PCD DPI 2008-09-09 WebEx

(DPI Profile Main Page)

Meeting Purpose

IHE PCD Device Point-of-care Integration (DPI) profile development discussions.

WebEx Information

Topic: IHE PCD DPI Profile TG

Date: Tuesday, September 9, 2008

Time: 14:00, Eastern Daylight Time (GMT -04:00, New York)

Duration: 90 Minutes

Note: Specific web & phone informaiton will be provided via e-mail to group members.

Contact Manny Furst for more information.

Proposed Agenda

1 Review DPI initial discussion document (mind map)

• PCD Profile Development Schedule Review
• Previous PCD PnP profile document review
• Profile Scope Discussion - what should / should not be included in the DPI scope
• PCD "device specialization" Profiles - What are they? How do they relate to DPI?

2 Open discussion

Attachments / Materials

Minutes for approval: (N/A)

Actions Items Brought Forward: (N/A)

Meeting Discussion "Mind Map"

Mind Map Reader Download Page

Minutes

Participants

Chair/Host: Todd Cooper (Breakthrough Solutions Foundry)

Jon Blasingame (Philips), John Garguilo (NIST), Joel Halle (Cardinal/VIASYS), Steve Merritt (Baystate Health), John Rhoads (Philips)

Discussion

Item	Topic	Discussion
1	Introductions & Agenda Review - Chair	Status/Discussion: Decisions/Issues: Agenda approved w/o modification. NOTE: The attached "mind map" was used for the discussion. Links are provided above both for the MM document & a reader application. Please review this document for additional details not contained in these miniutes. Action(s):
2	Approval of Minutes - Chair	Status/Discussion: N/A (this was the first meeting of the DPI group) Decisions/Issues: Action(s):
3	Action Items Review - Chair	Status/Discussion: N/A (this was the first meeting of the DPI group) Decisions/Issues: Action(s):
4	Development Schedule Review - Cooper	Status/Discussion: There was a general review of the dates and process for PCD profile development. Emphasis was placed on the fact that DPI includes a number of profiles, some that will be selected for the next 2008/2009 cycle and some that will come in subsequent years. To capture this, a DPI White Paper may be developed this year to lay out the strategy and rationale. There was also a discussion regarding the general interest in having a prototyping activity started this year so that something could be presented in the HIMSS '09 IHE Showcase PCD "New Directions" section. Decisions/Issues: Action(s): (Todd) Add a DPI White Paper proposal to the PCD Profiles page. (though this may move to a white paper's page)
5	PCD "PnP" Profile Review - Cooper	Status/Discussion: Previously, the IHE PCD had pursued a plug-and-play (PnP) profile development. The PnP Detailed profile proposal document was reviewed. The IHE PCD voted to develop a PnP Profile Supplement, which was being readied for Public Comment publication; however due to events in the summer of 2007, this profile was deferred. Much of the content of this proposal will either be copied to the new DPI profile proposal(s) or into a white paper. Given the anticipated scope of the new set of profiles, it was thought that "PnP" was a bit too narrow and that "point-of-care integration" better captured the differences between the current DEC enterprise integration profiles and what is targeted by this new activity. Also there was a discussion around regulatory requirements that vendors may face when they implement systems that support PCD profiles. It was pointed out that this is a general issue well beyond the scope of the PCD - most all of the companies involved understand the regulatory issues around these products, and the PCD technical framework focuses on "technologies" which depending on how they are implemented and the claims any one vendor makes regarding their products, may incur regulatory oversight. Perhaps a white paper or at least a wiki page discussing this issue should be drafted to help clarify the position. Given recent updates to the definition of a medical device as well as the FDA's draft "medical device data system" (MDDS) guidance and the controversy around the ISO 29321 and 29322 documents that address risk management processes associated with "health software," this white paper may have broader IHE-wide implications. Decisions/Issues: Action(s): (Todd) to propose migration of the PnP Detailed Proposal content to one or more proposals or a white paper. (Todd) to propose a PCD white paper on regulatory considerations related to the deployment of systems that implement PCD profiles.
6	Profile Scope Discussion - Cooper	Status/Discussion: After the review of previous PCD PnP work, there was a general discussion about the scope of the work that should be addressed in this new push for point-of-care integration profiles. In looking at the set of potential use cases (i.e., in the previous PnP profile proposal), Steve Merritt identified a couple of new cases: When transitioning a patient from ICU to OR and back again, reducing the need to reconfigure all the equipment, especially when many of the same modalities are used in both clinical contexts. Configuring a room between ICU and step down based on patient census information. Steve indicated that many new facilities are being designed for this adaptibility in order to better deploy resources to meet neds. Ease in dynamically changing equipment configurations based on patient condition (a.k.a "flexible monitoring"). Integrate information from devices that are brought to the hospital by patients, including personal health devices and more traditional critical / chronic care devices (e.g., from the "medical home"). These could run from a glucose meter (capturing readings from the last days and weeks) to a vent or infusion pump used by the patient. A basic distinction between clinical and non-clinical (but medical) use cases was also made. The set of target devices for these profiles was also discussed. In general, it was thought that the scope should include (as much as possible) all equipment around the point-of-care, not just traditional critical care devices. For example, this would mean that equipment such as beds should also be considered. In other words, the scope should be determined by the selected set of use cases. There was a review of various three-letter-acronyms (TLAs) for these profiles and it was thought that "device point-of-care integration" best captured the intended scope. This balances well against "DEC" and "integration" was broader than something like "communication" (i.e., DPC). In a way similar to the ITI XDS profiles, related DPI profiles would be designated by a dash'd TLA (e.g., DPI-PnP or DPI-XDC - external device control). It was also noted that DPI profiles are related to other PCD profiles including RTM, ACM, MEM (proposed), as well as DEC. Decisions/Issues: Scope should include (as much as possible) all equipment around the point-of-care, not just traditional critical care devices. "Device Point-of-care Integration" (DPI) should be used for these transaction profiles. Action(s): (Todd) Change the wiki & google groups to reflect "DPI". (Todd) Clearly define the relationship between DPI profiles and other PCD profiles (existing & proposed)
7	Device Specialization Profiles - Cooper	Status/Discussion: There was also a general discussion about the concept of "device specialization profiles" (e.g., physiological monitor, ventilatory, etc.) within the PCD Technical Framework. Part of this discussion included an overview of the 11073 Medical Device Semantic Architecture that will be discussed at the Vancouver meetings next week. Agreement on the various semantic layers or subject areas is needed in order to understand what might be included in a device specialization profile. Device specialization profiles are independent from DPI profiles: They define the content that is communicated using DPI profiles, as well as DEC and other PCD profiles. Therefore, DPI profiles are transactionally oriented (i.e., TF vol 2) vs. the device specialization profiles that are focused on abstract semantics. Decisions/Issues: Action(s):
8	Topics / Issues - Cooper	Status/Discussion: There was discussion about key open issues late in the session. Though everyone was pretty tired, the following were identified and added to the mmap: - Regulatory - potential complications (per discussion above) especially with plug-and-play networks. - Formal relationship between the various standards organizations and the profile work products developed by the PCD. - Strategies for migration from current vendor-proprietary technology deployment to a standards-based approach. (incl. value propositions for device manufacturers} Decisions/Issues: Action(s):
n	Next Meeting - Chair	Status/Discussion: In addition to the meeting Friday of this week, there will be DPI discussions during the Vancouver standards meetings next week. Given various meetings during the week of 09.22, a DPI meeting should be scheduled for that Monday, 2008.09.22 Decisions/Issues: Next meeting will be Friday 2008.09.12 @ 14:00 Eastern / 11:00 Pacific Action(s): (Todd) Schedule a DPI meeting 2008.09.22

Next Meeting

2008.09.12 Friday @ 14:00 Eastern U.S.

(Reviewed & approved by PCD DPI WG 2008-09-22)

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