N0304d1_draft_mtg_min_of_DEV-IEEE_meeting_2010-10-Cambridge_US Page 1 of 10 MEETING AGENDA DRAFT – Revision A Dated 2010-10-08 Reference ISO/TC 215/ WG7 – N 0304d1 Joint meeting of IEEE EMBS 11073 and HL7 Health Care Devices (DEV) WG, at the HL7 Working Meetings WG7 Secretariat: PATTY KRANTZ (ANSI) patty.krantz"at"medtronic.com Meeting dates: 2010/10/04 to 2010/10/08 (Monday, October 4 – Friday , October 8, 2010) WG7 Convenor, IEEE11073 Co-Chair, HL7 DEV WG Co-Chair: TODD COOPER (ANSI) t.cooper”at”IEEE.org IEEE11073 Co-Chair, HL7 DEV WG Co-Chair: MELVIN REYNOLDS (BSI) MelvinR”at”AMS-Consulting.co.uk HL7 DEV WG Co-Chair: JOHN RHOADS (ANSI) john.rhoads”at”philips.com Place: Hyatt Regency Cambridge 575 Memorial Drive Cambridge, Massachusetts, USA 02139-4896 Phone direct: +1 (617) 492-1234 or +1 (800) 233-1234 Fax: +1 (617) 491-6906 Maps & Directions Reservations www.cambridge.hyatt.com/hyatt/hotels/ Host organisation: ANSI - HL7 international - please register onsite (see http://www.hl7.org/events/boston102010/ for detail). Host: ANSI - HL7 international http://www.hl7.org/events/boston102010/ Participants: Present continued overleaf …
Transcript
N0304d1_draft_mtg_min_of_DEV-IEEE_meeting_2010-10-Cambridge_US Page 1 of 10
MEETING AGENDA DRAFT – Revision A
Dated 2010-10-08
Reference ISO/TC 215/ WG7 – N 0304d1
Joint meeting of IEEE EMBS 11073 and HL7 Health Care Devices (DEV) WG, at the HL7 Working Meetings
WG7 Secretariat:
PATTY KRANTZ (ANSI) patty.krantz"at"medtronic.com
Meeting dates:
2010/10/04 to 2010/10/08 (Monday, October 4 – Friday , October 8, 2010)
WG7 Convenor, IEEE11073 Co-Chair, HL7 DEV WG Co-Chair:
Q4 Jan’s Roadmap / Wittenber/X73+DCM+IHE+….) 11073-00000 + ISO TR or ???
Wittenber
Presentation from Jan Wittenber Healthcare Device Standards – Roadmap perspectives – Workshop (see document N305)
Tuesday AM Q1
NIST Test Tooling, FDA-Quality Results, example + WAN tooling RTMMS
Tool Demo and Review IEEE & IHTSDO IP Issues (see
NIST
WebEx session with DEV, NIST & IHE PCD (see document N306)
How does the work NIST doing fit into US national – HealthIT hitech (contributing to and alignment with)? NIST does not provide certification but provides tooling
Incorp of hRTM db (version 3M), Enhanced hRTM & x73 nomenclature db, improved UI, developed ventilator setting profile to support ICE-PAC Rapid device configuration project
Next steps – add hRTM db update capability, enumeration values, profile template cabability, select ASN.1 types for private attr, customize & save profile unit table, update PHD DIM & specialization profiles (almost ready for release from Continua)
Rosetta Terminology Mapping – Maria tool demo
Q2 DCM Update Rhoads et al. Presentation from Jay Lyle (see document N307)
Q3 DCM-MD Update + Ballot Comment Resolution
Rhoads Cooper
Lively ballot resolution discussion Motion made and seconded to approve the dispositions discussed so far. Motion so moved (11 quorum, 2 abstained, 1 negative)
PM
Q4
Program reviews / General Updates: ISO/IEEE Work Program
Cooper
IP issue regarding NIST Rosetta Management Tool & 11073-10101 (DB form to utilize). Similar discussion example around 20401 – ACTION ITEM for Allen Hobbs – form a task group, consisting of Malcolm Clarke (x73), Allen Hobbs (KP), and Greg Staudenmaier (VA), to provide a recommendation on how to manage this for 20401. Kathryn Bennett presented the IEEE SA update (see document N0308)
Day Time Event Chair Notes IHE Update (incl. current work program)
John Rhoads IHE update (see IHE update document)
Wednesday AM Q1
Terminology Gaps / Revision VMD IDs – Proposed … Version 2.0 Identify To Do’s List Long Term Management
RTMMS & IHTSDO Coordination KP Control MD Terminology (Convergent Medical Terminology tool – CMT)
Incl. Tooling & DB
Paul Schluter IHE PCD work and Rosetta project – VMD list (See document N0309)
Presented the proposed VMD terms that will be used in our PCD-01 gateway implementation for the upcoming IHE PCD Connectathon and IHE Showcase at HIMSS. Paul sent this out 2 months ago and has not received any feedback.
Document N0309 incorporates the suggestions that several people proposed during the meeting, highlighted in red
Paul would appreciate any feedback regarding the proposed terms or whether thare are any existing terms that we are unaware of or could not find in the -10101 nomenclature standard that could be use instead. If possible, we would appreciate receiving your comments by this Friday (10/8), as we would like to include them as the GE VMDs in the next update of the RTM that I would like to have available for the upcoming IHE PCD face-to-face meeting at ECRI.
ACTION ITEM for Jan Wittenber Provide Patty with the information to issue a call for Erratta submission; call for new term additions (RTM, PHD, etc.) - submission end by December 31, 2010. To do: refractoring the nomenclature to allow for better…. Terminology Long Term Management: Within x73
Day Time Event Chair Notes (joint working groups HL7 DEV and ISO/IEEE 11073), Continua, and IHE PCD there is consensus and should be moving forward with our efforts. There is momentum and consensus with vendors and device manufacturers. Critical that communication stay open (with IHTSDO for long term management of terminology (SNOMED, LOINC, CMT, RTMMS) and agreement on the different roles that the sources are playing). See KP CMT info: http://www.govhealthit.com/newsitem.aspx?nid=74750 ACTION ITEM for Jan Wittenber – after the IHTSDO meeting in Toronto (Oct 2010) write up report to document “level of agreement” and next steps.
Q2
GAS Update 15 minutes RDC Project
Rhoads Wittenber
GAS update: (See document N0310 – missing) Timing on the project – HL7 ballot in the second half of 2011 Rapid Device Configuration (RDC): Sub-group of IHE PCD (Device point of care Integration (DPI)) is watching and collaborating with ICE. Forming the ICE-PAC group (Integrated Clinical Environment - PCD Analysis Committee). Goal is to demonstrate at the next HIMMS showcase. Case study for the demonstration - rapid config of a ventilator due to device crash or patient transport. (See document N0311 - missing)
PM Q3
FDA Update / Coordination
Reed Cooper Cooper Wittenber
Terrie Reed – update on FDA Health Informatics (See document N0312). ACTION ITEM for future to-do: Overlap between event product codes plus strategy for including rich device-acquired (incuding clinical environment surrounding the event) in content (e.g., ICSR) ACTION ITEM for future to-do: Determine X73 format for "GHTF Attributes" that might be communicated electronically from a medical device
Day Time Event Chair Notes IEC 80001 / HL7 Project Proposal + X73 Discussion
(analogous to SPL specification in HL7 ver 3) GHTF paper being submitted (see http://www.ghtf.org/) ACTION ITEM for Todd Cooper: Discussion with John Rhoads, Todd Cooper, and Terrie Reed needs to occur in the near future as Todd is gathering input for next update of the ISO/IEEE 11073-10201 Domain Information Model and can propose needed attribution to support these regulatory needs. ASTER-D Project (IHE PCD group) use case for capturing AE (adverse event) directly by an ICE Supervisor. Recommend working with Tracy Rausch / DocBox Todd Cooper presented adraft HL7 project proposal (not directly related to an HL7 standard) for discussion. The project title is Application of IEC 80001-1 Risk Management within HL7 (where IEC 80001-1:2010 is the Application of risk management for IT-networks incorporating medical devices). The attending group members approve Todd going forward with continued discussion to complete the project proposal with the goal of submitting a project proposal by the end of the calendar year 2010.
Q4
LOINC Strategy for RTMMS SAMD Catch-up Discussion(s)
WGPnPs
Clem Cooper Group Krantz
Scan paper from Clem to PDF to be N0313
Thursday offsite VA meeting – coordinating efforts (Cooper, Rhoads)
Thursday AM Q1 MFER Maasaki Presentation made by Maasaki as update on latest
status of MFER. Proposed ISO/TS 11073-92001 is currently in ballot phase. Proposed 4 further standards but insufficient response for create working group.
Day Time Event Chair Notes Presentation of the salient technical aspects of the base standard. Maintains compatability with existing standards where possible. Has a library of viewers (www.mfer.org). Discussion on the compatibility between existing waveforms standards with respect to use of nomenclature such as 10101 and 10102. ACTION ITEM for Maasaki: Consider how to ensure that MFER maintains semantic interoperability. Request to determine if can exploit 11073 nomenclature and Ref Ids and seek ways to harmonise MFER with 11073 and HL7
MFER – long term ECG Presentation of rationale for a standard for long term (Holter) ecg waveform and of proposed MFER long term standard
CDA V2 and MFER Presentation on use of MFER in CDA V2.
Telematics Hobbs
Presentation of an introduction to traffic safety technologies. Discussion on application of PHD devices to monitor the driver and how to integrate devices within an intelligent car and the architecture to aggregate devices.
PHD Update Bogia
Report on status of PHD (SWG7.3) presented via Skype with slides (see document N0314) Reported that IEEE-SA has given award for 2010 IEEE-SA Emerging Technology Award
PM Q3 IDCO Steblay Presentation on status of IDCO (Implantable Device
– Cardiac –Observation). Description of the ICDO Profile for IHE-PCD01. IEEE Ballot group formation for IEEE P11073-10103 has started ready for ballot in Q4 2010. Requests from physicians for further features in the nomenclature including alerts, waveforms and to have harmonization with ACC/AHA/HRS key data elements for electrophysiology. Suggested that any new alert and waveform marker
Day Time Event Chair Notes and leave aECG for surface ECG. Discussion of how to provide governance of the nomenclature. ACTION ITEM: ISDO group to liaise with NIST to expand the RTMMS to manage the IDCO nomenclature (requires expansion of mid terms) and to investigate establishing governance policy for 11073 nomenclature.
aECG Schluter Reported that aECG nomenclature now harmonized and to be adopted in DICOM. Document in preparation ready for ballot.
WCM and Grouping Fuchs
Presentation (see document N0315) on representation of waveforms within HL7 and status of development as profile within IHE-PCD01. Description of the waveform model given. Examples of suggested model mappings with differing hierarchies to support separate requirements for all channels have similar properties (e.g. sample rate) versus separate properties. This profile will not correspond to an ECG device conforming to PHD specialization and using mapping. This is OK. IDCO has similar requirement for waveforms and IDCO group will look at this profile to determine if meets needs. Issue raised around the need to send annotations at the same time as a waveform, and need to recognize that these can be delayed and may not align with its block of data. Concensus to proceed with this approach.
Agenda Mgmt (e.g., segregate SDO specifics) All
There was concensus that due to the need to liaise with many other groups that it was impractical to segregate further than already achieved
Q4
Appeals Procedures Review All
Discussion regards the procedures and processes adopted. Agree that technical appeals must take place more quickly.
Day Time Event Chair Notes Suggestion that all assumptions of a base standard should be restated verbatim in a PAR of a specialization in order to ensure that not re-interpreted later and aspects descoped. If aspects are descoped then shall ensure that the resultant specialization should be forward compatible. If aspects are descoped then specialization should specify those aspects. These issues should be considered in the revision of the working group processes and procedures.
HL7 DMP Adoption Discussion Rhoads
Discussion on Decision Making Practices (DMP) Concensus to adopt HL7 DMP for the Medical Devices WG. The IEEE P&P are being revised and will be harmonized. Review the management of designation of meeting chair. Review the definition of “meeting” within the context of a quarter or seesion.
Call for items of business for next HL7 meeting to be held in Sydney
Friday AM
Q1
Lower Layers Update Clarke Presentation of current status -30300 reaffirmation -30400 approved -30300a in ballot An issue regarding wording of comments for figures. Agreed to use wording “overheating could occur”. Interest to investigate -20401. Small task group to be set up to make a proposal for way forward. Discussion around safety issues with respect to use of de facto and industrial consortium standards for communication technologies.
Day Time Event Chair Notes considered for inclusion in forthcoming revisions, amendments or developed standards. A specimen clause is to be circulated for comment.
Discussion of tooling to support -20101 The work has revealed that the specification of ASN.1 as used in -20101 is not consistent, has incorrect statements and does not use ASN.1 in a standard way. There is agreement that issues exist and it would be advantageous to consider the changes that would bring 20101 (and 20601) into alignment with current ASN.1 definition. Discussion of options to produce MDER encodings. Suggest to adopt ECN create customised PER encoding rules as a first step. PHD group to be made aware of this activity and invitation will be given for people to join working party. Presentation by Alessandro Triglia of OSS Nokalva of the ASN-1Step tool for ASN.1 definition and producing sample messages.
Adjourn
Next 'Devices' Meetings (does not include interim project / task meetings):
* ISO/TC215 Joint working groups. Rotterdam, Netherlands, Oct 10-13, 2010, CEN TC251 WGIV * HL7 Working Group Meetings. 9-14 January 2011 - Sydney, Australia
* HL7 Working Group Meeting, 15-20 May 2011 - Orlando, FL USA
* ISO/TC215 Plenary and joint Working Groups, 23-27 May 2011 Finland * 25th Annual HL7 Plenary & Working Group meeting, 11-16 September 11, 2011 - San Diego, CA
* HL7 Working Group Meetings. 15-20 January 2012 - San Antonio, Texas
