HL7 Healthcare Device SIG
Device Informatics Update to
Government Projects SIG
General Overview
and
IEEE PCD WG + IHE PCD
Activities
2006 September 12
Todd Cooper
ISO TC215 WG7, IEEE EMBS 11073, HL7 DEV SIG, IHE PCD, HITSP Board
Session Overview
Topics to be discussed…

Organizational & Project Overview

IEEE Personal Health Device WG

IHE Patient Care Device (PCD) Domain

Q&A
DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper
2
Foundational Concepts and Definitions
Enterprise Integration
(HL7, DICOM, X12,…X73)
Dialysis
Machine
Vent
Vital
Signs
Monitor
LAB
Pharmacy
CIS
Pulse Ox
Infusion
Pumps
PoC Integration (X73)
Device
Data
Manager
Gateway
PACS
HIS
Multi-vendor environment
Requires both semantic & technical interoperability
DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper
3
Foundational Concepts and Definitions
Key Benefits of PCD Interoperability:
– Heterogeneity – Multiple manufacturers + multiple
device modalities coexisting over a shared infrastructure
– Semantic Interoperability ( comparability) – shared
terminology and data models, interpret data based on
the clinical context, compare information from different
healthcare facilities, and interrogate systems across
enterprises and regions.
– Real-Time Availability – ability to provide data in a time
frame appropriate to the physiologic function being
measured, displayed or affected (controlled).
DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper
4
Medical Device Informatics Standardization
IHE Patient
Care Devices
Domain
ISO
TC215 WG7
Harmonized
Medical Device
Informatics &
Interoperability
Standards
DICOM
IEEE
EMBS 11073
Single set of
Internationally
CEN
TC251 WG4
HL7
DEV & CBCC
SIGs
DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper
5
-10303
Ventilator
-10306
ECG
-10309
Airway
-10316
Dialysis
-10312
Hemo
Medical Device Informatics Standardization
-20000 Application Profile – Framework & Overview
-20500 Security – Framework & Overview
-20400 Network Services - Framework & Overview
-20402
QoS Mngt
-20404
ID
-20401
IP protocol
(applies only to ENet, wLAN)
-20403
Location
-2040x -2040? -2040?
BT Data
-30000 Transport Profile – Framework & Overview
-30500 RF Wireless - Framework & Overview
Cabled
11073-30200
e.g.,
RS-232C
RS-422 (USB)
wPAN wPAN wPAN
wLAN
ENet
11073-30400
[802.3]
IrDA
11073-30300
DEV SIG – Update to the
11073 11073 11073
-30501 -30502 -30503
[BT / [low- [high802.15.1] rate]
rate]
802.15.4 e.g.,
MICs / UWB
SIG – 2006-09-12
MedRadio – Boca
11073-30503
e.g.,
802.11a
802.11b
Government802.11g
Projects
wMAN
wRAN
wWAN
Mesh
Networks
11073
-30504
11073
-30505
11073
-30507
e.g.,
802.16e
802.20–
Raton
e.g.,
2G
3G
Todd Cooper
WMTS
11073
-30508
6
ISO/IEEE Standards
Published ISO/IEEE 11073 Standards…

IEEE 1073 Framework & Overview (under revision)

ISO/IEEE 11073-10101 Nomenclature / Terminology

ISO/IEEE 11073-10201 Domain Information Model

ISO/IEEE 11073-20101 Application Profile – Base Std.

ISO/IEEE 11073-30200 Transport Profile – Cable
Connected
ISO/IEEE 11073-30300 Transport Profile – IR Wireless

DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper
7
ISO/IEEE Standards
Active ISO/IEEE projects (partial) …

-10102 Annotated ECG Terminology

-10103 Implantable Device, Cardiac Terminology

-20103 Clinical Context Management (CCoM)

-20301 Remote Control

-30400 Inter-LAN (IP protocol profiling)

-30503 wLAN & -30505 wWAN
DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper
8
IEEE 11073 Personal Health Device WG
PAR(s) for –1yyzz series work
Pulse
Blood
Oximeter Pressure Glucose
Pulse
Weight
Spirometer
OSI
…
Layer 7
Device Specializations
Serial
IrDA
Technical Report PAR
Bluetooth
USB
Layers 1-6
Transport
Consistent Data/Command Framework
ZigBee
PAR for –2yyzz series work
DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper
9
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
10
IHE Patient Care Device Domain
Expanding Reach
IHE
EHR- Longitudinal Record
IHE
IT Infrastructure
IHE
Radiology
13 Integration Profiles
4 Integration Profiles
16 Integration Profiles
IHE
Laboratory
5 Integration Profiles
IHE
Cardiology
New IHE
Patient
Care
Domains
Devices
2 Integration Profiles
Patient Care
Coordination
1 Integration Profile
5 Technical Frameworks
39 Integration Profiles, Testing at Multiple Connectathons Annually
DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper
11
IHE Patient Care Device Domain
IHE-PCD Charter
The Patient Care Devices Domain is
concerned with Use Cases in
which at least one actor is a
regulated patient care device. The
PCD coordinates with other IHE
clinical specialty based domains
such as medical imaging.
DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper
12
IHE Patient Care Device Domain
PCD Roadmap…
Year 1:
Enterprise sharing of Patient Care Data
Initial device classes – vital sign
monitors, infusion pumps, ventilators …
and possibly others
DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper
13
IHE Patient Care Device Domain
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!
DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper
14
IHE Patient Care Device Domain
 2006 Development Schedule:






Planning Committee decision:
Issue Public Comment version:
Public Comment Due:
Issue Trial Implementation version:
IHE Connectathon:
HIMSS Demo:
mid-January
June 2006
July 2006
August 8, 2006
January 2007
February 2007
DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper
15
IHE Patient Care Device Domain
DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper
16
IHE Patient Care Devices Domain
Test Framework …
HL7v2.x
Standard
IEEE 11073
Standard
11073
Standards
(DIM + Terms)
IHE-ITI
Patient
Administration
P11073-60101
HL7 V2.x ORI
(gateway)
ICS-Generator
-Attribute ID, Term
codes, value ranges,
qualifiers…
-Object Containment
Tree
ICS XML File
NIST
(XSLT)
IHE/PCD Technical
Framework (vol 2)
(Transactions)
IHE
Message
Profile
n
Testing
Framework
Message
Profile
xml
DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper
17
IHE Patient Care Devices Domain
 2006 Development Schedule:






Planning Committee decision:
Issue Public Comment version:
Public Comment Due:
Issue Trial Implementation version:
IHE Connectathon:
HIMSS Demo:
mid-January
June 2006
July 2006
August 2006
January 2007
February 2007
DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper
18
Q&A
DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper
19