HL7 Healthcare Device SIG Device Informatics Update to

Government Projects SIG

General Overview and

IEEE PCD WG + IHE PCDActivities

2006 September 12

Todd CooperISO TC215 WG7, IEEE EMBS 11073, HL7 DEV SIG, IHE PCD, HITSP Board

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Session Overview

DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper

Topics to be discussed…

IHE Patient Care Device (PCD) Domain

Organizational & Project Overview

Q & A

IEEE Personal Health Device WG

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Foundational Concepts and Definitions

DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper

Vent

Vital Signs

Monitor

Infusion Pumps

Pulse Ox

Dialysis Machine

PoC Integration (X73)

Device Data

Manager

Enterprise Integration (HL7, DICOM, X12,…X73)

HIS

PACS

CIS

Pharmacy

LAB

Gateway

Multi-vendor environmentRequires both semantic & technical interoperability

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Foundational Concepts and Definitions

DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper

Key Benefits of PCD Interoperability:

– HeterogeneityHeterogeneity – Multiple manufacturers + multiple device – Multiple manufacturers + multiple device modalities coexisting over a shared infrastructure modalities coexisting over a shared infrastructure

– Semantic InteroperabilitySemantic Interoperability ( comparability) – shared ( comparability) – shared terminology and data models, interpret data based on the terminology and data models, interpret data based on the clinical context, compare information from different clinical context, compare information from different healthcare facilities, and interrogate systems across healthcare facilities, and interrogate systems across enterprises and regions.enterprises and regions.

– Real-Time AvailabilityReal-Time Availability – ability to provide data in a time – ability to provide data in a time frame appropriate to the physiologic function being frame appropriate to the physiologic function being measured, displayed or affected (controlled). measured, displayed or affected (controlled).

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Medical Device Informatics Standardization

DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper

IEEEEMBS 11073

CENTC251 WG4

HL7DEV & CBCC

SIGs

ISOTC215 WG7

Single set of

Internationally

Harmonized

Medical Device

Informatics & Interoperability

Standards

IHE Patient Care Devices

Domain

DICOM

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Medical Device Informatics Standardization

DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper

Cabled

11073-30200

e.g., RS-232C

RS-422 (USB)

ENet

11073-30400 [802.3]

-20404ID

-20402QoS Mngt

-20403Location

IrDA11073-30300

-20400 Network Services - Framework & Overview

-20000 Application Profile – Framework & Overview

wLAN

11073-30503

e.g., 802.11a802.11b802.11g

-20401IP protocol

(applies only to ENet, wLAN)

wPAN

11073-30501[BT /

802.15.1]

-2040x BT Data

wPAN

11073-30502[low-rate]

802.15.4MICs /

MedRadio

wPAN

11073-30503[high-rate] e.g., UWB

-2040? -2040?

-30000 Transport Profile – Framework & Overview

-30500 RF Wireless - Framework & Overview

wMANwRAN

11073-30504

e.g., 802.16e802.20802.22

wWAN

11073-30505

e.g.,2G3G

Mesh Networks

11073-30507

WMTS

11073-30508

-20500 Security – Framework & Overview

-10316Dialysis

-10312Hemo

-10309Airway

-10306ECG

-10303Ventilator

WIRED WIRELESS

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ISO/IEEE Standards

DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper

Published ISO/IEEE 11073 Standards…

ISO/IEEE 11073-10201 Domain Information Model

ISO/IEEE 11073-20101 Application Profile – Base Std.

IEEE 1073 Framework & Overview (under revision)

ISO/IEEE 11073-30200 Transport Profile – Cable Connected

ISO/IEEE 11073-10101 Nomenclature / Terminology

ISO/IEEE 11073-30300 Transport Profile – IR Wireless

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ISO/IEEE Standards

DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper

Active ISO/IEEE projects (partial) …

-20103 Clinical Context Management (CCoM)

-20301 Remote Control

-10102 Annotated ECG Terminology

-30400 Inter-LAN (IP protocol profiling)

-10103 Implantable Device, Cardiac Terminology

-30503 wLAN & -30505 wWAN

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IEEE 11073 Personal Health Device WG

DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper

Serial IrDA Bluetooth USB ZigBee

Consistent Data/Command Framework

Tra

nsp

or

t

Layers

1-6

Layer

7

OSIPulse

OximeterBlood

Pressure Glucose Pulse WeightSpiro-meter

…Device Specializations

Technical Report PARTechnical Report PAR PAR for –2yyzz series work

PAR(s) for –1yyzz series work

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IEEE 11073 Personal Health Device WG

Proposed key milestones

08/04 ’06 Project Approval Request (PAR) submission deadline–Requires Phase I device specialization selection

09 ’06 Early draft specs available for November prototype testing

09/12 or 09/13

Data work group face to face meeting in Boca Raton with report out to ISO/IEEE 11073 general committee 09/14

11/12 or 11/13

Data work group face to face in Zurich (just prior to Medica in Düsseldorf)

12 ’06 Document updated based on prototype discovery

02/10 ’07 Bluetooth unplugfest to ratify nearly final specs

03 ’07 Final specification completed

DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper

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IHE Patient Care Device Domain

DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper

5 Technical Frameworks5 Technical Frameworks39 Integration Profiles, Testing at Multiple Connectathons Annually39 Integration Profiles, Testing at Multiple Connectathons Annually

IHE

EHR- Longitudinal Record

IHE Cardiology

IHE Laboratory

IHE Radiology

New IHE Domains

Patient Care Coordination

IHE

IT Infrastructure

16 Integration Profiles

5 Integration Profiles

4 Integration Profiles

13 Integration Profiles

1 Integration Profile 2 Integration Profiles

Patient Care Devices

Expanding ReachExpanding Reach

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IHE Patient Care Device Domain

DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper

IHE-PCD Charter

The Patient Care Devices Domain is The Patient Care Devices Domain is concerned with Use Cases in which at concerned with Use Cases in which at least one actor is a regulated patient least one actor is a regulated patient care device. The PCD coordinates care device. The PCD coordinates with other IHE clinical specialty based with other IHE clinical specialty based domains such as medical imaging.domains such as medical imaging.

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IHE Patient Care Device Domain

DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper

PCD Roadmap…

Year 1:Enterprise sharing of Patient Care Data Initial device classes – vital sign

monitors, infusion pumps, ventilators … and possibly others

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IHE Patient Care Device Domain

DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper

Year 2++ Point-of-Care Device PnP Connectivity Home Health / Personal Care Devices Emergency Care Real-time data archiving and communication PCD Alarm Management + smart alarms & interlocks Medication Management Device Control (e.g., Hospital Bed–Blood Pressure

Coordination) Mobile, enterprise-wide, reliable vital signs monitoring … many more!

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IHE Patient Care Device Domain

DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper

2006 Development Schedule:2006 Development Schedule: Planning Committee decision:Planning Committee decision: mid-Januarymid-January Issue Public Comment version: Issue Public Comment version: June 2006June 2006 Public Comment Due:Public Comment Due: July 2006July 2006 Issue Trial Implementation version: Issue Trial Implementation version: August 8, 2006August 8, 2006 IHE Connectathon: IHE Connectathon: January 2007January 2007 HIMSS Demo: HIMSS Demo: February 2007February 2007

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IHE Patient Care Device Domain

DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper

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IHE Patient Care Devices Domain

DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper

n

TestingFramework

HL7v2.xStandard

IHE/PCD TechnicalFramework (vol 2)

(Transactions)

MessageProfile

xml

ICS-Generator ICS XML File

-Attribute ID, Term codes, value ranges, qualifiers…-Object Containment Tree

11073Standards

(DIM + Terms)

IEEE 11073Standard

IHE-ITIPatient

Administration

P11073-60101HL7 V2.x ORI

(gateway)

IHEMessageProfile

IHEMessageProfile

(XSLT)

NISNISTT

Test Framework …

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IHE Patient Care Devices Domain

DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper

2006 Development Schedule:2006 Development Schedule: Planning Committee decision:Planning Committee decision: mid-Januarymid-January Issue Public Comment version: Issue Public Comment version: June 2006June 2006 Public Comment Due:Public Comment Due: July 2006July 2006 Issue Trial Implementation version: Issue Trial Implementation version: August 2006August 2006 IHE Connectathon: IHE Connectathon: January 2007January 2007 HIMSS Demo: HIMSS Demo: February 2007February 2007

19DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper

Q & A