HL7 Healthcare Devices/IEEE 11073 Working Group Meetings

2016.05.09 – 2016.05.12 – Montreal, Quebec, Canada

See meeting documents posted @ http://www.hl7.org/Special/committees/healthcaredevices/docs.cfm?

Details posted on Titan Pad: https://titanpad.com/t8n4YJOF15

Beginning Sessions for 2016.05.09 – 2016.05.12

Welcome & Introductions  Local and remote participants are introduced.  Agenda for the day is presented.

Review of IP / Patent Policy Review  Participants are informed by the presiding WG Chair of the IEEE/HL7 code of conduct, Patent Policy, and IP Disclosure Policy.

Monday – Q1, May 09, 2016

Recurring Participants (6)

 Stan Wiley (Dräger)  Ken Fuchs (Center for Medical Interoperability)  Masato Tanaka (Nihon Khoden)  John Rhoads (Philips)  John Garguilo (NIST)  Paul Schluter (GE)

Q1-Specific Participants (20)

 Stefan Schlichting (Dräger)

 David Gregorczyk (Dräger)

 Michael Faughn (Prometheus Computing)

 Malcom Clarke (Brunell University, BSI)

 Koichiro Matsumoto (Nihon Khoden)

 Brian Reinhold (LNI/PCHA)

 Swampna Ahbyankar (Regenstrief Institute)

 Björn Andersen (University of Lubeck)

 Daidi Zhong (Chongqing University)

1  Shu-Fang Newman (University of Washington Medical Center)

 Afsarieh Naimollen (xen partners)

 Yongji Fu (Hill Rom)

 Jan Wittenber (Independent Consultant)

 Recurring participants

Other Participants Pool (note – use for future Qs if present) (16)

 Adamu Haruna (Nokia Technologies)

 Kathryn Bennett (IEEE-SA)

 Yongji Fu (Hill-Rom)  Kai Hassing (Philips Healthcare)  Stefan Karl (Philips Healthcare)  Simon Baumhof (University of Lubeck)  Martin Kasparick (University of Rostock)  Clem McDonald (National Library of Medicine)

 Tracy Rausch (DocBox)  Ioana Singureanu (US Dept. of Veteran Affairs/Eversolve)

 Matthew Graham (Mayo Clinic)

 John Walsh (Partners Healthcare)  Beth Pumd (Kaiser Permanente)  Alexander Mense (HL7 Austria)  Ewout Kramer (Furore)  Arvind Jagannathan (Lantana Consulting Group)  Chris Courville (EPIC)

Minutes for Q1

 Session Summary . Agenda revision 0.4 was reviewed and accepted. . Minutes summary from January 2016 WG meeting was reviewed and accepted. . IEEE 11073 General Update  IEEE 11073 PoCD WG Membership Affirmation • A Call for Participation (CFP) to EMBS and Computer Society was issued. Approximately 60 new members were added. • Proposal for a PoCD WG website, similar to that from PHD:  http://www.11073.org/  http://www.11073.net/

2  http://www.11073.com/ • Overview of PoCD-PHD WG Activities  Admin  WG P&P approved  RTMMS migration  Cybersecurity whitepaper from IHE PHD  Command and Control  IEEE 11073 PHD Update • See posted presentation (Zhong/Kirwin) • 340 members • 200 different entities • Geographic representations • 25 Completed standards • 16 Project in process • Recent F2F with Bluetooth SIG

 Motions . Approval of meeting minutes summary from January 2016 – Passed: motion by Garguilo seconded by Fuchs.

 Action Items . None

Monday – Q2, May 09, 2016

Q2-Specific Participants (17)

 Recurring Participants from Q1 on Monday

 Stefan Schlichting

 David Gregorczyk

 Michael Faughn

 Swampna Ahbyankar

 Brian Rheinhold

 Malcolm Clarke

 Daidi Zhong

 Kathryn Bennett

 Adamu Haruna

 Koichiro Matsumoto

3  Jan Wittenber

Minutes for Q2

 Session Summary . IEEE General Update  IEEE SA Update . See posted presentation (K. Bennett) . Current Projects/Standards Statistics . Ballot Highlights . EMB/11073 Executive Summary (SASB Actions) . ISO Adoption Status – TC215 Update . WG P&Ps . Collaborative Relationships . ProCom Ad-Hoc for Continuous Maintenance Standards (f/k/a Database Standards)  AAMI/UL JC2800 Update (J. Wittenber/J. Rhoads) . Presentation of organization of family of standards (document architecture) . Absence on guidance to implementers . Concerns about the conformance to 2800 . Current efforts are longer-term focused.  IEEE 11073 PoCD P&Ps . IEEE 11073 PoCD WG – ballot passed, but were approved with comments regarding the absence of a Vice-Chair/Co-Chair; for sub-groups, do they need their own P&P? Continue in next Quarter.  Motions . Motion to GC leadership to conditionally approve move of P11073-20702 to sponsor ballot- offered by Fuchs, seconded by Wiley; Kirwin - absent; motion passed 4-0 based on quorum present.  Action Items . Investigate possible transparency of ISTO ICE Alliance and IEEE SA 11073: Action K. Bennett, as part of the regular Conference/Meeting updates

Monday – Q3, May 09, 2016

Q3-Specific Participants (16)

 Recurring Participants from Q1 on Monday

 Stefan Schlichting

 David Gregorczyk

 Michael Faughn

 Swampna Ahbyankar

 Brian Rheinhold

 Malcolm Clarke

4  Michael Faughn

 Kathryn Bennett

 Koichiro Matsumoto

 Jan Wittenber

Minutes for Q3

 Session Summary . 11073 PoCD WG P&P  11073 PocD WG P&P • Discussion on reconciling the role of Vice-Chair; based on comments from M. Clarke, and a new template from IEEE, the P&P will be updated and will require a vote of the WG. . IEEE Standards Maintenance (see posted presentation by K. Bennett)  Priorities for editorial work on preparing standards with 2018 expiration date.  IEEE 11073-10101 Revision  IEEE 11073-10201 Revision  IEEE 11073-20101 Revision

 Motions . None

 Action Items . Investigate editorial capacity at IEEE SA to baseline 10101, 10101a, 10201, 20101: K. Bennett. . Map out project scenarios for standards renewal that achieve ballot completions by 2018: J. Wittenber

Monday – Q4, May 09, 2016

Q4-Specific Participants (17)

 Recurring Participants from Q1 on Monday  Stefan Schlichting

 David Gregorczyk

 Michael Faughn

 Swampna Ahbyankar

 Brian Rheinhold

 Malcolm Clarke

5  Michael Faughn

 Kathryn Bennett

 Yongji Fu

 Koichiro Matsumoto

 Jan Wittenber

Minutes for Q4

 Session Summary o Infusion Pump Discussion . Overview of Pump Model – RTMMS Content and DIM Profiling Tools: Will include in Q1 on Tuesday o IHE PCD Meeting update (11073-relevant topics: J. Rhoads): . 5-day meeting; 2 days on pumps . ACM update – complete profile with a device back channel . Discussion of remote control using HL7 and PCD; will start new white paper . See wiki from IHE PCD: http://wiki.ihe.net/index.php/PCD_PC %26TC_F2F_2016_April_18-22_Webex . IHE PCD PCIM Whitepaper released to TC . WCM implementation interest . Remote audio activation o 11073 PoCD WG P&P Continuation . Table to Roadmap planning – proposal to modify clause 3.4.2 from P. Schluter. o IEEE Standards Maintenance . Deferring to IEEE 11073 Roadmap topics. o IEEE 11073 Membership Recruitment . Covered in Q1 on Monday o Licensing with IEEE SA . Review of exception case by Kai Hassing (PHC) . NIST web-site has listed 5 conditions regarding IP restrictions

 Motions o None

 Action Items o Provide Ken Fuchs with WORD file of proposed PoCD WG P&P updates: J. Wittenber

Tuesday – Q1, May 10, 2016

Q1-Specific Participants (21)

 Recurring Participants from Q1 on Monday  Stefan Schlichting

6  David Gregorczyk

 Michael Faughn

 Swampna Abyankar

 Brian Rheinhold

 Malcolm Clarke

 Michael Faughn

 Kathryn Bennett

 Yongji Fu

 Koichiro Matsumoto

 Kai Hassing

 Stefan Karl

 Björn Andersen

 Martin Kasparick

 Jan Wittenber

Minutes for Q1

 Summary o NIST Tooling: . IHE PCD v2 Tooling, RTMMS  Overview of NIST Test Tooling – see presentation from J. Garguilo and detailed presentation from M. Faughn on DIM Profiling Tool.  DIM Tooling Update and Demo – see M. Faughn

o DIM update (10201) . MDS Specialization Profiling . Overview of Pump Model – RTMMS Content and DIM Profiling Tools

 Motions o None

 Action Items o None

Tuesday – Q2, May 10, 2016

Q2-Specific Participants (23)

7  Recurring Participants from Q1 on Monday  Stefan Schlichting

 David Gregorczyk

 Michael Faughn

 Swampna Ahbyankar

 Clem McDonald

 Brian Rheinhold

 Malcolm Clarke

 Michael Faughn

 Kathryn Bennett

 Yongji Fu

 Koichiro Matsumoto

 Kai Hassing

 Stefan Karl

 Björn Andersen

 Simon Baumhof

 Martin Kasparick

 Jan Wittenber

Minutes for Q2

 Summary

o Terminology Update (P. Schluter) . 11073-10101a Status (see posted presentation)  Status: Approved and published  NIST RTMMS is updated.  hRTM2 not yet publicly available  New terms added; ~ 880 terms total  Co-constraints for several PHD devices . 11073-10101b Status  Status: In process; PAR approved  Extending 11073-10101:2004 and -10101:2015

8  Strong inclusion of Infusion Pump community inputs.  Expect to have draft available in end of 2016 (ahead of the pre- Connectathon)  Content overview . 11073-10101c Status  Status: PAR to be approved.  Will begin work in 8/2016, with expectation for start of sponsor ballot in Q4 2017.  Will cover events, alerts, physiological alerts, . 11073-10103a Status (IDCO)  Status: PAR approved

 Implanted Devices Cardiac – new IDC term content to extend IEEE P11073-10103:2012 – input from Heart Rhythm Society last week.

o Terminology Mapping (P. Schluter) . LOINC (C. McDonald/S. Abhyankar)  Implanted Devices Cardiac – new IDC term content to extend IEEE P11073-10103:2012 – input from Heart Rhythm Society last week.

. SNOMED-CT (K. Bennett/P. Schluter/M. Clarke)  ITHSDO has indicated that project is not a priority due to capacity limitations.  BSI may be receptive to funding a mapping initiative within the UK – Malcolm will advise at the next IEEE 11073 PoCD WG meeting.

 Motions o None

 Action Items o Initiate leadership eballot to approve PAR for 10101c: J. Wittenber

Tuesday – Q3, May 10, 2016

Q3-Specific Participants (24)

 Recurring Participants from Q1 on Monday  Stefan Schlichting

 David Gregorczyk

 Michael Faughn

 Swampa Abyankar

 Clem McDonald

 Brian Rheinhold

 Malcolm Clarke

9  Michael Faughn

 Kathryn Bennett

 Yongji Fu

 Koichiro Matsumoto

 Kai Hassing

 Stefan Karl

 Björn Andersen

 Simon Baumhof

 Martin Kasparick

 Swampna Ahbyankar

 Jan Wittenber

Minutes from Q3

 Summary o 11073 – SDC (S. Schlichting – see posted presentation) . Standards Document Review  PARs Overview • Regular meetings in Germany, hosted by DKE and DIN  Draft Documents (D. Gregorczyk) • 20701 SDC - no significant changes since Jan. WG meeting • 20702 MDPWS – document in editorial review with IEEE SA – expect completion in May 2016. • 10207 – BICEPs: final quality assurance checks in process. . Status Overview  Planned Events (B. Andersen) • June 20th/21st: ICCAS Open Days (international demonstrator presentation) in Leipzig, Germany: https://www.iccas.de/?lang=en • August 16th (?): Hands-On Implementation Tutorial in Orlando, Florida (accepted as a pre-conference half-day tutorial at the EMBC, date is not confirmed!): Point of Care Medical Device Communication: IEEE P11073-20701 Hands- On Implementation

10  OR.NET adopters

• http://www.ornet.org/projekt/partner/?lang=en • list of associated partners (app. 40) • http://www.ornet.org/projekt/assoziierte-partner/ . Ballot Discussion  BICEPs • Proposing two educational webinars at beginning of August 2016 and another 2 at end of August 2016 • Seeking to obtain authorization to start ballot formation group at next IEEE 11073 PoCD WG meeting. . DICOM Configuration Management and SDC (Björn Andersen)  Will review with DICOM group in meeting in Germany in May.  Motions o None

 Action Items o None

Tuesday – Q4, May 10, 2016

Q4-Specific Participants (16)

 Recurring Participants from Q1 on Monday  Stefan Schlichting

 David Gregorczyk

 Michael Faughn

 Brian Rheinhold

 Malcolm Clarke

 Michael Faughn

 Kathryn Bennett

 Jan Wittenber

 Koichiro Matsumoto

 Stefan Karl

Minutes from Q4

11  Summary . C4MI Update – K. Fuchs . C4MI is in process of assembling 3 different vendor coalitions. HDO (15% of purchasing in US); now starting to recruit vendors (Platform Technology Partners, Healthcare Device Vendors, Apps vendors). Initial meeting of 13 vendors was held. 1 day meeting – presentations from C4MI to address issues with interoperability; vendor presentations; next steps. . Pulling together a similar meeting with device vendors in mid-summer (July). . Goal of overall effort is to create reference architecture for interoperability and create test and certification around those protocols. . Expect to have consensus reference architecture by end of 2016. . Reference architecture is anticipated to be general as a start, but can include content that covers gaps with existing SDO standards. A reference architecture that could include multiple different protocols based on use case. . MDI Security – J. Wittenber o Overlaps multiple SDOs and few are aligned. o PHD has lead in developing profile under its Tiger Team. 20601 does not have controls for security. Therefore, Tiger Team now has produced a whitepaper, risk management template, and minimum set of threats to an insulin pump and remote controls of settings to a device. Now looking at implementation alternatives for security controls. o Intend to develop a “tool kit” adjunct to normative specification. o Whitepaper from AAMI UL 2800 on attributes for necessary security properties for system safety. . Optimized Association – J. Wittenber o Optimization of Association function is high[est] priority of 20101 revision o Alternatives analysis has been done and will be updated in inter-meeting period . UDI Update – J. Wittenber o Several standards groups working on this, incl. HL7, IHE PCD, IEEE 11073 PHD o HL7: Working on Use Case Models and format definition (distributed for comment) o General recommendation is for a system component, such as medical device, to maintain a textual representation of the overall UDI and a representation of UDI components. o Still determining recommendation for retaining embedded device/component UDI’s. o Other groups seem to be intending to use HL7 recommendations.

 Motions o None

 Action Items o None

12 Wednesday – Q1, May 11, 2016

Q1-Specific Participants (19)

 Recurring Participants from Q1 on Monday  Stefan Schlichting  David Gregorczyk  Michael Faughn  Brian Rheinhold  Malcolm Clarke  Michael Faughn  Kathryn Bennett  Koichiro Matsumoto  Tracy Rausch  Björn Andersen  Martin Kasparick  Yongji Fu  Jan Wittenber

Minutes from Q1

 Summary o OpenICE Update (T. Rausch): . Transition to AAMI  ASTM has transitioned 2761 to AAMI. 2761 will be extended in the AAMI Interoperability Work Group.  The Forensic data logger will be the first NWIP to be considered at the June 2016 meeting of the AAMI Interoperability Work Group . DIM impacts  New terms, Care Provider, Operator  QoS configuration  New HL7 Objective Care Provider concept . Communication Design Pattern (Objective/State with DDS)  Current State  Request Objective State  Objective State  Durability QoS policy  History QoS policy . Committee Discussion Points  Is Equipment in scope of 11073?  Is App (device as software) in scope of 11073?  How will 11073 deal with devices as “software”? . Representing queries from DocBox, MDPnP, and ICE Alliance.

13 o Dialysis System (IEEE P11073-10316) (J. Wittenber): . Dialysis group was active back in the 1990s. A first draft of Project 10316 was created for review by this industry. Market participants consolidate to approximately 4 major vendors. . Over the last 5 F2F meetings discussions have occurred to re-submit a PAR request to IEEE SA to initiate this standard. . Dialysis group is also interested in IHE PCD and FHIR based solutions. . A worksheet has been completed by the Dialysis group to document the information objects and related information of the containment model. . Approximately 200 information objects have been defined. These information objects may have implications to the DIM change request process. . “MDIDs” are now being defined. o No deliverables milestones are yet established.  Motions o None

 Action Items o Provide proposed redline to PoCD WG content for DIM standard (11073 -10201) to address issues raised by ICE modeling issues – T. Rausch o Provide url to T. Rausch for change request entries to DIM – J. Wittenber

Wednesday – Q2, May 11, 2016

Q2-Specific Participants (16)

 Recurring Participants from Q1 on Monday  Stefan Schlichting  David Gregorczyk  Michael Faughn  Brian Rheinhold  Malcolm Clarke  Michael Faughn  Kathryn Bennett  Koichiro Matsumoto  Yongji Fu  Jan Wittenber

Minutes from Q2

. Summary . PHD Terminology in RTMMS o Question was originally presented in Orlando, and was then re-visited in the IHE PCD F2F. o Defer to Q3.

14 . Overflow Topics o None

. 11073 Roadmap Planning (see chart from J. Wittenber) o 00xxx o 103xx o 102xx o 101xx o 2xxxx o 3xxxx o EMB/11073 Work Program Status as of 14 Jan 2016. Key decisions include: o PARs (3): 10101, 10102, and 20101 – publication termination dates are end of 2018; scope could range from re-affirmation to newly introduced content. o For 10101, we have addenda a, b, c. Should this revision include 10101 a, b, c? Is it feasible to incorporate this content by end of 2018? We must incorporate at least in 10101, 10101a. IEEE SA currently starting the “roll-up” document. Expected completion is TBD. o Decision: incorporate 10101b into the roll-up. o Decision: deadline draft roll-up document to support Dec. 2017 pre-Connectathon; by Feb 2018 for ballot. RevComm deadline for July xx, 2018. RevComm teleconference in TBD. o Decision: make final decision on the proposed roadmap at next IEEE 11073 PoCD WG meeting.

. Adjourn IEEE 11073 Meeting o Meeting is adjourned.

. Motions o Motion to adjourn the IEEE 11073 PoCD WG meeting by Fuchs; seconded by Garguilo: passed unanimously

. Action Items o Ask for extension for 10101 PAR: J. Wittenber o Ask for extension for 20101 PAR: J. Wittenber o Preparation of graphic to clarify the key milestones for document completions, ballot starts, and RevComm approvals: K. Bennett o Schedule Leadership web-conference to address several governance votes: K. Fuchs (needed before NESCOM (5/20) meeting or (8/5) NESCOM telecon).

Wednesday – Q3, May 11, 2016

Q3-Specific Participants (18)

 Recurring Participants from Q1 on Monday  Stefan Schlichting

15  David Gregorczyk  Michael Faughn  Brian Rheinhold  Malcolm Clarke  Michael Faughn  Kathryn Bennett  Koichiro Matsumoto  Yongji Fu  Jan Wittenber  Clem McDonald  John Walsh

Minutes from Q3

. Summary  Updates from HL7 Co-chair meeting o Deferred to Q4

 ISO 8601 (see presentation from M. Clarke) o Proposal for HL7 to replace definition of date/time (DTM) in A.2.22 – HL7 Infrastructures and Messaging WG o Adopt ISO 8601 with definitions as o Local time only: HHMM o Local time plus offset to UTC: UTC-HHMM±ZZZZ o Special case (Iceland/UK in the Winter) . Local time plus zero offset to UTC-HHMM+0000 o UTC only: HHMM-0000 o Note a CP will be required to include this in IHE PCD DEC. o Reference RFC# 3339

 Object Hierarchy Containment Tree (M. Clarke) o In doing a high-level architecture in PHD, a manager will have a full representation of all the agents connected to it. o Each agent of the manager will have an MDS.

. Motions  Endorse proposal for HL7 to adopt ISO 8601 definitions of time - offered by Clarke and seconded by Reinhold: passed – 1 abstention, 11 yes, 0 oppose

. Action Items  None

Wednesday – Q4, May 11, 2015

Q4-Specific Participants (16)

16  Recurring Participants from Q1 on Monday  Stefan Schlichting  Michael Faughn  Brian Rheinhold  Malcolm Clarke  Koichiro Matsumoto  John Walsh  Matthew Graham  Beth Pumd  Alexander Mense  Ioana Singureanu

Minutes from Q4

 Summary

Hosting Mobile Health (Graham)  mFAST o Short messaging strategy; going to ballot in next ballot cycle as a white paper o Project lead is Nathan Botts, PhD. o Provide standards for communicating health information with “short messages” o Low-cost, low infrastructure, low learning-curve o Use Cases: diabetes, smoking cessation, weight management, et. al. o Immunization use case o Barrier for adoption

 Consumer Mobile Health Functional Framework – CMH2F o Overview of project scope and project need o Project lead is Gora Datta o Define security, privacy, and data control standards for secure mobile health apps o How to interact with PHR and EHR systems o Jan. 2016 Ballot o MH Listserv Discussions

 FHIRframe (Phase 0) o Background  Development of mobile APIs  100,000 Health Apps already for IOS platform  165,000 mobile apps in the world today; on 12% account for 90% of downloads  What is the problem statement? How to provide interoperability from mobile device to EHR/PHR capture.

17 o Liaisons  Working with Continua  Tom Ericsson (BT SIG) and mobileHealth SoU – HL7 HQ has prepared a SOU with the BT SIG. o Current Status  Project lead is Dr. Christopher Doss  Project Need  Strategy  Meeting details - Mobile Health Weekly Friday calls 11:00 ET

 Wiki page  PSS approved on 9 May 2016 with comments o Request liaising with IEEE 11073/HL7 HCD  PSS to be distributed to HCD shortly; addressing comments from HL7 Steering Committee  PSS scaled back to literature survey; PSS to be distributed  Indirect impact on Continua wrt to FHIR and the WAN and HRN interfaces.

Object Hierarchy Containment Tree (M. Clarke)  In doing a high-level architecture in PHD, a manager will have a full representation of all the agents connected to it.  Each agent of the manager will have an MDS.  Is METRIC an object from 20601 or is it a measurement?  What is the purpose of the provided text? What problem is it trying to solve? What does the 4th level of OBX notation mean?

IHE PCD Update . Deferred to Q2 on Thursday

Updates from HL7 Co-chair meeting . Deferred to Q2 on Thursday

HL7 Projects Update  Anesthesia Work Group (AWG) Discussion – J. Walsh o Proposal to re-activate CDA for Anesthesia Record project o Domain Analysis Work on the Anesthesia Record – outline identified; expect to have DAM by Jan. 2017 Work Group Meeting. o State of work Group – Yellow: Having difficulty to convene all members. Work Group meets ad hoc, not regularly now. o Feedback from HL7 Board to work under HCD – no new information.  Review of Administrative HCD Documents (J. Rhoads) o Mission . Revising to address HL7 product lines . Expanding list of SDO relationships . Consistency with Service Aware Framework . Revisions to list of organization relationships

18 o Charter . Adding relationship with HL7 Security WG . Adding relationship with IHE International o SWOT . Deferred to Q2 Thursday o Decision-Making Practices . Deferred to Q2 Thursday

 Motions

o To approve updates to Mission and Charter changes as discussed in this session – offered by J. Garguilo and seconded by K. Fuchs: passed unanimously

 Action Items:

o Reconvene on web-ex a follow-up discussion on Object Hierarchy Containment Tree to frame problem or to define actions: J. Rhoads o Distribute xml of an illustration of the Containment model to facilitate understanding of the meaning of the Object Hierarchy Containment Tree: P. Schluter

Thursday – Q1, May 12, 2016

Q1-Specific Participants (15)

 Recurring Participants from Q1 on Monday  Koichiro Matsumoto  Jan Wittenber  Stefan Schlichting  David Gregorczyk  Ewout Kramer  Björn Andersen  Adamu Haruna  Arvind Jagannathan  Chris Courville

Minutes from Q1

 Summary o J. Rhoads was re-elected as a HL7 Co-Chair. o Hosting FHIR WG (HL7 HCD Project #1103) o Overview of DSTU3 release plan: targeting end of Dec. 2016; July 2016 deadline for submitting any DSTU2 defect tickets

19 o Review DSTU2 Resources on HL7 website o Review of DEV Resources and Maturity Metric o Review of GForge tickets on DEV Resources o Plan for prototyping and FHIR Connectathon o Investigating replacement of GForge ticketing system; possible candidate is Jira. Usability comments were motivation to consider replacement.

o Results of Co-Chairs Meeting (9 May 2016) – J. Rhoads/J. Garguilo . Review of TSC activities and decisions . Definition of “substantive change” . Harmonization meetings – consistency alignment of terminology across HL7 WGs . How to start an HL7 project – new version of PSS template . Steering Division Meeting – Domain Experts Section, voting on Mission and Charter Statements from the different WGs. PSS vetting. . Responsible for posting agenda 1 month in advance. Revised agendas should be posted on the Wiki page and on the meeting bulletin board

 Motions o None

 Action Items: o Conduct planning for FHIR Connectathon of DEV resources for Sep 2016: Courville, Schlichting, Rhoads, Reinhold o Supply Ewout Kramer with a list of codes to be included in FHIR for DEV: Rhoads o Follow-up with Reinhold comment on GForge: Garguilo o Confirm consistency of links on DEV wiki to align with TSC requirements: Rhoads

Thursday – Q2, May 12, 2016

Q2-Specific Attendees (10)

 Recurring Participants from Q1 on Monday  Koichiro Matsumoto  Jan Wittenber  Stefan Schlichting  David Gregorczyk

Minutes from Q2

 Summary o Dialysis Support Update (J. Wittenber) . See posted presentation

20 . Past overview of P1073.1.3.16 in 2005 . Current standardizations effort (last 90 days) . Business motivations for interoperability between dialysis machines and infusion pumps, and between dialysis machine in EHR/PHR . Dialysis Center Use Case . Informatics approach – begin with data dictionary leveraging IHE PCD infusion pump model – will use RTMMS and device profiling tools . Identification of MDS, VMD, containment tree . Now starting project in 11073 with PAR submission . Unclear if there will be a HL7 PSS or if FHIR resources are needed. . Anticipate implications to IHE PCD with the data dictionary. . Most informatics content is housed in the Dialysis host.

o HL7 Organizational Topics (J. Rhoads) . SWOT Update  Specifying examples of interworking with other WGs and SDOs for devices  Facilitate harmonization relative to FHIR for stakeholders interested in DEV  Establish ties with HL7 Security WG  Leverage DEV as an incubator for emerging standardization topics within HL7 . Decision-Making Principles Update  Currently use HL7 default best practices  Default quorum rule: 1 co-chair and 2 independent members

. HL7 Roadmap Planning  Dialysis  Anesthesia WG  Motion to consolidate project 850 and 1153  FHIR

 Motions o Authorization for J. Rhoads to prepare and submit updates to the SWOT and other administrative WG collateral, based on input from WG discussions during this F2F meeting cycle, on behalf of the WG provided by Garguilo, seconded by Schluter: approved unanimously (7-0). o Re-adopt our existing decision-making practices, so as it is aligned with the current HL7 template provided by Garguilo, seconded by Schlichting: approved unanimously (7-0). o Identify a sub-group that has responsibility for driving FHIR adoption with HL7 DEV: Courville

 Action Items o None

21 Adjourn Meeting

o Motion to adjourn – offered by Wiley seconded by Garguilo. Motion passed unanimously.

22