Minutes of ISO TC215 WG7 WGM, January 2006 – Phoenix, Arizona, USAISO/TC 251/ WG7 - N0078d2

FIRST DRAFT MINUTES of ISO TC215 WG7— DEVICES, jointly with IEEE EMBS 1073, and hosted by HL7 Health Care Devices (DEV) Special Interest Group (SIG), with and Anaesthesia (GAS) SIG at the HL7 Working Meetings

Quarter / Topic / Notes - Action items are shown in bold
Sunday 7
Q1 – Q4
Evening / HL7 International Affiliates Meeting
HL7/CEN/ ISO harmonisation meeting / Reynolds provided short verbal report of CEN TC251 activity relevant to HL7.
Agreed that HL7 should rapidly offer to harmonise with CEN EN 13606-1, which will require publication of 13606-1 to be postponed –a request will need to be submitted accordingly.
Monday 8
Q1 / Roll call
Agenda review
Status Update / Delegatesintroduced themselves. Apologies were noted.
Approved with details amended.
Cooper provided overview of x73 Editorial planandISO Workplan.
Monday 8
Q2 / -00000 F&O Review / Harrington reviewed circulated draft (N0078-11703-00000-d07a20060505-1.pdf) by walking through the clauses of the document, making some annotations for changes needed. The need for a document scheme that does not misleadingly relate to ISO OSI levels was discussed – Wittenber later provided a draft proposal, which was agreed as suitable.
Monday 8
Q3 / -20200 Assoc Ctrl Function Review
-20201 Polling Mode Review
-20202 Async Baseline Review
-20301 RCOP Review / Cooper reviewed status – ready for editing and ballot. It was clarified that the first 3 of these complete a full functional interoperability profile. ENV 13735 will be withdrawn imminently – these standards are necessary to replace it, and it is necessary to go to ISO ballot before July. On this basis it was agreed that these –202zzs should go to immediate simultaneous IEEE ballot. JW produced a short document resulting from a discussion of x73 scope.
Cooper reviewed status – ready for editing and ballot. Although the remote control is not required to complete a full profile, it is dependent on the –20202. On this basis it was agreed that this should go to immediate IEEE ballot.
Monday 8
Q4 / -00000 F&O Review (continued)
HL7 DEV SIG Co-Chair Election / Harrington to integrate initial commented document and start consensus review by end May.
Cooper to provide names for contributors.
First complete draft by Boca Raton meeting, but an ISO CD to be issued on the basis of the end May draft by July.
Election of DEV SIG Co-Chair postponed till September meetings
Tuesday 9
Q1 / HL7 v3 messages v CDA
TSC Co-chairs report
Education committee report
POCT1-A (-90101) update
Glucometer Specialization PAR Proposal / Beeler reviewed. In summary both are used but the suggested that the best long-term solution for device communication would be to use Templates ( / Profiles) based on the Clinical Statement model. It would then be possible to represent the device-originated information in the context of either a HL7 v3 or a CDA paradigm. (Or indeed in the context of an EN/ISO 13606-n archetype? – Reynolds)
Norgall gave a brief verbal report.
McCain: If a charged HL7 Tutorial is proposed, then it must be organised through Education; if a non-charged information session then simply inform marketing so it is printed amongst Tutorials in the Guide. 10-minute review to TSC also possible.
In ISO ballot.
NSBs are advised to return an ‘encouraging negative’ ballot stating that the improved, –A2, revision should be used in preference to the submitted –A1.
KyungHee Kang presented draft NWIP and discussed. After some discussion of details it was agreed that this work should be pursued as a specialisation of POCT1-A.
Reynolds presented the last slides of the UK DoH slide set, showing social, wellness, health monitoring transitions in their “integrated service model”, emphasising the business need for an integrated set of technical service standards.
Tuesday 9
Q2 / Glucometer Specialization PAR Proposal (continued)
HL7 v2.x ORI (-60101) Review / Set up IEEE list-server – include as initial membership: Trudel, Harrington, McCain, Norgall, Kraus, Wittenber.
Harrington and Reynolds presented the v0400 and changes they propose.
These changes were suggested (and subsequently approved) on the basis that the IHE PCD Year 1 profile for enterprise integration will deal with workflow issues and the related message flows. The consequence of this is that if HL7 is to incorporate guidance on device reporting in its documentation then some of the current content will probably need to be retained (at least at the referenced level) in that HL7 implementation guidance.
6.2.3 is curiously empty! Harrington to work with Firl or his local team to complete.
Patient demographic management can perhaps be excluded but noted as required for valid messaging. Similarly ID management.
7 needs pruning to provide consistent format and level of content.
8 provides the context for the trigger echo - so we can keep our specification almost to the level of the existing (OBX) comms descriptions given by manufacturers?
9 - IHE could cover this too bearing in mind that our messages are all the same except the trigger echo-back. Just needs to say field xxx carries echo of trigger.
Tuesday 9
Q3 / HL7 v2.x ORI (-60101) Review (cont.) / All of 10 is taken from the IHE POCT profile; is a poor fit and can be removed.
The methodology for deriving the 11073 payload should be explained.
13 is a loose collection of working thoughts and needs tidying or deleting
Annex A, Informative Examples, (the format got messed so 14, Message contents, is the start of Annex A) 15-16 can go (to IHE) if 9 does.
17 and 21-on is the ORI meat, but 18-20 can be omitted if 9 is.
The examples can be simplified so only the simplest covers both x73 and LOINC, not Local, and remainder contain only x73; but examples still need final check and device-related info inserting in OBXinstance1.
Harrington will finalise document for pre-ballot circulation and ballot.
Tuesday 9
Q4 / IHE PCD Update & Document Review
MFER (-90201) status review / Cooper reviewed the current programme and explained its relationship to ISO/IEEE HL7 devices work.
Masaaki Hirai reviewed the current document status and showed some further developments. There followed some discussion about related editorial and policy matters.
It was confirmed to proceed to ballot for an ISO Technical Specification –in the knowledge that this might raise some negative comments but recognising that a publication ballot is the best way to elicit feedback.
Wednesday
10
Q1 / Joint meeting with hosted by OO / IDC Recursive Act Relationship
  • Use Lab as example for recursive construct of Component on Act. Objective is to insert into a new ballot round in September.
  • The IHE implementation guide will need to put this back into V2. Can either use Parent/Child or OBX Sub-ID using the “dotted” approach.
Null Value
  • Various null flavors. Appear to be insufficient.
  • Examples are in V3 data type. If anything is missing, will work with Gunther/Patrick for a harmonization proposal.
  • We need a V2 proposal for OBX to allow to accept null code values. Gunther and Hans to check what needs to be changed in V2.
MedicalDeviceAct.code
  • If IEEE has a list, use that, otherwise further work with Vocab to establish.

Wednesday
10
Q1 – cont. / Joint meeting with hosted by OO / Filter Mechanism – What should we use for IHE Profile?
  • Year 1 has three profiles for Point of Care Devices.
  • Primary profile is the inter-enterprise communication of device data.
  • Third is PCD broker enabling requests for certain data, e.g.,
  • Check with Chapter 5 for V2.
Unsolicited Observations against Standing Orders
  • Check R30, R31, R32
Personal Health Record Updates
  • See Clinical Statement for relationship, with “non-clinicians” as authors/informants to deal with patients or persons on their behalf providing results.
    Check out ProviderOrPatientOrRelated in Clinical Statement RMIM.
  • In V2 check out the Role Segment and utilize the role code for participation/role definitions. Use Table 0443 as basis and use v3 to make necessary additions.
Message vs. Document
  • Key differentiation is the readable/formatted aspect of a document versus message. Next is that attestation is more likely on a document then on a message. Beyond that characteristics could be applied to either message or document.
  • Critical that to the extent that data can be structured by the source, the same structure is used. Clinical Statement is a good example of a pattern that conveys the core data as part of a message or a document. The packaging around it varies.
Personal Health Record Updates
  • See Clinical Statement for relationship, with “non-clinicians” as authors/informants to deal with patients or persons on their behalf providing results.
    Check out ProviderOrPatientOrRelated in Clinical Statement RMIM.
  • In V2 check out the Role Segment and utilize the role code for participation/role definitions. Use Table 0443 as basis and use v3 to make necessary additions.
Message vs. Document
  • Key differentiation is the readable/formatted aspect of a document versus message. Next is that attestation is more likely on a document then on a message. Beyond that characteristics could be applied to either message or document.
  • Critical that to the extent that data can be structured by the source, the same structure is used. Clinical Statement is a good example of a pattern that conveys the core data as part of a message or a document. The packaging around it varies.
Risk Management Paradigms
  • See slidespresented by Wittenber.

Wednesday
10
Q2 / Testing Strategy & Tool Development Update (NIST) / Testing strategy discussion per IEEE and IHE PCD work presented by NIST personnel.
Tool Development update. – tool freely available from website.
DIM and Terminology issues identified during tool development.
Vote taken to raise an IEEE1073 PAR for 11073–10202 standard to provide an equivalent of the abstract representation given in –10201 in XML notation (this work to use as its basis the NIST conformance work). Vote unanimous - 19 present.
Vote taken to include reference to 11073–10202 document in the forthcoming revision of –10201. Vote unanimous - 19 present.
Garguilo, NIST, to edit 10202Vote of thanks to NIST personnel conformance work undertaken to date. Vote unanimous - 19 present.
Action on NIST to provide an estimate of delivery timescale for a schema that could be used for supplier conformance purposes, including service and transport aspects.
Morrisey
to provide the minimum deliverable suitable for supplier conformance purposes.
Wednesday
10
Lunch / Emergency Care SIG Update / Met jointly over lunch to discuss the interrelation between the two SIGs.
Work arose from EHR functional model current data elements for HHS from DEEDS – need updating and coordinating with LOINC. Main EDIS suppliers active in WG which holds calls on Wednesdays at 13:00 US EST. See HL7.org website for SIG scope.
A joint Q to be scheduled in Boca Raton. DEV invited to join a EC conference call in ~July to define agenda.
Wednesday
10
Q3 / IDC Nomenclature (-10103) Review
Jointly with IDC SIG
/ Steblay presented–10103.
Nomenclature to be submitted to 11073 for harmonisation with the –10101 and –10102.
Representation of complex terms – to be resolved with JW, etc.
Discriminators - chiefly to applicable to chambers/leads. Combinations allowed but be careful to explicitly exclude unsafe combinations.
Systematic names: rules? Equivalent to a structured definition.
Hierarchy of terms wrt parameter groups is OK – but the appropriate placement needs to be clarified.
Wednesday
10
Q3 – cont. / SCP-ECG Update / Reynolds informed of imminent release for ballot of amendment to CEN EN1064. He offered to make the draft available for the purposes of comment and co-ordination (route comments to MR).
He also noted that, because the original proposal of SCP-ECG (AAMI draft version) has failed to get timely completion in IEC SC62D, it will be possible to introduce the approved CEN document to as a fast track adoption (ISO 11073-20401), notifying IEC of intent.
Wednesday
10
Q4
-
Jointly with Cardiology and GAS SIGS / Nomenclature questions: HL7 OIDs & New Term Addition Process
Cardiology SIG Update
Anesthesia / SNOMED terminology join / Shafarman:
Which OID do I use? ISO/ANSI database OID as registered in HL7. MR to repeat request to Cecil Lynch /Ted Klein at HL7 to de-duplicate – act with MS.
How do I get to register a term properly? A: Complete form and submit (MR to send form).
Longer term, what’s the mechanism? A: Maintenance agency to be established.
Shafarman will write letter seeking establishment of a web-accessible resource by IEEE/ISO.
Kisler -NIH Roadmap project (one of 12). Potentially many terms are already defined in n x73 – spend joint quarter on this in Boca Raton.
Monk and Hurrell presented the work undertaken with Andrew Norton. It is not yet complete but, in summary, good chance of a match – and hence viable join of x73-101xx to SNOMED CT.
Monk will share (spreadsheet) questions to enable –10101 revision corrections and to achieve harmonisation of mismatches.
Cooper + Monk to investigate the IPR issues to ensure free use.
Thursday 11
Q1 / Bluetooth SIG Update / Hughes reported on Bluetooth SIG Medical Devices Working Group.
Final draft and completed specifications are freely available.
Differentiating consumer from professional health devices? – Up to group consensus; but no internal objection use of ‘medical’ in name despite different market needs (personal health v audiology and sleep labs).
VA need for consistent requirements specification – here and elsewhere.
Trudel – no BT permitted in acute care areas on his Toronto hospital, so WG needs to involve BioMeds if the market is to open into institutional healthcare.
Current target – single profile or multiple? Single with options. Scalability? Understand roadmap scope then scope to profile.

Thursday 11
Q1 – cont. / Bluetooth SIG Update – cont. / Clarification of the joint development process was requested.
Reynolds to distribute the full CEN/ISO/IEEE process model.
HL7 DEV SIG activity relates only to enterprise level communication.
Thursday 11
Q2 / Kansas State lessons learned
ZigBee (& with USB) Update
Consumer / Home Health Device to Access Point Discussion / Cooper presented poster (paper attached).
Cnossen discussed ZigBee (but, e.g. Zwave / Insteon exist as proprietary). Wittenber observed that there’s strong resistance to use of a cable USB alternative for x73 – but that for USB > RF adaptor the case is distinct.
Bogia presented personal health care area and proposal for workgroup to address needs for common data command formats.
Norgall noted that the capability of the consumer transport devices (e.g. Bluetooth/mobile phone) will determine the scope of the payload and functionality.
Fastest possible publication in IEEE/ISO? A: 12 months excluding content generation.
Wittenber noted that mobile RF devices in general may need lightweight version of MDDL but retaining overall 11073 architecture and within a subset of the –1xxyy.
Thursday 11
Q3 / -30400 Inter-LAN Project Discussion / Schnell presented 11073-30400 work to date demo and zero-configuration association.
Discussion of terminology and grouping of profile components.
Thursday 11
Q4 / ATA Update
Work Plan for Lower Layers / Clarke reported on his participation in American Telemedicine Association meetings earlier in the week.
Cnossen presented summary of ‘lower layer’ activities. In discussion the following were agreed:
McCain to inform CHI of 1073 to 11073 name/number structure change.
Cnossen to prepare PAR proposal for –30000 F&O - scope and purpose.
Schnell to change PAR to convert 11073-30400 (Medical IP Profile) to only cover 802.3 Ethernet as a Transport spec.
Schnell to initiate PAR to create a new 11073-20401[1] spec to cover application of IP technologies (transport agnostic; all services). Note that some items may be OSI Application Layer items.
Morrisey to update RF Wireless and WiFi documents to reflect -20401 change.
Cnossen to (1) investigate the best way to co-operate with and /or reference consortia output and (2) send recommendations to HL7/GC reflector to enable initiation of Bluetooth PAR in July for approval at September IEEE NECSOM meeting.
Thursday 11
Q4 – cont. / Work Plan for Lower Layers – cont.
Strategy review / Cnossen to draft Bluetooth PAR (-30501) for GC decision in July for August 4 submission for approval at September IEEE NECSOM meeting.
Wittenber presented work item dependency flow.
Will work with Harrington to produce draft IEEE project plan on basis of this.
Friday 12
Q1 / Work Plan for Personal Care Devices. / The meeting approved, subject to ratification by the General Committee on the list by the end of May (dependent on scope availability to permit 2 week ‘ballot’ process), the establishment of a WG under the Chairmanship of Bogia to oversee drafting (not required to be sequential) of:
(1) PAR for a technical report ‘Health informatics - Personal health and care device data’ (motion JH, seconded DB, approved unanimously - 13 present);
(2) a PAR for –2yyzz series related work, initially Bluetooth focussed, and extensible to other transports;
(3) any consequent –1yyzz series work for device specialisations.
Bogia to craft a scope for the WG and the PAR for the TR.
Friday 12
Q2 / Location services (inc. RFID)
-00101 RF Guidelines Project Update
RF Standards Work Plan
-30505 wWAN Project Discussion
RFID In Healthcare discussion / Worth informing/consulting HL7 Patient Care (and in USA HITSB) for input.
Fuchs to initiate enquiries and seek interested parties.
Morrisey reported the current status of this document.
Morrisey reviewedRF workplan.
Include verbiage in –00101 and –zyy00s that indicates that the most current normative comment will be found in the specific standards.
Morrisey reviewedwWAN workplan and document.
Needs to include means to deal with technology and operator related issues – and options for dealing with these issues.
Also to be considered in 20401 under interoperability of public private networks in general.
Given the complexity of the AutoID area and the mix of standard and non-standard technology impacting patient, location and product identification an joint exploratory in HL7 is required. Needs to involve at least Patient Admin, Scheduling and Logistics, Pharmacy and ?Lab.
McCain to work with Cooper to draft and submit a proposal to TSC for a joint exploratory session on RFID at September meeting.
Wittenberwill use the ISO RFID transport standard to start profile for device location issues.
Friday 12
Q3 / -30500 RF F&O Project Discussion
-30503 wLAN Project Discussion / Jan Wittenber reviewed progress.
Jan Wittenber reviewed progress and current draft.

Continued overleaf ……

Meeting adjourned:14:30:00, Friday 12th May 2006.

Next meetings:10-15th September, IEEE1073 Joint Meetings with HL7 (no ISO TC215 WG7) Boca Raton, Florida, USA;
9-11th October, Joint Working Meetings (with CEN TC251 WG4 and IEC SC62A) Geneva, Switzerland;.
7-12th January, 2007, Joint Working Meetings with IEEE1073 and HL7 San Diego, California, USA;
May, 2007, Joint Working Meetings with IEEE1073 and HL7 (with CEN TC251?) Cologne, Germany (TBC);
25-29th March, ISO TC215 Plenary, Montreal, Canada.

Associated documents are provided with sequential numbers ISO/TC 251/ WG7 - N0076 to –N0108and associated with this document.

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[1] Editorial note: there may be a need to reconsider this Part number, or others already assigned to this partition.