Software Diagnostics and Conformance Testing Division Medical Device Communication Test Effort...
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Software Diagnostics and Conformance Testing Division IHE-PCD, PHD, IEEE 11073 and NIST Medical Device Communication Medical Device Communication Test Effort Test Effort HL7/IEEE WG Meetings (San Antonio) January 2008
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Transcript of Software Diagnostics and Conformance Testing Division Medical Device Communication Test Effort...
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IHE-PCD, PHD, IEEE 11073 and NIST
Medical Device CommunicationMedical Device CommunicationTest EffortTest Effort
HL7/IEEE WG Meetings (San Antonio)January 2008
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Medical Device Test EffortMedical Device Test EffortNIST Team Members
• John Garguilo ([email protected], 301-975-5248)
• Sandra Martinez ([email protected], 301-975-3579)
• Maria Cherkaoui ([email protected] Guest Researcher)
• Richard Theimer ([email protected] Group, Inc., Contractor)
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Meeting Topics
• NIST Test Tools Update– ICSGenerator – ValidatePDU
• NIST P11073-10202 DIM XSchema (PAR)– PAR Project Plan– X73-10202 Documentation
• Next Steps and Future Direction…– DIM XSchema Documentation– RT PnP Device Communication– Adapt PHD efforts into NIST Tools?
• http://www.nist.gov/medicaldevices
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CEN 13734 and 13735
DIM MOCICS
Reports
DIMXSchema
Compare Devices
HL7/OBXMapping
(XML)
Service Support ICS
ReportService Support
ICS XML
Transport ICS Report
TransportICS XML
General ICS
Report
General ICS XML
Device Specialization
(DIM MOC XML)
Device UML Diagram
ISO/IEEE 11073
DIMPart 10201
NomenclaturePart 10101
ICSGenerator
ICSGenerator Tool and XSchema
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ValidatePDU Tool
• ValidatePDU: Performs APDU syntax/structure and semantic validation using a MDER Coder.
APDU(XER)
ValidatePDU
(APDU Syntax and Semantic Validation)
Device Profile(xml)
ValidationReport
ROSEapdu(MDER) (MDER + XER Coder)
ValidatePDU
(APDU Syntax and Semantic Validation)
Device Profile(xml)
ValidationReport
ROSEapdu(MDER) (MDER + XER Coder)
ValidatePDU
(APDU Syntax and Semantic Validation)
Device Profile(xml)
ValidationReport
ROSEapdu(MDER) (MDER + XER Coder)
(From ICSGenerator)
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ValidatePDU Capabilities
• Validates APDU syntax against X73 DIM specifications and the X73 Application Profiles – Base Standard
• ASN.1 data types syntax.• Object hierarchy, cardinality, acceptable behaviors, notifications and
attributes in compliance with X73 Standards.• Relationship between ROSE and CMIP data types.
• Validate APDU semantic/content against device profile (object, attribute, behavior, notification and services implementation)
– Tool determines if:• a MOC, attribute, behavior and notifications identified in a message is
implemented by the device profile.• attributes identified in a message are implemented as part of a MOC in
the device profile. • the message contains the attribute as required by the device profile
(missing or unrecognized attributes).• the message contains valid MOC information, such as handle and
context-id according to the device profile.• the message contains valid attribute information, such as fixed values
and value ranges according to the device profile.• a behavior identified in a message is supported by the device profile.• MOC objects hierarchy complies with device profile specifications.• the message contains the MOCs as required by the device profile
(missing MOC or unrecognized MOCs)
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ValidatePDU Capabilities
• Decodes MDER PDUs and builds ASN.1 object instances.• Provides an interface to display a parsed message in the
following formats:– XER (in compliance with the standard XER where applicable).
– MDER binary– Enhanced view (JTree representation)
• Generates Validation Reports.• Highlight incorrect fields in enhanced view. • Associates report messages with Test Assertions.
Note: ValidatePDU functionalities are captured in a ValidatePDU Software Requirements Specification document. (Reviewed by members of the WG)
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ValidatePDU (Enhanced View)
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ValidatePDU (XER View)
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ValidatePDU (MDER View)
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ValidatePDU Recent Enhancements
ValidatePDU 2.0 ValidatePDU 3.0
Validates against Baseline Profile only Validates against polling mode profile and supports:
MDS Create Notification MDS-Poll-MDIB-Data
Process RoseInvoke and RoseResult types
Process of all Rose types
Process CMIP types: Get, Set, Create, EventReport
Process CMIP type : Action
Displays information concerning message (whether message from Agent or Manager, Rose type, CMIP Type, MOC object)
Displays Notification/Method name
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ValidatePDU Enhancements (Cont.)
ValidatePDU 2.0 ValidatePDU 3.0
Process the following notifications:
MDSCreateNotificationMDSAttributeUpdateAlertScannerScanEventReportEpiCfgScannerUnbufferedScanReportPeriCfgScannerBufferedScanReportContextScannerObjectCreateNotification
Added support for all Notifications in DIM
Attribute-UpdateSystem-ErrorMds-Create-NotificationMds-Attribute-UpdateClock-Date-Time-Status-ChangedSCO-Operating-RequestSCO-Operation-Invoke-ErrorUnbuf-scan-reportBuf-scan-reportFast-Buf-Scan-ReportObject-create-notificationObject-delete-notificationAlert-Scan-ReportOper-Create-NotificationOper-Delete-NotificationOper-Attribute-UpdatePatient-Demographics-ModifiedPatient-Demographics-State-Change
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ValidatePDU Enhancements (Cont.)
ValidatePDU 2.0 ValidatePDU 3.0
No processing of action type messages.
Supports all DIM Actions:Clear-SegmentsGet-SegmentsGet-Segment-InfoMds-Set-StatusClear-LogGet-Event-Log-EntriesSet-TimeSet-Time-ZoneSet-Leap-SecondsSet-Time-ISOOperation-InvokeGet-Ctxt-HelpRefresh-Episodic-DataRefresh-Operation-contextRefresh-Operation-AttributesGet-Mib-DataDischarge-PatientAdmit-PatientPre-Admit-Patient
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NISTICSGenerator
PnP MD AgentSimulator
PnP MD ManagerSimulator
PnP PoC RTPnP PoC RT11073-3020011073-3020011073-11073-30300(G)30300(G)11073-2010111073-2010111073-2020x11073-2020x
NISTValidatePDU
Device Profile Device Profile (XML)(XML) X73 APDU X73 APDU
(MDER)(MDER)
X73 PDUsX73 PDUs
Validation Report
Service SupportICS XML
TransportICS XML
General ICS XML
Device Specialization
(DIM MOC XML)
WIRESHARK
MDER Extraction Tool
““libpcap”file libpcap”file (Non-RT)(Non-RT)
Plug-n-Play Real Time Profile
Test Tool Validation of X73 APDUs
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DIM XSchema Status/Update
• Quick XSchema Component Review • PAR Approval DIM XSchema
– Approval Date: 05-December-2007– IEEE P11073-10202TMD01a Draft Standard for
Health Informatics – Medical Device Communication – Domain Information Model – XML Schema Format
• Project Plan• Next Steps• Future Directions?• Issues (Jan)
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DIM XML Schema
GeneralICS.xsd serviceICS.xsd
DIM_Values.xsd
PollingMode.xsd
MOC_Defs.xsd
MOC_Attr_Behav_Notif.xsd
DIM_Data_Types.xsd
(http://www.obj.sys.com/v1.0/XMLSchema)
osxdlib.xsd
(http://www.nist.gov/x73DIM)
DIM.xsd
include import
DIM XSchema Document Structure
Rose.xsd
Transport.xsd
Baseline-Manager.xsd
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DIM XSchema Objectives/Goals and Intent
• Objectives:1. Translate DIM (into XML) to develop conformance
related automation (tooling) [one of NIST’s original objectives],
2. Serve as feedback/loop mechanism to DIM standard,3. Enable standard-based implementation,4. Gain understanding of standard.
• Intent:Not intended to replace DIM, but enable
implementation of it…
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DIM XSchema Project Plan
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DIM X73-10202 XSchema Project Plan
• Completed (on-plan) Tasks– PAR Project Plan
Minor Revision to plan (post Atlanta, pre San Antonio) Requirements Gathering Identify Schema Best Practices and Approach for
Implementation Identify Approach for Object Inheritance Identify Approach for Content Model Extensibility Map Requirements to Schema Develop Textual Definitions ASN.1 Common Data Types
Map ASN.1 to Schema using ASN2XSD Tool Service Model ICS Tables Implementation, Validation, and Testing
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DIM X73-10202 XSchema Project Plan (cont)
• Completed (on-plan) Tasks (cont) Maintenance
Comments and issues to IEEE Standards Body DIM and Nomenclature
Updates to XSchema Libraries based on review comment
Update XSchema documentation to be consistent Design and Code revision and documentation Synchronize XSchema with Paper DIM
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DIM X73-10202 XSchema Project Plan
Outstanding and Near-term Tasks Development of X73-10202 document
Compose Outline (based on DIM, X73-10201) Compose first draft, review, and produce version 1.0
• Ongoing Tasks Present, Review, Update Plan (San Antonio Jan 08
mtg) Develop X73-10202 Document (version 1.0) Maintenance
Comments to Standards Body (DIM and Nomenclature)
Updates to XSchema Libraries based on review Update XSchema documentation to be consistent
Determine Future Needs Extensibility and Expandability
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Next Steps…Call for help w/ P10202 document content, issues, and review• Need (Industry involvement with) V & V
– Verification of translation: DIM XML Schema• Is it a faithful translation?
– Validation of tools by modeling devices• E.g., Monitor, Ventilator, Infusor (PHD devices?)• Do users find the XSchema correct? Usable?• How do we support it?
• 10202 Document and Standardization Process– Usability issues and content
• E.g., mapping of XML to/from paper DIM, nomenclature, etc.– Who is the audience?
• Could be the main users of the doc/project are conformance folks?– Is the draft a reasonable starting place?
• Still need 1 or more iterations to get things organized?– Tracking
• Issues: e.g., Informative vs. Normative, how do we handle copyright and IP issues, etc…
– Establish review process for DIM XSchema• Establish core review group
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Potential Future Direction…
• Future Direction?– RT PnP Profile– Leveraging NIST Conformance Tooling to PHD work
• PHD Application Profile (optimized exchange protocol) 11073-20601
• As ‘Specializations’ balloted (11073-104xx)– Manager/Agent Simulator– X73 APDU Message Generation
