ICEPAC Project Prospectus- Draft 2a

Jan WittenberISO/IEEE 11073 Upper Layers Subcmte Chair

November 13, 2008

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• Developed for IHE PCD DPI “ICEPAC” working group

• Scope and purpose: To provide initial set of materials for discussion concerning technical content and project planning

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Topics

Technical content Overview Detail

Topology (Care areas, Modalities, Info) Data flow Risk-managed Sup’y Ctl & Data Acq’n (SCADA)

ICE perspective Risk Mgmt perspective

Standards considerations Architectural “Roadmap”

See Appendix A for Abbreviations

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Technical content – Modeling overview

Supervisory Control and Data Acquisition (SCADA) perspective

Topological perspective

Risk Analysis cases

ICE Use cases

Devices (Medical, Network Infrastructure, User I/F)

Care areas (Use contexts), e.g. ICU, PACU, OR

Data Types

Data Flows

Control characteriz’n

Risk/Safety considerations

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Detail – Topological perspective

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Detail – Info Vectors

A

B

A)B)

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Detail – Data Flow (Left side, e.g. ICU)

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Detail – Data Flow (Right side, e.g. OR)

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Detail – ICE Use Cases

Examples

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Detail – Risk Management (RM) perspective

Example

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Topological perspective

Detail – Risk managed Supervisory Control and Data Acquisition (SCADA) perspective

Risk Managed

SCADA

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Detail – Risk managed Supervisory Control and Data Acquisition (SCADA) perspective

SCADA

Risk Managed

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Detail – Risk managed SCADA – Xray-Resp Sync - Schema

WHILE EXC_DATA_LOSS =

TRUE {ALERT, INHIBIT ACTUATION}

ACTUATE XRAY EXPOSURE WHEN

END_INSPIRATION = TRUE

MDS

VMD XRay

CHA XRay

SCO XRay

Activate Operation ActuateXRayExposure

Communication Stack

Operating Scanner

Context Scanner

Agent: XRay MDS

VMD Vent

CHA Resp

RTSA BreathAnnot’n

Communication Stack

Alert Scanner

Context Scanner

Agent: Vent

NU Exposure Duration

LinkStatus ={. . .XDL=True | False, …} Event: EndInspiration

Command: ActuateExposure

Command Confirmation

OpScan: ActuatedExposure

Confirmattion

Manager: Sync Xray Exposure

Communication Stack

User Interface Object Sync Xray to VentilatedInspiration

Remote Control Application

Software

MDS

VMD XrayExposure

SyncCoordinator BITS-16

LinkStatus

LinkXDLState=OK

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Standards considerations - x73 data language – Service and Control subject

Activate Operation

ActuateXRayExposure; StartApneaCtlMode; etc.

e.g.Limit Alert Operation

Hi/Lo HR, RR, SpO2, etc.

Set Value Operation

InfRate, RespRate, Gain, etc.

Select Item Operation

Choice of SampleRate or Period, Gain, etc.

Toggle Flag Operation

ToggleAlarmsOnOff; TogglePauseResume; etc.

e.g.:

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Standards considerations – x73 data language (“MDDL”) – overview

ASN.1

Service Model

DomainInformation Model

Communication Model

Nomenclature

See detail

Nomenclature DIM MDIB in operating context

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Standards considerations – x73 data language impacts

Nomenclature adaptations needed “Virtual Attributes” partition finalized, incl.

X73-10203 “Remote Control Package (RCoP)” IHE PCD “Rosetta”, esp. Ventilator extensions ICEPAC extensions

Control sequences imply need for rigorous control “language” to express safety criteria and [effective] performance

Is “C[++] acceptable? Some specialized control language? FSM-oriented?

OO abstractions (e.g. “Interlock”) may be needed

ASN.1

Service Model

DomainInformation Model

Communication Model

Nomenclature

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Standards considerations – x73 architecture

ASN.1

Service Model

DomainInformation Model

Communication Model

Nomenclature

ISO/IEEE 11073-based

-10201 ASN.1

Nomenclature

-10103 ICD

-10101 Ver12

-10102 aECG

Domain Info Model (DIM)

-10202 XML

IHE PCD HL7 ORI Gway-based

LOINC

Ref. Info Model (RIM) V2

Basic XML

V3 Nomenclature

TRANSPORT I/Fs

TCP UDP

DATA LANGUAGEs

PHD (Personal Health Devices)

-20601 Base

-104xx Specializ’’ns

IHE ROSETTA Nomencl.

IEEE 11073, 802.3, 802.11

-30200 Cabled, PoC, RS-232/802.3

-30300 Wless,

Infrared

-30400 Inter-LAN

802.3

-30500 Wless,

RF

-30501.2 wPAN

-30503 wLAN

Non-IEEE

USB

DATA LINKs /MACs

Zigbee Blue- tooth

SNOMED

UCUM

Upper Layers Appl’n Present’n Session Lower Layers: Transport Network Data Link Physical Link null Internet (IP)

-20401 COMMON SVCs

DHCP /bootp

Med. Data QoS

Other eg: Secur.

“Classic” Medical Devices

-20101 Base Std

-2020x Appl

Profiles

-3xxxx Specializations -203xx Appl Pkgs Infusor

/Pump Vent -ilator

VS Mon

Other . . .

ICE Svc Elem

Specializations

Generalizations

For standards modeling purposes, assume that there is an ICE “SE”.

Combination of components: - Information objects (OO abstractions) - Nomenclature - Services - Protocols - Management (e.g. “system health test; conformance)

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Standards considerations – x73 : ICE : IHE relationships

ASN.1

Service Model

DomainInformation Model

Communication Model

Nomenclature

ISO/IEEE 11073-based

-10201 ASN.1

Nomenclature

-10103 ICD

-10101 Ver12

-10102 aECG

Domain Info Model (DIM)

-10202 XML

IHE PCD HL7 ORI Gway-based

LOINC

Ref. Info Model (RIM) V2

Basic XML

V3 Nomenclature

TRANSPORT I/Fs

TCP UDP

DATA LANGUAGEs

PHD (Personal Health Devices)

-20601 Base

-104xx Specializ’’ns

IHE ROSETTA Nomencl.

IEEE 11073, 802.3, 802.11

-30200 Cabled, PoC, RS-232/802.3

-30300 Wless,

Infrared

-30400 Inter-LAN

802.3

-30500 Wless,

RF

-30501.2 wPAN

-30503 wLAN

Non-IEEE

USB

DATA LINKs /MACs

Zigbee Blue- tooth

SNOMED

UCUM

Upper Layers Appl’n Present’n Session Lower Layers: Transport Network Data Link Physical Link null Internet (IP)

-20401 COMMON SVCs

DHCP /bootp

Med. Data QoS

Other eg: Secur.

“Classic” Medical Devices

-20101 Base Std

-2020x Appl

Profiles

-3xxxx Specializations -203xx Appl Pkgs Infusor

/Pump Vent -ilator

VS Mon

Other . . .

ICE Svc Elem

Specializations

Generalizations

IHE PCD DPIIEEE 11073 ICE “SE”

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Standards considerations – “Roadmap” relationships

ISO/IEEE 11073-based

-10201 ASN.1

Nomenclature

-10103 ICD

-10101 Ver12

-10102 aECG

Domain Info Model (DIM)

-10202 XML

IHE PCD HL7 ORI Gway-based

LOINC

Ref. Info Model (RIM) V2

Basic XML

V3 Nomenclature

TRANSPORT I/Fs

TCP UDP

DATA LANGUAGEs

PHD (Personal Health Devices)

-20601 Base

-104xx Specializ’’ns

IHE ROSETTA Nomencl.

IEEE 11073, 802.3, 802.11

-30200 Cabled, PoC, RS-232/802.3

-30300 Wless,

Infrared

-30400 Inter-LAN

802.3

-30500 Wless,

RF

-30501.2 wPAN

-30503 wLAN

Non-IEEE

USB

DATA LINKs /MACs

Zigbee Blue- tooth

SNOMED

UCUM

Upper Layers Appl’n Present’n Session Lower Layers: Transport Network Data Link Physical Link null Internet (IP)

-20401 COMMON SVCs

DHCP /bootp

Med. Data QoS

Other eg: Secur.

“Classic” Medical Devices

-20101 Base Std

-2020x Appl

Profiles

-3xxxx Specializations -203xx Appl Pkgs

Infusor /Pump

Vent -ilator

VS Mon

Other . . .

IHE PCD DPI+DECIEEE 11073 ICE “SE”

-Nomenclature-ApplProfiles-RCoP-Common Svcs-Conformance Tooling

Rosetta(Rev 1)

DPI(Rev 1)

DPI PAC

DPI

IHE

x73

ASTM ICE-Part 1 (Revn)

ICEDEC

PCD

RTM

PCD01

Rosetta(Rev 2)

UL

LL

-InterLAN

ASTM ICE-Parts1-n

See Appendix A for Abbreviations

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Appendix A - Abbreviations

ASN.1 Abstract Syntax Notation One [of ISO]

ASTM American Society of Test and Measurement

CEN Committee for European Normalization

DEC Device-Enterprise Communication [of IHE PCD]

DIM Domain Information Model [of x73]

DPI Device Point of care Integration [of IHE PCD]

FSM Finite State Model [/Machine]

HL7 Health Level Seven

ICE Integrating the Clinical Environment (of ASTM)

IEC International Electrotechnical Commission

IEEE Institute of Electronics and Electrical Engineers

IHE Integrating the Healthcare Enterprise

ISO International Standards Organization

LL Lower Layers [of x73]

MDAP Medical Device Appl’n Profile [of x73]

MDDL Medical Device Data Language [of x73]

MDIB Medical Device Information Base [of x73]

MD PnP Medical Device Plug and Play

OO Object-Oriented

OSI Open Systems Interconnection [of OSI]

PAC PCD Analysis Committee [of IHE PCD DPI]

PCA Patient Controlled Analgesia

PCD Patient Care Devices [of IHE]

PHD Personal Health Devices [of x73]

RA Risk Analysis

RCoP Remote Control Package [of X73]

RM Risk Management

RTM Rosetta Terminology Mapping [of IHE PCD]

SCADA Supervisory Control and Data Acq’n [of x73]

SE Service Element

UL Upper Layers [of x73]

X73 ISO/IEEE 11073 series