 12/31/2014) v P 10101 Rev POC - Nomenclature § Recommendation:

PAR Maintenance Recommendations (Expiring 12/31/2014) v P 10101 Rev POC - Nomenclature § Recommendation: Extend v P 10201 Rev POC - Domain information model § Recommendation: Allow administrative withdrawal and open a new PAR when work may resume v P 20101 Rev POC - Application profile - Base standard § Recommendation: Extend v P 10413 New PHD - Device specialization - Respiration rate monitor § Recommendation: Extend v P 10419 New PHD - Device specialization - Insulin pump § Recommendation: Extend (Note: Open for 6 years) 4

SASB Actions Since May 2014 v Approved Drafts to be published § P 11073

SASB Actions Since May 2014 v Approved Drafts to be published § P 11073 -10424 PHD Sleep Apnoea Breathing Therapy Equipment (SABTE) § P 11073 -10425 PHD Continuous Glucose Monitor (CGM) § P 11073 -20601 REV PHD Optimized Exchange Protocol 5

ISO Adoptions Status v TC 215 Update § § § 11073 -10103 Published at

ISO Adoptions Status v TC 215 Update § § § 11073 -10103 Published at ISO 11073 -10102 Published at ISO 11073 -10418 Published at ISO 11073 -10417 Published at ISO 11073 -30200 a IEEE Proof Review 11073 -20601 a IEEE Proof Review 11073 -00103 Edits Recommended by IEEE to ISO 11073 -10441 Edits Recommended by IEEE to ISO 11073 -10424 To be submitted upon IEEE publication 11073 -10425 To be submitted upon IEEE publication 11073 -20601 REV To be submitted upon IEEE publication § K. Bennett to attend October 2014 meetings in Berlin 6

P&Ps v Sponsor § Current approved expires 12/31/2014 § New draft baseline ready for

P&Ps v Sponsor § Current approved expires 12/31/2014 § New draft baseline ready for this meeting (kudos to Ken and Stan!) v Work Group § Will be requested by Aud. Com after Sponsor is approved § Decision: Leaning toward one document for all WGs § Ken working through with Daidi 7

Policy Change: Public Review v SASB Approved June 2013: A public review shall start

Policy Change: Public Review v SASB Approved June 2013: A public review shall start simultaneously with the opening of the initial ballot and last for 65 days by April 1, 2015 § Individuals may purchase the initial ballot draft for information only, & have the ability to submit public review comments, without a vote § Goals § Better aligned with the World Trade Organization (WTO) Technical Barriers to Trade (TBT) principles § Better positioning as a global SDO § Engage a broader community § Supports Open. Stand principles (open process) § Completed activities: P&Ps, Functional Spec Development, Technical Spec Development § Activities in-progress § Tool Development and Testing § Messaging and Communication § Training and FAQs 8

Agreements v IEEE/HL 7 So. U – Renewal underway v IHE Mo. U –

Agreements v IEEE/HL 7 So. U – Renewal underway v IHE Mo. U – Auto renewal in August; uneventful v IHTSDO Mo. U – Current being considered by IHTSDO v NIST Royalty Free Agreement – Addendum submitted to NIST for execution v Continua Collaboration Agreement 9

2014/2015 Meetings/Conferences v ISO TC 215 WG Meetings, Fall Oct 5 -10 – Berlin,

2014/2015 Meetings/Conferences v ISO TC 215 WG Meetings, Fall Oct 5 -10 – Berlin, Germany v 802 Plenary, Nov 3 -7, San Antonio, TX v Healthcare Innovations & Po. C Technologies, Oct 8 -10, Seattle, WA v IEEE SASB Series, Dec 8 -10, Piscataway, NJ v m. Health Summit, Dec 7 -11, Washington, DC v 11073 Combined Working Group @ HL 7, Jan 19 -23, San Antonio, TX v e. Health/HL 7 Int’l Interoperability Conference, Feb 9 -11, Prague, Czech Republic v 802 Plenary, Mar 8 -13, Berlin, Germany v IEEE SASB Series, Mar 24 -27, Piscataway, NJ v HIMSS 2015, Apr 13 -16, Chicago, IL v ISO TC 215 US TAG Meeting, April 20 -24, San Francisco, CA v 11073 Combined Working Group @ HL 7, May 10 -15, Paris, France v IEEE SASB Series, Jun 10 -12, Piscataway, NJ 10

Alternative Publications v Nomenclature (11073 -10101) § IEEE Standards in Database Format Proposal §

Alternative Publications v Nomenclature (11073 -10101) § IEEE Standards in Database Format Proposal § Draft & flow chart proposal created § Targeted to be presented to Pro. Com in December 2014 v DIM (11073 -10201) § Digital content §. pdf files from Prometheus review by IEEE – no major hurdles § Prometheus working through modifications § XML – IEEE or Prometheus can generate – no major hurdles § Fits with IEEE Next Gen Publication goals = Win/Win 11

e. Health Strategy v Standards education § Planning to host one day education session

e. Health Strategy v Standards education § Planning to host one day education session about IEEE 11073 standards into 2015 § Still looking for instructors from 11073 community § Malcolm Clarke to do at IEEE EMBS Healthcare Innovation Pointof-Care Technology Conference Oct 8 -10, Seattle, WA § Malcolm Clarke and Michael Kirwin to do at m. Health Summit Dec 7 -11, Washington, DC v IEEE applied to be an Issuing Agency for UDI Registry § FDA approval pending § System under development – also serving as the nextgeneration Registration Authority platform – to be complete by mid November 2014 v RTLS – new development work § Workshop held at EMBC § Individual method PARs under construction & to be submitted by 10/20/2014 under EMB/Standards Committee 12

e. Health Stategy Con’t Blog on m. Health standards has published in m. Health

e. Health Stategy Con’t Blog on m. Health standards has published in m. Health News on July 18, 2014 For m. Health to succeed, we'll need standards Bill Ash & Kathryn Bennett by http: //www. mhealthnews. com/news/mhealth-succeed-well-need-standards 13

PR & Sales v PR § Evangelization via IEEE-SA Facebook, Twitter, etc. § §

PR & Sales v PR § Evangelization via IEEE-SA Facebook, Twitter, etc. § § § HIMSS 2014 National Public Health Week (7 -12 April) National Autism Month (April) Blood Pressure Education Month (May) National Health IT Week Promos (15 -19 Sept) v Sales § Subscription for e. Health to be available for sale 2014 Q 4 § Contains over 200 documents § Includes drafts & standards related to healthcare, medical § 11073 § 802 § 3 D Medical § And more…… 14

Sponsorship v Working through improvements with EMBS § EMB would like to resume receiving

Sponsorship v Working through improvements with EMBS § EMB would like to resume receiving a status reports and welcomes/encourages participation from 11073 § In 2012/2013 the IEEE-SA collaborated with EMB to have one IEEE presence at the HIMSS Conf 2014, EMBC 2014 & planned for Healthcare Innovations & Po. C Technologies Conf in October § EMB alerting the SA to publishing opportunities for 11073 § The IEEE-SA is committed to building the relationship between 11073 and EMB by: § Increasing communication § Increasing visibility § Improving collaboration between work activities of each group § IEEE-SA is committed to fostering collective collaboration & improvement to aid in producing a positive and productive relationship for all stakeholders 15

Contact Information Kathryn Bennett IEEE 445 Hoes Lane Piscataway, NJ 08854 Voice: 732 -465

Contact Information Kathryn Bennett IEEE 445 Hoes Lane Piscataway, NJ 08854 Voice: 732 -465 -5867 Mobile: 732. 850. 1768 Email: k. [email protected] org www. standards. ieee. org 16