PCD PC&TC 2009-05-04 to 08 F2F

Meeting Objectives

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

• Planning Committe: Review overall PCD activities, identify strategic next steps and update the "roadmap"
• Technical Committee: Review all materials slated for publication in May / June and resolve any issues so that final editing and publication may proceed.
• SDOs: The last two days of the meetings will be joint with IEEE EMBS 11073 and HL7 Health Care Devices WG. This is in lieu of participation in the Kyoto meetings being held the following week.

Schedule & Agenda

Daily Schedule

08:00 - 08:30 Check in at NIST front gate, stop at Visitors Trailer for badge; proceed to Building 222 ("Chemistry Building"); Meetings in Room A314 (third floor). IDCO WG meetings in room B341.

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

NOTE: Friday the meetings will end by 15:00.

Date	Hours	Committees	Topics
Monday 2009.05.04	08:30 - 17:00	PCD Planning Committee	Greeting & Introductions (NIST [Jim St. Pierre, Dept. Director of ITL] & IHE) Review & Approve Agenda IHE IP Managment Process Review Current PCD Program (incl. approved profiles) Identify Key Interoperability Issues Lunch U.S. HHS / ARRA: - IHE & NIST - ARRA (Carnahan) - Test Tooling Support (Snelick) - Terminology Mapping Update - Device Connectivity & HITSP/ARRA Message - HHS Security & Privacy Disclosure Feedback (Link 1 .. Link 2) Review & Update PCD Roadmap - ACM Roadmap - WCM - Requirements Review - Regulatory Considerations WP (a.k.a. MDDS/80001 & IHE)
Tuesday 2009.05.05	08:30 - 12:00	PCD Planning & Technical Committees	IDCO Profile Status Update PCD Roadmap Review IHE PCD User Handbook HIMSS '10 Showcase Discussion - Conceptual Approach - Vendor Equipment / Systems Policy Review PCD Marketing & Funding 80001-x & MDDS Update: PCD Story? PCD Schedule Review
Tuesday 2009.05.05	13:00 - 17:00	PCD Technical Committee	MEM Detailed Discussion Profile Optionality Management OBX, PID & ACK Discussion
Wednesday 2009.05.06	08:30 - 17:00	PCD Technical Committee	Cycle 4 Test Tooling Strategy (NIST) PCD Message Profile Registration (e.g., w/ HL7 repository) IHE International Update HITSP Engagement MoU Updates / SDO IP Management - IEEE - HL7 - ASTM/CIMIT ICE-PAC Review/Update Tour of NIST's Radiation Physics Lab (1:15 - 2:45 PM) - Limited to 24 visitors Detailed Cycle 4 Work Items Review - Technical Framework Update (DEC, v2.6,...) - Review pending updates - EUI-64 Usage - PIB - Incoming ID binding status notification - SPD - Proposed predicate enhancements - ACM Update - PIV Update PCD TF Architecture Discussion Patient-Device Association Continua Coordination Cycle 4 Development Activities Review
Thursday 2009.05.07	08:30 - 17:00	PCD Technical Committee & HL7 DEV WG & IEEE 11073	Terminology & Semantic Architecture IEEE 11073 & HL7 DEV WG Open Leadership Positions - Call for Nominations NIST Terminology Management Tooling Update 11073-10202 DIM Schema Update & Work Plan Rosetta: - Update & Harmonization w/ aECG & IDC nomenclatures - Inclusion of 11073 Personal Health Terms - Term Review ("vote off the island") IHTSDO Collaboration Update IDCO Profile Review Technical Framework Vol. 3 & Device Semantic Architecture Detailed Clinical Models (DCM) Update from TC215 Edinburgh Meetings Ventilator Terminology Update - Status Review - Respiratory Therapy "Booklet" Content / Template Discussion - WCM - HL7 v2.6 Proposal - ACM Integration - DPI WP (main discussion Friday) 2009 Survey Questions Review
Friday 2009.05.08	08:30 - 15:00	PCD Technical Committee & HL7 DEV WG & IEEE 11073	Device Point-of-care Integration (DPI) White Paper Draft Review NIST Tooling (ICSGenerator & ValidatePDU) Action Item Review (from this week) Supplements Roadmap & Review (defered to the 2009.05.13 Wednesday meeting) Adjourn Meetings by 15:00

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

Location Information

National Institutes of Standards and Technology (NIST)

Building 222, Room A314 (Conference Room)

100 Bureau Drive

Gaithersburg, MD 20899

• IMPORTANT REGISTRATION INFORMATION: Though there are no fees for this meeting, all participants must indicate their intention to attend by sending an advanced notification e-mail to John Garguilo (NIST) and Manny Furst (IHE PCD). Since these meetings are located at a U.S. government facility, international participants must provide additional information for security checks.

• General location information: NIST is about 30 miles north of Washington D.C. and located nearly equi-distant from three airports: Dulles (Northern Virginia - IAD), Washington National (Reagan), and Baltimore-Washington International (closer to Baltimore - BWI). If you are comfortable with taking the metro, Washington National may be the best solution, the other two require a rather lengthy/expensive taxi ride…(~25 - 40 miles). Dulles likely has the most international flights, but that may depend on which carrier you use.

• Additional information is available on the NIST visitors web site.

• Shuttle service: (Super Shuttle) is also available from Dulles, National and Baltimore airports. From Dulles to the Hilton costs $33, and from National to the Hilton costs $31 and from BWI it is $47. No reservations are required for the trip from the airport. To return to the airport requires a reservation, which we can try to coordinate during the F2F (which also reduces costs). Super Shuttle site

Attachments / Materials

Reference materials can be downloaded from ftp://ftp.ihe.net/Patient_Care_Devices/Minutes-and-Meeting-Summaries-Yr4-2009-10/F2F-2009May4-8/ Please note: some of the materials are in the recent Microsoft .docx, pptx formats. These have been converted to the earlier .doc and .ppt formats and are provided on the ftp site as well. Note: the conversions may have resulted in the loss of some details.

Decisions Summary

NOTE: These decisions are in addition to the action items listed above.

This section was established to track any items that came up that would require a ballot following the meeting. No such items were developed.

No.	Decision	Date	Description
1	xyz	2009.05.04	...
2	xyz	...	...

Action Items Summary

Action Items listed below were developed during the meetings. Action Items from the PC and TC are found in Discussion Summaries of those committees: PCD PC 2009-04-29 Webex and PCD TC 2009-04-22 Webex

No.	Action Item	Owner	Participants	Due	Open/Closed	Description/Update
1	PC: Monitor HITSP’s Work (also on TC list)	Jan Wittenber	Maria, Lisa Carnahan	2009.05.04	Open	Jan is on the relevant tiger team. Jan and several PCD members will participate in developing the response. Maria will generate the materials, Jan will get it to HITSP, Lisa will contact HITSP and USHIK (within AHRQ).
2	PC: Develop New Brief Profile Proposals for Cycle 5	...		2009.05.04	Open	For MEM: Battery management (leverage existing PCD-01), Location boundary alarms, Nomenclature requirements (Data types, names, value sets), Examine status of location services within HL7
3	PC: Vendor Recruiting for Cycle 5	Manny	Barbara, Monroe, Steve Merritt	2009.05.04	Open	Manny offered to make initial contacts with potential participating companies and asked Barbara to provide a list of what users want. Manny will contact companies identified by ECRI Institute and Monroe, and include a list of user needs and priorities for ACM. Press releases represent another tool. Manny to remind participants that PCD should provide press releases. He will draft a release. Barriers to vendor participation were identified. Steve will develop the “Getting Started” Wiki page. The PCD webinar being prepared(HIMSS09 Showcase presentation) may be useful.
4	PC: Certification of Systems Claiming Conformance	Elliot	Iaona	2009.05.04	Open	Elliot and Iaona will approach John Halamka, Steve Lieber and NIST regarding certification for PCD.
5	TC: Monitor HITSP’s Work (also on PC list)	Jan Wittenber	Maria, Lisa Carnahan	2009.05.04	Open	Jan is on the relevant tiger team. Jan and several PCD members will participate in developing the response. Maria will generate the materials, Jan will get it to HITSP, Lisa will contact HITSP and USHIK (within AHRQ).
6	TC: Set the date for TF final text version public comment release.	See existing TC Action Item		2009.05.04	Open	...
7	TC: Profile Optionality (should optional items be separate profiles)	John Rhoads		2009.05.04	Open	Is this something we need to address by issuing separate profiles? Manny to ask Steve about this issue. [Steve responded that this is up to the domain.]
8	TC: OID for PCD	Todd, John Garguilo		2009.05.04	Open	Seek IHE root.
9	TC: MOUs	Sandy		2009.05.04	Open	Follow up MOU status with CIMIT, ASTM. It is on the ASTM executive meeting agenda next week.
10	Patient Identity and PCD Messages	Todd, Khalid, Gary		2009.05.04	Open	How best to accomplish this tie will be addressed in the white paper for further development as a supplement to PIB (Todd). Coordination with IEEE (-20103 CCOM) and ICE-PAC will be accomplished Jan. Draft a patient association brief profile proposal (Khalid). The A04 registration message is not the commonly used message, while A01 is used by hospitals at admission (Gary). Gary will review this issue and it will be factored into the CPs for publication and testing in the 2010 Connectathon.
11	NIST Tools for RTM	Rob Snellick	John Garguilo, Paul, Todd	2009.05.04	Open	Engage and initiate discussions with Open Health Tools (OHT) to explore coordination - NIST, and PCD – John Garguilo and Rob Snellick. RTM Tool Usage Policy Team: Form a team to manage the introduction and release of the tool, including exploring the means to publicize the availability of the test tools and RTM project – Todd, Paul, John Garguilo
12	Test Tools	Rob Snellick	Manny	2009.05.04	Open	NIST will explore a registry for MWB files (Rob). Manny to request PCD Connectathon WG to post MWB files.
13	IDCO	Nick		2009.05.04	Open	Is there another transaction for pushing an IDCO report?
14	Cycle 4 Supplement Status	Ken, Todd		2009.05.04	Open	Ken will convene a WCM meeting (Wednesday, May 13) to draft the Supplement. John Rhoad, Monroe, Paul offered to review the document. Todd will set DPI meeting.
15		...		2009.05.04	Open

Meeting Minutes

Monday 2009.05.04

Participants:

Sam Carello – Welch Allyn, Maria Cherkaoui - NIST, Anupriyo Chakravarti – Surgical Information Systems, Malcolm Clarke – Brunel University (representing IHE UK, and HL7, IEEE), Todd Cooper - Breakthough Solutions Foundary, Inc., Bikram Day - Capsule, Fred Ehrhardt – Capsule, Al Engelbert - B Braun, Ken Fuchs - Draeger, John Garguilo - NIST, John Hotchkiss - LiveData, Barbara Majchrowski - ECRI, Sandra Martinez - NIST, Steve Merritt - Baystate, Gary Meyer - Cardinal, Monroe Pattillo - Philips, John Rhoads - Philips, Jeff Rinda - Hospira, Paul Schluter - GE, Tom Schultz - Medtronic, Erin Sparnon – ECRI Institute, Iaona Singureanu - VA, Greg Staudenmaier - VA, Nick Steblay – Boston Scientific, Sandy Weininger - FDA, Jan Wittenber – Philips, Scott Zaffrin – B Braun, Vaughan Zakian - Nuvon, Khalid Zubaidi - Cardinal,

Chairs: Ken Fuchs, Steve Merritt

Technical Project Manager: Manny Furst – Improvement Technologies/HIMSS

Item	Topic	Discussion
1	Welcome - John Garguilo	Status/Discussion: Welcome from NIST – Jim St. Pierre, ITL Department Director provided a description of NIST structure and an introduction to NIST’s participation in ARRA funding. The funds include - $220M grants formal bidding on technology - $20 M from HHS for interoperability, security, other EMR related grants Decisions/Issues: Action(s):
2	Introductions, Review of Agenda - Cochairs	Status/Discussion: Participants introduced themselves. Agenda was a approved with a few additions, notably OBX 4 and acknowledgement other than original ACK. Paul indicated that Ruth Berge asks that PCD address issues related to linking devices and data to the patient. Erin indicated that HIMSS has a patient safety group and that she will act as liaison. One of their interest in an implementation guide for EMRs and that has potential links to PCD’s implementation guide. Ken described the IP requirements for those participating. Todd referred to the IHE wiki page with the patent disclosure requirements. Decisions/Issues: Action(s):
3	Review of Profile Status and Cycle 4 Plans - Ken Fuchs and working group (WG) champions	Status/Discussion: ACM: Monroe indicated the direction will be to determine how to provide the output message and WCM. Paul asked if alarms can be added to RTM, and possibly a data model and priority. Monroe indicated a need for RTM to set a threshold for minimum data set that will tie the alarm to the patient. ACM should add one or more use cases that illustrate this extension. Discussion continued about the broad scope of potential alarm/alert notifications, the scope that includes messages from other domains (e.g., radiology, lab), the levels of significance (up to life threatening). Anupriyo indicated the variety of alarm subjects is too large to list. Vaughan indicated that the number of alarm possibilities and the number of recipients can reach a level that users will ignore them. Monroe summarized the difference between PCD’s interests (from devices to people) while other domains are most interested in data from the patient. The consensus was to first address those that are common. Ken suggested that a subscribe model be added to the existing push model. Manny suggested a webinar focused on the AM to AC communication. Todd observed that a new standard may be required and an early step will be to identify the standards group responsible. Iaona suggested that it may be other than HL7. DEC: CPs will be addressed, including a move to HL7 2.6. PIV: As above. Paul asked if drug id has been standardized. There are standards, none of which are used. Jeff indicated this will develop over time. - Jan proposed that key characteristics may also be desirable, such as pharmokinetics and the approach should permit future extension. Erin suggested these might include how to safely store the drug, where it is kept and other items. Anupriyo added reconciliation because there are multiple ways of identifying the drug. Erin indicated that when suppliers are changed both are acceptable. Todd observed that standardizing ID is not limited to drugs. Discussion indicated that drug nomenclature varies among countries, hospitals, companies. RTM: Paul provided a status report which indicated that it is substantially complete except for ventilator terms. The RTM-vent WG had a breakthrough recently that should lead to the ability to map vendor representation and machine representation. In addition, IDCO terminology is well along. - Anupriyo requested a way to indicate the basic measurement when there are multiple sources (e.g., heart rate developed from ecg, bp, etc.). Paul suggested adding synonyms to RTM. Iaona indicated this is available in HL7 v3. - Paul noted that the IDCO terminology mapping is consistent with the existing RTM table and with XML representation. DPI: Jan provided a status report. He noted that DPI depends upon other profiles. Following tghat identification, they will be able to write the white paper. This is scheduled for Friday morning. He suggested taking an hour in the PC to introduce the first white paper. Semantic White Paper: Will kick off in August. MEM: Steve asked if the high level approach used is adequate or if technical detail is required. He asked if RTM should include more device data as well as physiologic data. Todd indicated that the white paper should recommend priorities. Steve later provided this link with additional information: http://wiki.ihe.net/index.php?title=PCD_MEM_2009-05-05 Other work items for Cycle 5: Nomenclature requirements (Data types, names, value sets); Examine status of location services within HL7 Key Interoperability Issues: Priorities for PCD (roadmap). Harmonization with Continua, which will require an intermediary. Ioana indicated that the VA’s home care experiment is addressing the question of integrating this with inpatient applications using a “device manager”. Issues arose, including consistent time. TF: Todd asked that a date be set to move the TF to final text version. Decisions/Issues: Action(s): Manny will contact companies identified by ECRI Institute and Monroe, and include a list of user needs and priorities. Monitor HITSP’s work – Jan is on the relevant tiger team. MEM: - New Brief Profile Proposals for Cycle 5 - Battery management (leverage existing PCD-01) - Location boundary alarms Set the date for TF final text version public comment release.
4	ARRA and NIST Test Tooling - Rob Snellick, Lisa Carnahan	Status/Discussion: Rob Snellick and Lisa Carnahan introduced NIST’s support of testing and ARRA funding. Two of the three are of interest: testing and grants related to health IT. Grants funding is largely to non-profits and universities. $15 M will be contracted. Standards/subject matter expertise and testing will be the largest portions, mostly testing. The idea is that the tools would become services. NIST will build and fund the core, while SOA access will be tailored to the organization needing access. NIST will seek collaborators for development and evaluating the tools. IHE domains, CCHIT, ONC are among those expected to collaborate. No current work will be dropped (including PCD). In the short term, PIX PDQ v2, v3, lab results, and PCD pre-connectathon testing are at top of list being considered. These will be used to validate NIST’s approach. In the Fall NIST will have a workshop to evaluate its direction before addressing other test tools. Rob then provided a high level overview. SLIDES NOT YET AVAILABLE, WILL BE POSTED The tests will be conducted in Pre-Connectathon timing and provide more rigorous evaluation. Subject matter experts will be required to define the requirements. Access to the receiving system’s behavior may require a query function since the ACK does not provide detail and may not be sufficient to detect the receiving system’s proper performance with defective messages. Decisions/Issues: Action(s):
5	WCM within ACM - Multiple People	Status/Discussion: WCM within ACM: Discussion ensued regarding transmission of waveform requirements or leaving this to the device? Are waveforms and snapshots both required? What is the sequence if so? What about real time and historical continuous – which are different. What about including the annotation within the waveform transmission? Monroe recommended against setting a single way for sending pixels, since individual companies may seek different implementations. Issues of quantity and complexity arise when storing - considering the messages (the historian). E.g., resolution. Also, the AM should not modify/shape the waveform; the resolution should be set at the AR. Discussion followed on the requirements of the use cases and the definition of a snippet to elucidate the various sue cases. - Paul summarized: is the data retrospective or current, is the data a snippet or continuous until terminated. - Key use cases: see updated wiki page Decisions/Issues: Action(s):
6	ISO 215 April 2009 Edinburgh - Todd Cooper	Status/Discussion: Todd summarized the following (see multiple slide files): - WG7: They revised the scope. Among their contributions are a glossary. Patty Krantz (Medtronic) was elected Secretary. - 11073-91064 was published. - Projects update: ISO/IEEE 11073: the partner ISO-IEEE SDO agreement requires revision to move things through a fast track ballot. - Work in progress was listed. - ISO 800001-1 Completed ballot; on track for publication in 2010. Identified the need for -2 document to provide guidance eon applying the standard in various environments (800001-2 NWip Proposal). In contrast, the FDA’s regulations address vendor’s responsibilities. This will be a guidance document. Todd noted that the FDA is focused on intended use. Representatives from the NHS noted that the document should address actual, not only intended use. - WG7 received a request for standards for adverse event reporting. - Mapping between ISO/IEEE 11073 and IHTSDO SNOMED-CT Decisions/Issues: Action(s):
7	ARRA and PCD - Todd	Status/Discussion: How does device connectivity support the objectives of the ARRA/HITECH? Little is under consideration within HITSP right now. From HITECH Section 3002: 8 points (see slides); See items on slide 5. These can be associated: Lack of patient ID on medical data Decisions/Issues: Action(s):
8	Security and Privacy - <lead>	Status/Discussion: Lack of device id for security - device ID to be used to associate patient (use of back end) rather than embedding patient’s ID in the messages. Doing this will de-identify the transmission, providing a higher level of security. - Ensure ED/first responder data flows are enabled (e.g., encript PID only – to reduce bandwidth consumed - Ensure both wired and wireless connections are protect security and privacy (S&P) Technology to protect privacy and security - Ensure edge to edge across multiple links with varying technologies - Apply an 800001 process - Protect access to configuration areas of medical devices Decisions/Issues: Action(s):

Tuesday Morning 2009.05.05

Tuesday morning was a joint PC and TC meeting.

Participants:

Terry Bettis - Welch Allyn, Jon Blasingame - Philips, Sam Carello – Welch Allyn, Maria Cherkaoui - NIST, Anupriyo Chakravarti – Surgical Information Systems, Malcolm Clarke – Brunel University (TC215 participant), Todd Cooper - Breakthrough Solutions Foundary Inc., Bikram Day - Capsule, Fred Ehrhardt – Capsule, Fred Ehrhardt - Capsule, Al Engelbert - B Braun, Ken Fuchs - Draeger, John Garguilo - NIST, Colin Garstka - Epic, John Hotchkiss - LiveData, Alex Kraus - Biotronik, Barbara Majchrowski - ECRI, Sandra Martinez - NIST, Steve Merritt - Baystate, Gary Meyer - Cardinal, Monroe Pattillo - Philips, John Rhoads - Philips, Jeff Rinda - Hospira, Paul Schluter - GE, Tom Schultz - Medtronic, Erin Sparnon – ECRI Institute, Iaona Singureanu - VA, Greg Staudenmaier - VA, Nick Steblay – Boston Scientific, Sandy Weininger - FDA, Jan Wittenber – Philips, Scott Zaffrin – B Braun, Vaughan Zakian - Nuvon, Khalid Zubaidi - Cardinal,

Chairs: Ken Fuchs, Steve Merritt

Technical Project Manager: Manny Furst – Improvement Technologies/HIMSS

Item	Topic	Discussion
1	IDCO - Alex Kraus, Tom Schultz, Nick Steblay	Status/Discussion: Nick Steblay described the status of the IDCO profile. Their plan is to be prepared for the 2010 Connectathon. The profile has gone through one public comment period and then shelved for a year due to Cardiology Domain’s withdrawal of funding. Unsolicited orders and observations. Seven physicians from the Heart Rhythm Society provided a list of the data required in a summary report, rather than provide all possible data. The plan is to go to ballot in a couple of months. NIST plans to test to this profile and they have placed the profile in the MWB. Decisions/Issues: Action(s):
2	Roadmap - Ken and others	Status/Discussion: The revised roadmap can be found at ftp:\\ftp.ihe.net\Roadmap_and_Calendar\IHE-PCD_Roadmap-F2F-20090504.xls Discussion included the following: Ken led a discussion of the road map. Jan suggested that there are improvements desired for the subscription (PCD-02). ACM: Discussion about How to enroll companies to flesh out the profile? Users want the ability to know that alarms were received and not lost, there is a need for escalation. There is also a need to provide guidance to purchasers. Barb also indicated that smart alarms are very important – to prioritize alarms. Clinical culture will help determine how well this is received and used. Paul noted that vendors want the decisions on priority at the initial device and not have them reduced in priority later in the flow (could increase). John Hotchkiss noted that alarms are generally turned off int eh OR, but there are situations where certain alarms or combinations are employed. Paul suggested that the payload could provide additional information useful for research. Jan suggested that a study of workflow wuld contribute to optimum alarming; and there are may issues. The DPI white paper can help with this. Barb asked about alarms sent from home. Paul indicated that ACM can support this, but there are related problems. Discussion included the need to provide alarms from home and that this should be on the roadmap. Paul indicated that Continua should also be addressing this, and Ken asked if that is on their roadmap. Todd indicated that IHE Korea is interested in home health applications, including alarms, for their October 2010 Showcase because it is a national priority. - Jan suggested that the concept of “point of care” is very complex. Todd suggested a white paper to explore the many issues. Rosetta: Cycle 4 will include ventilators and alarm communication terminology mapping and PHD terminology. Semantic Architecture: Jan observed that there is a tight relationship between 11073 and PCD to provide the comprehensive androbust terminology/vocabulary. User Guidance Document: Steve Merritt lead the discussion. Discussion included how best to make it easy for those purchasing equipment to specify IHE conforming products. Testing and/or certification by NIST, CCHIT is the goal. In the interim there are needs for appropriate specification by the purchasing organization and for users to motivate vendors to develop conforming products. Decisions/Issues: Action(s): Manny offered to make initial contacts with potential participating companies and asked Barbara to provide a list of what users want.
3	HIMSS09 - Manny	Status/Discussion: PCD had an outstanding Showcase. The existing paradigm for PCD won’t work with additional vendors and profiles, so PCD will be challenged to develop a new approach to the demonstration. Decisions/Issues: Action(s):
4	Outreach - <lead>	Status/Discussion: ECRI Institute is potentially a good way to represent users as well as communicate with users. Manny asked participants to suggest publications for a news release. Jan suggested developing a blog. Anupriyo indicated that he is sending Tim Gee information for his blog. Decisions/Issues: Action(s): Manny to remind participants about press releases and draft a release
5	Funding - Todd	Status/Discussion: PCD leadership is looking at grant opportunities as well as sponsorship to facilitate PCD activities. Decisions/Issues: Action(s):
6	80001 and the FDA - <lead>	Status/Discussion: While not the same, these are related. Most IHE profiles don’t have regulatory implications, while PCD’s profiles do. Barb asked if PCD can develop tools for risk management and 80001. The FDA MDDS is not yet at a stage that can be addressed. 80001-2 will be a guidance document and may be the appropriate vehicle. Todd suggested that MEM could support implementation of 80001-1. Decisions/Issues: Action(s):
7	xyz - <lead>	Status/Discussion: Decisions/Issues: Action(s):
8	xyz - <lead>	Status/Discussion: Decisions/Issues: Action(s):

|}

Tuesday Afternoon 2009.05.05

Tuesday afternoon was a TC meeting.

Participants:

Terry Bettis - Welch Allyn, Jon Blasingame - Philips, Sam Carello – Welch Allyn, Maria Cherkaoui - NIST, Anupriyo Chakravarti – Surgical Information Systems, Malcolm Clarke – Brunel University (TC215 participant), Todd Cooper - Breakthrough Solutions Foundary Inc., Bikram Day - Capsule, Fred Ehrhardt – Capsule, Fred Ehrhardt - Capsule, Al Engelbert - B Braun, Ken Fuchs - Draeger, John Garguilo - NIST, Colin Garstka - Epic, John Hotchkiss - LiveData, Alex Kraus - Biotronik, Barbara Majchrowski - ECRI, Sandra Martinez - NIST, Steve Merritt - Baystate, Gary Meyer - Cardinal, Monroe Pattillo - Philips, John Rhoads - Philips, Jeff Rinda - Hospira, Paul Schluter - GE, Tom Schultz - Medtronic, Erin Sparnon – ECRI Institute, Iaona Singureanu - VA, Greg Staudenmaier - VA, Nick Steblay – Boston Scientific, Sandy Weininger - FDA, Jan Wittenber – Philips, Vaughan Zakian - Nuvon, Khalid Zubaidi - Cardinal,

Chairs: Ken Fuchs, Steve Merritt

Technical Project Manager: Manny Furst – Improvement Technologies/HIMSS

Item	Topic	Discussion
1	MEM - Steve Merritt	Status/Discussion: Slides have been posted. Software: One of the priorities Erin and Barbara identified was patch and update/upgrade management. RTLS: There is no common messaging, and MEM can make a real contribution. Monroe suggested that recruiting vendor participation will be more successful if we define the need for two transactions: how to send location information, how to ask for location information. Jan suggested that this can be broadened to compatibility management (e.g., compatibility with a wireless implementation – type, QoS, etc.). Operational Status and Monitoring, Battery Management – additional high priority information for the device. Data may be available in the device, in the CMMS or elsewhere. SNMP may be a useful tool. Todd suggested that the white paper will provide a roadmap to development of the various MEM components. Three of the potential areas were identified as potentially low hanging fruit to consider for the current cycle and recruiting participants. Much of MEM may be implemented within PCD-01 and other existing transactions with the addition of terminology. John Rhoads suggested that certain information be sent upon powering the device (e.g., device ID). MEM raises the question of remote access to the device. Todd mentioned TC215 efforts to consider Japanese standards on remote access, addressing security. Decisions/Issues: Action(s):
2	PIV - <lead>	Status/Discussion: CPs for TF which address PIV needs, in addition to the move to HL7 v.2.6. OBR and OBX have cardinality of 1…n, but the TF restricts this to a cardinality of 1. Multiple OBXs cannot be associated with one OBR. OBX-4 abstract model - Gary asked how to handle various types of pumps, channels. Todd offered several different ways – since there are different ways manufacturers implement their systems (e.g., are there separate serial numbers for each channel)? Todd indicated this will be a topic for discussion at the pump meeting in San Diego later this month. Paul suggested that the document have multiple drawings to illustrate at least the following: syringe pumps, modular and piggyback. The patient association will be at the level of the pump as a unit. The ACK question: the original ACK may have an error message associated. Gary suggested that the Enhance Accept ACK be used instead. Iaona suggested that two application acknowledgements be used. Todd referred o the ITI document which specified Original Acknowledgement mode. There is a need to identify the error types – such as inability to recognize the data type, or the drug is not in the library. Anupriyo indicated that a communication ID may be sufficient for some types of devices. Decisions/Issues: Action(s):
3	Profile Optionality Management - Todd	Status/Discussion: Todd summarized the issues arising from a lack of documentation of Connectathon testing and results when transactions are optional within the profile. DEC and ACM have optional actors or transactions. One approach is to use versioning as options (or future enhancements) are considered as, or become mandatory. Conformance Validation: Anupriyo raised the issue of the need to be able to point to an independent source of validation. This would be valuable to vendors in asserting that their systems are interoperable. Decisions/Issues: Action(s): Ask Steve Moore if the next version of Kudu/Gazelle addresses this issue.
4	Orientation to PCD for Prospective Vendors - <lead>	Status/Discussion: Anupriyo indicated that there are significant barriers to participation – lots of unknowns to learn about. Suggestions included a Getting Started Wiki page, recorded webinars, converting the Showcase PCD presentation to a webinar, and the IEEE TV program. Decisions/Issues: Action(s):
5	Guidance for Users Purchasing Devices and Systems - <lead>	Status/Discussion: Differentiate between connecting to device data and devices directly. For healthcare delivery organizations (HDOs), make evaluation/specification process as simple and straightforward as possible. :* Discussion ensued regarding how much PCD can contribute in listing features, functions, data displayed. Jan described the users’ views of these systems as black boxes that have to be described in user friendly fashion. Anupriyo suggested that the profiles remain technical documents for the vendors, and the user guidance documents support the users. Steve suggested that the users want a document that tells them what the system will do for them – insufficient detail. Decisions/Issues: Action(s):
6	xyz - <lead>	Status/Discussion: Decisions/Issues: Action(s):
7	xyz - <lead>	Status/Discussion: Decisions/Issues: Action(s):
8	xyz - <lead>	Status/Discussion: Decisions/Issues: Action(s):

Wednesday 2009.05.06

Participants:

Terry Bettis, Jon Blasingame, Lisa Carnahan, Maria Cherkaoui, Anupriyou Chakravarti, Malcolm Clarke, Todd Cooper, Bikram Day, Fred Ehrhardt, Ken Fuchs, John Garguilo, Colin Garstka, Patty Krantz (Guest), Alex Kraus, Sandra Martinez, Steve Merritt, Gary Meyer, Monroe Pattillo, John Rhoads, Iaona Singureanu, Paul Schluter, Tom Schultz, Elliot Sloane, Rob Snellick, Nick Stabley, Sandy Weininger, Jan Wittenber, Khalid Zubadi,

Note: Alex Kraus, Tom Schultz, Nick Stabley met separately on the IDCO profile.

Cochairs: Todd Cooper, John Rhoads

Guests: In the afternoon, we were joined by the following guests from CAS Medical: Robert Kopotic, Matt Dalene, John Gamelin

Technical Project Manager: Manny Furst

Item	Topic	Discussion
1	NIST Test Tools - John Garguilo	Status/Discussion: John Garguilo introduced the NIST MDC Testing presentations. John reviewed Rob Snellick’s presentation on Monday. Testing will include syntax, structure validation, semantic (content) validations,____ . Pre-Connectathon and Connectathon testing will be provided through “test agents” that act as the transaction partner or by monitoring communications between partners. Conformance testing will include system behavior as required by the TF. Paul asked if the LAN developed to support testing could be used as the home hub link. Rob indicated that the tools will likely have components that can be downloaded for users as well as central SOA applications. John continued by describing instance testing, isolated system testing, and peer-to-peer system testing. A lengthy discussion followed regarding the ability to test the receiving system (e.g., DOC )– did it receive and properly process the data? A query would show that the data was received and persisted for some period of time. However, the if the question is whether the receiving system did something clinically useful (e..g, display a graph) this requires a human observation. Paul noted that the query would verify that the data was correctly received; and accomplishes a part of the required testing. Ioana recommended that testable assertions will be required. John then described the test flows and proposed that as the profiles/TF is developed, the test detail be defined. Test tools will continue to use the MWB. John indicated that the PCD profiles test scenarios are required, along with the HL7 profiles, validation context, user provided tables or databases, and the HL7 transactions. Todd reflected upon discussions to this point and the need to provide high quality IHE and PCD products. John Garguilo reviewed the process for obtaining OIDs for profiles. Rob indicated that IHE and HL7 have processes (separate) for registration. Todd asked if gthis can be coordinated within IHE or if PCD needs to find another path. Decisions/Issues: Action(s): Out of profile optionality maintenance issue: is this something we need to address by issuing separate profiles. John Rhoads. Barriers to vendor participation: develop the “Getting Started” Wiki page. Steve Merritt PCD webinar material may be useful (e.g., HIMSS09 Showcase presentation). PCD (Todd) and NIST (John) to ask IHE for a root to use.
2	IHE International - <lead>	Status/Discussion: Elliot updated the group on IHE including some historical background. Decisions/Issues: Action(s):
3	MOUs - <lead>	Status/Discussion: IEEE MOU permits better leveraging of standards in PCD documents. CIMIT, ASTM related to ICE-PAC, in limbo. Jan raised the question about MOUs for IP protection for PCD and its participating members in developing DPI. These relate to the multiple standards that DPI will utilize. CCHIT – at some point PCD systems will desire/require certification. Todd noted that CCHIT is primarily focused on the clinical application of the product. For PCD this may tie to use cases. The question is should PCD build a relationship with CCHIT and if so, what should that look like? Is it a PCD/CCHIT or IHE/CCHIT relationship? Elliot suggested that this is a great time to reach out, perhaps through John Halamka and Steve Lieber. Jan recommended that PCD define the steps required to achieve certification. Action Items: Sandy to follow up MOU status with CIMIT, ASTM. It is on the ASTM executive meeting agenda next week. Elliot and Iaona will approach John Halamka, Steve Lieber and NIST regarding certification for PCD. Add to PC list. Decisions/Issues: Action(s):
4	HITSP and ARRA - <lead>	Status/Discussion: Jan described tiger teams – IS on data architecture, transaction architecture, security and privacy and … . Jan volunteered for the data architecture teams. They start by defining data elements then will proceed to normalization. Patient ID identification and harmonization with the multiple existing standards (e.g., HL7). Jan is leading a sub-team mapping from 11073 to the list that HITSP will use. Decisions/Issues: Action(s): Jan will and several PCD members will participate in developing the response. Maria will generate the materials, Jan will get it to HITSP, Lisa will contact HITSP and USHIK (within AHRQ).
5	ICE-PAC - <lead>	Status/Discussion: Point of Care Analysis Committee – evaluating use cases developed by ICE. They are using heparin to evaluate the model. Several use cases have been developed. These will be added to the DPI proposal. Jan indicated that workflow is an important consideration. Decisions/Issues: Action(s):
6	Continua - Paul	Status/Discussion: Paul summarized the current status. There are multiple standards for transmitting home care data over the Internet. Continua plans to support home health with only simple approach. He provided a model based upon PCD-01 (see slides ). Paul would like to see Continua adopt a reduced version of PCD-01 with multiple benefits to all. Decisions/Issues: Action(s):
7	Patient Identity Binding - Todd	Status/Discussion: As background: - When initially proposed, this was implemented as an enterprise level activity. With the development of PIV, this binding became more important. Several vendors have implemented a form of patient ID binding in other devices as well. Khalid noted that there is no standard for transferring the information from the enterprise to the device. Jan noted that there is an 11073-20103 (clinical context) effort to automate the transfer of this information to additional devices. Additionally, there is a need for a device to generate a temporary patient ID for data transmitted before the caregiver can provide the :-::- ID binding – especially in emergency situations. Paul proposed a Session ID comprised of the device ID (EUI-64) and the time stamp (NTPS). Action Items: Decisions/Issues: :* This will be added to the DPI discussion session and insertion to the white paper for further development as a supplement to PIB. Coordination with IEEE (-20103 CCOM) and ICE-PAC will be accomplished Jan. Draft a patient association brief profile proposal (Khalid’s) The A04 registration message is not the commonly used message, while A01 is used by hospitals at admission. Gary will review this issue and it will be factored into the CPs for publication and, the 2010 Connectathon.
8	ARRA - <lead>	Status/Discussion: Elliot summarized the security requirements of the HITECH portion of the bill. The new law requires that individual PHI includes: - Audit trail to permit patient to know where the data has been sent - Patient notified if security has been breached - Penalties Elliot asked: is this an issue for PCD? He suggested that PCD add this to the roadmap. HHS has offered a suggestion with robust security standards requirements and high security scrubbing of memory when deleted. Malcolm indicated that privacy is the big issue in the UK, with security having been addressed. With patients able to limit access, there are situations where a patient has limited access to the primary caregiver and thus prevented access by other physicians. Decisions/Issues: Action(s):

Thursday 2009.05.07

Participants:

Terry Bettis, Jon Blasingame, Lisa Carnahan, Maria Cherkaoui, Anupriyou Chakravarti, Malcolm Clarke, Todd Cooper, Bikram Day, Fred Ehrhardt, Ken Fuchs, John Garguilo, Colin Garstka, Alex Kraus, Sandra Martinez, Gary Meyer, Monroe Pattillo, John Rhoads, Iaona Singureanu, Paul Schluter, Tom Schultz, Nick Stabley, Sandy Weininger, Jan Wittenber, Manny Furst

Item	Topic	Discussion
1	NIST Tool for RTM - John Garguilo, Paul Schluter	Status/Discussion: John Garguilo introduced the detailed discussion of NIST Tooling to Support RTM Process – the “RTM Management System”. Maria’s presentation on this subject is found within the slide group ____ . The RTM maps vendor terminology to MDC codes which are to be the only interoperable terms used. Maria demonstrated the structure and use of the database. Discussion followed with requirements for additions, changes, such as the need to have: historical information about changes, deprecations, and versions for each individual term, Discussion followed about the release of the RTM tool – at what stage will it be open to users? Paul indicated the table is stable enough (with the exception of ventilator terms). The other considerations are - Access control to avoid inadvertent errors - Relationship to an SDO to review and validate entries - Todd indicated further review is not needed at this time - John Garguilo asked which SDO is appropriate - Jan suggested the linkage to the ICS Generator be considered in this decision - Jan suggested a pilot program be run first - John Garguilo suggested the cycle be similar to the PCD Connectathon/Showcase cycle Maria offered to provide a “first version” and discussion indicated the following are required first - Identify volunteers from several companies to provide company tables, use the tables (e.g., export XML) - Vendors submit XML files, not Excel - Identify which SDO will have maintenance responsibility – and avoid issues around mapping to/from standards other than 11073 - Define the change mechanism, terminology authoring to fill gaps Paul then provided an update on the RTM project (file RTM-MDC.8f.2009-05-02.final). This includes the implantable device cardiac (IDC) terms. The table includes the fundamental physics definition that will be searchable. This will help identify existing terms and avoid duplication/redundancy. He recommended that only the SDO manager would have access to add to the table. Addiotns and changes include: - Add version - basePart and baseCode to provide the base definitions - unit of measure override – to accommodate the rate of the event (e.g., PVC becomes PVCs/min.) - A list of other changes is found at ___________ - Todd asked that generalization/specialization be added to the list The changes, for the most part, are deferred in order to move the RTM project forward to release. That version will be ready in two weeks, while the ventilator terminology will take a few more months. See SLIDES: TRM.update.1a.doc Paul suggested that ACM begin developing a list of events to illustrate this capability. Decisions/Issues: Action(s): Engage and initiate discussions with Open Health Tools (OHT) to explore coordination - NIST, and PCD – John Garguilo and Rob Snellick RTM Tool Usage Policy Team: Form a team to manage the introduction and release of the tool, including exploring the means to publicize the availability of the test tools and RTM project – Todd, Paul, John Garguilo
2	IDCO - <lead>	Status/Discussion: IEEE Ballot Proposal: Tom Schultz described the ballot proposal document. Need to post IDCO Supplement: The updated version (Monday, May 11) has been posted. Discussion followed: there is a need for a patient id, even if a temporary id when the actual id is not available. Todd suggested that there is no need to specify an ADT link at the DOC. Jan indicated the need to tie the patient to the record. Paul emphasized the need to avoid delaying the patient care process while a patient ID is obtained. Anupriyo suggested that there are two means: the device ID or the patient ID. Decisions/Issues: Action(s): Is there another transaction for pushing a report? Nick
3	Stakeholder Survey - Manny	Status/Discussion: Manny indicated that Ray and he are proposing some changes for the next survey. The email to the PC describes the proposed changes and includes the results from last year’s survey. Decisions/Issues: Action(s):
4	WCM: Snippets with Annotations - Ken	Status/Discussion: Ken asked for volunteers to develop this document as HL7 v2.x. Decisions/Issues: Action(s): Ken will convene a meeting (Wednesday, May 13) to draft the Supplement. John Rhoad, Monroe, Paul offered to review the document.
5	DPI - <lead>	Status/Discussion: Jan introduced the discussion noting that - a transformation is required from DPI 11073 cloud to the DEC HL7 cloud (see diagram). - HL7 v3 does not appear to be harmonized in any degree. - Referred to IEEE 11073-00101 includes issues related to wireless requirements. - Providing the infrastructure for decision support. - The concept of “point of care” – discussion explored the practical definition - not a physical one, but defined by the nurse and patient(s), i.e., caregiver focused, even over a wide network, vs. the original and possibly the official one, of the patient’s vicinity. Jan suggested that there may be several kinds of point of care. Discussion turned to the queston of which standards to use for communication to/from devices to the DEC-based network. Issue include latency (e.g., needing IEEE 11073 as opposed to HL7). Ioana suggested that the messages can be lighter weight to be more efficient (e.g., no need to repeat patient ID within an established context). Decisions/Issues: Action(s):
6	xyz - <lead>	Status/Discussion: Decisions/Issues: Action(s):
7	xyz - <lead>	Status/Discussion: Decisions/Issues: Action(s):
8	xyz - <lead>	Status/Discussion: Decisions/Issues: Action(s):

Friday 2009.05.08

Participants:

Jon Blasingame, Lisa Carnahan, Maria Cherkaoui, Anupriyou Chakravarti, Malcolm Clarke, Todd Cooper, Bikram Day, Ken Fuchs, John Garguilo, Sandra Martinez, Gary Meyer, Monroe Pattillo, John Rhoads, Iaona Singureanu, Paul Schluter, Sandy Weininger, Jan Wittenber, Manny Furst

Item	Topic	Discussion
1	DPI - Jan, Todd	Status/Discussion: Jan described a DPI “Intermediary” architecture include ref to slide. The intermediary functions to aggregate multiple devices, translate among data models, handle legacy devices, etc., as needed. Paul expressed concern that customers will resist the addition of an additional encoding process if that I required. Jan responded that the DPI connection is optional to address the possibility that it will be needed for enterprise communications not manageable with HL7 (in the upper right of the diagram). Jan suggested that this architecture will be needed to accommodate the variety of mapping requirements to align data models from HL7 and IEEE. Jan noted that the ICS Generator 11073 model provides discovery and subscription. He added that device communication to the enterprise or to another device requires this intermediary by establishing associations from multiple devices and a single association to the enterprise. Todd suggested these applications: - Enterprise is looking for specific applications - Device needs a source of information (needs to discover) - Caregiver wants to automatically determine all devices on a patient Jan added that enduring binding of the communication is possible, maintaining the binding in the face of communication interruption, etc. Paul observed that one function of the intermediary is to notify the enterprise of what devices are connected, and this can be provided with a PCD-01message having OBXs without data. Todd described the DPI discussion as a profile(s) that in effect addresses how the various aspects of past, and some current, PCD work fit together. Decisions/Issues: Action(s): Todd will set a DPI meeting.
2	Test Tools (MDC Tool Review slide) - John Garguilo	Status/Discussion: See the MDC Tool Review slide among the NIST slides. John Garguilo described the library of tools required to build the ICS Generator (Information Conformance _______ ). Action Items: NIST will explore a registry for MWB files - Rob. Manny to request PCD Connectathon WG to post MWB files. Decisions/Issues: Action(s):
3	xyz - <lead>	Status/Discussion: Decisions/Issues: Action(s):
4	xyz - <lead>	Status/Discussion: Decisions/Issues: Action(s):

Next Meeting

The next meetings are:

A joint TC and PC webinar May 13, 2009: PCD PC&TC 2009-05-13 Webex.

The Technical Committee will hold a webinar meeting May 20 PCD TC 2009-05-20 Webex

The Planning Committee will hold a webinar meeting May 27 PCD PC 2009-05-27 Webex

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