PCD PC&TC 2012 Oct. 16-19 F2F

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Meeting Objectives

These face-to-face meetings have a number of objectives depending on the committees involved:
  • Planning Committee: Review, plan and initiate PCD activities; contribute to planning of the HIMSS Interoperability Showcase and other Showcases and events; recruit vendors and users.
  • Technical Committee: Review and accept brief workitem/profile proposals; develop detailed workitem proposals; develop Supplements, update Profiles and the TF; contribute to Connectathon test tools, tests, and procedures.

Reminder: the Inellectual Property policy is in force, and participation counts toward voting rights.

NOTE: "Suggested Agenda Items/Topics" are developed further down the wiki page.

Location & General Schedule

Location:
Philips IntelliSpace Event Management
8051 Congress Ave
Suite 400 (fourth floor)
Boca Raton, FL 33487
Tel: 561.886.3108
Meeting in the Training Room
Monroe suggests flying into/out of Fort Lauderdale (FLL); the alternative is Palm Beach International (PBI).
Hotel
Hilton Garden Inn, 8201 Congress Avenue
$95 + tax until September 24.
www.bocaraton.stayhgi.com and request group code: PCDC or call the hotel at 561-988-6110 and request the Philips Healthcare – Patient Care Device Group Rate
Dates:
Tuesday, October 16 through TBD Wednesday: PCD Planning Committee
Wednesday, October 17 through Friday October 19 (3:30 pm): PCD Technical Committee
Wednesday, October 17 time TBD: Joint PC/TC meeting with focus on the profile proposals


Daily Schedule
08:00 - 08:30 Meet at Philips
Meeting will start promptly at 08:30 each day.
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
Friday the meetings will end by 15:30

Attachments / Materials

PCD Schedule/Deadline Information: Patient Care Device and Domain Milestones
Documents related to the meeting when established will be found at ftp://iheyr2@ftp.ihe.net/Patient_Care_Devices/FaceToFaceMeetings/2012-October-BocaRaton unless otherwise noted. Documents are available without a password.
The Cycle 8 Brief Workitem Proposals are at ftp://ftp.ihe.net/Patient_Care_Devices/IHEPCDyr8-2013-2014/Year8-BriefProposals/.
PCD PC Action Items PCD Planning Committee Action Items. PCD TC Action Items PCD Technical Committee Action Items.
PCD PC Preliminary Agenda spreadsheet - superceded by this wiki page
Attendee list spreadsheet
Rosetta for Events and Alarms files - Schluter
Hypothetical system for PCIM Discussion - Rhoads
Device Specialization Proposal Discussion - Cooper
PCD reference data discussion presentation (esp. GForge)- Rhoads
Point-of-Care Identity Management discussion slides - Rhoads

Webex Sessions

The password for the Webex sessions is the same one used for working group meetings. It is not posted here for security reasons. Members can find the password in the PCD weekly meeting schedule. A separate Webex session will be established for the NIST Test Tool Tutorial.

Morning sessions begin 8:30 EDT, afternoon sessions begin 1:30 EDT. The NIST Tutorial is set for 11 am; when that ends the rest of the morning session will not be recorded.

Tuesday Morning Meeting Number: 929 427 512 https://himss.webex.com/himss/j.php?ED=206540642&UID=0&PW=NYTM3MjAxYjU4&RT=MiMxMQ%3D%3D

Tuesday Afternoon Meeting Number: 921 699 354 https://himss.webex.com/himss/j.php?ED=206540787&UID=0&PW=NZTRhY2E1MmFl&RT=MiMxMQ%3D%3D

Wednesday Morning Meeting Number: 926 650 765 https://himss.webex.com/himss/j.php?ED=206541827&UID=0&PW=NOGU1YjBmZWU4&RT=MiMxMQ%3D%3D

Wednesday Afternoon Meeting Number: 922 460 564 https://himss.webex.com/himss/j.php?ED=206542067&UID=0&PW=NYmM0MGYzMjlj&RT=MiMxMQ%3D%3D

Thursday Morning Meeting Number: 925 400 349 https://himss.webex.com/himss/j.php?ED=206542227&UID=0&PW=NNmYwZTdkNDcy&RT=MiMxMQ%3D%3D

Thursday 11 am EDT NIST Tool Tutorial Meeting Number: 925 660 127 https://himss.webex.com/himss/j.php?ED=206542487&UID=0&PW=NOTRkYWYwYmJi&RT=MiMxMQ%3D%3D

Thursday Afternoon Meeting Number: 926 054 100 https://himss.webex.com/himss/j.php?ED=206542592&UID=0&PW=NNDkwMmZjMDU4&RT=MiMxMQ%3D%3D

Friday Morning Meeting Number: 929 211 348 https://himss.webex.com/himss/j.php?ED=206678277&UID=0&PW=NOTc2OTRkMDJj&RT=MiMxMQ%3D%3D

Friday Afternoon Meeting Number: 920 620 935 https://himss.webex.com/himss/j.php?ED=206678342&UID=0&PW=NMjVhNGM3OWI0&RT=MiMxMQ%3D%3D

Suggested Agenda Items/Topics

Please list suggestions here:

- RTM best practice marketing PC Action Item 128
- Stakeholder survey PC Action Item 78
- AAMI Alarm Committee PC Action Item 133
- ACM publication for AAMI PC Action Item 134
- Commercially available test bed PC Action Item 137
- OIDs Update (John Garguilo) TC Action Item 82
- Po98int-of-Care Identity Management update
- Managing Document Versions - GForge and Subversion methods (John Rhoads) TC Action Item 93
- Messages Without Demographics (Jeff Rinda) TC Action Item 109
- Should we provide means for a device to query its patient?
- Managing Document Versions. (John Rhoads, Paul Schluter) TC Action Item 93
- Messages Without Demographics (?) TC Action Item 109
- Implementation Guide - Are TF Vols. II + III enough? (John Garguilo) TC Action Item 118
- NIST Test Tool Tutorial (to be recorded) for Cycle 7 IHE-PCD HL7 Pre-Connectathon tooling (Garguilo)
- Rosetta for Events and Alarms and which are associated with parameers(Schluter, Rhoads)
- More consistent time for devices (Rhoads, Garguilo, Schluter)
- WCM harmonization?
- Does the roadmap need revision?
- Infusion pump specialization
- Physiological monitor specialization
- Ventilator specialization
- How are we doing on the roadmap?
- Discussion on "visionary stuff" - what next big things should be on the roadmap?
- MCD Codes: Proposed by Terry Bettis, Others (Paul Schluter)

Detailed Schedule & Agenda

Tuesday Morning

Date Hours Committees Topics
Tuesday Q1

2012-09-16

08:30 - 10:00 PCD Planning Committee (PC)
  • 08:30 > Meeting Starts
  • 09:00 > Roadmap Review and Update
What is next
Date Hours Committees Topics
Tuesday Q2

2012-09-16

10:30 - 12:30 PCD Planning Committee (PC)
Continue Roadmap Review and Update
Marketing and Communications - what is missing to educate providers/clinicians?


Tuesday Afternoon

Date Hours Committees Topics
Tuesday Q3

2012-09-16

1:00 - 2:45 PCD Planning Committee (PC)
Connectathon Planning
HIMSS 2012 Showcase Planning
Recent Summits
FDA/AAMI Interoperability
FDA/AAMI/ACCE/ECRI/JCAHO Alarms
AAMI/FDA Infusion Device
Date Hours Committees Topics
Tuesday Q4

2012-09-16

3:15 - 5:00 PCD Planning Committee (PC)
Review Cycle 8 Brief Proposals
Optimized Message Syntax - OMS
DPI
Device Specialization - Physiological Monitor **
Device specialization - Ventilator **

Wednesday

Date Hours Committees Topics
Wednesday Q1

2012-09-17

08:30 - 10:15 PCD Planning Committee (PC)
IHE IP Management Process (5 minutes)
IHE TF templates
General Intro - IHE approach content pg 7, real world architecture pg 10, Content profiles relationship to our vol3
Vol 1 - Actor groupings and bindings pg 9,
Appendix F Integration Statements, Commercially available?, Connectathon product version?
Marketing and Communications
Commercially available test bed PC Action Item 137
User Handbook v3
Stakeholder survey PC Action Item 78
RTM and DOD/VA
RTM best practices marketing PC Action Item 128
ACM publication PC Action Item 134


Date Hours Committees Topics
Wednesday Q2

2012-09-17

10:30 - 12:00 PCD Planning Committee (PC)
Continued carry-over from Q1
IHE Inventory of Profiles
Brief Proposal Final Discussions



Date Hours Committees Topics
Wednesday Q3

2012-09-17

1:30 pm - 3:00 pm PCD Technical Committee (TC)
Greetings and Introductions (John Garguilo / John Rhoads)
Review and Approve Agenda
Federal EHR participation in IHE Connectathon (Greg Staudenmaier)
(Lightning) Quick review of profiles to identify topics for deeper dives later in meeting (John Rhoads + Integration Profile Leads)
DEC (Rhoads)
PIV (Rinda)
IPEC (Rinda)
ACM (Patillo)
WCM (Fuchs)
RDQ (Zalinski/Rhoads)
POI (Ioanna)
DPI (Cooper / Garguilo)
PCIM (Rhoads / Flanders)
Device Specializations (Cooper)
Date Hours Committees Topics
Wednesday Q4

2012-09-17

3:25 - 5:00 PCD Technical Committee (TC)
Physiological monitor specialization (Cooper)
Ventilator specialization (Cooper)


- More consistent time for devices (Rhoads / Schluter)

Thursday

Date Hours Committees Topics
Thursday Q1

2012-09-18

08:30 - 10:00 PCD Technical Committee (TC)
  • Review IHE International "Emerging" Strategic Plan (Cooper)
  • ACM Topics (Patillo)
  • Managing Document Versions - GForge and Subversion methods (John Rhoads) TC Action Item 93
  • How are we doing on the roadmap?(John Rhoads - from TC perspective)
  • Discussion on "visionary stuff" - what next big things should be on the Roadmap? (John Rhoads TC perspective)
  • Brief (New/Proposed) Profile Technical Discussions - As needed beyond PC dicussions

[Year 8 Brief Profile Proposals]ftp://ftp.ihe.net/Patient_Care_Devices/IHEPCDyr8-2013-2014/Year8-BriefProposals

Optimized Transactions (Ken Fuchs)
Event Communication (Todd Cooper)
Device Specializations (Phys. Monitor + Vent.) (Cooper)
DPI - Device Profile Integration (from 2008) (Rhoads / Cooper / Garguilo)


Date Hours Committees Topics
Thursday Q2

2012-09-18

10:30 - 12:00 PCD Technical Committee (TC)
  • NIST Test Tooling (John Garguilo)
RTMMS brief update
X73 DIM Work / ICSGenerator Tooling
Revised Version of x73 DIM
UML Model of DIM
Generation of DIM Standard
Generation of Device Specializations / Profiles
Implementation Guides - Are TF Vol II + III enough? (Action item 118)


  • IHE-PCD Pre-Connectathon/Connectathon Tooling Tutorial (Garguilo)
IHE-PCD Tooling Tutorial @ 11 via Webex


Date Hours Committees Topics
Thursday Q3

2012-09-18

1:00 - 2:45 PCD Technical Committee (TC)
  • Point-of-Care Identity Management update (temp if not talked in Q1)(John Rhoads / Robert Flanders)
  • Messages Without Demographics TC Action Item 109 (Jeff Rinda)
  • Should we provide means for a device to query its patient? (related to PCIM?) (?? / Rhoads)
Date Hours Committees Topics
Thursday Q4

2012-09-18

3:15 - 5:00 PCD Technical Committee (TC)
  • RTM (Schluter)
New Terms requested (e.g., from Terry Bettis)
Rosetta for Alarms / Events (and which are associated w/ parameters)

Friday

Date Hours Committees Topics
Friday Q1

2012-09-19

08:30 - 09:00 PCD Technical Committee (TC)
- IHE IP Management Process
Infusion Pump Specialization (Todd Cooper / Jeff Rinda)
  1. Review Composite Infusion Pump Model (ICS Generator)
  2. Review outstanding issues with Pump Rosetta Specifications
  3. Joint White Paper w/ Pharmacy on Medication Administration
Date Hours Committees Topics
Friday Q2

2012-09-19

09:10 - 10:00 PCD Technical Committee (TC)
Infusion Pumps, continued (Todd Cooper / Jeff Rinda)
1. PIV Use Case Support ...
  • Bolus from Bag
  • Rate Change / Titration
  • Syringe - VTBI
  • PCA
2. Gary Meyer's HL7 proposal for new RXV segment


Date Hours Committees Topics
Friday Q3

2012-09-19

10:10 - 11:00 PCD Technical Committee (TC)
Action Item Review (Garguilo/Rhoads
Meeting Review / Action Item recordation (Garguilo/Rhoads)
Close Meeting (Garguilo/Rhoads)


Note: Additional evening working sessions may be scheduled as needed.

Discussion Summaries

Tuesday, October 16

Item Topic Discussion
1 Introductions & Agenda Review
- Chair 		Status/Discussion:

Participants introduced themselves.

Attendance:

- Dominick Anggara, Todd Cooper, Bikram Day, Paul Elletson, Al Engelbert, Barrett Franklin, Ken Fuchs, Manny Furst, John Garguilo, Jeff McGeath, Steve Merritt, Monroe Pattillo, Doug Pratt, John Rhoads, Jeff Rinda, Craig Robinson, Paul Schluter, Ioana Singureanu
- Co-chairs: Monroe Pattillo, Steve Merritt
- Quorum: This meeting was promoted as a decision meeting. Quorum requirement (on site and via Webex (if participating) is 8; 10 are on site. Quorum requirement was met.

Steve Merritt reviewed the agenda, providing details and context for each item. He noted the IHE deadlines and indicated the hope that the PCD ballot can be closed tomorrow, meeting quorum requirements.

IP Patent and Disclosure

Steve summarized the IP policy and remined those present of their obligations. All present represented IHE member organizations. Discussion followed about the obligations of participants who are required to notify IHE if the work in process may be impacted by a patent.

Decisions/Issues: Agenda approved

Action(s):

2 Agenda Items
- As Noted 		Status/Discussion:

Tuesday Morning and Afternoon

Roadmap: Monroe led discussion of the roadmap.

Roadmap Review 2012-13 (Finishing Cycle 7 [2012-13]and moving into Cycle 8 [2013-14])

- Reference current IHE-PCD road map (on ftp site)
- Discussion on when a cycle actually start/end
- (Ioanna) Discussion for a potential work item to provide, perhaps by IHE-PCD the baseline set of standards used providing the complete stack or dependency standards/specifications (or pointer to that set). Her comment comes from a new user perspective - trying to dive into the specs - what looks deceivingly simple, there are layer upon layer.
o MDICC??
- Architecture
o Security and privacy - TF / ACM (at least) have adopted a required practice (stakeholder of supplement developer could find this and plug it in...) -- Maybe need a new page providing document guidance (for new
o Create possibly, in TF Vol I new template, a matrix matching profiles to referenced standards
o Creating a template for Profile Authors for Security and Privacy (as part of a resource page) - [note: This would be PCD specific (as there are differing views from other domains), Rhoads]
o (Merritt) There doesn't appear to any specific mention around patient safety - this would be in alignment to what we might have for security - characterized as "when looking at a profile, these patient safety areas need to be considered or at least a concern(s): E.g., although the PIV has "5 rights" each of the other Integration Profiles should at least explicitly mention "2 rights - right patient, right device"
o HL7 V2.8 - IPEC is 2.8 + 2.9 - basically allows us to define new triggers; have a note referencing new versions coming down the road.
o Add (if not there already) - reference the HL7 list providing the per version relevance and analysis (there may already be an action item around this - check action item list)
- Device-Enterprise Communications
o Discussion on how to Create a CP to take out an option/feature only to be added back in to the TF later
o Question (from Cooper) PCD-05 - is there anything missing (in the process that we should consider changing) to make it more usable to AR on the device side?
- (Monroe) There is some text in ACM, however not around "who the alarm would get delivered to? - Answer, nothing more comes to mind...
o (Rhoads) Is there an archive for keeping a separate IPEC? (response: Cooper) Want to keep IPEC as a separate profile as it is established. So, do we need to fire this off as a separate effort, or as a CP kind of activity...
- Two points (Schluter) - IPEC has picked a direction (pre-coordinated and phase) and can be captured; we have the ACM so we can capture events in a harmonized (or capture the differences and still make sense together) [ Paul will talk to this point on Thursday] 2) A Rosetta for events and alarms.
- (Rhoads) - from an organizational point of view - what do the parents think (keepers of IPEC) - feeling was, yes, keep separate
- (Cooper) - commented again that IPEC seems to be a separate document (that has a "computable format" to give out - e.g. to NIST to test)
- (Rhoads) there has to be separate docs to ensure we have ample resources to develop - this is implied already in the two device specializations
o Event Communcation (ECM) - general communication
- We have not formally put together a brief proposal for "ECM"
- Discussion of the “cycles” led to acceptance of the overlap of two cycles (cycle 8 will start with the brief proposals, cycle 7 will end at the HIMSS showcase). John Garguilo noted that PCD should attempt to follow the pattern of the other domains. John Rhoads noted that PCD was in sync with the IHE milestones in this last cycle.
- HL7 2.8: Monroe noted that ACM and IPEC are affected by 2.8. Todd noted that IPEC has an interest in 2.9. Todd suggested that there be a section in the TF that identifies version change impacts. ACTION ITEM: Develop a separate PCD section to identify and document the impact of HL7 version changes.
- ACM PCD-05 removal in order to permit ACM going to Final Text (FT). While there are recognized values in implementing this, the issues for vendors include having to redo risk management for the device. A CP will remove it, and it will be rewritten as a supplement so that it is available when vendors want to implement it.
- RDQ (Replaces ADQ): There is one RDR, one RDQ registered for the Connectathon. If tested it won’t be promoted as ready for the FT TF; it is likely to continue to evolve as well as not be sufficiently tested.
- OMS - Optimized Message Syntax
o Proposing that IHE create a version of the transactions that is optimized for legacy physical layers (e.g. RS232, which have substantially slower transfer rates)
For PCD01, PCD02, and PCD04
This may include the removal of certain data requirements or data points based on the assumption that this information is already known in the point to point environment.
Looking at legacy devices and backwards compatibility, but also looking at new devices which are using RS232 or similarly constrained transaction towards a interoperable architecture instead of a smaller propriety data set
Concern was discussed over the use of this for legacy systems, versus new systems.
Development of a ‘protocol light’ may provide additional abilities.
Ultimately – is the project worth spending a few months to ‘flesh out’ the requirements
If it has to take out data points from the mandatory spec it would need to be a new _____ .
- Event Communication ECM (General Event Communication): The nomenclature is being developed. IPEC will remain separate. A proposal will be added – and there is a quorum on site.
o Start with IPEC profile and then extend to other device types (e.g. – ventilators, physiological monitors, etc.)
o Will include reporting items and event items
o Would likely start with 11073 nomenclature
o Should include event and alarms, separated but both within the communication as separation is current state.
o Identified as alarms and events
o There remains issues, syntactic, between IPEC and ECM
IPEC sends an event stream to a system
ACM transmits to a system and requires immediate action
- DPI WP is actively in process, with re-affirmation likely.
- Device Device Integration (ICE, an ASTM standard): There are numerous dependencies that indicate this should be in cycle 9. If DPI is successful in cycle 8 then this may become feasible in cycle 9.
- Discovery and Association and other DPI: moved to cycle 8 from cycle 9. Device Control and Symmetric Communication remain.
- RTM: The constrained value set will be incorporated in volume 3 of the FT TF. Vent terms will continue under development into cycle 9. Coordination with ISO on ventilator terminology is one desired precursor. Continua has not been enthusiastic of NIST’s participation in the PHD terms. John Garguilo noted that terms approved by standards organizations (e.g., IDCO terms) are added to the tools. Additions: Events and Alarms, RTM migration to RTMMS added to cycle 8.
- Semantic Architecture (TF vol. 3) became available in cycle 7.
- Device Document Template¸vol.3: removed in favor of new item addressing coordination with other IHE domains for the TF document (Technical Framework Alignment.
- The new proposal Optimized Message Syntax is addressed in Cycle 9¸architecture.
- Coordination: Continua is working on RESTFUL architecture and other communications (pre-hospital transport, wellness and fitness) and interested in PCD ACM.
- Add message security and safety.

Decisions/Issues:

Action(s):


Wednesday, October 17

Wednesday Morning

Item Topic Discussion
1 Introductions & Agenda Review
- Chair 		Status/Discussion:

Participants introduced themselves.

Attendance was the same as yesterday with the addition of Khalid Zubaidi

- Dominick Anggara, Todd Cooper, Bikram Day, Paul Elletson, Al Engelbert, Barrett Franklin, Ken Fuchs, Manny Furst, John Garguilo, Jeff McGeath, Steve Merritt, Monroe Pattillo, Doug Pratt, John Rhoads, Jeff Rinda, Craig Robinson, Paul Schluter, Ioana Singureanu, Khalid Zubaidi
- Inhel Rekik joined the morning meeting via Webex.
- Co-chairs: Steve Merritt, Monroe Pattillo


Decisions/Issues: Agenda approved

Action(s):

2 Agenda Items
- As Noted 		Status/Discussion:

IP Patent and Disclosure

Only one person had not been present yesterday and he was familiar with the IP policy. The portion of the meeting when Inhel was present did not include IP related items.

Technical Framework: Proposed Revisions to the Template

Todd led discussion noting that the major changes are in volume 3.

- Ihe.net. --> technical framework --> open for public comment
- Documents are available for download at http://www.ihe.net/Technical_Framework/public_comment.cfm
- Comments can be submitted at http://www.ihe.net/ihetemplates.cfm
- General comment: amount of time each year to update is substantial - what are the expectations of the new templates for getting existing documents into "compliance"
- What is realistic (hopefully by end of the year) - to do proactively - internal to PCD and based on our domain cycle.

Volume 0 - Template for New Volume 0

. General Introduction
o Note Content modules will be of particular interest for IHE-PCD
- Section 0 (IHE Overview)
o Last sentence - does not mention anything about devices - only information systems - do we as a domain propose adding "medical devices" to read:
[action] IHE-PCD Group will flush out actual suggested language
- Content Modules
o Section is described as 'content profile' --> should we push back on the labeling of this section.
Previously profiles required inclusion of transactions; please clarify
o Content Modules are really (generally) a 'CDA content module'. PCD introduced 'semantic content' to clarify or distinguish. Within PCD content is exchanged using HL7 V2... and arguably the majority of HL7 content being exchanged in the real world. Content Module is a defined concept.
o New term "transport actor" - data mapping to content module to transaction is call "data binding".
[action][question] Is "transport actor" defined? (review glossary or elsewhere?)

Volume I review

- PCD specific information will likely be included here
- Actual Profile has some new information
o Bindings
o Security considerations now called out
o Product implementations a new concept (section 2.4)
- Among the items discussed: The introduction attempts to bring much of what is common that existed in all volumes. There was a suggestion that volume 1, section paragraph 1 include a reference to devices as well as information systems. Later in the document there is a reference to content profiles; the suggestion is to use “content module” as used in CDA instead. Todd described the “data binding” concept also appearing in section 10. In section 2.4 there’s a suggestion that the product implementation section be moved to the introduction. Steve noted that binding (e.g., CT) will be described in volume 1 in the section referring to groupings.

Volume II review

- Security considerations have been enhance/blown up
- Security section - PCD/Devices - we need to make distinguishment when information is not patient identifiable (prior to association. Risk analysis should/has to include the degree in which it is related to a patient. It should not fall under the same security scrutiny.
o Suggestion: Add under security risks, add patient identifiable (transport level protection, or no risk?)
o This would include narrative about the integrity of data (reliable transport), but perhaps prior to device/patient association not the risk once association is established.
- Risk analysis is foreign to the templates/content -
- Do we need to add (in appendix, either in Vol II Security Considerations, or more generally Vol I) discussion
o [action item]/[question] Consider adding this description to Volume I (new template) - section 2.2
- Enumerating the options that exist (via a risk assessment)
o e.g., either they are dealing with patient or not (e.g. MEM vs. other profiles)
o Whether there is demographics or not?
o Do this by naming "options"
- [question]/key point/[action item] Perhaps the solution is in Volume I utilize General in 2.2, more profile specific in X.5, transactions in Y.5.
o Bring this to Axel Wirth for guidance? MEM? (security within PCD - how would PCD internally handle this - template appears to provide adequate sections to carry this out...)
o Related to security template sections, do we want to add "safety" (which was removed); Safety is an extremely important area, as pointed out in many recent summit/meetings (e.g., AAMI/FDA Interoperability Summit in Oct, 2012)
- Perhaps make it "security and safety considerations" in place of just "security" in a general section
- Section 9 -
o either make it Security + Safety,
o add another section on Safety (recommended by group), separate from Safety
- John Rhoads noted that the security considerations have been beefed up. Ioana noted that there needs to be a distinction between systems that have patient demographics, location or those that don’t have either. This will vary by profile. The location for raising the issue is likely most appropriate in section 2, volume 1. The specific security aspects (from no risk to high risk) would be addressed in each profile. Ioana suggested that the various levels be described in one place so that there would be references to one of these in a consistent approach in each profile. Todd suggested that this be located in section 2.2 and X.5 (for each profile) and potentially in the profile level (3.Y.n). Ken noted that there are broader security issues not related to IHE.
o Steve raised the question of making safety a visible element in the TF. PCD will recommend a separate section.

Volume 3

- Existing today:
o Links to content (e.g., profiles produced by ICSGenerator, device specializations/profiles)
o Rosetta - design concepts of Rosetta, non-device and device content modules. Most of the existing PCD volume 3 will move to section 4 in the revised volume 3.
- Appendices: Todd described these, now all in one place. This includes a consolidated glossary. Appendix E addresses Standards Profiling and Documentation Conventions. Appendix F addresses Integration Statements. Steve questioned whether there has to be a commercially available product and a reference to the product version to have an IS. He noted that even if there is a version the delivered product may be a different version. PCD recommends a commercially available product be a mandatory requirement. Similarly, the document does not require final text (the profile may be a supplement). PCD recommends that the wording change to requiring that the IS identify the profile version.
- Test Bed for Company Testing: Steve led discussion. He noted that PCD has not provided detail of what it wants to accomplish with the availability of such a test bed. This is required for the discussion with the potential provider. Costs and logistics argue against the original idea, but there are alternative approaches to explore.
- User Handbook: This should be continued. Barrett suggested including an acronym spreadsheet or that they appear in the glossary. These can also serve as a reference as people go further. Ken suggested that the handbook could lead to other materials.
- Stakeholder Survey: Discussion addressed the questions of whether a survey is worthwhile; would PCD learn from it, would those receiving it find value and possibly it would serve a marketing benefit as well. The quality of the survey is an essential element.
o ACTION ITEM: Manny will locate the earlier survey or draft, contact Ray. Barrett offered to help.
- RTM and DOD: A Webex will take place to orient DOD to the RTM.
- Promote RTM Including As Best Practice: This is to identify and promote value sets to developers. Ioana suggested these be organized by data specialization (e.g., those associated with a pulse oximeter and these would have an OID).
- Marketing: Manny asked if there is a way to market RTM which in the process markets PCD. Paul suggested this is part of a larger set of tools, including the NIST tools. He compared this with the consumer devices that are readily available in the pharmacy. Paul described various benefits of use of PCD work to companies. Manny asked if it is a question of venue. Ioana suggested that the issue is the type of communication – too technical. Barrett suggested ECRI and MDBuyline would be useful channels – providing simple documents – general IHE PCD – that they can use and send to their subscribers. This would quickly be used in procurement documents. IHE has obtained help from RSNA’s web marketing staff. Monroe suggested asking purchasing agents where they would go for the information and then provide it there. Ioana suggested that the message can be simplified. Close this item, open one focused on those who are purchasing the devices.
- ACM Publication (Action Item 134): This will become part of Barrett’s AAMI efforts.
o ACTION ITEM: Update the IHE.net Profile list and the Google Doc index. Ask Steve Merritt if he’ll do this. Add RDQ, content modules as ITI does.
o Note: title - Content Module / Semantic Content, per Todd's comment notated in document (template)
o Section 4: Domain specific content
- Note: replaced continuation of numbering from Vol. 2
- Is this where IHE-PCD TF Vol III content sections go?
- Why is HL7 CDA content modules given its own section? But not other like DICOM or CID (context identifiers - chunks of vocabulary)
- What's the relationship between 'content modules' and 'constrained value sets'
o All the current material in Volume III would be put into Sub-sections of section 4 in new template
o Section E
- [question]Does this replace ITI reference for HL7 profiling?
- [action/question] Internal for PCD: do we have to conform to this, or is this similar to what we have we already done? Who in IHE is responsible for developing and maintaining these sections?
o Section F (Integration Statements) - this seems good as this was never described
- Describes - What's in a IS?
- Describes - What does it look like?
- [Question from Steve Merritt: product version - does it have to be an actual available product - or could a vendor simply provide a version of their software - and what does that really mean?
o Perhaps - Integration Statements are reserved to commercially available products
- No mention about having an Integration Statement tied to a supplement (item 6 - perhaps require that vendor provide the profile version). F.1 #6 - changed "vendor may elect" to indicate version to "shall" and add a note when/what version of Connectathon was version tested...


Decisions/Issues:

Action(s):


Wednesday Afternoon

Item Topic Discussion
1 Introductions & Agenda Review
- Chair 		Status/Discussion:

Participants introduced themselves.

IP Patent and Disclosure

Unnecessary to repeat. John Rhoads confirmed that those in attendance were familiar with the IHE Intellectual Property policy.

The agenda was approved.


Attendance was the same as this morning except that Steve Merritt and Barrett Franklin were not present.

- Dominick Anggara, Todd Cooper, Bikram Day, Paul Elletson, Al Engelbert, Ken Fuchs, Manny Furst, John Garguilo, Jeff McGeath, Monroe Pattillo, Doug Pratt, John Rhoads, Jeff Rinda, Craig Robinson, Paul Schluter, Ioana Singureanu, Khalid Zubaidi
- Co-chairs: Steve Merritt, Monroe Pattillo


Decisions/Issues: Agenda approved

Action(s):

2 Agenda Items
- As Noted 		Status/Discussion:

Federal EHR Participation in the IHE Connectathon: Ioana led discussion of the VA’s interest in testing their EHR with PCD systems at the Connectathon. Funding is one issue in the way.

o ACTION ITEM: See if there’s a way to get the VA into the Connectathon and possibly the Showcase. Manny will identify people for the VA to talk with.

NIST Tools: John Garguilo indicated that there will be a few RDQ tests. Discussion followed regarding discrepancies between PCD profiles and HL7 and how best to document this so that developers are aware of these. In addition, there may be CPs to HL7, PCD or other actions. Business rules can evolve to additional use cases.

Update on Profiles, Options:

- PIV: On Friday Jeff Rinda would like to talk about extensions such as programming a bolus or rate change with existing infusions.
- IPEC: Todd described the ability of IPEC to inform EC and the Device Specialization Infusion Pump. ACTION ITEM: Todd will edit the IPEC TI version to include the approved CPs and provide it to Mary to publish.
- ACM: Monroe led discussion of the current status. Not yet in TF FT. PCD-05 still in. Coordination with Pump WG produced change in PCD-05 to R42 from R41. Other elements have been updated as well. ACTION ITEM: Document in an implementation guide.
- WCM: The receiving system must be able to display the waveforms at the Connectathon.
- POI: Ioana described questions for the participating systems regarding implementation questions. John Garguilo proposed four simple tests. ACTION ITEMS: Ioana has six tests in mind. -
- DPI: Recent work has addressed X73. The PC has approved transition to Detailed Workitem Proposals and this will be the focus the rest of this calendar year. Todd indicated the IEEE 11073 meeting in November will include related pump items. ACTION ITEM: set new time and Webex for meeting. Potentially Thursdays 2 ET starting first Thursday in Nov. (Nov. 1). Manny to ask John Z if this will be available through January.
- PCIM: Ioana indicated the Vanderbilt and the VA in Nashville have a lab that could be helpful. John Rhoads mentioned some significant issues, such as messages without demographics. He indicated that this leads to a concern about discharging a patient from a device – which is a human issue.

DEVICE SPECIALIZATIONS: John Rhoads described issues identified by Julian Goldman, MD. He suggested a short guideline document that would address this subject. He suggested “Network Time Synchronization¨ a well written book. Todd led discussion on Device Specialization. Please see the slides.

- Todd referred to Ken’s slide for physiologic monitors, noting that there are no required components among the modules. He asked if these VMDs are still valid, are there more, are any mandatory? The types of devices that might send data through the physiologic monitor is open ended (e.g., ventilator). There were suggestions that spot check devices be separated from continuous monitors.
- Discussion continued with ventilator specialization.


Thursday, October 18

Thursday Morning

Item Topic Discussion
1 Introductions & Agenda Review
- Chair 		Status/Discussion:

Attendance:

- Dominick Anggara, Todd Cooper, Bikram Day, Paul Elletson, Al Engelbert, Barrett Franklin, Ken Fuchs, Manny Furst, John Garguilo, Monroe Pattillo, Doug Pratt, John Rhoads, Jeff Rinda, Paul Schluter, Ioana Singureanu, Khalid Zubaidi
- Co-chairs: John Garguilo, John Rhoads
- Remote via Webex: Craig Robinson

Quorum: This meeting was promoted as a decision meeting. Quorum requirement (on site and via Webex (if participating) is 8; 9 are on site. Quorum requirement was met.

Decisions/Issues: Agenda approved

Action(s):

2 Agenda Items
- As Noted 		Status/Discussion:

IHE Strategic Plan: Todd led discussion in advance of the public comment period. ACTION ITEM: PCD suggestions:

- Add safe and secure access to the vision.
- Add definition of “deployment committee” where it is referenced via footnote, link or other mechanism.
- 3.2: change “countries’” to “national and regional”
- 3.4: data-driven and results-oriented are hyphenated.

ACM Topics:

- If the AM only passes messages, doesn’t concern itself with things like national extensions, Rosetta, then these would be the responsibility of the AR. The goal is to define where the information is passed, presented and kept. Paul suggested making the individual company’s description available without mandating standard strings. This can provide a coded term without limiting a company’s or user’s choice and a company adding a display string can view those used by others. 60601 can provide the coded terms. Note that HL7 CWE in 2.8 is problematic.

Managing Document Versions:

- John Rhoads led discussion (refer to slides). He noted that documents on ihe.net are not under our control. The wiki.ihe.net is under PCD control, and this is both a good and bad thing. Bit maps with illustrations (e.g., block diagrams) can be posted, but PDFs cannot. Last, PCD documents are on ftp.ihe.net as well.
- John described the many issues, problems and confusing approaches to posting and searching the ftp site.
- John noted that version control is another large problem. Microsoft’s inherent version management is not usable. Paul suggested xml would be usable. John described Subversion and GForge. John described several features and its ready availability.

NIST Tools: John Garguilo described some background information about the tool and future direction. This was recorded in the Thursday morning Webex (not in the NIST Tool Tutorial). https://himss.webex.com/himss/lsr.php?AT=pb&SP=MC&rID=62698142&rKey=0a435beba33d5a6c PCD F2F Th Morning-20121018 1416-1 Thursday, October 18, 2012 10:16 am New York Time (20 Minutes)

- NIST Tutorial: This was recorded and available at. https://himss.webex.com/himss/lsr.php?AT=pb&SP=MC&rID=62702832&rKey=34bfd9f7f732a0be

PCD NIST Tool Tutorial Oct 2012-20121018 1504-1 Thursday, October 18, 2012 11:04 am New York Time 53 Minutes

- Attending via Webex: Nicolas Crouzier, Julien Deshayes, Robert Flanders, Jonathan Walton

Roadmap: John Rhoads asked if the TC has comments/suggestions or desired goals related to the roadmap.

- Monroe suggested that RTLS vendor be sought and that ACM be prepared to accommodate this.

Thursday Afternoon

Robert Flanders joined for Point of Care Identity Management (PCIM)

- John Rhoads led the discussion. Please refer to the slides.
- PCIM is to specify transactions that meet the defined needs for identified use cases.
- Discussion emphasized that decisions will be on a case-by-case basis with appropriate risk analysis.
- John provided a slide with Hypothetical System of Systems to illustrate how data would be restricted from sharing with the enterprise until associated by an authorized person, preferably at the time the device is placed on the patient.
- Extensive discussion followed regarding how and when the data (physiologic or alarm) would be associated with the patient.
- Jeff Rinda reminded the group that there was a clone of the DEC profile that differed in clearly indicating that there was no associated patient identity.
- Monroe suggested that replacing R01 can be replaced by R41 indicating that patient ID is known or will be available later.
- Al suggested that this can be addressed in the PID section.
- Paul suggested that a clear difference be drawn between devices with patient ID version device ID.
- Robert Flanders described the draft profile, having two actors, one transaction.
- ACTION ITEM: Seek null flavors in HL7 2.9 – For PCIM which could indicate the known missing identification. Ioana believes this should be the responsibility of the developer and the TF can specify how to do this.

ROSETTA: Paul Schluter led discussion of requested additions.

- Terry Bettis requested several terms. Paul found several in 11073 and will discuss with Terry, John Rhoads and Jan Wittenber.
- Monroe requested alarm and event terms.
- Paul’s presentation included discussion of Goals for Rosetta Events and Alarms. He described the process he used and invited developers who have defined new terms to provide them.
- Paul described the process as exemplified by Anatomy of an Event or Alarm. For simplicity and/or consistency numerical values will have limit values reported. The OBX identifies the VMD as an alarm/event and this need not be specified in the eREFID. The eType specifies alarm limit exceeded.


Decisions/Issues:

Action(s):


Friday, October 19

Item Topic Discussion
1 Introductions & Agenda Review
- Chair 		Status/Discussion:

Attendance:

- nDominick Anggara, Todd Cooper, Bikram Day, Paul Elletson, Al Engelbert, Barrett Franklin, Ken Fuchs, Manny Furst, John Garguilo, Jeff McGeath, Monroe Pattillo, Doug Pratt, John Rhoads, Jeff Rinda, Paul Schluter, Ioana Singureanu, Khalid Zubaidi
- Co-chairs: John Garguilo, John Rhoads
- Intellectual Property Policy: All present were present earlier and familiar with the policy.

Quorum: This meeting was promoted as a decision meeting. Quorum requirement (on site and via Webex (if participating) is 8; 9 are on site. Quorum requirement was met.

Decisions/Issues: Agenda approved

Action(s):

2 Agenda Items
- As Noted 		Status/Discussion:

Infusion Pump Specialization: Todd described the achievements to date and led discussion. Please refer to the document that identifies issues resolved and remaining for discussion/decision.

o Discussion of disassociation: Manny suggested the desirability of PCIM resetting the individual devices (via list or location or other technique) as well as notifying the EHR as a user friendly alternative to disassociating each individually.

White Paper: Todd led discussion of the WP.

- Todd described the IHE-wide scope of the WP.
- The Pharmacy Domain is looking forward to the draft, having participated at an earlier stage.

RATE CHANGE: Jeff Rinda proposed a minor change to accomplish the goal of the earlier HL7 proposal for a new segment (HL7 RXV Pharmacy Treatment Order Infusion Segment).

- Jeff Rinda reviewed the work Gary Meyers did preparing the document, but did not have time to lead it through the HL7 process.
- Jeff proposed that PCD proceed in a PCD-only way using existing transactions, seeking minimal HL7 changes. He prepared a CP to Support Programming an Infusion Rate or Dose Change. This can be accomplished fairly quickly, in contrast to adding a segment. Vendors may not be able to implement this immediately, but can do so in the future if desired.


Decisions/Issues:

Action(s): Set date, location for Spring F2F

Follow up with PCD members and Jim St. Clair re Supportive Testing when there are no other tests.


Action Items - PC

The Action Items that follow and approved in subsequent committee meetings will be added to the committee Action Item page.

Action Items - TC and WGs

The Action Items that follow and approved in subsequent committee meetings will be added to the committee Action Item page.


Next Meetings

PLACEHOLDER

Joint Planning and Technical Committee: PC and TC October 24, 2012 PCD PC&TC 2012-10-24 Webex

TC __, 2012 PCD TC 2012-__ Webex

PC __, 2012 PCD PC 2012-__ Webex


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