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Software Diagnostics and Conformance Testing Division Medical Device Communication Test Effort IHE-PCD, PHD, IEEE 11073 and NIST Medical Device Communication.

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Presentation on theme: "Software Diagnostics and Conformance Testing Division Medical Device Communication Test Effort IHE-PCD, PHD, IEEE 11073 and NIST Medical Device Communication."— Presentation transcript:

1 Software Diagnostics and Conformance Testing Division Medical Device Communication Test Effort IHE-PCD, PHD, IEEE and NIST Medical Device Communication Test Effort HL7/IEEE WG Meetings (San Antonio) January 2008

2 Software Diagnostics and Conformance Testing Division Medical Device Test Effort Medical Device Test Effort NIST Team Members John Garguilo ) Sandra Martinez ) Maria Cherkaoui Guest Researcher) Richard Theimer CENTECH Group, Inc., Contractor)

3 Software Diagnostics and Conformance Testing Division Meeting Topics NIST Test Tools Update –ICSGenerator –ValidatePDU NIST P DIM XSchema (PAR) –PAR Project Plan –X Documentation Next Steps and Future Direction… –DIM XSchema Documentation –RT PnP Device Communication –Adapt PHD efforts into NIST Tools?

4 Software Diagnostics and Conformance Testing Division CEN and DIM XSchema Compare Devices HL7/OBX Mapping (XML) Device UML Diagram ISO/IEEE DIM Part Nomenclature Part ICSGenerator ICSGenerator Tool and XSchema

5 Software Diagnostics and Conformance Testing Division ICSGenerator Capabilities Generates Implementation Conformance Statements (ICSs) –Required in conformance section (10) of DIM x73 document –Ensures common format for ICS generation Builds Device Profile (XML) –Generates an electronic (XML) version of device data model based strictly on the IEEE x73 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 –Ensures correct containment relationship and terminology at the object class and related attribute, notification, and behavior level –Compare Device ICSs Device ICSs comparison capability aids in identifying potential interoperability issues Generates HL7 OBX Segments Generates Device UML Diagram

6 Software Diagnostics and Conformance Testing Division 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) Validation Report ROSEapdu (MDER) (MDER + XER Coder) ValidatePDU (APDU Syntax and Semantic Validation) Device Profile (xml) Validation Report ROSEapdu (MDER) (MDER + XER Coder) ValidatePDU (APDU Syntax and Semantic Validation) Device Profile (xml) Validation Report ROSEapdu (MDER) (MDER + XER Coder) (From ICSGenerator)

7 Software Diagnostics and Conformance Testing Division APDU Structure MDS System-Type AttrSystem-Model Attr MDSCreateInfo System-TypeSystem-Model EventReport MDSCreateInfo Operation invoke EventReport CMDISE ROSE Medical Device System Common Medical Device Information Service Element Remote Operation Service Element

8 Software Diagnostics and Conformance Testing Division 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)

9 Software Diagnostics and Conformance Testing Division 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)

10 Software Diagnostics and Conformance Testing Division ValidatePDU (Enhanced View)

11 Software Diagnostics and Conformance Testing Division ValidatePDU (XER View)

12 Software Diagnostics and Conformance Testing Division ValidatePDU (MDER View)

13 Software Diagnostics and Conformance Testing Division Assertions (Example) Message must be confirmed Message type checked MDS-create-notification must be confirmed MOC must be either Simple MDS, Hydra MDS, Composite Single MDS or Composite multi Beds MDS MOC checked MOC is invalid, it should be MDS, Simple MDS, Hydra MDS, Composite Single Bed MDS or Composite multi Beds MDS …

14 Software Diagnostics and Conformance Testing Division ValidatePDU Recent Enhancements ValidatePDU 2.0ValidatePDU 3.0 Validates against Baseline Profile onlyValidates 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

15 Software Diagnostics and Conformance Testing Division ValidatePDU Enhancements (Cont.) ValidatePDU 2.0ValidatePDU 3.0 Process the following notifications: MDSCreateNotification MDSAttributeUpdate AlertScannerScanEventReport EpiCfgScannerUnbufferedScanReport PeriCfgScannerBufferedScanReport ContextScannerObjectCreateNotification Added support for all Notifications in DIM Attribute-Update System-Error Mds-Create-Notification Mds-Attribute-Update Clock-Date-Time-Status-Changed SCO-Operating-Request SCO-Operation-Invoke-Error Unbuf-scan-report Buf-scan-report Fast-Buf-Scan-Report Object-create-notification Object-delete-notification Alert-Scan-Report Oper-Create-Notification Oper-Delete-Notification Oper-Attribute-Update Patient-Demographics-Modified Patient-Demographics-State-Change

16 Software Diagnostics and Conformance Testing Division ValidatePDU Enhancements (Cont.) ValidatePDU 2.0 ValidatePDU 3.0 No processing of action type messages. Supports all DIM Actions: Clear-Segments Get-Segments Get-Segment-Info Mds-Set-Status Clear-Log Get-Event-Log-Entries Set-Time Set-Time-Zone Set-Leap-Seconds Set-Time-ISO Operation-Invoke Get-Ctxt-Help Refresh-Episodic-Data Refresh-Operation-context Refresh-Operation-Attributes Get-Mib-Data Discharge-Patient Admit-Patient Pre-Admit-Patient

17 Software Diagnostics and Conformance Testing Division ValidatePDU 3.0 Restrictions Performs semantic validation at the device profile level (as constrained by the user) only. Device profile must be an instance of the NIST DIM Schema. Processes only ROSE apdu ASN.1 type encoded in MDER. –This restriction excludes BER encoded ACSE messages.

18 Software Diagnostics and Conformance Testing Division NIST ICSGenerator PnP MD Agent Simulator PnP MD Manager Simulator PnP PoC RT (G) x NIST ValidatePDU Device Profile (XML) X73 APDU (MDER) X73 PDUs Validation Report WIRESHARK MDER Extraction Tool libpcapfile (Non-RT) Plug-n-Play Real Time Profile Test Tool Validation of X73 APDUs

19 Software Diagnostics and Conformance Testing Division DIM XSchema Status/Update Quick XSchema Component Review PAR Approval DIM XSchema –Approval Date: 05-December-2007 –IEEE P TM D01a Draft Standard for Health Informatics – Medical Device Communication – Domain Information Model – XML Schema Format Project Plan Next Steps Future Directions? Issues (Jan)

20 Software Diagnostics and Conformance Testing Division DIM XML Schema GeneralICS.xsdserviceICS.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 includeimport DIM XSchema Document Structure Rose.xsd Transport.xsd Baseline-Manager.xsd

21 Software Diagnostics and Conformance Testing Division DIM XSchema Objectives/Goals and Intent Objectives: 1.Translate DIM (into XML) to develop conformance related automation (tooling) [one of NISTs 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…

22 Software Diagnostics and Conformance Testing Division DIM XSchema Project Plan

23 Software Diagnostics and Conformance Testing Division DIM X 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

24 Software Diagnostics and Conformance Testing Division DIM X 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

25 Software Diagnostics and Conformance Testing Division DIM X XSchema Project Plan Outstanding and Near-term Tasks Development of X document Compose Outline (based on DIM, X ) Compose first draft, review, and produce version 1.0 Ongoing Tasks Present, Review, Update Plan (San Antonio Jan 08 mtg) Develop X 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

26 Software Diagnostics and Conformance Testing Division DIM Issue (outstanding from Atlanta) Attribute inheritance –NIST assumption: inheritance is captured in the attribute groups. –Inconsistencies: Demo document (attribute table for infusion pump Hydra MDS): MDS inherits the handle attribute from VMS DIM : Handle is not part of any attribute groups inherited by MDS

27 Software Diagnostics and Conformance Testing Division 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? 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

28 Software Diagnostics and Conformance Testing Division Potential Future Direction… Future Direction? –RT PnP Profile –Leveraging NIST Conformance Tooling to PHD work PHD Application Profile (optimized exchange protocol) As Specializations balloted ( xx) –Manager/Agent Simulator –X73 APDU Message Generation

29 Software Diagnostics and Conformance Testing Division PHD Project IEEE P IEEE P makes use of information objects that are defined in ISO/IEEE Std , adapting these information objects to the domain of Personal Health Device communication. The information objects are specialized and therefore modified in the following ways: –The definition of attributes that are mandatory, optional, or conditional may be different * –Additional Object Services may be defined –Additional Attributes may be defined –Some features of the original model might not be used When discrepancies occur between these standards, the referenced standards take priority. IEEE P replicates relevant portions of ISO/IEEE Std and incorporates new nomenclature codes to add. (pg. 4)

30 Software Diagnostics and Conformance Testing Division ICSGenerator, DIM XSchema and PHD-DIM ICSGenerator uses an XML representation of the DIM specification. –A new XML configuration file must be created to represent the IEEE P specification. Basically taking the current XML file and adding additional attributes, methods and behaviours and removing any definition that is not required by the P specification. –The new xml configuration file would not validate against the current x73 DIM XSchema, therefore a PHD-DIM XSchema must be developed. –The tool could be enhanced to generate PHD profiles by allowing the user to select type of profile to generate. –The X73-DIM XML configuration file could be use to allow user to extend the objects by using additional object attributes as defined by x73 DIM. A PHD-DIM XSchema must be created –This XSchema will adopted the DIM XSchema architecture and reuse some of it components when applicable.

31 Software Diagnostics and Conformance Testing Division PHD-DIM XML Schema GeneralICS.xsdserviceICS.xsd PHD-DIM_Values.xsd PHD-MOC_Defs.xsd PHD-MOC_Attr_Behav_Notif.xsd PHD-DIM_Data_Types.xsd (http://www.obj.sys.com/v1.0/XMLSchema) osxdlib.xsd (http://www.nist.gov/x73DIM) PHD-DIM.xsd includeimport DIM XSchema Document Structure DIM.xsd

32 Software Diagnostics and Conformance Testing Division ApduGen APDUs Engine Communication Services ASN.1 Module & Type services Agent Simulator/ Manager Scenario Validation Reports Device Profile PDUs NIST ICSGenerator Moving forward…Integration of Validation Test Tools PDUs

33 Software Diagnostics and Conformance Testing Division Agent/Manager Simulator Device profile –Generated using ICSGenerator. –Used to build an agent/manager simulators Message Exchange Scenarios –An xml file describing a message exchange. –Using message interaction diagrams and the finite state machine. –Used as input to the simulator to manage messages to be sent. Engine –Drive entire simulation process APDUGen –Generates APDUs using a device profile. Communication Services –Provides presentation, session and transport services. ASN.1 module and type services –Provides ASN.1 library to decode and encode BER, MDER and XER. Validation Reports –Report syntax/structure and semantic validation errors –It will also include behavioral validation

34 Software Diagnostics and Conformance Testing Division Benefits A non-proprietary x73 simulator that can be used by any x73 implementer. –Helps implementers understand the x73 standard. –Could be used as a reference implementation for helping others to implement their own version of the standard. Provides conformance testing capabilities.


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