1. IEEE 11073 – Oct’15 F2F – Agenda Annotation – PoCD WG focus October, 2015 F2F, Atlanta J. Wittenber IEEE 11073 – Oct15_F2F-Agenda_Annotation_jw1.pptx 1

2. Contents 3.Agenda Overview 4.Standards Framework 5.11073 Profiles 6.PoCD aka “Classic” MDI MDAP standards 7.Tuesday, Q2 8.Tuesday, Q3 9.Tuesday, Q4 10.Wednesday, Q1/Q2 11.Wednesday, Q3 12.Thursday, Q3 13.Thursday, Q4 14.Thursday, Q4, IEEE Plan 15.Key discussion Notes (1) 2

3. Agenda (v4->v5) Overview Q2*TUES. Q2-Q3 REVISION* Licensing w/IEEE-SA Standards Maintenance IEEE-SA Public Review (there isn't much to say about this) Q3 IEEE Update Central Desktop, e.g. Video LinkVideo Link 3 Slides

4. Standards Framework There are a number of overlapping interoperability domains in the general medical device data usability ecosphere. The following relation shows key domain profiles (columns) and layered functional subsets (rows). General LayeringIEEE 11073-PoCDIEEE 11073- PHD IEEE 11073- SDC IHE PCD /ITI IHE-PCD-DEC et al/HL7 v2 (reusing IEEE 11073(DIM, Nomen(RTM))) HL7 v2,v3 Con- tinua ASTM ICE AAMI /Ul2800 EHRRPMRPM; IHE TF  CDAIHE TF MD I/FMDIPHDSDCTech. FrameworkTech. Framework Parts 1-3FHIR -App Spec’z’n103xx: 1030310303104xx: 1041910419PCIM, DEC, ACM, IPEC, PIV, MEM, WCM -DIM1020110207[selective profile  HL7 v2]RIM -NOMEN1010x: 10101a; 10103’; 1010410101a [1010x]+PHD[1010x]+SDC[1010x]; LOINC< SNOMED@ HL7v2 - App Profile[s]20xxx; 20101’; 20202; 203012010120301 2060120701 /2070220702 Discovery, Security Security HL7 v2 OBR/OBX, …[/ITI()]ITREST/SOA [/ITI()] [ICE] -Transport3020030200-30400[30xxx]+PHDInternet+SDCTyp. TCP/IP[ITI()]ITI[*] IEEE 11073 IHE HL7 ASTM…AAM I Conti nua 4

5. PoCD “Classic” suite “MDAP” SDC suite PHD suite “MDDL” IEEE 11073 Profiles The 11073 comprises a set of Profile suites, e.g. (l-r) “PoCD aka ‘Classic’”, PHD, and SDC. “Reuse”  selective profiling of referenced standard. -103xx MDS Specializations -104xx PHD MDS Specializations -10201 DIM -1010x Nomenclature -20101 “Classic Base Standard -2020x “Classic” Profiles -30x00 Transport Profiles -20601 PHD Optimized Profile -10404 -1047x -... -10207 BICEPS -20701 SOMDA -20702 MDPWS 5

6. PoCD aka “Classic” MDI MDAP standards UDI whitepaper CyberSecurity whitepaper CR spreadsheet Harmonization – SDC; PHD; IHE PCD [?] Scanner ops whitepaper 6

7. Monday – Q3/Q4 7 Agenda Review & Approval Minutes and Action Item Review & Approval Infusion Pump Discussion Overview of IHE PCD Pump Model – RTMMS Content and DIM Profiling ToolsPump Model

8. Tuesday – Q2 Licensing with IEEE-SA Standards Maintenance (Comments from K. Bennett, IEEE-SA) The standards you discuss are expiring 12/31/2018. If revisions of those standards are not process, approved and published by that date, the standards will move into an "inactive" state. So, I am demonstrating to you the 4 standards in this countdown and if you currently have Revision PARs open. 10101 and 20101 have Revision PARs open. Regarding 10101 and 20101 REV PARs (both expire 12/31/2016) which if completed by 12/31/2016, will reset the clock on both standards and give them an additional 10 years of life. Regarding 00101, we have methods we can use to try and gain a critical mass to revise that standards if deemed worth revising. I can request a call for participation. If you simply want to keep it alive and there are no updates needed, you can simply open the revision PAR and run the ballot with no document changes.00101 Regarding 10201, as we have discussed in the past, you will need to submit a new revision PAR. I would open the revision PAR at your earliest convenience so that detail is complete. All 4 of these drafts should be in ballot by early 2017 to ensure approval before 12/31/2018. Standard #YearCommitteeTitleSASB Exp REV PAR?Status 11073- 001012008EMB/11073/PoCD Health informatics--PoC medical device communication Part 00101: Guide-- Guidelines for the use of RF wireless technology12/31/2018NO 11073- 101012004EMB/11073/PoCD Health informatics -- Point-of-care medical device communication -- Part 10101: Nomenclature12/31/2018YES 11073- 102012004EMB/11073/PoCD ISO/IEEE 11073-10201:2004, Health informatics - Point-of-care medical device communication - Domain information model12/31/2018NO 11073- 201012004EMB/11073/PoCD ISO/IEEE 11073-20101:2004, Health informatics - Point-of-care medical device communication - Application profile - Base standard12/31/2018YES IEEE-SA Public Review Overview 8

9. Tuesday – Q3 IEEE SA Update Central Desktop CD Overview. CD Overview Review CD x73 site updated CD siteupdated CD site Common Functions. Common Functions IEEE 11073 PoC-WG Membership AffirmationPoC-WG Membership Review of discussions during DPI Calls Overview of Calls (STC) Usability review @ Profile entry Pulse Oximeter – focusing on XML Export, supporting MDI Prototyping project; XML @ DIM vs. PCD, SDCDIMPCDSDC PCA Infusion Pump Physiological (VS) Mon DIM UML Model review/upgrade//correspondence @ :2004 version; XML SchemaXML Schema Profile Tool update/revision Profile Tool DPI/MDI Issues review UDI Support Continua UDI document; HL7 UDI document Continua UDI documentHL7 UDI document Current thinking: it might be best to add the missing constituent parts of a UDI to the Production Spec and not the UDI as a whole. Field- and/or text-based representation alternatives being considered.alternatives being considered BT LE working on a NWP for UDI IEEE PHD Update PHD Slideset AAMI/UL 2800 Standard structure slide AAMI/UL 2800 presentation slide 9

10. Tuesday – Q4 IEEE 11073 Membership Recruitment Review of SDC Spec documentsSDC Draft Documents BICEPS (P11073-10207, Domain Info. & Service Model) BICEPS MDPWS (P11073-20702, Med. Dev. Profile for Web Services) MDPWS IEEE 11073 Membership Recruitment 11073-SDC  Standards Document Review  Status Overview  Ballot Discussion Bennett/Fuchs et. al. Schlichting 10

11. Wednesday – Q1/Q2 (Chris Courville) Terminology Update – 11073-10101a Status10101a Announcement @ Paul Schluter receiving 2015 IEEE-SA “Medallion Award” "for leadership in the creation and support of innovative and internationally recognized medical device informatics methodologies, particularly nomenclature and related development tools.” 11073 – 10101b Planning IHE PCD (Infusion Pump) Nomenclature proposal and IPEC update IHE PCD (Infusion Pump) Nomenclature IPEC update Assume detail for Pump Nomenclature model has been previously covered by Todd on Monday IDCO Preparing PAR for Addendum to -10103 (Craig Reister et al)-10103 PAR request submitted to RevCom on 10/5/15 by PoCD WG Chair for RevCom consideration at their Dec’15 meeting Particular semantic subsets still being resolved Terminology Mapping LOINC SNOMED (IHTSDO) Other PHD Update AAMI/UL 2800 Update IP / Patent Policy Review Welcome & Introductions Terminology Update  11073-10101a Status  11073-10101b Planning  IDCO Fuchs Schluter/Wittenber Schluter Terminology Mapping  LOINC  SNOMED-CT Schluter 11

12. Wednesday – Q3 NIST Tooling IHE PCD v2 Tooling, RTMMS DIM Tooling Update and Demo IEEE Publishing Tooling Post-May’15-F2F dialog LaTeX-based.pdf submitted to IEEE Editorial for review (May’15) IEEE Editorial tCon comments (Jun’15) IEEE Editorial tCon comments “Our Senior Staff Editor and long time 11073 Editor, Don Messina, reviewed the PDF, and basically, it works. However, please see identified issues below. Formatting issues acknowledged by Prometheus. - Several IEEE-SA Style Contingencies: - Several related consideration, including: - The DIM is an ISO adopted document, so, there may be some additional issues we'll need to consider given that nuance. Bennett will take an action item to gather this information. - REMINDER: working group will always be responsible for their own maintenance, though we can archive the files. This has been a productive next step in our progression on the future publication of the DIM. We look forward to continuing the effort.” Discussion about tooling roadmap To update: Kat update @ IEEE Pubs process/dependencies, incl. DIM content @ tooling export re-use, paralleling Nomenclature re-use conventions DIM Revision DIM Revision – Tooling Process UML model: Use Case, Activity and Class DiagramsUse CaseActivityClass DIM Roadmap planning Roadmap discussion notes Issues spreadsheet resolution Issues spreadsheet NIST Tooling:  IHE PCD v2 Tooling, RTMMS  DIM Tooling Update and Demo  IEEE Publishing Tooling  Discussion about tooling roadmap DIM Revision:  Tooling  DIM Roadmap planning Garguilo Prometheus Wittenber All Wittenber 12

13. Thursday – Q3 C4MI Update MDI Security Overflow Topics Fuchs Wittenber Wittenber C4MI Update CyberSecurity Security whitepaper Overflow topics IHE PCD Fees/Membership Reciprocity IEEE PoCD – IHE PCD tCons Resourcing tCon schedule coordination STC/DPI – PHD - SDC IHE PCD Pump – AAMI/UL 2800 Other ? 13

14. Thursday – Q4 New Standards Planning See Framework, MDAP, and IEEE PoCD Plan (next slide)FrameworkMDAP IEEE 11073 Plan See next slide New Standards Planning:  Optimized Association o Modify 20101?  Point to Point over multiple Physical Layers  CNS convergence  Specializations  Remote Control  Other? Standards Roadmap Planning:  HL7 HCD 3 Year Plan  IEEE 11073 Plan Open items Adjourn Meeting Wittenber HL7 Co-Chairs Wittenber 14

15. Thursday – Q4 – IEEE Plan 201520162017 00xxx 00101 Go/NoGo decision 00101’ Prelim Draft00101’ Rev Ballot Ready 103xx 1030x Go/NoGo decisions 102xx 10207 Prelim draft DIM Profile Editor Beta complete 10201’ Prelim draft; 10207 Ballot draft IHE PCD DEC 10301-10303 profiles verified DIM/Nomen correspond –ence verific’n complete 10201 ‘ Revision Ballot Ready 101xx 10101a Ballot completed 10101 Pump Nomen in RTMMS 10101b PHD Nomen in RTMMS 10101b Prelim draft 10101b Ballot Ready 10101’ Prelim Draft 10101’ Rev Ballot Ready 2xxxx 20702 Prelim draft 2020x Go/NoGo decision 20701 Prelim draft 20101’ Prelim draft ready 2020x, 20301 Prelim draft ready; 20701/2 Ballot ready 20101’ Ballot ready 2020x Ballot ready 20301 Ballot ready 3xxxx 30xxx, e.g. Internet, Wireless Rev[s] Go/NoGo decision[s] 15 Allocations are nominal and are expected to be adjusted based on decision-making discussion, which may proceed into inter-F2F period. 10101b, 10104 PARs

16. Key Discussion Notes (1) Monday, Q3 Monday, Q4 Tuesday, Q1 Tuesday, Q2 Tuesday, Q3 Tuesday, Q4 Wednesday, Q1 Wednesday, Q2 Wednesday, Q3 Wednesday, Q4 Thursday, Q1 Thursday, Q2 Thursday, Q3 Thursday, Q4 16