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Integrating the Healthcare Enterprise, IEEE 11073 and The National Institute of Standards and Technology Patient Care Medical Devices Test Effort January 2007. Introduction. Presenter Jan Wittenber (for NIST Team) NIST PCD Team John Garguilo ( [email protected] , 301-975-5248) - PowerPoint PPT Presentation
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1 National Institute of Standards and Technology • Technology Administration • U.S. Department of Commerce Integrating the Healthcare Enterprise, IEEE 11073 and The National Institute of Standards and Technology Patient Care Medical Devices Patient Care Medical Devices Test Effort Test Effort January 2007
Transcript
Page 1: Introduction

1

National Institute of Standards and Technology • Technology Administration • U.S. Department of Commerce

Integrating the Healthcare Enterprise, IEEE 11073

and The National Institute of Standards and

Technology

Patient Care Medical Devices Patient Care Medical Devices Test EffortTest Effort

January 2007

Page 2: Introduction

2

National Institute of Standards and Technology • Technology Administration • U.S. Department of Commerce

IntroductionPresenter• Jan Wittenber (for NIST Team)

NIST PCD Team• John Garguilo ([email protected], 301-975-5248)• Sandra Martinez ([email protected], 301-975-3579)• Rick Rivello ([email protected], 301-975-3519)

Outline• Meeting Goals• NIST 11073 XSchema• NIST Conformance Test Tools

– HL7 Test Framework (including Message Maker)– ICSGenerator

• Implementation Conformance Statements• Capabilities and Enhancements (since last WG meeting…)

– ValidatePDU• Next Steps… • Call for Help…

Page 3: Introduction

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National Institute of Standards and Technology • Technology Administration • U.S. Department of Commerce

Meeting Goals• Describe high-level IEEE/IHE PCD test focus

areas• NIST XSchema

– Provide status update• Provide Tool Inventory/update:

ICSGenerator– Brief description of development capabilities and

enhancementsValidatePDU

• Next Steps• Gather Feedback…

– Call for vendor/clinical engineers and WG members to review/use the NIST XSchema and ICSGenerator

Page 4: Introduction

4

National Institute of Standards and Technology • Technology Administration • U.S. Department of Commerce

n

1073Standard

(DIM)

How the NIST Test Framework/Message Maker and ICSGenerator could contribute to the IHE/PCD Initiative…

(XSLT)

NISNISTT

*HL7 v2.x Message Profile: Captures and describes a set of HL7v2.x messages used to solve a Use Case.

(Year 2+ )

P1073.6.1.1ORI

(Gateway)

HL7 v2.xStandard

IHE/PCD TechnicalFramework (Vol. II)

(Transactions)

IEEE 11073Standard

IHE-ITIPatient

Administration

*HL7 MessageProfiles

XML

*HL7 MessageProfiles

XML

IHEProfile(Paper)

HL7 Message

ProfileBuilder

(e.g., MWB)

ICS-Generator ICS XML File

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

NIST IHE Test

Framework

NIST XSchema

11073 Standard(DIM + Nomenclature)

Page 5: Introduction

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National Institute of Standards and Technology • Technology Administration • U.S. Department of Commerce

IEEE 11073

DIM

Nomenclature

ICSGenerator Device Profile(Valid XML File)

ICS

XSchema File

ICSGenerator Inputs/Outputs

Page 6: Introduction

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National Institute of Standards and Technology • Technology Administration • U.S. Department of Commerce

DIM XSchema Status• XSchema modifications:

– Added capability to associate values with data types– Created DIM_Values.xsd library containing textual object information

such as reference, object id, object name, etc. • Reason:

– Facilitates access and manipulation of this type of information.– Reduces size of DIM.xsd.– Facilitates upgrades to DIM.xsd.

– Created separate schema library for DIM data types• Reason:

– Facilitates access and manipulation of data types.– Makes data types reusable by other application. – Facilitates upgrades to DIM.xsd– Reduces size of DIM.xsd

– Optimized XSchematron rules in DIM.xsd.– Applied XML Schema best practices for optimization purposes in

different areas of the DIM.xsd.• Developing draft IEEE 11073 DIM XML Schema document

– Used IEEE 11073.1.1.2 aECG Nomenclature template as example.

Page 7: Introduction

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National Institute of Standards and Technology • Technology Administration • U.S. Department of Commerce

Conformance Test Tools(based on 11073 DIM Schema)

• ICSGenerator– Facilitates creation of vendor conformance statements.– Provides Medical device data such as parameters or attributes with value ranges

and restrictions. [This data can be used as needed by Message Maker (in addition to testing options, data source(s) and HL7 V2.x profile file) to build the test messages.]

• http://www.nist.gov/medicaldevices

Page 8: Introduction

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National Institute of Standards and Technology • Technology Administration • U.S. Department of Commerce

ICSGenerator Capabilities• Generates ICS’s as required in DIM document.• Ensures common format for ICS generation.• Generates an electronic (XML) version of device data

model based strictly on the IEEE 11073 DIM.– Includes private or manufacturer-specific extensions.

• Provides validation against DIM Schema.– A device data model generated using this tool can be validated

against an updated version of the DIM XSchema.

• Provides high level semantic interoperability– Ensuring correct containment relationship and terminology at the

object class and related attribute, notification and behavior level.– Device ICS’s comparison capability aids in identifying potential

interoperability issues.

Page 9: Introduction

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National Institute of Standards and Technology • Technology Administration • U.S. Department of Commerce

ICSGenerator Capabilities (cont.)• Dynamic tree generation

• Ability to generate UML diagrams• Device data model comparison reports.

– Exported to HTML or PDF document format.• General and Service Support ICS captured in XML• Transport ICS for IRDA Cable Connected profile.• Ability to handle private or manufacturer-specific

extensions.• DIM MOC, Attribute, Notification and Behavior ICS

tables generated into HTML.

Page 10: Introduction

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National Institute of Standards and Technology • Technology Administration • U.S. Department of Commerce

ICSGenerator Capabilities(cont.)

• Ability to add an Application Guidance Statement for the MOC

• CREATE/DELETE Service Support for MOC's • Ability to Add Attribute Access for an attribute.

(e.g., GET, SET, SCAN...) • Enhanced ability to Add/Remove Attributes,

Behaviors and Notifications.• Code added to ICSGenerator that enables users to

add/delete Composite MDS to the containment tree

Page 11: Introduction

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National Institute of Standards and Technology • Technology Administration • U.S. Department of Commerce

ICSGenerator Enhancements(since last WG meetings [Boca Raton, Sept 06])(since last WG meetings [Boca Raton, Sept 06])

• Interface upgrades– Added menu bar to re-start application– Added PDF report generation for ICS Tables.– Added pop-up menu to MOC in JTree to manipulate the

objects.– Improved JTree collapsing behavior when manipulating

the objects.• Created an installer to automatically install

ICSGenerator.

Page 12: Introduction

12

National Institute of Standards and Technology • Technology Administration • U.S. Department of Commerce

ICSGenerator Work-in-Progress

• Value/Data type association– Creating a DIM data type library

• Adding value input dialog• Mapping observation values to HL7 OBX segments

– OBX-2, OBX-3, OBX-4, OBX-5, OBX-6 and OBX-7• Updating ICSGenerator code to compile and run under

Java 1.5• Updating Users Guide to include latest ICSGenerator

changes

Page 13: Introduction

13

National Institute of Standards and Technology • Technology Administration • U.S. Department of Commerce

Conformance Test Tools (continued)

(based on 11073 DIM Schema)

• ValidatePDU– Provides a basic syntax and structure check for a set of

captured messages.• Future Enhancements

– Translating BER/MDER XML• Needed for 11073 syntax/structure/semantic testing

• http://www.nist.gov/medicaldevices

Page 14: Introduction

14

National Institute of Standards and Technology • Technology Administration • U.S. Department of Commerce

Next Steps• NIST 11073 DIM XSchema

– Document IEEE 11073 Normative Standard • PAR approved 9/15/06?• Project Plan under development• Maintenance issue of electronic file (versus paper documentation) in

Standard

• ICSGenerator– Add Remaining Transport Profiles– Continue Enhancing Interface and Usability; Documentation– Work w/ IHE PCD Team and Medical Device Vendors– Unit of Measurement (e.g., convert IEEE units of measurement to

UCUM, if adopted) – Mapping IEEE x73-10101 (Nomenclature) ‘Unit Codes’ to

Reference Identifiers

• Look into issue of Unit Attribution Semantics (long range)

Page 15: Introduction

15

National Institute of Standards and Technology • Technology Administration • U.S. Department of Commerce

Next Steps (continued…)

• IHE PCD Test Case Development (Year 2)– Support HL7 Profile Development (using MWB

and Message Maker)• Output test messages

– Obtain data values• To be used w/ Message Maker test generation

– Research potential link of IEEE X73-basedICS files (XML) into MWB and Message Maker

Page 16: Introduction

16

National Institute of Standards and Technology • Technology Administration • U.S. Department of Commerce

Call for Help…

• IEEE X73/IHE WGs, Vendors/Clinical Engineers– Validate NIST XSchema– Install and evaluate ICSGenerator

• Provide feedback on utility and functionality

– Recommendations for enhancements

NIST Contacts: John Garguilo ([email protected])Sandra Martinez ([email protected])Richard Rivello ([email protected])


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