PCD Connectathon&Showcase 2011-08-02 Webex

PCD Connectathon & Showcase Fifth Meeting 2011-2012 Cycle, August 2, 2011

Action Items

You can find the Action Items at PCD-Connectathon&Showcase-ActionItemsCycle6-2011-2012

Agenda

You can find the agenda at http://wiki.ihe.net/index.php?title=PCD_Connectathon%26Showcase_WG_2011-12

Participants

Bikram Day, Al Engelbert, Robert Flanders, Ken Fuchs, John Garguilo, Sungkee Lee, Khalil Maalouf, Elizabeth Peters, John Rhoads, Sandy Vance, Vaughan Zakian, Khalid Zubaidi, Manny Furst

Guests: Landen Bain, Michael Celeste (Pfizer); Michael Ibara (Pfizer); Brian Jacobs (Children’s National); Terrie Reed (FDA); Sandy Weininger (FDA)

Discussion

Item	Topic	Discussion
1	Introductions & Agenda Review - Manny	Status/Discussion: Introductions: the guests were introduced. Elizabeth Peters introduced herself - she recently joined HIMSS as Coordinator for the HIMSS Showcase, working for Sandy Vance. No changes were made to the agenda Discussion Summary was reviewed and approved PCD_Connectathon&Showcase_2011-07-26_Webex Decisions/Issues: Action(s):
2	HIMSS12 - As Noted	Status/Discussion: FDA/Pfizer Safety Reporting (Events) Michael Celeste discussed the FDA/Pfizer safety reporting project slides that were distributed to the WG in advance of the meeting. The slides were distributed in advance, and are largely self explanatory. Additional comments: Terrie Reed referred to the requirement for UDI and the FDA will be issuing a proposed regulation. John Garguilo asked about coding of the UDI and Terrie replied that it will be appropriate for HL7. Michael and Terrie discussed the potential relevance to PCD. Terrie asked if swapping an infusion pump might be a trigger. Brian Jacobs noted that certain devices are so critical that a malfunction always requires replacement, while others such as key stroke errors for infusion pumps are addressed with the device first. John Rhoads referred to work in another PCD WG that is exploring the ventilator use case. He cited the event communication profile that is out for public comment. Khalil asked if this project originated at the FDA or with Pfizer. Terrie responded that she raised the question when she learned about ASTER. ASTER was developed in response to a Partners Healthcare initiative for drugs. Discussion followed about the possibility of developing a demonstration using events. Brian and others noted that most events do not represent a reportable event but that a combination of events may be needed to provide a human with the option of deciding it is a reportable event. John Garguilo cited the RTM as an element in making this possible. HIMSS12 Registration Process Sandy described the HIMSS12 Showcase registration process. Registration will include a survey to learn about the each system’s capabilities. These will later be used to identify the roles the systems will play. The survey will be available Thursday. Registration can begin at www.interoperabilityshowcase.org. The HIMSS registration staff will acknowledge registration with a welcoming letter that will include the link. Decisions/Issues: Discussion of the Pfizer/FDA proposal will continue in two weeks. Action(s):
3	2012 N A Connectathon - Manny	Status/Discussion: Steve Moore's Requirement for Integration Statements Manny to ask Steve if this applies to existing profiles. Decisions/Issues: Action(s): Manny to ask Steve if this applies to existing profiles.
4	Next Meetings - Manny	Status/Discussion: The next meetings will take place at the same time. Decisions/Issues: Action(s):

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Return to main PCD Connectathon/Showcase WG page: PCD_Connectathon&Showcase_WG_2011-12