PCD PC&TC 2010-10-18 to 22 F2F

Meeting Objectives

These face-to-face meetings have a number of objectives depending on the committees involved:

• Planning Committee: Review overall PCD activities, review Cycle 6 proposals
• Technical Committee: Review all materials slated for publication Fall 2010 and resolve any issues so that final editing and publication may proceed.

Location

Meetings will take place at ECRI Institute, 5200 Butler Pike, Plymouth Meeting, PA 19462.

https://www.ecri.org/About/Visiting/Pages/Directions.aspx (610) 825-6000

Please reserve a place at the table as early as possible so that logistical planning can accommodate your attendance. Send your anticipated arrival and departure dates/times, cell phone number and hotel to Manny Furst. If you would like more information contact Manny.

Many in the group will stay at the Marriott Courtyard, 651 Fountain Road, Plymouth Meeting, PA 19462.

Related Documentation

The current version of the Technical Framework: http://www.ihe.net/Technical_Framework/index.cfm#pcd

Work Item Proposals: http://wiki.ihe.net/index.php?title=PCD_Proposals_Cycle_6

IHE Webinars related to Profiles in all domains, the upcoming Connectathon and Showcase: http://www.ihe.net/Events/webinars2010.cfm

Schedule & Agenda

Daily Schedule

Meeting generally runs from 8:30 to 5:00 PM

Monday - 08:30 - 10:00 is an introductory meeting.

- Official meeting start is 11:00.

Friday - Meeting adjourns at 12:30.

General Schedule:

08:00 - 08:30 Meet at ECRI Institute

08:30 - 10:30 Session #1

11:00 - 12:30 Session #2

12:30 - 13:30 Lunch (location to be announced)

13:30 - 15:00 Session #3

15:30 - 17:00 Session #4

NOTE: Friday the meetings will end by 12:30.

Date	Hours	Committees	Topics
Monday Morning 2010.10.18	08:30 - 10:30	New Attendees, ECRI Staff, Visitors	Introduction to IHE and the PCD Domain
Monday 2010.10.18	11:00 - 17:00	PCD Planning Committee	Greeting & Introductions - Introduce the Cochairs (Election Review) Introduction and orientation to the IHE and PCD for Regional Interested Individuals Review & Approve Agenda IHE IP Management Process Impedence Matching Review Current PCD Program: - Roadmap Review - Schedule / Milestones Review - Active Profiles - Medical Device Aquisition (Guide) - Continua Coordination - White Papers Cycle 6 Brief Profile Proposals Lunch Cycle 6 Brief Profile Proposals Web / wiki / FTP Review
Tuesday Morning 2010.10.19	08:30 - 12:00	PCD Planning and Technical Committees	- Introduce the Cochairs (Election Review) IHE IP Management Process PCD Marketing & Funding Roadmap & Schedule Technical Framework Final Text Discussion Technical Framework process for Change Proposals LUNCH
Tuesday Afternoon 2010.10.19	13:00 - 14:00	PCD Planning and Technical Committees	Tour of ECRI Facility
Tuesday Afternoon 2010.10.19	14:00 - 17:00	PCD Planning and Technical Committees	IHE IP Management Process Technical Framework Final Text Discussion 2011 HIMSS Showcase Discussion 4 PM T-con PCD Showcase Planning
Wednesday Morning 2010.10.20	08:30 - 12:00	PCD Technical Committee (TC)	IHE IP Management Process Test Tooling: Connectathon & Beyond... - Tooling update - NIST HL7 V2, RTMMS (ISO-IEEE x73, SNOMED CT, LOINC) - Test Agents (Cycle 6; 2010-2011) - Message Wrapper(s) Discussion
Wednesday Afternoon 2010.10.20	13:00 - 17:00	PCD TC WG Meetings	IHE IP Management Process General topic of "Really Consistent" system time and time error propagation: what refinements are needed, when is defined worst-case maximum time error in whole system crucial? (2:00 Webex) Device-Patient Association Use Cases and Issues How to report data when the patient is unknown (Jeff Rinda) ECM: Event Communication Management (preliminary name) - Infusion Pump Event Communication (Jeff Rinda) - Generalizing Event Communication (Rhoads) - How do existing receiving systems use (1) aperiodic measurements (2) general events? - How will this change in the future with additional clinical decision support capabilities?
Thursday Morning 2010.10.21	08:30 - 12:00	PCD TC WG Meetings	IHE IP Management Process General Profile Update Reports - WCM: technical discussion (Fuchs - 1 hr) - ACM review and prospect: (Pattillo) - RTLS: Industry Status Update (Pattillo) - DEC: Future refinements and capabilities; strengthing event handling (?) - RCT: More on time management and "Really Consistent Time" - use cases, DEC enhancements for time management - MEM: how much can we do with DEC? - Security: requirements, time frames - SNMP et al.: Network Configuration Management needs? Flexible network discovery and configuration? - WS*: strategy for using "quasi-standards"
Thursday Afternoon 2010.10.21	13:00 - 17:00	PCD TC WG Meetings	IHE IP Management Process Other updates - (1:30 Webex) Domain Analysis Model / Detailed Clinical Models for Medical Devices (Singureanu and team) - Device Point-of-Care Integration / Integrated Clinical Enviroment / Rapid Device Configuration - HL7 / IEEE 11073 meetings in Cambridge (Rhoads) - General Overview of Activities in Personal Health Devices: 11073-20601 Personal Health Device standards, Continua status (Schluter) - Korea 2010 Slides Report from IHE Int'l Board Meeting (earlier in the day) Asynchronous Data Query - can general data query be strengthened to accomodate it? Public Review Process Discussion Quo Vadimus? What is the long term PCD Vision? Do we have one? Need to get one? Is "certification" crucial? If so, how do we get there from here?
Friday 2010.10.22	08:30 - 14:00	PCD Technical Committee	IHE IP Management Process ECRI Pump Safety Discussion: (Erin) SOA Discussion: WP Development? TF Appendices: OID Usage Cycle 6 Work Program Review Any technical items we still haven't discussed Planning Wrap-up 2011 F2F Meeting Planning 2011 International Connectathon and Showcase Plans? Review Deadlines for Supplements, Connectathon Minutes / Resolutions / Action Item Review

Attachments / Materials

Ken Fuchs - IHE PCD Introductory Presentation

Folder for Presentations from 2010 October meetings at ECRI, Plymouth Meeting, PA

EventComm subfolder

PatientDeviceAssociation subfolder

[1] contains:

Excel spreadsheet has table of contents for MEM Security WP

ACM Update folder

Event Communication folder

NIST Presentations folder

Patient Device Association folder

Rosetta Update folder

Other Presentations

Participants

Monday: Participants in the regular meeting, following the orientation:

• Terry Bettis, Jon Blasingame, Anupriyo Chakravarti, Brett Cohen, Bikram Day, Al Engelbert, Ken Fuchs, John Garguilo, Khalil Maalouf, Sandra Martinez, Steve Merritt, Robert Neff, Monroe Pattillo, John Rhoads, Jeff Rinda, Paul Schluter, Ioana Singureanu, Elliot Sloane, Erin Sparnon, Richard Swim (representing AAMI), Richard Tevis, Scott Zaffrin, John Zaleski ,Vaughan Zakian, Manny Furst. Participants introduced themselves.

Tuesday:

• Terry Bettis, Jon Blasingame, Anupriyo Chakravarti, Brett Cohen, Bikram Day, Al Engelbert, Ken Fuchs, Colin FX Garstka, Khalil Maalouf, Barb Majchrowski, Robert Neff, Monroe Pattillo, John Rhoads, Jeff Rinda, Paul Schluter, Ioana Singureanu, Elliot Sloane, Erin Sparnon, Richard Swim, Vaughan Zakian, Manny Furst.

Wednesday:

• Terry Bettis, Jon Blasingame, Anupriyo Chakravarti, Brett Cohen, Bikram Day, Al Engelbert, Ken Fuchs, John Garguilo, Colin FX Garstka, Chris Lavanchy (ECRI Institute), Khalil Maalouf, Sandra Martinez, Monroe Pattillo, John Rhoads, Jeff Rinda, Paul Schluter, Ioana Singureanu, Elliot Sloane, Erin Sparnon, Richard Swim, Kristina Wilson, Vaughan Zakian, Manny Furst.

• Device-Patient Association Webex: Gary Meyer led discussion and these others participated via Webex: Robert Britton, Eric Chetwynd, Robert Flanders, Sarah Hopkins, Roger Kittelson, Brad Lunde, Nuno Pino, Greg Scott, Lee Suprenant, Khalid Zubaidi.

Thursday:

• Terry Bettis, Jon Blasingame, Anupriyo Chakravarti, Bikram Day, Al Engelbert, Ken Fuchs, John Garguilo, Khalil Maalouf, Sandra Martinez, Robert Neff, Monroe Pattillo, John Rhoads, Jeff Rinda, Paul Schluter, Ioana Singureanu, Erin Sparnon, Kristina Wilson, Manny Furst.

- Jay Lyle (Department of Veterans Affairs) participated in the afternoon via Webex.

Friday:

• Jon Blasingame, Bikram Day, Al Engelbert, Ken Fuchs, John Garguilo, Khalil Maalouf, Sandra Martinez, Monroe Pattillo, John Rhoads, Paul Schluter, Ioana Singureanu, Erin Sparnon, Manny Furst.

Parking Lot (temporary)

• Our Entity Identification needs

MSH-3 and EUI-64

subproblem: cross-domain identifiers

other fields

• Review Tuesday's 2011 HIMSS Showcase After Hours Discussion

Action Item Summary

Template: will be completed following Wed. Oct. 27 meeting.

F2F Number	Action	Owner	Participants	Due Date	PC or TC or Closed?	Comments
1	SAMPLE ITEM 1	MF	GH	6/1/08	OPEN	none
2	SAMPLE item 2	IK			CLOSED
3
4
5
6
7
8	sample n	ST	UV	9/1/08	OPEN
9	sample n	ST	UV	9/1/08	OPEN
10	sample n	ST	UV	9/1/08	OPEN
11	SAMPLE ITEM 1	MF	GH	6/1/08	OPEN	none
12	SAMPLE item 2	IK			CLOSED
13
14
15
16
17
18	sample n	ST	UV	9/1/08	OPEN
19	sample n	ST	UV	9/1/08	OPEN
20	sample n	ST	UV	9/1/08	OPEN
21	SAMPLE ITEM 1	MF	GH	6/1/08	OPEN	none
22	SAMPLE item 2	IK			CLOSED
23
24
25
26
27
28	sample n	ST	UV	9/1/08	OPEN
29	sample n	ST	UV	9/1/08	OPEN
30	sample n	ST	UV	9/1/08	OPEN

Discussion Monday October 18 (Planning Committee)

Discussion Summaries do not require formal approval, while minutes of meetings where votes are taken do. Participants are encouraged to review and bring up significant issues with discussion summaries of previous meetings. Votes will be taken to approve meetings where votes took place; these may be email ballots.

Item	Topic	Discussion
1	Orientation - Chair	Status/Discussion: The cochairs welcomed participants and presented an introductory session for those new to PCD and those interested, in person and over Webex (Al Gould). The slides are available at ftp.IHE.net/Patient_Care_Devices/Presentations Decisions/Issues: Action(s):
2	Introductions, Agenda Review and Intellectual Property Policy - Ken Fuchs	Status/Discussion: The regular meeting convened at about 11:10 am with review of the Planning Committee agenda. Participants in the regular meeting, following the orientation: Terry Bettis, Jon Blasingame, Anupriyo Chakravarti, Brett Cohen, Bikram Day, Al Engelbert, Ken Fuchs, John Garguilo, Khalil Maalouf, Sandra Martinez, Steve Merritt, Robert Neff, Monroe Pattillo, John Rhoads, Jeff Rinda, Paul Schluter, Ioana Singureanu, Elliot Sloane, Erin Sparnon, Richard Swim (representing AAMI), Richard Tevis, Scott Zaffrin, John Zaleski ,Vaughan Zakian, Manny Furst. Participants introduced themselves. - Participants in the orientation who did not participate further on this day: Jim Keller, John DeGrandpre. - Ken Fuchs chaired the meeting. Ken provided the slides and presented the IHE Intellectual Property policy. Ken described the IHE process and workflow leading from ideas and concepts to projects and technical solutions. IHE USA: Elliot described the current status of IHE USA, where he is a member of the board. It is set up as a 501 (c) 3 organization and is now a separate organization. The IHE-USA is a national deployment organization, will have its own organization and role to play, and will launch a website next month. National deployment organizations will be responsible for the national differences as well as Connectathons that take place in its borders as well as related activities. There are likely to be membership fees. Decisions/Issues: Agenda approved Action(s):
3	PCD Roadmap - Ken	Status/Discussion: PCD Roadmap: Ken then reviewed the current version of the PCD Roadmap, offering suggestions for changes to reflect current efforts before proceeding to develop the updated version. He noted that the schedule posted to ihe.net should be updated and Cycle 6, 2011 schedule added. He noted that links to Profiles in development. John Rhoads added that the RDC effort has sufficient overlap with the RDC effort (largely focused on ventilators) to enable combined, cooperative effort. This is an extremely complex and difficult effort. IDCO has posted the nomenclature for IEEE ballot. MEM WP is largely done, and TI Supplements are in development. PIV is addressing Event Communication which will later support other profiles. RTM is extending parameters and the Continua LAN tables will become available. WCM will be discussed this week and readied for TI. Decisions/Issues: Action(s):
4	Work In Progress - Ken	Status/Discussion: Implementation Guide: John Garguilo described this as a needed “how-to” guide for vendors to help them develop code, to help interpret and understand constraints within standards and TFs. Other domains have looked at this, but none have begun development. Medical Device Acquisition Guide: Erin indicated that work continues on developing RFPs for various device types. Continua Coordination: Paul described their work to develop alarm communications, largely motivated by the UK’s NHS. He expressed hope that RTM table for this purpose will result in common PCD/Continua compatibility. MEM WP: Steve described the six functions and use cases, with proposed timeline for development. Two brief profile proposals follow this week (below). Decisions/Issues: Action(s):
5	Web/Wiki/FTP reviews -	Status/Discussion: Domain Name: Ken noted that various documents, files, web sites, etc. have the domain name as singular and plural. Today’s discussion indicated the preferred name will be the plural in the future (Patient Care Devices). Integration Statements: - Ken noted that potential purchasers have to devote much effort to learn about a product’s conformance, and this is not desirable. There are many ways to obtain information, but many are incomplete and require further research. Comments from others noted that users are not likely to know where to look and what to look for. - The Integration Statement is only an attestation that your system meets the requirements; it does not mean successful Connectathon testing but can provide a link to Connectathon results. Ken asked how to make information readily available: how does a purchaser know what is conveyed in the statement? He noted that this issue is also critical for vendors: once companies test a profile a number of years they may not continue, and this would remove opportunities for new vendors to test against partners. Manny and Paul suggested that the statement include additional information about where and what was tested. Elliot suggested that more frequent opportunities to test, the use of virtual Connectathons, etc. will make changes necessary. He added that the international applications further complicate the issues. - Extensive discussion followed, with issues of policy and participation, addressing motivation, costs, necessity to test new profiles/options, etc. There are a number of reasons why an active vendor may no longer participate in addition to costs: e.g., as a vendor and system adds profiles and options, time at the Connectathon may not be sufficient to test a profile again. The PCD domain may need to lead the way to assure that users can easily and intelligently purchase systems and new vendors will have test partners and be able to indicate implementation and marketing devices/systems. - Paul suggested that vendors need to at least participate in Virtual Connectathons between Connectathons or following a minimum number of in person Connectathons. - John Rhoads suggested that PCD begin by defining minimum information to be included in the Integration Statement. He further suggested that PCD develop a supplementary statement. - Steve noted that most PCD vendors that have participated are not listed in the existing directory (http://product-registry.ihe.net) . Apparently, most systems are not yet commercially available even though the vendors have multiple years’ experience in testing. - Ken suggested that this needs to be taken to the Domain Coordination Committee. - Elliot noted that NIST will certify the certification bodies. Decisions/Issues: Action(s): Action Item: PCD will establish a group to develop the PCD Supplement to the Integration Statement.
6	Profiles and White Papers to be considered for Cycle 6 - Ken, Steve Merritt	Status/Discussion: Existing profiles to be considered for Cycle 6 (see link, above): - DPI: No work has been accomplished in Cycle 5. - Device Integration Profiles Guidance: No work has been accomplished in Cycle 5. New or updated/reconsidered profiles: - Location Tracking: ITI was asked to participate, but did not made this a priority. PCD developed requirements, use cases. This wasn’t a priority in the past due to lack of RTLS vendor resources. Steve Merritt has gathered a group of RTLS and CMMS system vendors to develop the Supplement or to repurpose an existing profile.Monroe suggested an additional use case: when an alarm is sent (PCD0-04) the location will be included. - Query for Bulk Data: Ken described the use cases. Elliot suggested changing “forensic” to “archival”. Jon suggested that this can also be used in an investigation of an adverse event. - Device to Patient Association (PoC ID Management): Richard Swim indicated that this is a big issue for Baylor and the loss of data. Robert Neff noted that it is important that data be associated with the correct patient. John Rhoads noted that PCD-01 requires patient id, but there are complications with adding and removing devices. From the Parking Lot: - Asynchronous Data Query: Ken suggested that QBD should be able to meet this need. Discussion addressed time stamps and enterprise time which may differ and will need to be considered. Discussion followed regarding how devices would communicate their time accuracy (when, to which synchronized, etc.). Ken asked if time management should become a separate work item. - MEM: Aspects other than those discussed above are deferred. - Enterprise ACM: Will remain deferred. Existing White Papers to be considered for Cycle 6: - DPI - Semantic Architecture (Todd will provide introduction in TF Volume 3 TI version). - Regulatory Considerations will be covered in a 510K to FDA for a virtual device. The idea is to help develop the FDA’s criteria for their requirements for 510K submissions of complex devices which are systems of systems and may be closed loop. This is not an IHE effort, but will address issues that had been anticipated for this WP. Sandy Weininger and John Murray of the FDA are involved. New White Papers: - Medical Device Cybersecurity: this is fairly well along. Decisions/Issues: Action(s): Additional use case for RTLS – provide location of patient in PCD-04. Manny to draft ballot for prioritizing the work.

Discussion Tuesday Morning, October 19 (Joint Planning and Technical Committees)

Discussion Summaries do not require formal approval, while minutes of meetings where votes are taken do. Participants are encouraged to review and bring up significant issues with discussion summaries of previous meetings. Votes will be taken to approve meetings where votes took place; these may be email ballots.

Item	Topic	Discussion
1	Introductions, Agenda Review and Intellectual Property Policy - Chair	Status/Discussion: Ken chaired the morning meeting, repeating the IP management process. Decisions/Issues: Agenda approved Action(s):
2	Marketing IHE and PCD - Erin	Status/Discussion: Erin indicated that she is participating in the IHE marketing effort. Elliot described Connect – the federal agencies that came together to comply with government standards for healthcare decided to collaborate with open standards work rather than develop their own. Elliot is on the steering committee, and has advocated PCD’s work. The group includes CMS, FDA, CDC, NASA, Social Security and others; www.connectopensource.org. A number of companies and state HIEs are collaborating with Connect. He noted that PCD collaboration with Connect would be worthwhile. They sponsor student activities and Elliot included a PCD component in this year’s competition. They also participate in the HIMSS Showcase. David Reilly is the Director, Greg Fairnak is the chief architect (http://www.gov2expo.com/gov2expo2010/public/schedule/speaker/75861 and http://www.interoperabilityshowcase.org/himss10/docs/summary/NHINandCONNECTProject/Connect%20Project%20Educational%20Sessions%20Brochure.pdf). Ioana added that Continuity of Care was the focus of the last presentation of David Reilly’s that she heard. Elliot offered to share PCD information at the upcoming European research group as well. Decisions/Issues: Action(s):
3	Funding - Ken	Status/Discussion: Ken summarized the source of PCD’s funds and the desire to secure additional funds from AAMI and ACCE to support staffing to enable faster progress. Jon is leading the ACCE marketing effort and is seeking funding for a variety of ACCE activities. ACCE will be recruiting corporate members. Discussion continued about the potential collaboration that PCD can provide to benefit vendors with AAMI and HIMSS. Discussion revealed that AAMI’s position on standards for interoperability is significantly different from IHE’s. Decisions/Issues: Action(s):
4	Roadmap and Schedule: - Ken	Status/Discussion: Glossary may no longer be needed; has been addressed by others? Note that the IHE Domain Cochairs will be sensitive to consistency across domains. PCD-01 will be in Final Text (FT) for the first time in Cycle 5 (existing cycle). PCD-02 will likely not reach FT until Cycle 6. Alarm Communication Management (ACM) components: AC in cycle 5, AM to AR in cycle 6, AA in cycle 7. Device Content Management: Patient – Device Binding: PIB was removed in favor of a new effort – Device Patient Association Medical Equipment Management (MEM): WP in cycle 4, Security WP in cycle 5, Point of Care PIB (ITI Bar Coding?), RTLS starting in cycle 5. Future areas of attention: Patch Management, Battery Management, Operational Status, … Device Point of Care Integration (DPI): A number of items are on the existing roadmap, but have not been addressed. John Rhoads noted that work with ICE-PAC will include some aspects of PoC. ICE-PAC and DPI have been tightly tied. All items will be retained, but delayed. Content Management: Rosetta Terminology Mapping Project is moving forward and will eventually be transferred to NIST. Several specific areas of development are noted. Volume 3 of the TF will include a portion of what had been included the Semantic Architecture WP. Device Document Template (Volume 3) and Device Specializations are placed in cycles 6-8. Device Extra-Enterprise Communications: These are in support of Continua’s, CMS’s, VA’s efforts related to home care. Elliot noted that FCC and CMS have allocated funds related to home care and commissioned a study. ONC and FDA are coordinating as well. Device Order Management: Pump group items remain. Quality: Nothing at this time. HL7 version 3 and CDA are placed in cycle 7. Elliot suggested that PCD identify a way to work with ONC on devices. Decisions/Issues: Action(s): Manny to check with Steve Merritt regarding whether the Glossary is still needed. Promoting PCD to ONC: The PCD cochairs will send an email to Joyce and Elliot will speak with her, to set a discussion to promote PCD’s seat at the table. Update PCD_Schedule Wiki page. Verify that all proposals are on the ftp site: email received after the meeting from Steve Moore urgently requested that Proposals be placed on the ftp site.
5	IHE and PCD Process - John Rhoads	Status/Discussion: John Rhoads reviewed the IHE processes, noting the various responsibilities and requirements. These can be found on the IHE Wiki from the Process link on the left. Specifically, the transition of the Technical Framework (TF) from Trial Implementation (TI) to Final Text (FT) is relevant to the current effort. The TF TI was recently updated and published. The TF FT is now available for review; the PCD needs to issue a ballot. - The Wiki Main Page link to Process is at http://wiki.ihe.net/index.php?title=Process Decisions/Issues: Action(s): Manny will prepare and send ballots for the FT versions. These will go to the TC and, following approval, to the PC.
6	The Joint Planning and Technical Committee adjourned. - Ken	Status/Discussion: Decisions/Issues: Action(s):

Discussion Tuesday Afternoon, October 19 (Technical Committee)

Discussion Summaries do not require formal approval, while minutes of meetings where votes are taken do. Participants are encouraged to review and bring up significant issues with discussion summaries of previous meetings. Votes will be taken to approve meetings where votes took place; these may be email ballots.

Item	Topic	Discussion
1	Tour of ECRI Institute - Erin	Status/Discussion: The meeting resumed following the tour. There was no need to repeat the IP policy. No additional people were present. Decisions/Issues: Action(s):
2	Connectathon, Pre-Connectathon and Showcase - Manny	Status/Discussion: Manny provided an update on Connectathon, Pre-Connectathon and Showcase Registrations brought new companies, new parameters (hearing screening). PCD members agreed to support the parameters to enable testing and demonstration while not within their business plans. Pre-Connectathon tests will hopefully be available around November 1. Connectathon tests will follow. Showcase demonstration will not include IDCO. The fourth wall could be Meaningful Use; we will need volunteers to develop that use case. It will include appropriate devices. When time permits, a review and update of devices/systems registered following the official deadline may reveal an opportunity to add a scenario with Continua. Similarly, there may be one or more DOCs implementing PCD-02 – which had not been the case up to the deadline. John Rhoads recommended that participants arrange to penetrate their firewall when possible. John Rhoads asked, and participants agreed that HL7 v2.6 is the version for testing this cycle. Decisions/Issues: Action(s):
3	Entity Identifier - yyy	Status/Discussion: Entity Identifier: The TF had stated a preference for EUI-64. Others are accepted, and should be a universal ID as shown in the HL7 table. Decisions/Issues: Action(s):
4	Agenda for Remaining Days - John Rhoads	Status/Discussion: John Rhoads described the agenda for the rest of the week. Decisions/Issues: Action(s):

Discussion Wednesday October 20 (Technical Committee)

Discussion Summaries do not require formal approval, while minutes of meetings where votes are taken do. Participants are encouraged to review and bring up significant issues with discussion summaries of previous meetings. Votes will be taken to approve meetings where votes took place; these may be email ballots.

Item	Topic	Discussion
1	Introductions, Agenda Review and Intellectual Property Policy - John Rhoads	Status/Discussion: John Rhoads chaired the meeting, repeating the IP management process. Decisions/Issues: Agenda approved yesterday. Action(s):
2	NIST Tools - John Garguilo, Sandra Martinez	Status/Discussion: John Garguilo and Sandra presented the NIST Test Tools including present status and future directions. The slides are available at _____ . Discussion revealed subtle issues which will be addressed by NIST. Extensions to the NIST tool (Behavior Testing) should be available for the 2012 test cycle and available at the Connectathon. A preliminary test may be available in January. John Garguilo noted that there are a number of issues related to the wrappers that are provided in the web services messages (e.g., WS addressing, security, coding, etc.) and will need to be addressed, especially when Continua’s messages are considered. NIST is addressing this, and PCD messages will be considered in the future. Decisions/Issues: Action(s): John Garguilo will lead a discussion of the existing static tests on November 2 in the PCD Connectathon and Showcase WG meeting, and include determination of the device identification to be used in messages this cycle. John and Sandra will discuss these extensions with the individual WGs (ACM, IDCO, PIV).
3	Rosetta Terminology Mapping Management System (NIST) and RTM - John Garguilo, Paul Schluter	Status/Discussion: RTMMS John Garguilo provided an update on RTMMS, describing the issues that have been addressed and those remaining in making this available. The slides are available at ____________ . Rosetta Update: Paul Schluter presented the Rosetta Update: Slides, with details, are available at _______ The update included: - Brief introduction to RTM - Vendor VMD - LOINC terms (infant screening) – column added, at least temporarily – Paul recommended that LOINC and SNOMED terms go directly into the RTMMS rather than into RTM and then into RTMMS. - RTM Respiratory and Ventilator – making excellent progress on “ventilator mode” then will be followed by breath-by-breath modeling. - RTM for events (pumps first) – ACM and the new Event Communication profile; content models, including cardinality. - PHD devices (Continua 1.5 WAN) – using IEEE standard PHD specializations. Dot level 2 is not used, so the OBX-3 has zero to represent the missing level (e.g., 1.0.1); therefore representations with PCD messages are consistent. Paul indicated that time stamp can be included in the measurement wrapper. Decisions/Issues: Action(s):
4	Brief Work Item Proposals - As Noted	Status/Discussion: Time Synchronization White Paper WP will review the Use Cases and create guidelines to handling unsynchronized time sources and address the required accuracy to meet clinical needs. If the device itself cannot support the accurate time with the CT profile, this will address how to provide a “best effort” value. Device Patient Association: Gary led the discussion. Gary Meyer and these others participated via Webex: Robert Britton, Eric Chetwynd, Robert Flanders, Sarah Hopkins, Roger Kittelson, Brad Lunde, Nuno Pino, Greg Scott, Lee Suprenant, Khalid Zubaidi. Ruth had proposed that the identifier be coded as RI (resource identifier) type. This approach requires two PID segments. Gary noted several concerns (see the document). Several PCD members indicated they are not in favor of the A24 message. A second approach is to use one of the Patient Schedule messages (for appointments). This has the advantage of addition, cancellation. Robert noted that some CIS systems won’t support this message type. A third approach is to use Observation Messages. Christof suggested that an observation type message with an SPM segment would be beneficial. Gary noted that the ORU message requires the patient identification section. Thiswould be an Unsolicted or a Solicited ITI-30 or -31 message. The fourth approach is to use Patient Registration, A04 messages. This requires HL7 clarification (see document page 7 of 9). If the PRT segment is available, this would provide all information needed. The only question is whether a new ADT message should be proposed to segregate device identification from other such messages. Gary proposed the use of the ADT A04 with PRT segment, within HL7 v.2.7. Monroe suggested that PRT is not used for assigning this type of relationship. Gary responded that the definition “Identifier for the device participating” appears to leave room for this application. Gary suggested that a member of HL7 explore the intention behind this broad definition; John Rhoads indicated that an HL7 member will follow up. Monroe asked how devices would be disassociated. Gary noted that the PRT segment has an action code that can be used to disconnect the device. The Observation option (third one above) does not have this action item. Monroe suggested that the Scheduling option has symmetry for adding and removing the association. It was suggested that ITI be consulted and that other domains might want additional components for billing or other applications. Discussion followed regarding whether associating the patient and device removed from the physical device introduces the possibility of error in the association. [Note: the discussion was continued later.] Event Communication Jeff led the discussion, referring to the Infusion Pump Event Communication, version 09242010. The events are milestone events (e.g., infusion start, stop). He noted that the pump and its messages know about the pump’s operation, but not about the clinical application. With three basic operation, start, stop, complete. Pause is the same as stop. This does not preclude the pump systems from sending an alarm for the same event (i.e., when the infusion supply needs to be replaced). Extensive discussion addressed whether every transition should have a start and stop, as contrasted with an event that includes a change in rate within an existing event. John Rhoads led discussion of Events, including definitions, types, attributes, etc. The slides are found at __________- Questions arose, some which should be included as requirements for the TF or Implementation Guide. Among the questions: should the escalated message contain information that time has elapsed and this is the escalated message; this might have clinical implications. Decisions/Issues: Action(s): Event Communication: Monroe will include the escalation item along with indication that the AC may want to make decisions on how to prioritize and escalate the message.

Discussion Thursday, October 21 (Technical Committee)

Discussion Summaries do not require formal approval, while minutes of meetings where votes are taken do. Participants are encouraged to review and bring up significant issues with discussion summaries of previous meetings. Votes will be taken to approve meetings where votes took place; these may be email ballots.

Item	Topic	Discussion
1	Introductions, Agenda Review and Intellectual Property Policy - Chair	Status/Discussion: Decisions/Issues: Agenda approved previously. John Rhoads chaired the morning meeting. It was unnecessary to repeat the IP management process because no newcomers were present. Action(s):
2	Profile Proposals for Cycle 6 - As Noted	Status/Discussion: WCM (continued): Ken discussed the WCM profile, specifically the public comments received. The primary issue was grouping – how to change some attributes of certain parameters without having to affect all of them during a single series of data messages. The current approach is that if any attributes change a new waveform group is required. Paul suggested that each message contain an OBR setting the dot level, while Ken believed that subsequent OBRs would continue at the prior level. Ken had proposed sending each channel individually, thus not requiring data within each channel’s data messages to require an OBX if unchanged. Ioana suggested that it is not necessary to have a single approach as long as each approach is carefully detailed. Paul suggested that other waveforms may shed light on options – e.g., trends. Paul suggested that waveform group identifier would always be known to be at dot level 3, with the waveform data at dot level 4. Ken suggested that dot levels could float depending upon channels, vmds. Dot level 3 would then be a waveform “wrapper”. Among the issues will be whether OBRs can float. Christof’s email expressed concern about OBR nesting. Ioana noted that some parsers don’t support this. Ioana added that the rules make it possible for NIST test tools to verify compliance. John Garguilo agreed with John Rhoads that an implementation guide is needed to address this and this would permit future flexibility. He added that clear, unambiguous rules permit testing. Paul noted that existing use of channel levels prevent waveforms at that level – waveforms might be contained within a message that uses channel level (e.g., ventilator data). Further, if the waveform wrapper is at dot level 4, like metrics, then waveform data would be at dot level 5. Paul recommended input from a few of ASN1 and Continua experts. Paul described two approaches using ventilator messages. He asked if waveforms can be included in the same channel as numerical data, or if a separate channel is required. John Rhoads responded that the latter is the case. Paul noted that this means the waveform data then needs to be one level further down. If at dot level four, this would preclude wrappers. Paul summarized two approaches: Method 1, Wave message, dot level 3 or 4 - filters, attributes (or pointers to) (N.M.X.Y) - ECG lead = “1” - ECG lead = aVR - ECG lead = VL Method 2, OBX-17 observation message (Ioana), dot level 4 - MDC_ECG_WAV_AVR (dot level 4) - filters, attributes (or pointers to) (N.M.X.Y) - Filter Seq - Filter - Filter - Gain - Color - MDC_ECG_WAV_AVL (dot level 4) - filters, attributes (or pointers to) (N.M.X.Y) - Filter Seq - Filter - Filter - Gain - Color - Issues include conformance to IEEE 11073, ASN1, whether OBX can contain a pointer for a filter (one of many available). Iona elaborated saying that waveforms and filters be declared and then referenced. - Using a ventilator example, he described how waveforms would be at dot level 4 with filters at dot level 5, and waveform attributes could be coded as facets. Ken raised the question - in the absence of an OBR, how to define filters? Paul responded that filters, at dot level 5, would be defined under the first time it is used; and will require a pointer afterward. This would permit overwriting with new attributes. Pump STAT Application (Messages without patient identification): Jeff and Kristina reported request for sending device data in the absence of patient identification when device-patient association is not available. PCD-01 currently requires data to ba associated with a patient, even if that is a John Doe type of patient identification. Discussion revealed that there are vendors who want to later associate the patient with the data. Extensive discussion followed. Issues: should this be permitted, how specific fields are coded, and how to communicate to the purchaser in the conformance statement so that the purchaser understands the functionality available. Ioana suggested that HL7 v.2.8 provides a way to address this issue. John Rhoads suggested that this be an option; this minimizes the change to the TF. Erin noted that this ties into the discussion on Monday related to PCD’s changes to the Interoperability Statement. Khalil asked that the implementation reveal when and how the association was accomplished. HL7 Domain Analysis Model This was developed by the Veteran’s Administration. Ioana led discussion. Links to the Medical Devices DCM discussed this afternoon: - GForge project site: http://gforge.hl7.org/gf/project/dcmmd/frs/?action=FrsReleaseBrowse&frs_package_id=148 - HL7 Ballot: http://www.hl7.org/v3ballot/html/dams/uvmd/uvmd.htm - This will be sent to HL7 ballot in May, planning to include additional use cases. ACM: Monroe presented the updates to the ACM profile (see slides). Monroe asked about MSH-21 which identifies the profile. John Garguilo suggested that the PCD OID could fill this need. Jhn Rhoads added that this should be incorporated into the TF or the Profile and this would enable testing. Remote Monitoring for Chronic Care: Paul Schluter noted that 11073 PHD is used, and trimmed in conformance with reduced need for complexity. Ken then added proposals that have not yet been discussed. Additional Proposals: ADQ: A combination of QBD and --- john zaleski’s --- to yield Asynchronous Data Query (ADQ). RCT: Really ConsistentTime (not a fully completed proposal): This is a new proposal. Deferred to Friday: PCD Vision: John Rhoads asked: does PCD need one? John Garguilo suggested this be a PC item. Certification: John Rhoads asked: is this crucial and how will it be addressed? Decisions/Issues: Action(s): Paul will prepare a brief document with criteria to be met in the profile with regard to waveform attributes. Ken suggested that PCD-02 also provide waveform filtering. Schedule discussion of WCM for TC meeting Nov. 3 and ballot. Schedule discussion of Pump STAT Application for TC meeting Nov. 17 and ballot. Manny to draft Ballot to select Proposals for Cycle 6. Ballot will address Priority and Commitment (i.e., willingness of company to support the effort). - See Wiki page http://wiki.ihe.net/index.php?title=PCD_Proposals_Cycle_6. A two part ballot will be provided. Deferred to Friday: - PCD Vision: John Rhoads asked: does PCD need one? John Garguilo suggested this be a PC item. - Certification: John Rhoads asked: is this crucial and how will it be addressed?

Discussion Friday, October 22 (Technical Committee)

Discussion Summaries do not require formal approval, while minutes of meetings where votes are taken do. Participants are encouraged to review and bring up significant issues with discussion summaries of previous meetings. Votes will be taken to approve meetings where votes took place; these may be email ballots.

Item	Topic	Discussion
1	Introductions, Agenda Review and Intellectual Property Policy - Chair	Status/Discussion: Decisions/Issues: Agenda reviewed John Garguilo chaired the meeting. It was unnecessary to repeat the IP management prolicy because no newcomers were present. Action(s):
2	Announcements - John Garguilo	Status/Discussion: Moberg Research: John Garguilo led review of discussions that took place with Dick Moberg and staff last night at Moberg Research. There is a desire to have their participation in PCD and IHE. John Rhoads noted that they have participated in DPI and ICE-PAC. They believe the issue preventing IHE PCD participation is availability of their time. Khalil noted that while they are expert in IEEE 11073 they have not used HL7. Erin summarized the recent FDA/AAMI Infusion Pump meeting. She noted the summary on the http://www,AAMI.org website. That page lists 13 priorities for infusion pump safety. The FDA wants to see safety assurance documents from vendors, and these would include clinical evaluations, but did not provide details on what that contains. The FDA had previously presented their point of view, the recent meeting provided opportunities for vendors and users to present their points of view. Decisions/Issues: Action(s): John Garguilo will invite Moberg Research to join IHE and the PCD Google Groups. Manny will follow up.
3	OIDs - John Garguilo	Status/Discussion: OIDs: There is a need to define the tree for IHE PCD OIDs and national extensions. Ioana suggested that the cochairs control the issue of an OID for profiles, etc. John Garguilo noted that OIDs will be useful in testing. Decisions/Issues: Action(s): John and John Rhoads will develop a proposal for the TC.
4	Profiles for Cycle 6 (Continued) - As Noted	Status/Discussion: Profiles: MEM Security White Paper: - Steve sent an outline of this WP (Excel spreadsheet) ftp://ftp.ihe.net/Patient_Care_Devices/FaceToFaceMeetings/2010-10-18PlymouthMeetingPA/ RTLS: No comments were received; MEM is trying to gather technical resources from the stakeholders. - From Steve via email: He seeks more collaboration from CMMS vendors on the Event Communication work. This would be a huge win for management of devices. If the use cases cannot be accomplished with Event Communication MEM will need device and CMMS vendors to provide an alternate messaging profile. Decisions/Issues: Action(s): Recruit CMMS vendors.
5	Spring F2F - John Garguilo	Status/Discussion: Potential Locations: Cerner Kansas City, Philips Bothell, Philips Andover, Philips Emergin, Boca Raton, ECRI Institute - Discussion included the length of the meeting, reaching out to clinicians, including message to visitors at HIMSS (Showcase, CE-IT Symposium) about the Spring F2F, need to develop preliminary Spring F2F agenda in December (first day anyway and consider Webex). Decisions/Issues: Action(s): Manny will check with Cerner, ballot several dates with PCD. HL7 meeting is in mid-May in FL. Meeting should be at the end of April or beginning of May.
6	Recruiting and Orientations - Erin	Status/Discussion: In December PCD should address the next PC F2F, prepare to leverage HIMSS11 as a venue for recruitment, consider a Webex to recruit users and vendors, leverage IHE Marketing (Erin a member) and ECRI Institute (would include Continua, MD PnP). Volunteers: Erin, Ken, Steve, Jon, Khalil - Discussion included the length of the meeting, reaching out to clinicians, including message to visitors at HIMSS (Showcase, CE-IT Symposium) about the Spring F2F, need to develop preliminary Spring F2F agenda in December (first day anyway and consider Webex). Decisions/Issues: Action(s): Volunteers: Erin, Ken, Steve, Jon, Khalil will address recruiting and orientations.
7	Connectathon and Showcase - Manny	Status/Discussion: Connectathon: Pre-Connectathon tests should be available approximately Nov. 1. Connectathon tests shortly afterward. John Rhoads noted that IHE developed a course to qualify Connectathon leaders for international Connectathons. Showcase: Mother/baby Manny will explore Continua link again. We will need to emphasize Meaningful Use to show devices are important. Manny to solicit volunteers to develop a scenario and coordinate on other scenarios. John Rhoads volunteered. Manny to ask Todd, Sarah, Gary, Lisa Carnahan. Decisions/Issues: Action(s): Ask Lisa Spellman to project other, non-US Connectathons, Showcases – which, when. How did the Korean Connectathon and Showcase work out?
8	FDA and PCD - Khalil	Status/Discussion: FDA and PCD: Khalil asked if the PCD has a relationship with the FDA. Decisions/Issues: Action(s): Manny to ask Joyce and Elliot if this is in place within IHE or can be arranged.

Next Meeting

The next meetings are: A joint PC and TC meeting on October XX, 2010 PCD PC&TC 2010-10-27 Webex

TC November 3, 2010 PCD TC 2010-11-03 Webex

PC meeting November 10, 2010 PCD PC 2010-11-10 Webex

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