Standards for Diabetes Data
the facilitatorof patient self-care

Joseph Cafazzo p. .mng

@JOsephCafazzO

92
T UNIVERSITY
%...
Why standards?
Why standards? 

planes,  trains,  and automobiles

all forms of construction

internet and data communication
Why standards? 

Arbitrary data formats and
radio transport systems
Why standards? 

Redundant,  wasteful effort: 
time,  funding,  personnel
Why standards? 

Encourage new entrants: 
researchers and companies
Why standards? 

Create an market ecosystem of innovation
(notjust a product)
Why standards?
Why do manufacturers reject standards?
Why do manufacturers reject standards? 

“Our product is too sophisticated"
Why do manufacturers reject standards? 

“We don’t have the resources”
Why do manufacturers reject standards? 

“We don’t see demand”
Why do manufacturers reject standards? 

<unspoken>
“We want to maintain control . .
Why do manufacturers reject standards? 

<unspoken>
“We want to maintain control . .

liability
Why do manufacturers reject standards? 

<unspoken>
“We want to maintain control . .

customer relationship
Why do manufacturers reject standards? 

<unspoken>
“We want to maintain control . .

protecting against competition
Why do manufacturers reject standards? 

<unspoken>
“We want to maintain control . .

view of the role of the patient
Why standards? 

FDA
Why standards? 

FDA

less variability:  predicate devices
more transparency
industry consensus
addresses security issues
FDA Recognizes 12 IEEE Technology
Standards For Medtech Communication

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INSULIN PUMP STD :  IEEE 11073-10419

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- Ahmad HaidarMCG| LL

- Darrell M.  Wilson STANFORD

- Pantelis ...
What’s Next? 

Reducing the Barriers: 

Assisting Industry Partners
Workshops

Demonstration of Standards
Allow access of ...
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STANDARDIZED
DATA EXCHANGE
Standards for Diabetes Data
the enabler of patients and providers

Joseph Cafazzo W. ..

@jOsephCafazzo

92
T UNIVERSITY
%...
"Standards for Diabetes Data: the Facilitator for Patient Self-Care"
"Standards for Diabetes Data: the Facilitator for Patient Self-Care"
"Standards for Diabetes Data: the Facilitator for Patient Self-Care"
"Standards for Diabetes Data: the Facilitator for Patient Self-Care"
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"Standards for Diabetes Data: the Facilitator for Patient Self-Care"

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Dr. Joseph Cafazzo, Lead for the Centre for Global eHealth Innovation, lays down the gauntlet on Diabetes Industry Standards at the 2014 DiabetesMine Innovation Summit at Stanford School of Medicine.

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"Standards for Diabetes Data: the Facilitator for Patient Self-Care"

  1. 1. Standards for Diabetes Data the facilitatorof patient self-care Joseph Cafazzo p. .mng @JOsephCafazzO 92 T UNIVERSITY %’ or TORONTO (. ¢-nH- '<Il‘1l(I'I‘I| Q) eHealth Innovation
  2. 2. Why standards?
  3. 3. Why standards? planes, trains, and automobiles all forms of construction internet and data communication
  4. 4. Why standards? Arbitrary data formats and radio transport systems
  5. 5. Why standards? Redundant, wasteful effort: time, funding, personnel
  6. 6. Why standards? Encourage new entrants: researchers and companies
  7. 7. Why standards? Create an market ecosystem of innovation (notjust a product)
  8. 8. Why standards?
  9. 9. Why do manufacturers reject standards?
  10. 10. Why do manufacturers reject standards? “Our product is too sophisticated"
  11. 11. Why do manufacturers reject standards? “We don’t have the resources”
  12. 12. Why do manufacturers reject standards? “We don’t see demand”
  13. 13. Why do manufacturers reject standards? <unspoken> “We want to maintain control . .
  14. 14. Why do manufacturers reject standards? <unspoken> “We want to maintain control . . liability
  15. 15. Why do manufacturers reject standards? <unspoken> “We want to maintain control . . customer relationship
  16. 16. Why do manufacturers reject standards? <unspoken> “We want to maintain control . . protecting against competition
  17. 17. Why do manufacturers reject standards? <unspoken> “We want to maintain control . . view of the role of the patient
  18. 18. Why standards? FDA
  19. 19. Why standards? FDA less variability: predicate devices more transparency industry consensus addresses security issues
  20. 20. FDA Recognizes 12 IEEE Technology Standards For Medtech Communication By Sara: Jerorne [. _1': ‘;irr1:_ic ll-LEE, a professional association for the technology industry, coztiiztt-nt1c«. l the FDA this week for rucouriiziixg 12 IEEE 11073 health informatics standards that enable communication between medical, healthcare, and wellness devices and with external computer systems. The 12 FDA—reoognized IEEE 11073 standards are; - IEEE 11073-10101: "Health informatics- Point—of—care medical device communication—Part 10101; Nomenclature" - IEEE 11073-10201 “Health int'ormatics—Point—of—care medical device communication—Domain information model" - IEEE 11073- 20101 ‘Health int'ormatics—Point-of—care medical device communication——Application profile- Base standard" - IEEE 11073-20601 “Health informatics—Personal health device communication—Part 20601: Application profi1e—0ptimized exchange protocol" u-‘nu ; .. .. 1.1 - r . - n 11 1.: 1 - - . - n . ;
  21. 21. I i , J J as, .9 Jr - x vfifldllri in ! .lliI. tHhU, _ _ . .a . . , and HT “ 4. u . ..-I y. , . . . ll’“ 4.. . ‘rd _. , _. H. : , .. _ , .
  22. 22. 0 . O 0 A €‘xCin_cinnati ' Stanford % lrpnn um‘ Chfldmns Hospital & Clinics . t. -.l. . ll 1. Sim! V’ IIALE New Haven Cambridge University Hospitals ® in u i .4 -. u »» ‘Au’; -| msioundotion M1 fiuummwlom Health Health $ SW9‘ ”°a'"‘ HEALTHCARE C5)‘ r$(otté1lt1tt' The Chfldrenls Hospital of Philadelphia . uciovolallllclillc
  23. 23. ) r 1
  24. 24. 26
  25. 25. I i , J J as, .9 J? I x I_. nUdI. lIi II I. IlIII. t:IhU, _ _ . .a . . , and HT “ 4. u . ..-I I. , . . . Il’“ 4.. . n. .I _. , _. H. : , .. _ , .
  26. 26. iPhone US Market Share 032014 3 . e do «ttw
  27. 27. iPhone Global Market Share 032014 ii.7% die
  28. 28. Successes
  29. 29. Successes DICOM
  30. 30. before DICDM GE SIEMENS HITACHI PHILIPS imaging imaging imaging imaging
  31. 31. before DICDM GE SIEMENS HITACHI PHILIPS imaging imaging imaging imaging GE SIEMENS HITACHI PHILIPS PACS PACS PACS PACS
  32. 32. after DICDM SIEMENS - DATA EXCHANGE - HITACHI PHILIPS imaging imaging PACS PACS - PACS PACS PACS - I We -
  33. 33. ‘I ~
  34. 34. BENSON, GEORGE lkvv u1/nllllwu t. <-u. v.~. v unknown l'. r‘(-I' IL‘ n. u)u1: [Eu-,0-. Lluiiu . . ~ "°°" W/ L Iaceuci l'0')7lS Av“. IIIOI/ "1004 I0 E3'5| nil Dd " l‘! Wh Ihzflllvd 51Il'lIE1 ' -' G09 &4hll c1 3141.0 nA>. :'llD lVP: lJD 5 own man: lny-dtd nomr omnpaauv 9 )m| /wt 1 Emir we-it auun sum: Sczzprmul , - m . ... .a. .,ua. ,. uoav nmns I)/ Of/100111! r. s:sI In mm 7! Ann» [M nu. ..» ma r>e4.. .« I sun. 0 em a, , 1; . »I <«u ll —, mt v. .4 -u, u, . . x , ... »i Is-I I Sun in I l<: .«x’. s'l'| .'2 A: 5 5 5 a J. '17 r‘FOH¢NIF-INZUIJ
  35. 35. before DICDM GE SIEMENS HITACHI PHILIPS imaging imaging imaging imaging GE SIEMENS HITACHI PHILIPS PACS PACS PACS PACS
  36. 36. ROCHE MEDTRONIC DEXCDM ANIMAS product product product product ROCHE MEDTRONIC DEXCDM ANIMAS software software software software
  37. 37. THE ARTIFICIAL PANCREAS PUMP CONTROLLER All
  38. 38. THE ARTIFICIAL PANCREAS EHR/ PHR 8 TELEMONITORING CGM PUMP CONTROLLER IAN
  39. 39. O‘ Conunua HEALTH ALLIANCE
  40. 40. Conflnua HEALTH ALLIANCE Manage Chronic Conditions Digital Home Family Disease Healthcare Personal Care Management Health Givers Service Pr°Vid°r Record
  41. 41. Interfaces & Standards Personal Device Aggregation Telehealth Heanh Manager Service Records Center Vhevrnometev °u| se Oxlrneter ‘ Ins‘ C°. .'. '.'. ¥.' Pulse Blood Pressure Weight Scale blucose Men-v Continua BT Profiles Lardio Strength BIuetooth' Indeuendem Lwmg Actlwiy 96:10! ‘low Medication Adherence Physical A; rlwty / ‘S B 2. is n I E E] Device Connectivity
  42. 42. Board Members Fuiiisu ome- HEALTHCARE . BARTNERS. PHILIPS orange "‘ " "" ”' QuALcoMM
  43. 43. Open Promoter Members '““~”““‘°“a' E Fufirsu mm: omen. suuu: -ouoru MM-V l‘: NOVARTIS OITIROD. ORACLE. HEALTHCARE $355: Plnllnnh PHILIPS QuALooMM ideas rorrire orange @*‘""""°' Lmedfleaml Gm" Ilerlfinwireless
  44. 44. Industry Liaisons Q QEBQQ 9B| uetooth” 1' ccFf: ;: c 0'5 Nictiz i ; ’)zig3ee' Control your worl
  45. 45. {Q/ mi? gig? 2“ Q x >_ V ) ‘:1 I . r )0 U Lb C: Vancouver N‘ ‘)7? / /1 Q/ ~L, ,,, d°, , Amsterdarir ~ ~ June 2009 - V 2°07 2°“ . _ o r I. x; g, .. - , . ~ I», -.1 ' I - 4 , y‘’’ / Ireland 0 4-‘ ’ L‘-“‘°'“b°I-"I wt! ‘ ‘v_> . January 2°0:, rBelfastQ'APr“ 1°03 '’ Q ’ ‘ L19‘ , § . 0 -. - r_~ ", ~ Bospn '_ J San Francisco ‘ °i’3°b°" 7-005» June 2006, 9 (5 ” ; .oo7. 2008. 2009 Spain 2007» 2°03 5 n ‘en (; Vashington D C March F ruary 2010 2011 ‘ ' 2009 7 Austin M 2012 ‘F ? ~‘_ ‘x (es. ' . Singapore vwzx -7 Q 6‘ . 2011 5 . K 2012:Aus7 , BerHn {: ::f) : i 4% 2013: Portland, Edinburgh, Taipei , ° l sponsored public symposiums and member summits
  46. 46. E3 Bluetoothi Standards ° Bluetooth and Bluetooth 4.0 Low Energy (BLE)Medica| Working Group ° Scope: improve the user experience for B/ uetooth—enab| ed medical, healthcare, and fitness devices. ° Critical for Bluetooth LE devices (not covered by | EEE—11073 standards) 4 9 Bluetooth”
  47. 47. IEEE-11073 Personal Health Devices - Focus on interoperability of personal health devices (PHD) for personal use rather than in- hospital ° Transport agnostic ° Open group, including both industry and academic participation IEEE
  48. 48. -10404 Pulse Oximeter -1040? Blood Pressure Standards Overview -00103 Technical Report - Overview Device Specializations -10408 —1o415 -10417 -10441 -10419 Thermo- Weighing Glucose Cardio Insulin meter Scale Meter Pump —20601 Optimized Exchange Protocol Communication Protocols Bluetooth USB -10425 -1o4xx CGM Zigbee OSI Layers 5-7 OSI Layers 1-4
  49. 49. F‘-”‘“/ A ‘H . ‘-‘ L_: ;-; —_-_—t ‘ Pump Controller , . K/ . ‘ fig) EHR/ PHR Telemofiitoring
  50. 50. Bluetooth Low Energy SIG Profiles IEEE Personal Health Device (PHD) Specialization I . l BLE CGM profile BLE Insulin Pump profile ' " IEEE Std 11073-10425 IEEE Std 11073-10419 I §; '— I l T Cm“ BGWI CGM * * Puinp Controller BLE Glucose Meter profile l IEEE Std 11073-10417
  51. 51. BLE IEEE i-IR/ PHR gmoffitoring Continua Health Alliance
  52. 52. Sponsorship Archive . Request Withdraw Stgfiélgredg Project Standard ' Authorization IEEE Std 11073-10425" Continuous . Working . Publish Glucose Monitor Standard Group IEEE Standards Assembly Development process IEEE Std 11073-10417 Blood Glucose | EEE§$rri§lards Drafting. /lonitor (version 2) Approval Standard Committee . 1 2 , _ Review Balloting n IEEE Std 11073-10419“ 3 . Insulin Pump
  53. 53. IEEE STANDARD . ¥ 11073-10425-2014 — Health informatics--Personal health device communication - Part 10425: Device Specialization--Continuous Glucose Monitor (CGM) Description: Within the context of the ISO/ IEEE 11073 family of standards for device communication, a normative definition of the 5111-us; communication between continuous glucose monitor (CGM) devices and uigiiig . ,i. ~ U managers (e. g., cell phones, personal computers, personal health appliances, and set top boxes), in a manner that enables plug-and-play interoperability, is established in this standard. It leverages appropriate portions of existing standards including ISO/ IEEE 11073 terminology and information models. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality of CGM devices. In this context, CGM refers to the measurement of the level of glucose in the body on a regular (typically 5 minute) basis through a sensor continuously attached to the person. Working Group: Oversight Committee: EMB/11073 - IEEE 11073TM Standards Committee Sponsor: mmmm C? Cal‘ Tl-sic CO-anrilarr-I
  54. 54. CGM STD : IEEE 11073-10425 Nate Hamming UHN - Alan Carter MRI GLOBAL.0RG - Nick Oliver IMPERIAL - Robert KircherDOSESAFETY - Joseph Youssef DHSU - Pau Herrero Vinas IMPERIAL - Dave Kurisko BD - James Petisce BD - Roman Hovorka CAMBRIDGE - Nathaniel Heintzman UCSD - Darrell Wilson STANFORD - Lane Desborough MEDTRONIC - Rick Sullivan BOSTON BIOMED - Pantelis Georgiou IMPERIAL - Eyal SDRIl SANSUM - Ahmad Haidar MCGILL - Ciro Vega INSULET
  55. 55. INSULIN PUMP STD : IEEE 11073-10419 Melanie Yeung UHN - Ahmad HaidarMCG| LL - Darrell M. Wilson STANFORD - Pantelis Georgiou IMPERIAL COLLEGE - Lane Desborough MEDTRONIC ' P‘j'”‘°" Kf’"“'”V"°‘ “Va _ Eyal Dam" SANSUM - Rick Sullivan BOSTON BIOMED _ Joseph H Youssef IHSU - Robert Kircher DOSESAFETY - Nathaniel D. Heintzman UCSD . Roma" Hovorka CAMBRIDGE - Ronald Pettis BD ° Nick Oliver IMPERIAL COLLEGE - Christian Luszick ROCHE
  56. 56. What’s Next? Reducing the Barriers: Assisting Industry Partners Workshops Demonstration of Standards Allow access of code to Industry Partners JDRF H E I M S L EY -'_‘: -rrrnitrn-. --'i. ' - ("C-'»'. ‘-bow! an - f<‘r. ':-o~'. '>
  57. 57. ROCHE MEDTRONIC DEXCOM ANIMAS product product product product ROCHE MEDTRONIC DEXCOM ANIMAS software software software software
  58. 58. DIABETES tomorrow MEDTRONIC DEXCOM ANI pmmmt pmmmt pm siam it/ ‘J fififigx ROCHE MAS product duct E ‘at STANDARDIZED M””” W W E DATAEXCHANGE W
  59. 59. DIABETES tomorrow product product product 7|| ||| ||| ||| |E IEEEEEUUUUUUUE EUUEEUEUUEEUE IUUUEEUUUEUUUE in “Am ROCHE product Ihxxxfi _ _h ff, STANDARDIZED - fig DATAEXCHANGE W M M APP _APP_ 0 _AP _ PP- — PP. - P. . ' pp ' IBAPPTA APP Q APPAI: APP ‘b
  60. 60. DIABETES tomorrow DEXCOM product ANIMAS product STANDARDIZED DATA EXCHANGE
  61. 61. Standards for Diabetes Data the enabler of patients and providers Joseph Cafazzo W. .. @jOsephCafazzo 92 T UNIVERSITY %’ or TORONTO (Ii-Iiin l(I| lilulml Q) eHealth Innovation

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