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

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.

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

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	Introductions, Agenda Review and Intellectual Property Policy - Chair	Status/Discussion: Decisions/Issues: Agenda approved placeholder Action(s):
2	xxxx - Chair	Status/Discussion: Decisions/Issues: Action(s):
3	xxx - yyy	Status/Discussion: Decisions/Issues: Action(s):
4	HIMSS11 Showcase - Manny	Status/Discussion: Decisions/Issues: Action(s):
5	yyy -	Status/Discussion: Decisions/Issues: Action(s):
6	Action Items - Chairs	Status/Discussion: Decisions/Issues: Action(s):
7	Announcements - All	Status/Discussion: Decisions/Issues: Action(s):
8	xyz -	Status/Discussion: 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 - Chair	Status/Discussion: Decisions/Issues: Agenda approved placeholder Action(s):
2	xxxx - Chair	Status/Discussion: Decisions/Issues: Action(s):
3	xxx - yyy	Status/Discussion: Decisions/Issues: Action(s):
4	HIMSS11 Showcase - Manny	Status/Discussion: Decisions/Issues: Action(s):
5	yyy -	Status/Discussion: Decisions/Issues: Action(s):
6	Action Items - Chairs	Status/Discussion: Decisions/Issues: Action(s):
7	Announcements - All	Status/Discussion: Decisions/Issues: Action(s):
8	xyz -	Status/Discussion: Decisions/Issues: Action(s):

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 placeholder Action(s):
2	xxxx - Chair	Status/Discussion: Decisions/Issues: Action(s):
3	xxx - yyy	Status/Discussion: Decisions/Issues: Action(s):
4	HIMSS11 Showcase - Manny	Status/Discussion: Decisions/Issues: Action(s):
5	yyy -	Status/Discussion: Decisions/Issues: Action(s):
6	Action Items - Chairs	Status/Discussion: Decisions/Issues: Action(s):
7	Announcements - All	Status/Discussion: Decisions/Issues: Action(s):
8	xyz -	Status/Discussion: Decisions/Issues: Action(s):

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 approved placeholder Action(s):
2	xxxx - Chair	Status/Discussion: Decisions/Issues: Action(s):
3	xxx - yyy	Status/Discussion: Decisions/Issues: Action(s):
4	HIMSS11 Showcase - Manny	Status/Discussion: Decisions/Issues: Action(s):
5	yyy -	Status/Discussion: Decisions/Issues: Action(s):
6	Action Items - Chairs	Status/Discussion: Decisions/Issues: Action(s):
7	Announcements - All	Status/Discussion: Decisions/Issues: Action(s):
8	xyz -	Status/Discussion: Decisions/Issues: Action(s):

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

PCD Home