IEEE 11073 Nomenclature Status IEEE 11073 GC at HL7, La Jolla Tuesday, September 12, 2017 Paul Schluter

Topics IEEE P11073-10101b – New Observation Identifiers IEEE P11073-10101b – Events, Alerts and {REFID,disc,code} 3-tuples IEEE P11073-10103a – IDC Extensions Terminology Coordination with other groups NIST RTMMS {REFID,disc,code} assignment process

IEEE P11073-10101b Observation Identifiers Extends ISO/IEEE Std 11073-10101:2004 and -10101a-2015: Initial Proposal REFIDS Definitions UoM Enums WG Appr Codes N/A Infusion pumps and infusion events (IHE PCD PIV and IPEC) Ventilator mode, high-frequency ventilation, annotations NMT Neuromuscular transmission (level of neuromuscular block) * Finalize the WCM waveform attributes Ventilator E:I ratio, Ipart, Epart and other terms IHE PCD Device Management Control (DMC) IHE PCD Real-Time Location Services (LS) Event and Alert Identifiers (in progress) Dialysis Surgical and OR devices (by OR.NET at http://www.ornet.org/) Hemodynamic parameters using transpulmonary thermodilution and pulse contour analysis Note: Inclusion of new terms in draft standard is contingent on timely completion.

IEEE P11073-10101b Events and Alerts The existing list of ISO/IEEE 11073-10101:2004 MDC_EVT_ identifiers has been extended to support the IHE PCD Rosetta for Events and Alerts and ACM. Extends existing -10101:2004 nomenclature with contributions from GE, Philips and others. Events and alerts will be included in IEEE P11073-10101b , based on earlier discussions. Physiologic events and alerts – largely done, with par-src-evt 3-tuples. Proposed par‑src‑evt 3-tuples: phys.4n.x6i.x4b.2017-09-05T18.par-src-evt.xls Technical events and alerts – 800+ proposed and existing REFIDs and definitions based on GE, Philips and -10101:2004 standard (also expecting contributions from Dräger). See RTM HTML with definitions: XSL Output.tech.4n.6xi.x4n.2017-07-11T16.html Early par‑src‑evt 3-tuples: tech.4n.x6i.x4p.2017-09-11T21.par-src-evt.HL7.xls

IEEE P11073-10101b par-src-evt 3-tuples description remarks ecg-phys MDC_ECG_HEART_RATE MDC_EVT_LO MDC_EVT_HI Heart rate limit exceeded + reuse of existing numeric identifiers + additional lo|high variants MDC_ECG_V_P_C_CNT MDC_DEV_ARRHY ? MDC_EVT_ECG_V_P_C_RonT R-on-T PVC ’named’ event/alert fully identifies – src is largely arbitrary and redundant ecg-tech MDC_ECG_LEAD_RA MDC_ECG_LEAD_* MDC_EVT_LEAD_DISCONN Lead disconnected + src and evt convey useful information vent-tech Estimated leak flow rate ? MDC_EVT_VENT_PAT_CIRCUIT_DISCONN Patient circuit disconnected ’named’ event/alert fully identifies – src is unnecessary Comments: 1. par-src-evt representation works reasonably well (par is typically required in most protocols). 2. src identifier is not consistently obvious if evt is already a strong standalone semantic concept. Recommendations: IEEE P11073-10101b (or RTMMS) shall provide a full description with each par-src-evt 3-tuple. Alternatively stated, one or more valid src values shall be specified with each event/alert term-row. This is consistent with how many user and service manuals are written and would facilitate direct conversion of on-the-wire par-src-evt 3-tuples to text messages that could be displayed on the device.

IEEE P11073-10103a Implanted Devices Cardiac Extends IEEE P11073-10103:2012 Implanted Devices Cardiac New IDC term codes, extending IEEE P11073-10103:2012. Notifications (‘alerts’) are largely complete with the definition of 14 standardized notification categories that convey publically- disclosed vendor-specific notifications. [This reflects the sometimes significant differences in the underlying vendor design of these devices.] Several dozen new terms and term-sets have been reviewed by the Heart Rhythm Society (HRS) and will be included in the standard. The IDCO WG meets weekly on Fridays at 10:00 AM Central (US).

http:/all vendor platform 23.04.2018 Masterlayout © BIOTRONIK Let’s now talk about details and open issues of the ISO/IEEE 11073-10103 Implantable Devices - Cardiac - (IDC) Nomenclature Device Programmer Device Programmer 2017 More systems, more interfaces IHE EPRC-IE IHE IDCO IDCO adapter CDISC Home environment Patient portal http:/all vendor platform FDA GUDID Internet (( FDA CDRH UDI ACC NCDR Device management, Cardiology Module, Clinic EMR http://www. IHE RCS-EP ? IHE EPRC-IE ? IHE IDCO Practice/Hospital electronic health record Vendor web services

IDC Nomenclature The scope of the next version of the standard The scope of the existing IDC nomenclature V 1.0 (ISO approved: 2014) The discrete terms necessary to convey a clinically relevant summary of the information obtained during a device interrogation … summary interrogation information from all vendor devices The extended scope of the IDC nomenclature V 1.1 Scope of V1.0 above plus more remote monitoring information notifications (‘alerts’) new device types (S-ICD,…), new vendors more implantation related information (DFT-Test?) new coded values (e.g. all the new episode types) if possible, EGM

Coordination Topics IHE PCD MEM-LS and -10471 and -10441 PHD Location Info MEM-LS will likely reference home dwelling names in IEEE ISO/IEEE 11073-10471 “Independent Living Activity Hub”. MEM-LS currently defines GPS, [X, Y, Z] and uses HL7 ‘named’ room locations for in-building care facilities. Extensions to ISO/IEEE 11073-10102-2012 Annotated ECG (aECG) The proposed SCP-ECG V3.0 (revision to EN 1064) project may required additional ECG terms, and these can be added to the existing term groups aECG.

Interesting Topics and Next Steps ... Physiologic Events and Alerts ECG ST lead-group alerts (named or generic groups) Technical Events and Alerts Alert distribution scope: local device display (only) local area network to other devices and systems enterprise network to gateways, alarm reports, biomed lab and EMR Next steps ... Preliminary assignment of event/alert {REFID,disc,code} 3-tuples After IEEE 11073 and IHE PCD review, use NIST RTMMS to assign numeric codes.

IEEE 11073 and NIST RTMMS Terminology Process BACKGROUND SLIDES

New Term REFID and Code Assignments Background for this discussion, motivated by the desirability of assigning numeric codes at the earliest possible time. Use the NIST RTMMS as the authoritative numeric code validator (and generator) for new terms to guarantee non-overlap between multiple organizations, e.g. IEEE 11073 PoCD, IEEE 11073 PHD, IHE PCD Rosetta, PCHA/Continua, MDPnP, OR.NET and others. If the assigned Reference ID, Disc, Part::Code is discarded during balloting, it is retired as a “zombie term” and cannot be re-used. Terms that are assigned codes must have complete definitions, UoMs, enum values and other information when they are submitted as an Excel worksheet, formatted exactly as it would appear in the published standard. Is this a good idea? Yes, if we can keep the number of “zombie terms” to a small number (e.g. < 1 to 3% of new terms defined). No, we could end up with a ‘free-for-all’ if this is uncontrolled without any degree of editorial review and curation.

Code and Term Assignment Process  Proposed 0^MDCX terms that have not been approved by a recognized working group, let alone by the larger IEEE 11073 community.  Provisional terms that have been approved by a recognized working group (e.g. IEEE 11073 PoCD, PHD, IHE PCD Rosetta, PCHA/Continua, MDPnP, OR.NET and others) may have numeric codes assigned to them prior to IEEE balloting. The status of each term (proposed, provisional, published) will be maintained on the NIST RTMMS.  Published terms are those that have been balloted, approved and published as an IEEE 11073 standard. Note: If a provisional term is rejected during IEEE balloting, the { Reference ID, Disc, Part::Code } 3-tuple will be retired as a “zombie term” and the Part::Code shall not deployed in messages nor recycled for use with another term in the future (enforced by NIST test tools). Proposed and provisional terms are subject to change and are not final until published in an IEEE 11073 standard. CF_CODE10^REFID RTMMS Status Meaning 0^MDCX_term  Proposed Proposed term nnnnn^MDC_term  Provisional Assigned numeric code (could become zombie)  Published IEEE 11073 Balloted, Approved and Published

Additional Required NIST RTMMS Capabilities Clearly indicate { proposed, provisional, published, zombie } status for all terms. Maintain list of { published ∪ provisional ∪ zombie } terms, from which new provisional REFIDs and Part::Codes shall not be drawn. Essential First Steps ... The IEEE 11073 PHD WG should copy or move their terminology {REFID,disc,code} 3-tuples and definitions to NIST RTTMS so that it can function as the single authoritative numeric code generator. The entire set of all {REFID,disc,code} 3-tuples should be verified against other vendor databases to ensure correctness.