Interoperability Interoperability Showcase Showcase

IHE Domain Updates:IHE Domain Updates:

Patient Care Devices

Co-Chairs:Co-Chairs:Todd CooperTodd Cooper Ken FuchsKen FuchsSteve MerrittSteve Merritt John RhoadsJohn Rhoads

Welcome and Overview

Brief IHE Overview – big picture

Domain overview - Mission/scopeProfile overview

New Profiles for 2010

Future Work – Roadmap Upcoming events & Resources

Q & A & Wrap

IHE Overview

IHE is… a global initiative started in 1997 that creates the framework for passing vital health information seamlessly – from application to application, system to system, and setting to setting – across multiple healthcare enterprises.

IHE Overview

IHE is… led by volunteer members and sponsors representing diverse

communities:– 300 organizational members worldwide on four continents and

over 24 countries representing– Academic Medical professionals– Practicing Clinicians– Healthcare Administrators– Membership Organizations [ACP, HIMSS< RSNA etc]– HIT Vendors, Consultants– And more

IHE Overview

IHE… hosts two major types of activities:– Conformance testing at

Connectathons– Demonstrations at

Interoperability Showcases

IHE Process IHE Process OverviewOverview

12 IHE Development Domains12 IHE Development Domains

IHE Domains

Anatomic PathologyCardiologyEye CareIT InfrastructureLaboratoryMammographyNursing SCPatient Care Coordination

(PCC)Patient Care Devices (PCD)Patient Care Devices (PCD)

PharmacyQuality, Research & Public

HealthRadiology Radiation OncologyFuture Domains may include:DentistrySurgery …And more

PCD Domain Overview

• Established in 2005 when the “charter” was awarded to the ACCE

• Jointly sponsored by ACCE and HIMSS as of July 1, 2006

• Technical Framework 2006-7 developed to communicate patient data (asynchronous)

• Successful demonstration at the Connectathons and HIMSS Interoperability Showcases since 2007

PCD Domain Overview

IHE PCD Charter• The Patient Care Devices Domain is concerned with Use

Cases in which at least one actor is a patient-centric point-of-care medical device that communicates with at least one other actor such as a medical device or information system.

• The PCD domain coordinates with and supports other domains, such as Radiology (medical imaging), Laboratory, and Cardiology to ensure consistency in use cases involving regulated medical devices as they occur throughout the Enterprise.

PCD Domain Overview

• Heterogeneity – Coexistence & interoperability in a multi-manufacturer / multi-modality world, leveraging shared infrastructure

• Semantic Interoperability – … from the sensor to the HER• Reduce healthcare delivery cost by improving efficiency,

reliability, and operational flexibility for healthcare providers • Expand the international marketplace for patient care device

vendors • Enable innovative patient care capabilities• Improve patient safety and clinical efficacy

PCD Profile Value Objectives:

Device Enterprise Communication (DEC) Profile - Year 1

HL7 v2.6 ORU Message

ISO/IEEE 11073 Semantics

Preserves device “context”

Device Data Subscription& Filtering

Rosetta for Semantic Interoperability

IHE PCD Rosetta Terminology Management

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

AlarmSource

AlarmAggregator

AlarmReceiver

AlarmCoordinator

AlarmDisseminator

AlarmCommunication

AlarmEndpoint

AlarmCommunication

(AC)

AlarmCommunication

(AC)

AlarmManagement

(AM)

AlarmManagement

(AM)

AlarmReporter

(AR)

AlarmReporter

(AR)

AlarmReporter

AlarmCache

Alarm

Query

(AQAQ)

Alarm

Query

(AQAQ)

Communication detailed in ACM profileCommunication detailed in ACM profile

Communication not detailed in ACM profileCommunication not detailed in ACM profile

.

.

.

.

.

.......

PCD Inputs(PM, NC, Resp,

Pump, etc.)

PCD Inputs(PM, NC, Resp,

Pump, etc.)

Output Devices(Marquee Sign, Pager,

Wi-Fi Phone or Badge, etc.)

Output Devices(Marquee Sign, Pager,

Wi-Fi Phone or Badge, etc.)

HIS, EMRHIS, EMROptionalOptional

Alarm CommunicationManagement

AlarmReporter

AlarmManager

AlarmCommunicat

or

HL7HL7

HL7 Messagesper ACM andWCM profiles

HL7 Messagesper ACM andWCM profiles

AlarmArchiver

Waveforms and annotations asevidentiary data items

Waveforms and annotations asevidentiary data items

DeviceSpecificgraphics

DeviceSpecificgraphics

Profiledefined

dataitems

Profiledefined

dataitems

Historical StorageHistorical Storage

Alarm InformationSource, Phase, State, Priority

PatientLocationInstance

Alarm textCallback

TimestampEvidentiary data (WCM)

Dissemination StatusInstance

Accepted by ACUndeliverable

DeliveredRead

AcceptedRejected

CancelledCallback start/stop

AlarmSource

CommunicationDevice

HL7HL7

ACM & Waveform Comm. Management (WCM)

Point-of-Care Infusion Verification (PIV)

Nurse

Review

MAR Entry

Pharmacist reviews

order detail

(Pharmacy

System)

eMAR updated

Medication

DispensedNurse removes

Medication

from Dispensing

Unit or Med Room

Nurse Confirms 5

Rights:

Right Patient,

Medication,

Dose, Time, Route

AT THE BEDSIDE

Medication

Administered

Physician reviews

data and places

Orders

Nurse

Review

eMAR Entry

Pharmacist reviews

order detail

(Pharmacy

System)

eMAR updated

Medication

DispensedNurse removes

Medication

from Dispensing

Unit or Med Room

Nurse Confirms 5

Rights:

Right Patient,

Medication,

Dose, Time, Route

AT THE BEDSIDE

Medication

Administered

Physician reviews

data and places

Orders

Point-of-Care Infusion Verification - Actors

Implantable Device – Cardiac Observation (IDCO)• 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]

Implantable Device – Cardiac Observation (IDCO)

Device Point-of-Care Integration

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

Semantic InteroperabilitySemantic Interoperability

Monitored ParametersMonitored ParametersAlarms & LimitsAlarms & LimitsWaveforms (Real-Time)Waveforms (Real-Time)Control ParametersControl Parameters

Device Reporting, Device Reporting, Management & Management &

ControlControl

Device Reporting, Device Reporting, Management & Management &

ControlControl

Real-TimeClinical Decision Support

Point-of-Care

Applications Real-Time

Closed / OpenLoop Control

DPI Manager / Enterprise

Gateway

DPI Manager / Enterprise

Gateway

Medical EquipmentManagement (MEM)

DEVICE MANAGEMENT

REPORTER

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 on

Day/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

IHE

PC

D

Sta

nd

ard

s b

ased

T

ran

sact

ion

s

DEVICE MANAGEMENT

CONSUMER

DPIDECACM

Risk ManagementRisk analysisRisk evaluationVerification of risk control measuresResidual risks

NIST - Test Tooling Support

• NIST Test Tools– ICSGeneratorICSGenerator

• Medical Device Profiles (specializations)• Implementation Conformance Statements

– ValidatePDUValidatePDU • X73 Application Layer Message Syntax and Semantic Validation

• NIST Medical Device Standards Work– ISO/IEEE 11073 Standard (X73): Medical Device Communication

• XML SchemaXML Schema: NIST P11073-10202 Domain Information Model• Collaborations

– Integrating Health Enterprise - Patient Care Devices (IHE-PCD)– IEEE 11073 Personal Health Devices (PHD) Working Group (WG)– ISO/IEEE 11073 WG

• On-going Work and Future Direction…– IHE-PCD profile and message generation and testing (includes enterprise – e.g., HL7 V2 & V3HL7 V2 & V3)– PHD X73 profile and message testing (ContinuaContinua)– X73 Java Class LibraryX73 Java Class Library

• NIST Team Members– John Garguilo (john.garguilo@nist.gov 301-975-5248), Sandra Martinez,

Maria Cherkaoui (guest researcher), and Richard Theimer (contractor)

http://www.nist.gov/medicaldeviceshttp://www.nist.gov/medicaldevices

NIST Test Tooling Support

DIM MOCICS

Reports

DIMXSchema

Compare Devices

HL7/OBXMapping

(XML)

Service Support ICS

ReportService Support

ICS XML

Transport ICS Report

TransportICS XML

General ICS

Report

General ICS XML

Device Specialization

(DIM MOC XML)

Device UML Diagram

ISO/IEEE 11073

DIMPart 10201

NomenclaturePart 10101

ICSGenerator

www.nist.gov/medicaldevices

Now Developing

Terminology Management

Tools

PCD & PCD & SDO CoordinationSDO Coordination

PCD coordination with SDOs…PCD coordination with SDOs… IHE - HL7 IHE - HL7 (MoU)(MoU)

IHE - IEEE EMB IHE - IEEE EMB (MoU)(MoU)

IHE – ISO TC215 IHE – ISO TC215 (Liaison)(Liaison)

……

… … don’t reinvent the wheel or don’t reinvent the wheel or “base” standards!“base” standards!

PCD & ICE-PAC JWGPCD & ICE-PAC JWG

(From ICE-PAC Overview Update 2009.06.22 to IHE PCD)

PCD & Continua PCD & Continua Health AllianceHealth Alliance

Continua & IHE established a Memorandum of Understanding Continua & IHE established a Memorandum of Understanding (“MoU”) (“MoU”) to “to “enable and promote interoperability of healthcare enable and promote interoperability of healthcare devicesdevices.”.”

SeeSee http://www.ihe.net/News/ihe-continua_mou_release_2008-10-28.cfmhttp://www.ihe.net/News/ihe-continua_mou_release_2008-10-28.cfm  

Joint participation in 2010 IHE Showcase!Joint participation in 2010 IHE Showcase!

Coordination on HITSP RMON SDE#2 is laying the foundation Coordination on HITSP RMON SDE#2 is laying the foundation for interoperability from bedroom to OR!for interoperability from bedroom to OR!

HIMSS ’09 IHE HIMSS ’09 IHE Showcase SponsorsShowcase Sponsors

PCD & HITSPPCD & HITSP

Support for Support for ARRA / ARRA / HITECH & HITECH & Meaningful Meaningful UseUse

Get involved

• Membership is free! • To learn more, visit

www.ihe.net/governancewww.ihe.net/governance//

• Visit the PCD “cube”!• PCD Contact:

Manny Furst (efurst@imp-tech.com)

Thanks for joining us!

Find out more at ihe.netFind out more at ihe.net