1 Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt,...

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1 Todd Cooper, Breakthrough Solutions Todd Cooper, Breakthrough Solutions Foundry Foundry Ken Fuchs, Mindray North America Ken Fuchs, Mindray North America Steve Merritt, Baystate Health Steve Merritt, Baystate Health John Rhoads, Philips Healthcare John Rhoads, Philips Healthcare Patient Patient Care Devices Care Devices Overview & Overview & Update Update HIMSS Webinar – 3 August HIMSS Webinar – 3 August

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.

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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

Page 2: 1 Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt, Baystate Health John Rhoads, Philips Healthcare Patient Care.

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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

Page 3: 1 Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt, Baystate Health John Rhoads, Philips Healthcare Patient Care.

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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?

Page 5: 1 Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt, Baystate Health John Rhoads, Philips Healthcare Patient Care.

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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

Page 22: 1 Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt, Baystate Health John Rhoads, Philips Healthcare Patient Care.

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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

Page 28: 1 Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt, Baystate Health John Rhoads, Philips Healthcare Patient Care.

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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

Page 30: 1 Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt, Baystate Health John Rhoads, Philips Healthcare Patient Care.

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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

Page 31: 1 Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt, Baystate Health John Rhoads, Philips Healthcare Patient Care.

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PIV Profile

Point-of-Care Infusion Verification

Trial Implementation

PCD Published Profiles

Page 32: 1 Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt, Baystate Health John Rhoads, Philips Healthcare Patient Care.

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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

Page 34: 1 Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt, Baystate Health John Rhoads, Philips Healthcare Patient Care.

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DEC!DEC!

PIV Actors & Data Flows

Page 35: 1 Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt, Baystate Health John Rhoads, Philips Healthcare Patient Care.

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IDCO Profile

Implantable Device – Cardiac – Observation

Trial Implementation

PCD Published Profiles

Page 36: 1 Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt, Baystate Health John Rhoads, Philips Healthcare Patient Care.

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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

Page 37: 1 Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt, Baystate Health John Rhoads, Philips Healthcare Patient Care.

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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

Page 39: 1 Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt, Baystate Health John Rhoads, Philips Healthcare Patient Care.

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RTM Profile

Rosetta Terminology Mapping

Trial Implementation

PCD Published Profiles

Page 40: 1 Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt, Baystate Health John Rhoads, Philips Healthcare Patient Care.

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Rosetta for Semantic Interoperability

Page 41: 1 Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt, Baystate Health John Rhoads, Philips Healthcare Patient Care.

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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)

Page 43: 1 Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt, Baystate Health John Rhoads, Philips Healthcare Patient Care.

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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

Page 45: 1 Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt, Baystate Health John Rhoads, Philips Healthcare Patient Care.

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Device Point-of-Care Integration[DPI]

PCD Emerging Profiles

Page 46: 1 Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt, Baystate Health John Rhoads, Philips Healthcare Patient Care.

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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

Page 49: 1 Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt, Baystate Health John Rhoads, Philips Healthcare Patient Care.

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

Page 50: 1 Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt, Baystate Health John Rhoads, Philips Healthcare Patient Care.

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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

Page 53: 1 Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt, Baystate Health John Rhoads, Philips Healthcare Patient Care.

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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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58

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

Page 65: 1 Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt, Baystate Health John Rhoads, Philips Healthcare Patient Care.

65

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!

Page 66: 1 Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt, Baystate Health John Rhoads, Philips Healthcare Patient Care.

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PCD @ HIMSS 2010

Page 67: 1 Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt, Baystate Health John Rhoads, Philips Healthcare Patient Care.

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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

Page 70: 1 Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt, Baystate Health John Rhoads, Philips Healthcare Patient Care.

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HIMSS ’09 IHE PCD Showcase

Page 71: 1 Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt, Baystate Health John Rhoads, Philips Healthcare Patient Care.

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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

Page 73: 1 Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt, Baystate Health John Rhoads, Philips Healthcare Patient Care.

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IHE PCD – HIMSS ’10 Wall 2

Page 74: 1 Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt, Baystate Health John Rhoads, Philips Healthcare Patient Care.

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IHE PCD – HIMSS ’10 Wall 3

Page 75: 1 Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt, Baystate Health John Rhoads, Philips Healthcare Patient Care.

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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

Page 77: 1 Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt, Baystate Health John Rhoads, Philips Healthcare Patient Care.

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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

Page 78: 1 Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt, Baystate Health John Rhoads, Philips Healthcare Patient Care.

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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!

Page 79: 1 Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt, Baystate Health John Rhoads, Philips Healthcare Patient Care.

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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