Transcript 11073 POC-MDC standards - Med-e-Tel

Protocols, Networks and Standards for
point-of-care device communication
CEN/ISO/IEEE 11073 Standards
Med-e-Tel, Luxembourg, 23 April, 2004
Melvin Reynolds, AMS Consulting, Ross-on-Wye, UK
Chair CEN TC251 WGIV Health informatics – Technologies for interoperability,
Co-chair ISO TC215 WG2 Health informatics – Messages and communications; Chair ISO TC215 WG2.1 Health informatics – Device communications,
Co-chair IEEE1073 Medical device communications.
Thomas Norgall, Fraunhofer Institute for Integrated Circuits, Erlangen, D
Co-chair CEN TC251 WGIV Health informatics – Technology for interoperability,
Co-chair ISO TC215 WG2.1 Health informatics – Device communications, Co-chair HL7 LAPOCT SIG.
Todd Cooper, Breakthrough Solutions, San Diego, USA
Chair IEEE1073 Medical device communications.
CEN/ISO/IEEE 11073 Standards
Point-of-care: all change
Fixed configuration, e.g. anaesthesia
Data Processing
System / PDMS
Patient Monitor
Syringe Pumps and Infusors
Respirator
Additional Pump
Additional Monitor
– but changing
periodically, and
evolving over time
CEN/ISO/IEEE 11073 Standards
Point-of-care: all change
Variable configuration, e.g. intensive care
Data Processing
System / PDMS
Patient Monitor
Many Syringe Pumps and Infusors
Respirator
- changing
frequently and
within minutes
CEN/ISO/IEEE 11073 Standards
Interoperability
Interoperability:
ability of two or more systems or components to
exchange information and to use the
information that has been exchanged
source: IEEE Standard Computer Dictionary: A Compilation of
IEEE Standard Computer Glossaries, IEEE, 1990
Functional interoperability:
Shared Architectures, Methods & Frameworks
Semantic interoperability:
Shared Data types, Terminologies, Codings
CEN/ISO/IEEE 11073 Standards
Interoperability
Point-of-care medical device communication
(IEEE1073) Charter:
 Provide real-time plug-and-play interoperability for
patient-connected medical devices
 Facilitate the efficient exchange of vital signs and
medical device data, acquired at the point-of-care,
in all health care environments
… Leveraging off-the-shelf technologies, scaling across
a wide range of system complexities, and supporting
commercially viable implementations.
CEN/ISO/IEEE 11073 Standards
Development
A history of co-operative and complementary
working:
Arrows indicate effective transfer of development and/or
maintenance responsibility.
CEN/ISO/IEEE 11073 Standards
Context
Health informatics:
Generally interpreted as being
in ISO/OSI Level 7
Medical device communication:
Works at all ISO/OSI Levels,
Directly in ISO/OSI Levels 7 – 5
In Levels 1 – 4, chiefly by
reference to other standards
(such as IrDA or 802.11)
ISO/OSI Level 7:
Application
ISO/OSI Level 6:
Presentation
ISO/OSI Level 5:
Session
ISO/OSI Level 4:
Transport
ISO/OSI Level 3:
Network
ISO/OSI Level 2:
Datalink
ISO/OSI Level 1:
Physical
CEN/ISO/IEEE 11073 Standards
Architecture
Requirements:
 True interoperability across all 7-layers from the ‘connector’ to the end application
 Quality of Service mechanisms to support the
strong requirements placed on regulated
medical devices
 Maintainability as communications
technology and applications change
CEN/ISO/IEEE 11073 Standards
Series title
(National, e.g. BS) EN ISO/IEEE
11073-xyyzz
Health informatics Point-of-care medical device
communication x partition (general):
yy subsection (group) zz detail (specialised)
CEN/ISO/IEEE 11073 Standards
Series structure
11073.1xxxx
Data & Information Definitions
11073.2xxxx
Application Profiles
11073.3xxxx
Transport & Physical Layers
11073.5xxxx
Internetworking Support
11073.6xxxx
Application Gateways
11073.9xxxx
Related – some shared concepts
CEN/ISO/IEEE 11073 Standards
11073-1xxxx content
11073.1xxxx
Data & Information Definitions
Semantics needed to communicate a device’s
application data, status and control
information.
Three main components:
 Nomenclature: 11073.10101
 Domain Information Model (DIM): 11073.10201
 Device Specialisations: 11073.103xx
CEN/ISO/IEEE 11073 Standards
11073-1xxxx content
Nomenclature:
A set of numeric codes
that identify every item
that is communicated
between systems.
Context-sensitive parts
Codeblock Number (Hi-order 16 bits)
1
2
3
4
Object-Oriented (OO)
Supervisory Control and Data
Acq’n (SCADA)
Events
Dimensions (Units of Msmt)
5
Virtual Attributes
6
Parameter Groups
7
[Body] Sites
8
Infrastructure
…
256 External Nomenclature Ref's
…
1024 Private
Term Code (Lo-order 16 bits)
31 . . . . . . 23 . . . . . . . 15 . . . . . . . 7 . . . . . .
0
msb
lsb
Context-free code
CEN/ISO/IEEE 11073 Standards
11073-1xxxx content
Domain Information Model:
An object oriented data model that specifies
objects, attributes, attribute groups, event reports,
and services that may be used to communicate
device data and to control / configure the reporting
of information . . .
 Medical Devices and
Functionalities
 Measured Data and
Settings
 Alert Information
 Remote Control
 Patient Information
 Communication
CEN/ISO/IEEE 11073 Standards
Domain Information Model
VMO
Session-Test
(from Archival)
MDS
(from System)
0..1
0..n
1
VMD
0..1
1
0..n
Channel
0..1
1
0..n
0..n
0..n
Metric
0..n
PM-Store
0..n
1
1..n
Numeric
Time-SA
Sample Array
Distribution-SA
0..n
Enumeration
RealTime-SA
Complex Metric
0..n
0..n
PM-Segment
CEN/ISO/IEEE 11073 Standards
Development Process
Domain
Information
Model
‘On-the-Wire’
Format
Abstract
Syntax
(ASN.1)
Transfer
Syntax
(MDER)
CEN/ISO/IEEE 11073 Standards
11073-2xxxx content
11073.2xxxx
Application Profiles
Application profile standards...
 Provide specific sets of capabilities tailored for a
class of communication needs / architectures
 Limit the options that are available
 Remaining options must be discovered and in some
cases negotiated when a connection is made
(enabling plug-and-play interoperability!)
CEN/ISO/IEEE 11073 Standards
11073-2xxxx content
11073.2xxxx
Application Profiles
Application profile standards...
 Define a generic (non-device specific) set of data
and services needed to initiate, configure, and
maintain communication: Connect / Disconnect,
Create / Delete, Get / Set, Event Report, Invoke,
etc.
 Specify the use of Standard Service Elements:
ACSE, ROSE, CMISE, ASN.1, MDER (based on BER+),
etc.
 Provide optional packages, e.g for remote control
 For XML & Web Services are under development
CEN/ISO/IEEE 11073 Standards
11073-3xxxx content
11073.3xxxx
Transport & Physical Layers
Available (point-to-point) transport standards…
 IrDA-Based Cable Connected
 IrDA-Based Infrared Wireless
(11073.30200)
(11073.30300)
Transport standards (LANs) under consideration…
 RF Wireless – high emphasis on QoS!
(TR 11073.00101)
 IP-Based (Ethernet)
CEN/ISO/IEEE 11073 Standards
TR: Guidelines … RF wireless
11073.01010
TR – Guidelines ... RF wireless ...
Benefits of wireless communication…
 No cable ‘spaghetti’ in conventional medical
device use environments
 Increased freedom available to users –
healthcare professionals and patients alike
 Expanded areas of use – community and
global mobility
CEN/ISO/IEEE 11073 Standards
TR: Guidelines … RF wireless
11073.01010
TR – Guidelines ... RF wireless ...
Possible difficulties to be overcome…
 High importance of data communicated
 ‘Unknown’ communication capacity available
 Security implications for different types of
medical information remain difficult to
determine – and standardise
CEN/ISO/IEEE 11073 Standards
TR: Guidelines … RF wireless
Use case topological overview
Caution –
work-in-progress;
known omissions!
CEN/ISO/IEEE 11073 Standards
TR: Guidelines … RF wireless
Trans-portable monitoring use case architecture
Caution –
work-in-progress;
known omissions!
CEN/ISO/IEEE 11073 Standards
11073-5xxxx content
11073.5xxxx
Infusion Pump
Ventilator
Pulse-Oximeter
11073
Agent
Device
Examples:
11073
Agent
Device
11073.3xxxx
Transport
Internetworking Support
11073.3xxxx
Transport
11073.5xxxx
Internetworking
11073
Manager
System
Patient Monitor
Device Manager
11073.3xxxx
Transport
11073
Manager
System
LAN Access Points,
Wired-to-Wireless Transport Gateways
CEN/ISO/IEEE 11073 Standards
11073-6xxxx content
11073.6xxxx
Application Gateways
Objectives: Interoperability between different
application-layer protocols
+
Bi-directional transparency
11073
System
(Agent/
Manager)
11073.3xxxx
11073.6xxxx Gateway
Transport
11073.3 /.5xxxx non-VITAL
Application
Transport
Example: HL7 / 11073 Gateway: 11073.60101
HL7 - Observation Reporting Interface
CEN/ISO/IEEE 11073 Standards
11073-9xxxx content
11073.9xxxx
Related – NCCLS POCT-1A
CEN/ISO/IEEE 11073 Standards
11073-90101 POCT-1A
CEN/ISO/IEEE 11073 Standards
11073-90101 POCT-1A
CEN/ISO/IEEE 11073 Standards
POC Devices co-existence
ECG Device
POCT Device
MDC Devices
Ventilator
IV Pump
1073 Cabled
1. Acute Care
POCT Device POCT1
Monitor
IEEE 1073
& IrDA AP
DMI
EDI
D
POC Data Mgr.
5.
POC Dev w/ EDI
HIS
IR
o
POCt Device
ECG Cart
Other Dev.
Pocket PC
POCT1 IR
2. General Clinic
CIS
o
IrDA AP
Palm PDA
3. Remote Device using Modem
4.
POC Dev w/ DMI
POCt Device
modem
modem
Other Dev.
modem
modem
POCT Device
modem
Other Dev.
modem
Analog Phone Line
modem
modem
Terminal
Server
CEN/ISO/IEEE 11073 Standards
Conclusions
 11073 is the only comprehensive system of point-of-care
medical device communication standards
 11073 modality categories range from real-time-operating
medical equipment to point-of-care test devices
 11073 supports wired, wireless IR (and hopefully future
wireless RF) network technologies
 11073 provides plug-and-play, internetworking and
application gateway capabilities
 If health care providers and management organisations
want point-of-care to record transparency of information,
then they must demand medical device interoperability
using 11073
CEN/ISO/IEEE 11073 Standards
Conclusions
 To meet continued user demand,11073 must deliver plugand-play, internetworking and application gateway
capabilities
 Wherever possible use existing, commodity, standards as
the basis for covering the range of requirements
 Use deliberate co-ordination of simultaneous development,
comment and ballot in all the participating bodies
 In addition to the core development bodies, the activity coordinates regularly with other health informatics activities –
notably HL7, DICOM, NCCLS and IHE
 Weekly conference calls, specific email lists and co-location
of meetings facilitate rapid consensus formation
CEN/ISO/IEEE 11073 Standards
Contact details
Thank you for your attention
 Melvin Reynolds
AMS Consulting
Walford Road, Ross-on-Wye, HR9 5PQ, UK
[email protected]
www.ieee1073.org