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Transcript of 1 Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt,...
![Page 1: 1 Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt, Baystate Health John Rhoads, Philips Healthcare Patient Care.](https://reader038.fdocuments.us/reader038/viewer/2022102710/551492a5550346b0158b6113/html5/thumbnails/1.jpg)
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Todd Cooper, Breakthrough Solutions FoundryTodd Cooper, Breakthrough Solutions FoundryKen Fuchs, Mindray North AmericaKen Fuchs, Mindray North AmericaSteve Merritt, Baystate HealthSteve Merritt, Baystate HealthJohn Rhoads, Philips Healthcare John Rhoads, Philips Healthcare
Patient Care Patient Care DevicesDevices
Overview & UpdateOverview & UpdateHIMSS Webinar – 3 AugustHIMSS Webinar – 3 August
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Devices and Interoperability Medical Devices - Not a Simple Problem!! IHE PCD – Overview IHE PCD – Profiles IHE PCD – Testing and Demonstrations Getting to Yes!! Questions & Answers
IHE Patient Care Devices -Overview and Update
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President Barack Obama announces an audacious plan: Computerize all health records within five years.
- January 12, 2009
2009 – Obama vows to continue the HIT Plan begun by President Bush
February 17, 2009 – the American Reinvestment and Recovery Act (ARRA) is signed into law• HITECH Act component of ARRA provides a $19 billion
program to stimulate the adoption and use of HIT, with a focus on meaningful use of certified EHR-S
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Download HITSP/TN905 @ www.HITSP.org
What about Device Connectivity?
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HITSP/TN905 Roadmap
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The Dream!The Dream!HeterogeneityHeterogeneityMultiple manufacturers + multiple device & application
modalities coexisting & interoperating over a shared infrastructure
“Best of Breed” Selection
Comprehensive, Real-time Availability
Semantic Comparability
Enables…Enables…Ability to base product acquisition on most appropriate technology without requiring HIT re-engineering.
Harmonized semantics (terminology & models) enable next generation applications, incl. real-time CDSS.
Timely health care decisions based on richer, more complete information.
Medical Device HIT:Medical Device HIT: No longer a “nice to No longer a “nice to have”have”
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The Benefits!The Benefits!
Integrity of data – automatic population of all information systems – reducing medical errors
Automated systems saves time for cliniciansImproved agility of enterprises to meet varied patient loadsImproved life-cycle cost of ownershipAutomated clinical data capture for EHRAccess to patient data across devices and systems so
custom communication interfaces can be eliminated.Allows for best of breed selection
Integration – Provider value propositions…Integration – Provider value propositions…
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Devices and Interoperability Medical Devices - Not a Simple Problem!! IHE PCD – Overview IHE PCD – Profiles IHE PCD – Testing and Demonstrations Getting to Yes!! Questions & Answers
IHE Patient Care Devices -Overview and Update
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Multiple Care ContextsMultiple Care Contexts
(Jan Wittenber, Philips Medical, HITSP/TN905)
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Device Integration for Multiple ApplicationsDevice Integration for Multiple Applications
(Jan Wittenber, Philips Medical, HITSP/TN905)
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Medication AdministrationMedication Administration
(Erin Sparnon, ECRI Institute, IHE-PCD Infusion Pump Summit, 2010.02.16, wiki.ihe.net)
It’s not just interfacing the infusion pumps!
Many clinical systems must be integrated – from many vendors – using many technologies!
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Example: CDSS & Multi Data SourcesExample: CDSS & Multi Data Sources
(John Zaleski, Nuvon, HITSP/TN905)
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Devices and Interoperability Medical Devices - Not a Simple Problem!! IHE PCD – Overview IHE PCD – Profiles IHE PCD – Testing and Demonstrations Getting to Yes!! Questions & Answers
IHE Patient Care Devices -Overview and Update
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IHE Patient Care DevicesIHE Patient Care DevicesIHE-PCD Charter
The Patient Care Device Domain is concerned with use cases in which at least one actor is a patient-centric point-of-care medical device. The PCD coordinates with other IHE clinical specialty based domains such as medical imaging and lab to ensure consistency of medical device integration solutions across all IHE technical frameworks.
NOTE: NOTE: Formed in 2005 & sponsored by HIMSS & ACCE
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ADT, OrdersPhysiological and
Operational Data (PCD)
Information Reporters:Medical Devices with Server/Gateway
Information Reporters:Standalone Medical Devices
Information Consumers: (HIS, PhIS, eMAR, EMR)
Physiological and Operational Data (PCD)
ADT,Orders
Server/Gateway
ADT, Orders
Physiological and
Operational Data (PCD)
Technical Framework
IHE PCD Overview
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• Heterogeneity – … coexistence in a multi-vendor & multi-modality world, leveraging shared infrastructure
• Semantic Interoperability – … from the sensor to the EHR
• Real-time Availability – … facilitating more timely clinical decisions
PCD Profile Primary Objectives:PCD Profile Primary Objectives:
Ultimately providing improved – … safety, quality of care & workflow efficiency
PCD Domain Overview
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Profiles Simplify DevelopmentProfiles Simplify Development
All implementation detail!
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IHE PCD ProfilesIHE PCD Profiles Current Profiles:Current Profiles:
Enterprise sharing of Patient Care Data (DEC) Subscribe to Patient Data (SPD) Rosetta Stone Terminology Project (RTM) PCD Alarm Communication Management (ACM) Point-of-care Infusion Verification (PIV)
Work in Process:Work in Process: Device Point-of-care Integration (DPI) Waveform Communication Management (WCM) Event Communication (EVT) Medical Equipment Management (MEM) Patient – Device Association (PDA)
Initial device classes…Initial device classes…vital signs / physiological monitors, infusion pumps and ventilators
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CPOE/ Pharmacy System
FuturePCD
CurrentPCD
Infusion Pump
Barcode Medication
Administration System
Other Devices
EquipmentManagement
System
Future Non- PCD
Clinical Decision Support System
Implantable Device
IDCO
ACM, DEC, WCM
ACM, DEC, WCM
ACM, MEMACM,
DEC, WCM
ACM: Alarm Communication ManagementDEC: Device Enterprise Communication
IDCO: Implantable Device – Cardiac – ObservationMEM: Medical Equipment ManagementPIV: Point-of-Care Infusion Verification
WCM: Waveform Communication Management
Home BasedSystem
Ventilation/Anesthesia
System
EMR/EHR
CIS
Physiologic Monitoring
System
DEC
ACM, DEC
ACM, DEC, WCM
PIV
IHE PCD – Profile Overview
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IHE Patient Care DevicesIHE Patient Care Devices 2009 White Paper Proposals2009 White Paper Proposals
Device Point-of-care Integration (DPI) Medical Equipment Management (MEM) – Complete! Medical Device Semantic Architecture Regulatory Considerations in Deploying Systems
Incorporating IHE PCD Profiles
IHE PCD Users HandbookIHE PCD Users Handbook What is & is not specified in PCD Profiles How to assess PCD profile support System verification & validation testing considerations
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Devices and Interoperability Medical Devices - Not a Simple Problem!! IHE PCD – Overview IHE PCD – Profiles IHE PCD – Testing and Demonstrations Getting to Yes!! Questions & Answers
IHE Patient Care Devices -Overview and Update
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DEC Profile
Device to Enterprise Communication
Trial Implementation
PCD Published Profiles
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DEC Profiles
• PCD DEC profile supports the communication of patient clinical data from devices.
• This data can include:• Vital Signs (profile available)• Alarm information (2008/2009 profile)• Waveform information (emerging profile)• Device configuration information (MEM)• Etc.
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Device to Enterprise Comm. (DEC)The Device to Enterprise Communication (DEC) profile allows a consuming device to receive patient clinical information including vitals, settings, demographics and location from a reporting device.
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MSH|^~\&|INFO_SRC_PHILIPS^ACDE48234567ABCD^EUI-64||||20061215153500||ORU^R01^ORU_R01|PMS116621490051| P|2.5|||NE|AL||8859/1 PID|||AB60001^^^Philips Medical^PI||Brooks^Albert^^^^^L||19610101|M PV1||I|UNIT_1^^Bed1 OBR|1|PMS116621490051^INFO_SRC_PHILIPS^ACDE48234567ABCD^EUI-64| PMS116621490051^INFO_SRC_PHILIPS^ACDE48234567ABCD^EUI-64| 69837^MDC_DEV_METER_PHYSIO_MULTI_PARAM_MDS^MDC|||20061215153500 OBX|1|ST|184326^MDC_ECG_STAT_ECT^MDC|1.5130.1.184326|""||||||F OBX|2|ST|184327^MDC_ECG_STAT_RHY^MDC|1.5130.1.184327|Sinus Rhythm||||||F OBX|3|NM|150456^MDC_PULS_OXIM_SAT_O2^MDC|1.5238.1.150456|99|262688^MDC_DIM_PERCENT^MDC|||||F OBX|4|NM|147842^MDC_ECG_HEART_RATE^MDC|1.5130.1.147842|81|264864^MDC_DIM_BEAT_PER_MIN^MDC|||||F OBX|5|NM|150037^MDC_PRESS_BLD_ART_ABP_SYS^MDC|1.5190.1.150036|126|266016^MDC_DIM_MMHG^MDC|||||F OBX|6|NM|150038^MDC_PRESS_BLD_ART_ABP_DIA^MDC|1.5190.1.150036|76|266016^MDC_DIM_MMHG^MDC|||||F OBX|7|NM|150039^MDC_PRESS_BLD_ART_ABP_MEAN^MDC|1.5190.1.150036|92|266016^MDC_DIM_MMHG^MDC|||||F OBX|8|NM|148065^MDC_ECG_V_P_C_CNT^MDC|1.5130.1.148065|0|264864^MDC_DIM_BEAT_PER_MIN^MDC|||||F OBX|9|NM|150045^MDC_PRESS_BLD_ART_PULM_SYS^MDC|1.5190.1.150044|26|266016^MDC_DIM_MMHG^MDC|||||F OBX|10|NM|150046^MDC_PRESS_BLD_ART_PULM_DIA^MDC|1.5190.1.150044|9|266016^MDC_DIM_MMHG^MDC|||||F OBX|11|NM|150047^MDC_PRESS_BLD_ART_PULM_MEAN^MDC|1.5190.1.150044|14|266016^MDC_DIM_MMHG^MDC|||||F OBX|12|NM|149538^MDC_PLETH_PULS_RATE^MDC|1.5238.1.149538|55|264864^MDC_DIM_BEAT_PER_MIN^MDC|||||F OBX|13|NM|150067^MDC_PRESS_BLD_ATR_LEFT_MEAN^MDC|1.5190.1.150064|4|266016^MDC_DIM_MMHG^MDC|||||F OBX|14|NM|150087^MDC_PRESS_BLD_VEN_CENT_MEAN^MDC|1.5190.1.150084|12|266016^MDC_DIM_MMHG^MDC|||||F
PCD-01 Message Example
Note: Extensive message examples on the PCD FTP Site:ftp://ftp.ihe.net/Patient_Care_Devices/ConnectathonsIncludingProcessAndTesting
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Subscribe to Patient Data (SPD)
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ACM ProfileACM Profile
Alarm Communication ManagementAlarm Communication Management
Trial ImplementationTrial Implementation
PCD Published Profiles
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Alarm Communication Management
enables systems to deliver the right alarms, with the right priority, to the right individuals via devices with the right content, escalating to other individuals via devices (based on system configuration)
Alarm Communication Management (ACM)
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AlarmSource
AlarmAggregator
AlarmReceiver
AlarmCoordinator
AlarmDisseminator
AlarmCommunication
AlarmEndpoint
AlarmCommunication
AC
AlarmManagement
AM
AlarmReporter
AR
AlarmReporter
AlarmCache
Communication detailed in ACM profile
Communication not detailed in ACM profile
.
.
....
PCD Inputs(PM, NC, Resp,
Pump, etc.)
Output Devices(Marquee Sign, Pager,
Wi-Fi Phone or Badge, etc.)
HIS, EMRAlarm
ArchiverAA
Report Alarm
Alarm StatusAlarm Status**
*Note: Implementation TBD*Note: Implementation TBD
Subscribe to AlarmSubscribe to Alarm **
** Disseminate Alarm Dissemination StatusDissemination Status **
Report AlarmReport AlarmSubscribe to Alarm Subscribe to Alarm **
Gap!Gap!
ACM Data Flows
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Fill Gap: Alarm Manager (AM) to Alarm Communicator (AC)
Define alarm identifier codes (RTM for alarms) Extend implementation of actors &
transactions Expand to additional IHE domains
ACM Status Update
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PIV Profile
Point-of-Care Infusion Verification
Trial Implementation
PCD Published Profiles
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Point-of-Care Infusion Verification supports the electronic transfer of infusion parameters from a Barcode Point of Care (BPOC) system, also known as a Bar Code Medication Administration (BCMA) system, to an infusion pump.
PIV Objective
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This is the focus ofThis is the focus ofPIV … only!PIV … only!
PIV Workflow Context
Nurse removes
Medication
from Dispensing
Unit or Med Room
Nurse removes
Medication
from Dispensing
Unit or Med Room
Medication
Dispensed
Medication
Dispensed
Pharmacist reviews
order detail
(Pharmacy
System)
eMAR updated
Pharmacist reviews
order detail
(Pharmacy
System)
eMAR updatedPhysician reviews
data and places
Orders
Physician reviews
data and places
Orders
Nurse
Review
eMAR Entry
Nurse
Review
Medication
Administered
Medication
Administered
Nurse Confirms 5
Rights:
Right Patient,
Medication,
Dose, Time, Route
AT THE BEDSIDE
Nurse Confirms 5
Rights:
Right Patient,
Medication,
Dose, Time, Route
AT THE BEDSIDE
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DEC!DEC!
PIV Actors & Data Flows
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IDCO Profile
Implantable Device – Cardiac – Observation
Trial Implementation
PCD Published Profiles
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IDCO specifies the creation, transmission, and processing of discrete data elements and report attachments associated with implantable cardiac device interrogations (observations) or messages.
IDCO Objective
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ImplantableCardiac Device
Leads for Sensingor Delivering Electrical Therapy
Implantable Cardiac Devices
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• Device is interrogated via inductive or wireless telemetry in clinic or home environment using vendor proprietary equipment
• Information is transferred to clinic system as structured HL7 v2.6 ORU message using IEEE 11073 IDC nomenclature [PCD-09]
IDCO Profile Context
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RTM Profile
Rosetta Terminology Mapping
Trial Implementation
PCD Published Profiles
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Rosetta for Semantic Interoperability
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Rosetta for Semantic Interoperability
VendorTerms
RTM1400 rows
HarmonizedTerms
hRTM440 terms
ISO/IEEE 11073Semantic Standards
Vendor A
Vendor B
Vendor C
HL7 V2 Messages
HL7 V3 CDA/CCD
11073PnP Comm
VendorSemantics
IHE PCD Technical Framework Content
• Open consensus process• Observation identifiers and co-constraints• New terms incorporated into standards• hRTM used for conformance testing
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Group REFID DIM UOM_MDC UOM_UCUM
CVS_ECG_HR MDC_ECG_HEART_RATE T-1 MDC_DIM_BEAT_PER_MIN {beat}/min {beats}/min 1/min /min
CVS_ECG_ST MDC_ECG_AMPL_ST_I ML2I-1T-3ML2I-1T-3
MDC_DIM_MILLI_VOLTMDC_DIM_MICRO_VOLTMDC_DIM_MILLI_M#
mV uV (added by scripting rule) mm# (voted “off-the-island”)
GASMON_AA_ENFL MDC_CONC_ENFL_ET L3L-3LMT-2L-2LMT-2L-2
MDC_DIM_VOL_PERCENTMDC_DIM_KILO_PASCALMDC_DIM_MMHG
%{vol} kPa mm[Hg]
Specifies for each IEEE 11073 REFID observation identifier: the 11073 MDC and UCUM units-of-measure
includes dimensional analysis to ensure correct ‘units-math’ enumerated values and measurement sites numeric codes, where appropriate
An extract from the hRTM is shown below:
http://wiki.ihe.net/index.php?title=PCD_Profile_Rosetta_Terminology_Mapping
Harmonized Rosetta (hRTM)
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Unified semantics and semantic model are essential prerequisites for safe and effective interoperability between devices and systems.
The hRTM rigorously defines what may be sent and informs recipients of what they may expect to receive. For each observation identifier, the hRTM specifies the units-of-measure, enumerated values, measurement sites and other co-constraints.
The hRTM is based on the ISO/IEEE 11073 standards and leverages and extends that work by using an open consensus process.
The hRTM is publicly available for IHE PCD clinical devices and will be available shortly for IEEE 11073 personal health devices.
The hRTM supports message conformance testing frameworks that can be used for both clinical and personal health devices.
RTM & hRTM Highlights
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Emerging Profiles Waveform Communication Management (WCM) Medical Equipment Management (MEM) Event Communication Device Point-of-Care Integration (DPI) Real Time Location Tracking Real-time data archiving and communication Mobile, enterprise-wide, reliable vital signs
monitoring … many more!
PCD Emerging Profiles
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Device Point-of-Care Integration[DPI]
PCD Emerging Profiles
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DPI: Scope – Device Point-of-care Integration (DPI) is concerned with use cases that include care contexts that fall within the stated charter of the IHE PCD, namely where "at least one actor is a regulated patient centric point-of-care medical device," and that require device-to-device communication.
Device Point-of-Care Integration
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Device Point-of-Care IntegrationDevice Point-of-Care Integration• Discovery and Association (PnP)Discovery and Association (PnP)• Real-Time Data ReportingReal-Time Data Reporting• Bi-Directional / SymmetricBi-Directional / Symmetric• External ControlExternal Control
Enterprise IntegrationEnterprise Integration
Semantic InteroperabilitySemantic Interoperability
Monitored ParametersMonitored ParametersAlarms & LimitsAlarms & LimitsWaveforms (Real-Time)Waveforms (Real-Time)Control ParametersControl Parameters
Device Reporting, Device Reporting, Management & Management &
ControlControl
Real-TimeClinical Decision Support
Point-of-Care
Applications Real-Time
Closed / OpenLoop Control
DPI Manager / Enterprise
Gateway
Device Point-of-Care Integration
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Medical Equipment Management [MEM]
Imagine … Imagine …
What if I.T. & device vendors gave me What if I.T. & device vendors gave me EVERYTHING I ever wanted?!EVERYTHING I ever wanted?!
PCD Emerging Profiles
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MEM (Medical Equipment Management)
Patch ManagementPending patchesPatch history
Location ServicesCurrent locationPrevious locations (Trending)Boundary controls (Alarm when
device leaves area)
Device Configuration Management
Recall ManagementUnique device identificationHardware configuration (serial numbers, etc)Software configuration (revision numbers, etc)
Device ReconfigurationUse profiles (NICU vs. CICU)
Operational Status and Monitoring
Is the device currently in useUsage historyAlarms – which are active, what the trigger
levels, how long has the alarm been onDay/time of last self check and its resultEvent log recordingPreventative Maintanence
Last PMNext scheduled PMLast repair time/date
Battery ManagementOn A/C or D/C? Charge level (% of full)/Est.
operating time left. Charging / Discharging historyBattery type and installation date Est. battery life
Risk ManagementRisk analysisRisk evaluationVerification of risk control measuresResidual risks
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2009 – White Paper2009 – White Paper Ongoing workOngoing work
• Cycle 5 Brief Profile Proposal • Real Time Location Tracking
• Location Boundary Alarms• Battery Management• Semantic Content Requirements
MEM Status
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WaveformWaveformCommunicationCommunication
Management [WCM]Management [WCM]
PCD Emerging Profiles
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Waveform Communication ManagementWaveform Communication Management
will extend the [DEC] profile to provide a method for passing near real-time waveform data using HL7 v2 observation messages between a Reporter and a Consumer.
• A filter will be an optional element
STATUS:STATUS:• Supplement currently undergoing TC reviewSupplement currently undergoing TC review
WCM Objective
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DevicesAggregation
Manager
Telehealth Service Center
Health Records
PAN
LAN
WAN HRNPersonal
AreaNetwork
LocalArea
Network
WideArea
Network
HealthReportingNetwork
Continua / IHE PCD WAN Interface
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Message Transport
Web Services WS-I BP
IHE IT Infrastructure TF Vol 2Appendix V Rev 6.0WS-I BP over SOAP 1.2
Plus WSI-BSP, TLS and IHE ATNA
HL7 MLLP
IHE HL7 V2 Msg Transport
HL7 Minimum Lower Layer Protocol (MLLP) over TCP/IP
Messaging HL7 V2.6 constrained byIHE DEC PCD-01 and RTM .
Semantics IEEE 11073-20601 and 104xx terms
IEEE 11073-10101 terms and –10201 info model
(beyond the firewall) (behind the firewall)
Continua/IHE PCD DEC WAN
Note: This is new to the IHE PCD … not IHE ITI … test tooling, test scripts, etc.
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(From ICE-PAC Overview Update 2009.06.22 to IHE PCD)
ICE-PCD Analysis Committee (ICE-PAC)ICE-PCD Analysis Committee (ICE-PAC) – JWG underway to perform a map & gap analysis between “ICE” use case analyses, ISO/IEEE 11073 standards & the IHE DPI WG.
PCD & ASTM “ICE”/CIMIT MDPnP
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RDC Project ~ Building on Clinical Requirements
RiskAnalysis
SystemModeling
Technical Solution and
Clinical Implementation
Des
ign
Eng
inee
rsC
linic
al E
ngin
eers
ClinicalScenario
Clinical Workflow
Workflow Analysis
ClinicalScenario
Clin
icia
ns Gathering Requirements from Clinical System
Providing Traceability of System Requirements
Provide Systems Level Risk Analysis
Provides Traceability to Mitigating Risk
Designing for the System, not modifying the system causing unintended consequences
General Building Blocks and Interactions between the blocks are key to Safety
If General Building Blocks make up Specific Systems then Systems are safe
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RDC Project ~ Logical Actors / Intermediary Architecture
Logically, the actors are relatively simple. DTBR must supply configuration & status info to the RDC. The RDC also retrieves configuration (static & operational) from the DR + interacts with the clinician, especially to resolve non-compatibility DTBR-to-DR issues; RDC may also automatically program the DR if supported; otherwise, it may monitor DR configuration status as the clinician interacts both with it and the DR (manually configuring / confirming).
DTBRDTBR
DOR/agent
Rapid DeviceRapid DeviceConfiguratorConfigurator
DOC/manager
DRDR
DOR/agent
Monitor Device Configuration / Status
Auto-Configure Device (external control)
Clinician Reviews / Manually Configures Device via User Interface
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Devices and Interoperability Medical Devices - Not a Simple Problem!! IHE PCD – Overview IHE PCD – Profiles IHE PCD – Testing and Demonstrations Getting to Yes!! Questions & Answers
IHE Patient Care Devices -Overview and Update
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IHE Standards Adoption Process
59Document Use Case Document Use Case RequirementsRequirements
Identify available Identify available standards (standards (e.g. HL7, e.g. HL7, DICOM, IEEE, IETF)DICOM, IEEE, IETF)
Develop Develop technical technical
specificationsspecifications
Testing at Testing at ConnectathonsConnectathons IHE IHE
DemonstrationsDemonstrations
Products Products with IHEwith IHE
Easy to integrate Easy to integrate productsproducts 59
Improved safety, Improved safety, quality & efficiency!quality & efficiency!
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Locked in the … dungeon?!
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IHE Testing Process
In-HouseTesting
Demonstration
DeploySystems
Testing Results
ApprovesTest Logs
IHE Technical Framework (IHE Profile Specifications)
Product +IntegrationStatement
Users
Sponsors:Project Management Team
Vendors
Sponsors:Exhibits
Implement Profile Actors
Develop Testing Tools
ConnectathonInterview
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Conformance Testing of an HL7 V2 Message
ReportReport
Test Artifacts• Conformance Profile• HL7 Tables• ‘Device’ Test Agents• ISO/IEEE 11073/Rosetta
Terminology
Test Artifacts• Conformance Profile• HL7 Tables• ‘Device’ Test Agents• ISO/IEEE 11073/Rosetta
Terminology
HL7 V2MessageValidation
HL7 V2MessageValidation
Services Test Management
HL7 V2 MessageValidation Test Case
HL7 V2 MessageValidation Test Case
ResultsHL7 V2 MessageValidation Report
ResultsHL7 V2 MessageValidation Report
Test Harness(Java Code)
Test Harness(Java Code)
Test Execution
User
Web Application
Client
HL7 V2 MessageHL7 V2 Message
Registry/Repository
NIST Tools: Instance System Test Environment
See NIST HL7-PCD Validation Tool @
http://xreg2.nist.gov:8080/PCD-HL7WebCon/
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IHE-PCD Testing using a Web Application Client
ReportReport
IHE-PCDDOR/DOFTest Agent
IHE-PCDDOR/DOFTest Agent
HL7 V2Message
Generation
HL7 V2Message
Generation
IHE-PCDDOC
Test Agent
IHE-PCDDOC
Test Agent
HL7 V2Message
Validation
HL7 V2Message
Validation
ServicesTest Management
Router/Logger/ProxyRouter/Logger/Proxy
Vendor
System Under Test
IHE-PCD ClientTest Scenario
IHE-PCD ClientTest Scenario
ResultsHL7 V2 Message
Validation Reports
ResultsHL7 V2 Message
Validation Reports
Test Harness(Java Code)
Test Harness(Java Code)
Test Execution
Web Application
Client
IHE-PCDIOR
Test Agent
IHE-PCDIOR
Test Agent
IHE-PCDAM
Test Agent
IHE-PCDAM
Test Agent
IHE-PCDIOC
Test Agent
IHE-PCDIOC
Test Agent
IHE-PCDAR
Test Agent
IHE-PCDAR
Test Agent
IHE-PCDIDCC
Test Agent
IHE-PCDIDCC
Test Agent
IHE-PCDIDCR
Test Agent
IHE-PCDIDCR
Test Agent
NIST Tools: Isolated System Test Environment
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A Framework for Building Test Systems—an SOA Approach
Test DataTest Data
Services Test Management
TestDescription
TestDescription
ResultsResults
TestHarness
TestHarness
Test Execution
Router/Logger/ProxyRouter/Logger/Proxy
User
Facilitator
Monitor
System Under Test
System Under Test
ValidationValidation
GenerationGeneration Test AgentTest Agent
Evaluation Agent
Evaluation Agent
Aggregated Services
Aggregated Services
Test ArtifactsTest Artifacts
TimeTimeReportReport
SecuritySecurityLoggingLogging
ProxyProxyLog AnalyzerLog Analyzer
SpecializedValidation
SpecializedValidation
ExternalServicesExternalServices Other ServicesOther Services
TestAnalyzer
TestAnalyzer
NIST Tools: Peer-2-Peer Test Environment
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IHE Standards Adoption Process
65Document Use Case Document Use Case RequirementsRequirements
Identify available Identify available standards (standards (e.g. HL7, e.g. HL7, DICOM, IEEE, IETF)DICOM, IEEE, IETF)
Develop Develop technical technical
specificationsspecifications
Testing at Testing at ConnectathonsConnectathons IHE IHE
DemonstrationsDemonstrations
Products Products with IHEwith IHE
Easy to integrate Easy to integrate productsproducts 65
Improved safety, Improved safety, quality & efficiency!quality & efficiency!
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PCD @ HIMSS 2010
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CPOE/ Pharmacy System
FuturePCD
CurrentPCD
Infusion Pump
Barcode Medication
Administration System
Other Devices
EquipmentManagement
System
Future Non- PCD
Clinical Decision Support System
Implantable Device
IDCO
ACM, DEC, WCM
ACM, DEC, WCM
ACM, MEMACM,
DEC, WCM
ACM: Alarm Communication ManagementDEC: Device Enterprise Communication
IDCO: Implantable Device – Cardiac – ObservationMEM: Medical Equipment ManagementPIV: Point-of-Care Infusion Verification
WCM: Waveform Communication Management
Home BasedSystem
Ventilation/Anesthesia
System
EMR/EHR
CIS
Physiologic Monitoring
System
DEC
ACM, DEC
ACM, DEC, WCM
AAMIDemo
PIV
IHE PCD – AAMI Demonstration
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HIMSS ’07 IHE PCD Showcase
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HIMSS ’08 IHE PCD Showcase
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HIMSS ’09 IHE PCD Showcase
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HIMSS ’10 AtlantaShowcase Floorplan
HIMSS ’10?
Too big for a single diagram!
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IHE PCD – HIMSS ’10 Wall 1
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IHE PCD – HIMSS ’10 Wall 2
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IHE PCD – HIMSS ’10 Wall 3
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IHE PCD – HIMSS ’10 Wall 4
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Devices and Interoperability Medical Devices - Not a Simple Problem!! IHE PCD – Overview IHE PCD – Profiles IHE PCD – Testing and Demonstrations Getting to Yes!! Questions & Answers
IHE Patient Care Devices -Overview and Update
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Great Expectations?Great Expectations?IHE PCD – Vendor value propositions…
Simplify product development process
Spend time innovating rather than supporting infrastucture work – again & again & ...
Facilitate clinical decision support - innovation - increased functionality
Reduce regulatory impact/work
Improve patient safety - reduce liability - make operations easier - device aware
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The Dream … Deferred!The Dream … Deferred!Why has it not yet happened?
Incomplete standards … but no longer the case! Uncoordinated & inconsistent demand
from providers and other user stakeholders Undefined stakeholder value propositions Resources – esp. for standards–related projects Dr. Brailer: Infrastructure is a hard sell:
Concentrated cost – Diffuse benefit
A business issue – not a lack of technology!A business issue – not a lack of technology!
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Devices and Interoperability Medical Devices - Not a Simple Problem!! IHE PCD – Overview IHE PCD – Profiles IHE PCD – Testing and Demonstrations Getting to Yes!! Questions & Answers
IHE Patient Care Devices -Overview and Update
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Q & AQ & A
Find out more at www.ihe.netFind out more at www.ihe.net