IHE PCD 2016 Spring F2F Profile PC and TC Updates ACM, MEMDMC, MEMLS Monroe Pattillo – PHI, LLC

Planning (PC) Updates

Alert Communication Management (ACM) Status: Final Text, in current PCD TF, was in 2016 NA C’thon, was in 2016 HIMSS Annual Interoperability Showcase, was in 2015 HIMSS Showcase at AAMI, plan is for same demonstrations this cycle Technical details during TC portion of presentation Current PCD TF contains all ACM CPs passed as of its publication. More CPs expected this cycle, to be integrated into updated TF. ACM documented alert attribute MDCs reflect IEEE 11073-10101a. Improve AR compliance to documented minimum attribute requirements. Increase demonstrations of alerts containing device cached LS data, AM added location data, alerts from CMMS systems, & alerts from LS systems. Continue work on alerts (alarms & advisories) and containments list. Need more participating AC vendors. Would like to see demo of ACM+WCM (AM or AC generated ECG graphics) IHE ITI mACM (AR–AM FHIR based, Opt AC, AM–AC WCTP) Cross Domain WG on IHE profile workflow mgmt (PCD, RAD, PCC, QRPH)

Medical Equipment Management – Device Management Communication (MEMDMC) Status: Updated Trial Implementation (TI), was in 2016 NA C’thon, was in 2016 HIMSS Interoperability Showcase, was in 2015 HIMSS Showcase at AAMI, plan is for same in this cycle Technical details during TC portion of presentation Current version of TI includes all approved CPs A few more CPs expected this cycle, produce updated TI Drafted REFID/MDC inputs for IEEE 11073-10101b (date TBD) WP for device remote command and control (alert audio pause) Need more participating CMMS vendors

Medical Equipment Management – Location Services (LS) Status: Trial Implementation (TI) updated, was in 2016 NA C’thon, was in 2016 HIMSS Interoperability Showcase, was in 2015 HIMSS Showcase at AAMI, plan is for same testing and demonstrations this cycle Technical details during TC portion of presentation Current version of TI includes all approved CPs A few more CPs expected this cycle, produce updated TI Drafted REFID/MDC inputs for IEEE 11073-10101b (date TBD) Increase detail in definition of confined spaces (rooms, halls, etc.) Related Works: IEEE p1847 LS for Healthcare Need more participating LS vendors

TECHNICAL (TC) Updates

Alert Communication Management (ACM) AR actors pls verify your compliance to TF minimum requirements Will be requesting C’thon Tools to verify PCD-04 min requirement CPs on worklist, not yet ready for balloting Change ARs to identify physio limit exceeded events as alerts in OBR Needed by PCD-04 receivers to improve routing Formalize Alert Attribute for Hyperlinks, avoids AC actor/mobile UI guessing HL7 2.8 OBR EI datatype Print/Display component for AR to optionally pass additional alert text to receivers in PCD-04 Classify Alert Advisory types for workflow mgmt (DT String, until defined) Add opt attributes for workflow mgmt engines: prior, current, possible next(s) Add FHIR flavors of PCD-04 and PCD-05 to align with ITI mACM Harmonized catalog of alerts and events – need vendor samples

Alert Communication Management (ACM) cont. Discussion: Currently no ACM profile documented mechanism in Report Alert PCD-04 basic containment for communication of any items in IEEE 11073-10201 Alert Status Alert-Flags, specifically state of local-audible Some alerts (technical alarms, advisories) may be communicated to clinician (AC) without producing alert originating device local audio annunciation, even though local audio is enabled IEC 60601-1-8 6.3.3 Auditory Alarm Signals, Table 3 Note d – auditory component generation of LOW PRIORITY ALARM CONDITION optional State of, particularly absence of, device local audio in presence of an active alert should be included in ACM’s PCD-04 basic containment otherwise decision-making for alert fatigue management and retrospective analysis not empowered Alert instance specific state of device local audio at time alert is sent from AR to AM – distinctly different from what ACM currently communicates which is device operator manually asserted control of alert local audio as indicated in ACM Alarm Inactivation State audio-paused and audio-off which communicate using the name of the negative of the audio enables Currently no values in Alert Flags, in which local-audible is defined, communicated in ACM basic containment – need new basic containment OBX MDC/REFID communicating Alert Flags Currently no MDC/REFID for communication of state of local-audible (a Boolean) in OBX-5 – local-audible implies audio for alert is annunciating, how do we indicate local-silent? Implementation would result in ACM CP, small number of MDC/REFID additions to 11073-10101

Medical Equipment Management – Device Management Communication (MEMDMC) TI housekeeping updates – TBD CP to update power source and battery status triggers and attributes from IHE 2016 NA C’thon effort (BBraun to EQ2)

MEM – Device Management Communication (MEMDMC) – Cont. Whitepaper for communication to devices aka Medical Device Remote Command and Control Effort initiated as a result of an approved proposal for this cycle Security and safety issues – separate F2F MEM discussion topic Define 1st in HL7 v2/11073 to identify the details (FHIR future?) Defines baseline for future expansion of capabilities & use cases To improve re-use by others define in PCD MEM DMC WG Initial use cases (multiple PCD areas – alerts, pumps) Pause audio (reduces ambient noise, doesn’t clear alert) Clear vol infused so far (clinical documentation, easier than digging through to do at pump, doesn’t alter active program) Temporarily pause an infusion (doesn’t alter active program)

Medical Equipment Management – Location Services (LS) TI housekeeping updates - TBD Change Proposals Ability to pass boundaries (rectangle [origin and extent point] or polygon [origin and points] - TBD) with associated named coordinates so that receiver and sender know pixel coordinates, also consideration for impassable areas – walls versus doors, to solve walk paths (see also https://en.wikipedia.org/wiki/Dijkstra%27s_algorithm)

MEMDMC Remote Command AND Control Security and Safety SEPARATE F2F DISCUSSIONS MEMDMC Remote Command AND Control Security and Safety

Device Remote Command and Control Initially a whitepaper to identify issues/scope, permit demonstration Successful whitepaper and demonstration will result in an enhancement to the MEMDMC profile in a future cycle.

Device Remote Command and Control – Security and Safety Whitepaper to contain separate sections on Security and Safety Viewpoint is request receiver (sender misbehavior assumed) Security is avoiding being commanded by unacceptable senders Security is a frontline to preventing some safety issues Safety is preventing commands that would adversely affect patient Other security and safety concerns identified as out of scope Protocol security not in scope, common cross profile, addable Likely within scope of PCD MEM Cybersecurity WG effort

Device Remote Command and Control – Security Only senders with sufficient/matching data permitted to command Contextual data (avoids defining credentials for all senders) Awareness/routing to destination receiver (IP address, port) Act alert ID – unsolicited/short lived (context, no credentials) Order ID – known to limited actor audience (PIV – IOP IOC) Can sender identify the receiver of the request application, facility, MDS, VMD, CHAN, device (EUI) Credential items (username, password, presumes contextual data) Credentials improve access security (fine grain auditing) Permissible command (product capabilities, current circumstance) Does receiver permit commanding by the specific sender? IP, appl, fac, trig, prof OID, MDS, VMD, CHAN, device

Device Remote Command and Control – Security Control domain – how far away can you do it? Defined by configuration, by practicality, within care unit Actual contextual and/or credential gating defined in request receiver Implementation / licensing / configuration / context IHE PCD should define a minimally acceptable set Likely only contextual

Device Remote Command and Control – Safety Limits can be ranges, enumerated values, enable states, or abilities Command constrained by limits of device Physical – mechanical/electrical device design limits (absolute) Design – design specified limits (manufacturer established) License – customer purchased limits (manufacturer established) Command constrained by gating library. Safety limits – drug library (pharmacological/physiological based) Command constrained by targeted usage (site established) Care unit, patient physiological parameters, and/or condition

Device Remote Command and Control – Safety cont Command classification by risk potential/ability to affect operation Indicative – affects indicators or documentation counters pause alert audio (doesn’t clear alert or affect program) reset counters (doesn’t affect active infusion program) Operational – operation affecting infusion – pause or stop, program set alert limits Limits are not always implemented fully (device, mfgr, site specific) Absent context and/or credentials a device without sufficient safety limits should not be in consideration for remote commanding

Device Remote Command and Control – Considerations Commands should be closed loop – command and response Response should provide prior state/prior value Single request/multiple command or single request/single command Reversion if command fails Ability to read capabilities/containment tree (don’t attempt to do it if you know it can’t do it, right now or ever) Pause alert audio for default or specified duration Add safety section to IHE PCD profiles

SEPARATE F2F DISCUSSIONS IHE PCD COOKBOOK

IHE PCD Cookbook Purpose – educate hospital device purchasers Regarding IHE in general and specifically IHE PCD profiles Identification of information sources PCD profiles on Wiki, IHE Integration Statements, Connectathon Results Browser, IHE Product Registry, PCD Commercially Available List How to create RFQs that include IHE PCD profile actor references Cookbook Status Hasn’t been updated in a few years Somewhat usurped IHE cross domain Interoperability for Dummies Jeff Rinda provided pump updated integrated copy Monroe to integrate ACM deployment related changes and produce version this cycle as updated WP for IHE publication