Devices at HL7



HL7 DEV SIG / IEEE EMBS 1073 / ISO TC215 JWG

@ HL7 WGM 2006 January – Scottsdale Arizona

(X73 2006-01 Scottsdale Devices - notes (v3).doc)

|Quarter |x73 |Topic |Notes |

|Sunday 8th | |HL7 International Affiliates Meeting |MR provided short report of CEN TC251 activity relevant to HL7 |

|Q1 – Q4 | |HL7/CEN/ ISO harmonisation meeting |MR reviewed HTTF activity WRT prospective harmonisation of MD/HI standards. |

|Monday 12 th | |Attendance and patent registration sheets distributed |Apologies attached |

|Q1 | |Conference call with IEEE HQ on 11073-10101 maintenance |Attendance and patent disclosure agreement sheets circulated quarterly. |

| | |issues |MR / TC call in presence of WG. MR to deliver to IEEE: polished business case, maintenance example(s) – ANSI, cost |

| | | |models (GMDN?) and ISO contact persons. |

| | | |Actions: MR to deliver to IEEE: 1) polished business case, 2) maintenance example(s) – ANSI, 3) cost models (GMDN?) and |

| | |X73 v2 Nomenclature Update |4) ISO contact persons. |

| | | |MR noted, after the call, that he has a started a log of issues, but that there are preceding email threads that will |

| | | |also need inclusion and resolution. |

|Q2 | |Risk management (RM) conference call session |TC reviewed ISO TC 210/ IEC SC62A relationship. Sanibel report CH_210-0041_05.pdf |

| | | |MR reviewed HTTF draft. attach |

| | | |JW reviewed his paper on RM for MDs, esp. WRT ISO . RM process_1.doc |

| | | |Discussion of nature of types of risk and extremely granular and dynamic nature of risks. |

| | | |GM mentioned need to keep in mind policies that impact. |

| | | |BB CEN CatRisk can inform comms aspects. TS-15260 |

| | | |GM & JF both indicated that JW paper will inform company discussions. |

| | | |MS need for SLAs for MD capable networks. |

| | | |JW RM framework view preferable. |

| | | |GM: voluntary conformance profile (for e.g. reliability), negotiated real-time binding, if failure to work together the |

| | | |whole area will necessarily become regulated. |

| | | |JW performance profiles a useful and good approach. |

| | | |VA isolation architecture, and other, CDRH meeting presentations – will make available. |

| | | |MR to provide CEN QoS analysis – prTR 15253.pdf |

|Q3 | |Agenda review |Approved and amended |

|Q4 | |Status Update |TC/MR provided overview of editorial plan. FEF name restriction (… , neurophysiological observations) would ease ISO |

| | | |adoption. TC introduced new work items. See plan |

| | |-30400 Review |JW reviewed discussions and presented to 3-slide doc – JW to update. MS commented this would probably be the first x73 |

| | | |to use IP-centric then reusable to other –3xxyy documents. |

| | |-20200 Assoc Ctrl Function Review |Not covered |

| | |-20201 Polling Mode Review |Not covered |

| | |-20202 Async Baseline Review |Not covered |

| | |-10104 Virtual Attributes Review |Not covered |

|Tuesday 13 |OO DEV |Agenda setting with OO parent |JF represented DEV to liaise |

|Q1 | | | |

| |jointly with |-00000 F&O Review |TC has recent draft for circulation. TN noted need to fold in the content used in recent presentations. Open issues |

| |CBHS | |F&O issues.pdf |

| | |-20301 RCOP Review |CEN WGIV did substantial revision of the draft at the October meeting. Now needs review before ballot. JW noted that |

| | | |completion of this work is a high priority because a failure to complete to publication risks the potential for |

| | | |unconstrained implementation drift; this was agreed by those present. MR to recirculate draft for review. |

| | | |Korean input for discussion – pptx2. LS to provide draft work item proposal. For circulation. JW to work with LS to |

| | |Glucometers |transform on basis of existing NIBP draft. LD offered to contribute other device data from candidate devices. |

|Q2 | |HL7 v2.x ORI Context intro. |JW reviewed the scope and high level structure and semantics of x73 communication in the context HL7, NCCLS, etc. |

| | | |CBHS trigger of need for informational session(s) re Pt Care. Dev SIG need for same to be addressed (with HL7 Education|

| | | |TC encouragement to disseminate to other lists). |

| | | |TC reviewed IHE PCD activity. |

|Q3 | |DEV SIG Co-Chair Elections |TC and TC elected. |

| | |HL7 v2.x ORI Review |JF to get draft from BB and finalise by Feb 3. Distribute to ORI list for comment. draft |

| | |ISO/IEEE products WRT HL7 publication |As the ORI is entirely conformant with regular v2.6 requirements there is only a need for extracts from ORI text to be |

| | | |added to v2.7 (and subsequent) as implementation guidance for DEV. |

| | |HL7 v3 ORI Review |JF reviewed issues relating to X73 to HL7 Mapping, particularly the use of templates. ppt |

|Q4 | |HL7 v3 ORI Review |JF reviewed issues relating to X73 to HL7 Mapping, particularly the use of clinical statement for observations in |

| | | |templates. ppt |

| | |Physiological Exam Report using MFER |Exam report (Hirai) – incl. MFER type information integration, poss. w/ CDA R2 where the template construct is used ass |

| | | |a means to populate either a v3 message or, as the case of Japan, inCDSv2R1. ppt |

| | |IDC |Not covered – see Wednesday Q3 |

|Wednesday 14 |OO jointly with |Common Models and Issues |PMJ described Lab proposals and requirement descriptions. folder |

|Q1 |CBHS and LAB SIGs | |DEV asked about viability of reporting in Clinical Statement as a simple template to enable ‘v3’ construct to be |

| | | |produced but capable of being used as either CDA or v3 Message according to requirements imposed by receiving systems |

| | | |(see MH presentation from registry. |

| | | |DEV registered concern about ambiguous IOD registration of external code systems. |

| | | |DEV asked about the general issue of making explicit analysis of Risk Management issues |

|Q2 | |Conformance Testing Update (NIST) |RR presented NIST work on ICS. |

| | | |Need for message snipper – but not currently in tooling. |

| |OO jointly with |Common Models and Issues |MR attended to observe the resolution of current Lab proposals – many (reversal) changes of both general and Lab. By |

| |CBHS and LAB SIGs | |end of week it appeared to him that the Clinical Statement model was, in this case, broadly equivalent to the Template |

| | | |approach used by MH and Jf; and that both, if carefully modelled, would be close to the structure already defined for |

| | | |the ORI. |

|Q3 |jointly with |Cardiology overview |TC reviewed DEV scope and products WRT cardiology. Slideset. |

| |Cardiology, IDC and| |Card.SIG motivated to involve professional societies for clinical input for semantic interoperability. Grew from NIH |

| |aECG-RCRIM SIGs | |roadmap project at Duke, so largely US-oriented at present. Differing requirements for delivery of cardiology results –|

| | | |often comprising aggregated data from different areas of order processing. |

| | | |PS reviewed. Ppt. Some discussion of mapping to, e.g., SNOMED CT. |

| | |aECG Nomenclature Review |DB reviewed current status. Actions: systematic names, defns, template. PS to give latest aECG. |

| | |IDC Nomenclature Review |Not covered here. |

| | | | |

| | |X73 v2 Nomenclature Update | |

|Q4 |jointly with |Anesthesia activities update - SNOMED “join” discussion |AN presented IOTA work to date. Need for (post co-ordination) qualifiers in SCT for some of x73 complexity. MH need to|

| |GAS | |clean up some of the systematic name links (e.g. pertains to / concerns?) – TN requested issues for resolution. MH – |

| | | |does sequence for elements of systematic names matter? JW not necessarily critical – but in general safest to use the |

| | | |sequence. |

| | | |MR to ensure Gas have –10102. |

| | | |GAS will present to SCT in Feb meetings; prime goal the existing map, secondarily, how x73 data accessed through |

| | | |repository using SNOMED terming as basis. If terms modelled then adoption by SNOMED more likely. |

|Thursday 15 |jointly with |Review use cases that may motivate need for CAN and |HZ presented brief overview of CANopen. Some general questions on current general use and technology issues. |

|Q1 |CANopen |inter-system coordination; networked medical devices, |TC introduced need for use-cases that may be particularly applicable to use of CANopen technology from FDA “networked |

| | |etc. |medical devices” workshop December 12. |

| | | |TM: current (IHE-PCD) examples poor. |

| | | |AN: Infusion (e.g. rapifentanyl) much more important use case (infusion pump with ECG) with documented risk (see UK |

| | | |NPSA). MH – however, the physiological time constant for metabolism of rapifentanyl is way longer than the capability |

| | | |of the actuator control system… |

| | | |TM: another much more complicated case – peak pressure / rate on ventilator. AN – very complex to work up use case |

| | | |because of need for haemodynamic monitoring, with compliance, oxygen. 10s of seconds < minutes involved in assessment |

| | | |and resetting. |

| | | |AN: vascular and neurosurgical surgery use cases, but noted that the marketing of such a ‘solution’ to an expert market.|

| | | | |

| | | |TM: Laser surgery with O2 at too high a concentration can cause an airway fire – so that might be another. |

| | | |MH: ophthalmic (retinal) laser surgery over telemedicine (or even local). |

| | | |TM: kidney lithotripter/laser surgery is critical upon respiration. |

| | | |CS; CANopen is optimised for control. |

| | | |PS: OK for control with kinaesthetic feedback, but for most medical devices the device takes control as requested by |

| | | |target setting – as a opposed to tight inter-device co-ordination. |

| | | |JW: agreed with PS that such appropriate partitioned comms enables more freedom of implementation with QoS. |

|Q2 |jointly with |Technical review of issues and strategies for mapping |JW presented overview of x73 architectural topological correlation, throughput and control frequency response. |

| |CANopen |between X73 upper layers, HL7 and CANopen |JP presented brief overview of x73 – CANopen; focussed on IHE-PCD bed/BP use-case. |

|Q3 |jointly with |Technical Frameworks supporting use cases |TC introduced nomenclature with respect to domain model. |

| |CANopen | |JW suggested we use the Remote Control Annex B model as an exemplar for a mapping model. |

| | | |Consensus that joint exploratory work is needed to define an interoperability framework. |

| | | |Actions: Establish a Joint Task Force; HZ and TC to facilitate recruiting of participants. |

| | | |JW and JP to do use case analysis on 1) bed – BP, 2) closed loop infusion and 3) use an existing CANopen scenario as |

| | | |basis for another use case. |

| | | |Need for mutual education / information; HZ and TC to facilitate (specifications are available at can- | |

| | | |downloads). |

| | | |HZ and TC to fix next meeting date. |

|Q4 | |Synch / co-ordination |PS reported meeting with IDC group scheduled production of XML representation to include SNOMED CT terms. Need to use |

| | | |text descriptions for Enumeration value attributes. |

| | | |MR noted that he was informed that HL7 / SNOMED Terminfo process is keen to see cleanly identified nodes in any |

| | | |hierarchical terminological scheme (e.g. MDC -> SCT). |

| | |-20103 Clinical Context Management (CCoM) Discussion |Wittenber reviewed rationale for ensuring attribution of patient to the associated devices. Can be done by higher level|

| | | |association with clinical domains but there may some significant lag in updating domain rosters. Showed schematic state|

| | | |diagram. |

| | | |Melvin mentioned that IHE PIR profile might assist. |

| | | |Content: Wired wireless, persistence across context changes with tracking of topological status or mobility. |

| | | |CIA context with appropriate security. |

| | | |Patient ID WRT logistical/ADT info / context in admitted state. |

| | | |Need management model and/or state machine. |

| | |Updated RM model |JW presented overview of current draft. Much detailed discussion. JM made action list. |

| | |-00201 Profile Template |Not covered. |

|Friday 16 |[Note: Q1 OO & IDC|Update on week’s discussions covering HL7 / IEEE / ISO |TC presented overview – and highlighted issues that might be published in different forums. |

|Q1 and Q2 |met] |scope charter discussion | |

| | |-00101 RF Guidelines Project Update | |

| | | |JM presented overview and will email out updated email items. |

| | | |Actions: Use cases (add personal [home, mobile, …]), diagrams need updating – BH (+ JW); |

| | | |JW will update RM. |

|Q2 |TC215 meets jointly|Joint ISO TC215 / DICOM meeting |DICOM: CL introduced Emmanuel Cordonnier as new Vendor Co-chair of DICOM. New areas of activity: |

| |with DICOM | |pathology, vetinary, surgery (including ORF [Prof Remke, Berlin]), application hosting and clinical trials (industry |

| | | |driven). HC reviewed updated supplements. |

| | | |ISO: noted that ballot for 12050 finishes February 9 2006 – no major issues yet obvious so approval might be anticipated|

| | | |– if not FDIS is a further 2 months. MR noted that CEN will adopt after publication. |

| | | |TM requested liaison re DICOM datatypes for ISO datatypes standard. |

| | | |MR suggested that parties be sure that comments to HTTF Draft Report be submitted in time. Also mentioned that WG7/DEV |

| | | |SIG has requested that HL7 begin to consider to Risk Management. |

|Q3 | |-30400 Inter-LAN Project Discussion |MS + SW presented overview of current ideas |

| | |-30500 RF F&O Project Discussion |JM led discussion and a preliminary content framework was agreed. |

| | |-30505 wWAN Project Discussion |JM led discussion of scope and it was agreed tight scope should be used with cross-dependencies to be mentioned in F&O. |

| | | |Lively discussion of end-to-end services-requirement v technology-for-purpose approach. |

| | | |MR reported that the Final draft TR (rev) has been submitted for final scrutiny by NSBs. |

| | |TR21730 RF interference | |

|Q4 | |Updated RM model |JW presented overview of current draft. |

| | |-30503 wLAN Project Discussion |JW presented overview of current ideas based on SLA approach. |

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