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ISO/IEEE 11073, IHE-PCD, PHD and NIST
Medical Device CommunicationMedical Device CommunicationTest EffortTest Effort
HL7/IEEE WG Meetings (Phoenix, Arizona)6 May 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/Discussion
• Testing focus areas of IHE-PCD– Device to Device (via ISO/IEEE 11073 protocols)– Device to Enterprise (via HL7 protocols)
• Focus areas of IEEE PHD WG– Standards development (X73-20601 and 104xx)– Device to Device (via ISO/IEEE 11073 protocols)
• NIST Test Tool Inventory and Update– Patient Care Device focus (mainly IHE-PCD)– Adaptation to Personal Health Device
• NIST P11073-10202 DIM XSchema (PAR)– PAR Project Plan– X73-10202 Documentation Discussion– Feedback to standards
• http://www.nist.gov/medicaldevices
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Test Focus Areas
• NIST Test Tools Inventory– Device Communication
• ISO/IEEE 11073– ICSGenerator – ValidatePDU– XML Schema (ISO/IEEE P11073-10202TMD01a)
– Enterprise Communication• IHE-PCD
– Data Mapping from device to “enterprise” (via IHE-PCD Vol II/III Framework Doc)
• HL7 (general across all IHE domains)– MWB (VA), MessageMaker (NIST)– MESA / Kudu (IHE, Steve Moore and Erik Poiseau)– Web Services (mainly Validation) (NIST)– Gazelle (next generation building on Kudu [and other tools])– Cypress Collaborative – just kicked off
• Cypress wiki: http://collaborate.nist.gov/twiki-cypress/bin/view/Cypress/WebHome
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IHE-PCD Year 3+ Profile ProposalPCD-Real Time Plug-n-Play
PCD
PCD Client
Device ObservationReporter
Device Observation Consumer
PCD
PCD
PCD-01 &PCD-02
PCD-RT PnP
Device Observation Consumer
Gateway / ManagerX73
APDU
• Validate APDUs against Standard• Determine if APDUs meets device profile (defined using
ICSGenerator)
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What are we doing? Test Tools
Test Tools ICSGenerator ValidatePDU
What is it? Implementation Conformance Statement Generator, Profile builder
X73 Message validation: profile and standard
Why? •Easy to use interface •Based on standard
Promote Interoperability
Who’s using it?
Most major medial device manufactures –IHE-PCD participants (pre-connectathon, connectathon, HIMSS)–PHD participants (smaller devices - Continua effort)
A few small manufactures have expressed interestCountries participating: US, Europe, Japan, Korea, Canada
How is it being used?
As a requirement to standard (ICSs)Early stage interoperabilityValidate Standard
IHE-PCD profile validationMessage validationValidate Standard
Who are we working
with?
•IHE-Patient Care Domain•Personal Health Device WG•IEEE 11073 WG
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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
DIMParts 10201/
20601
NomenclaturePart 10101
ICSGenerator
ICSGenerator Tool and XSchema
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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
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ICSGenerator EnhancementsWhat’s new since our last meeting…• Added PHD Profile
– Agent
• ICSGenerator has been enhanced to allow the generation of X73-PHD 104xx XML configuration files in compliance with the IEEE P11073 20601.– The tool prohibits users from developing non-compliant
IEEE P11073 20601 configuration files. – (e.g., restricting a user from abstractly defining a
“conditional” attribute (which is “mandatory” in the standard).
– Currently we have developed configuration files for:• 10415 Weighing Scale• 10404 Pulse Oximeter• 10441 Cardiovascular fitness and activity monitor• 10442 Strength fitness equipment
• ICSGenerator also generates ICS’s tables as required by IEEE P11073 20601.
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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
Encode/Decode)
(From ICSGenerator)
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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 Capabilities(Detailed)
• 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 Enhancements
What’s new since our last meeting…• No new enhancements
• See coming slides for next steps…
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IEEE P11073-10202TM/D01a XML Schema Topics of Discussion
• Purpose• Status• Strategy for Review• Content of Document• Next Steps…
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IEEE P11073-10202TM/D01a XML SchemaPurpose
• What the XSchema is…– To enable conformance to standard (specifically Domain Information
Model and Nomenclature)• Needed for conformance testing• Needed by tooling for automation/consistent approach
– Otherwise one must do this by hand, which usually leads to errors propagated into standard(s)
– Attempt to document how DIM (ASN.1) Data Types map to XML
• What the XSchema is not…– Not intended to replace ASN.1 defined in DIM
• Exercise of formalizing DIM in a normalized way– Verification
• What does it mean to verify the XSchema• Classic – more definition, resource issue?• PHD – less definition, more resources (across more devices)
– Validation• Using tools to express device• Expressing the device according to the standard (Schema tie)
– All of XSchema content (XSD) will go into document
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IEEE P11073-10202TM/D01a XML SchemaStatus
• To date we have been presenting our work and test tools based on the “classic” DIM– ICSGenerator
• Generates ICSs• Device specializations (abstract representation compliant to DIM)
– ValidatePDU• Validates syntax of APDU• Validates low level semantics of APDU against profile (from
ICSGenerator
• DIM XML Schema• Java Class libraries
– ASN.1 data types in Java (including MDER)
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IEEE P11073-10202TM/D01a XML SchemaStrategy for Review
• Strategy for review/discussion of x73-10202 Document– First Exposure
• Description of how documentation maps to the problem– E.g., Object Definition and relationships
– Second Exposure• Eye-ball each section (text, example, MOC Attributes)
– Third (Detailed) Exposure• Editorial – go through line by line for emissions, redundancy,
etc. leading to a ‘design review’• Some level of traceability to do conformance testing
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IEEE P11073-10202TM/D01a XML SchemaDocument Content
• Overview, Normative References, Definitions, Abbreviations and Acronyms, Guiding principles
• XSchema Design Approach• XSchema Architecture• XSchema Object Definitions
– Data Types• Common Data Types• Attribute Data Types
– Object Definitions• Containment relationships• Object Inheritance
– Attribute Definition– Behaviour Definition– Notification Definition– Private Extensions
• Annexes– DIM Traceability (Normative) – how to trace back to DIM– Automated Conformance Toolkit Architecture (Informative)– Bibliography (Informative)
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IEEE P11073-10202TM/D01a XML SchemaDocument Content - Design
• Based on Object-oriented approach from DIM• The DIM is an object-oriented model that consists of objects,
the object attributes, and methods which are abstractions of real-world entities in the domain of medical devices.
• UML Diagram (packages in the form of object diagrams)
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IEEE P11073-10202TM/D01a XML SchemaDocument Content – Design (Cont.)
The following UML components are addressed: • Containment Relationship• Inheritance• Encapsulation• MultiplicityThe following textual elements of the IEEE 11073 DIM are also
addressed:• Managed Object Classes (MOC) Definitions• Attribute Definition• Attribute Groups• Behavior Definition• Notification Definition• Attribute groups• Private extensions• Common Data Type• Terminology• Service Model• ICS tables
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IEEE P11073-10202TM/D01a XML SchemaDocument Content - Architecture
• 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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IEEE P11073-10202TM/D01a XML SchemaDocument Content - Architecture
• DIM XML Schema Diagram
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IEEE P11073-10202TM/D01a XML SchemaDocument Content – Object Definitions
Example• Common Data Type Example
– 8-bit unsigned integer INT-U8 ASN.1 type mapped into XSD
INT-U8::=INTEGER(0..255)XSD Representation using ASN2XSD tool:<xsd:element name="INT-U8" type="iNT-U8"/>
<xsd:simpleType name="iNT-U8"><xsd:restriction
base="xsd:unsignedByte"/></xsd:simpleType>
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IEEE P11073-10202TM/D01a XML SchemaXSchema:DIM Traceability (Normative)
XSchema Component
DIM Clause(s) Comments
DIM_Data_Types.xsd 7.1.2, 7.3.2.1, 7.3.3.1, 7.3.4.1, 7.3.5.1, 7.3.6.1, 7.3.8.1, 7.3.9.1, 7.3.10.1, 7.3.11.1, 7.3.12.1, 7.3.13.1, 7.3.13.2, 7.4.1.1, 7.4.2.1, 7.4.3.1, 7.5.1.1, 7.5.2.1, 7.5.2.2, 7.5.2.3, 7.5.7.2, 7.5.8.1, 7.5.8.2, 7.5.9.1, 7.5.10.1, 7.5.10.2, 7.5.10.3, 7.6.1.1, 7.6.1.2, 7.6.1.3, 7.6.2.1, 7.6.3.1, 7.6.4.1, 7.6.5.1, 7.6.6.1, 7.6.8.1, 7.6.9.1, 7.7.1.2, 7.7.1.3, 7.7.2.1, 7.7.4.1, 7.7.5.3, 7.7.7.1, 7.7.7.3, 7.7.9.3, 7.8.1.2, 7.8.1.3, 7.8.6.1, 7.8.7.1, 7.9.2.1, 7.9.4.1, 7.10.1.1, 7.10.1.2,
Represents common data types and all type definitions in the DIM.
DIM_Values.xsd 7.2, 7.3, 7.4, 7.5, 7.6, 7.7, 7.8, 7.9, 7.10 Associates general information such as reference clause, qualifier; object, attribute, behavior and notification term codes; object , attribute, behavior and notification name; attribute_Id, behaviour_Id, notification_Id; behavior action parameter type, behavior action result type and notification event parameter
type
MOC_Attr_Bahav_Notif.xsd
7.2, 7.3, Associate values defined in DIM_values.xsd to specific attributes, behavior or notification.
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IEEE P11073-10202TM/D01a XML SchemaDocument Content
• Overview, Normative References, Definitions, Abbreviations and Acronyms, Guiding principles
• XSchema Design Approach• XSchema Architecture• XSchema Object Definitions
– Data Types• Common Data Types• Attribute Data Types
– Object Definitions• Containment relationships• Object Inheritance
– Attribute Definition– Behaviour Definition– Notification Definition– Private Extensions
• Annexes– DIM Traceability (Normative) – how to trace back to DIM– Automated Conformance Toolkit Architecture (Informative)– Bibliography (Informative)
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IEEE P11073-10202TM/D01a XML SchemaNext Steps (near term goals)
• Take a detailed pass to see if the document is on target.
• Determine, through use: Can the XSchema/Tooling be used to express manufacturer’s devices?
• Help calibrate what’s in conformance tools……and tie tools back into the standard
• Feedback back into the standard (through issues)• Lead to another document for PHD DIM XSchema
(20601)• Driven by Users:
– What will users do with this document?– Will tooling be enough (for the validation part)– Feedback from use of tools should drive document (and
standard)
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IEEE P11073-10202TM/D01a XML Schema
• Questions and Further Discussion…• Actions/Take-aways
• Thanks for your input and attention
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Begin Sandra’s PHD Slides
• Sandra’s slides
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PHD ProjectIEEE P11073-20601
• IEEE P11073-20601 makes use of information objects that are defined in ISO/IEEE Std 11073-10201, 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
• If there is a discrepancy between standards, the IEEE P11073-20601 standard takes priority.
• IEEE P11073-20601 replicates relevant portions of ISO/IEEE Std 11073-10101 and incorporates new nomenclature codes.
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Leveraging NIST Tools to PHD
X73 DIM(IEEE 11073-10201)
ICSGenerator
DIM XSchema
PHD-DIM(IEEE-11073-20601)
PHD XSchema.
DIM XML config.
PHD XML
config.
ValidatePDU
X73-104xx
XMl config.X73-104xx
XMl config.X73-104xx XML config.
X73-104xx
XSchematron.
PHD-DIM(IEEE-11073-104xx)
Device SpecializationsDevice
SpecializationsDevice Specializations
ICS’sICS’s
ICS’s
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ICSGenerator, DIM XSchema and PHD-DIM
PHD XSchema
• A PHD-DIM XSchema has been developed to represent the IEEE P11073 20601 standard.
• The PHD XSchema adopts the DIM XSchema architecture and reuses some of it components, when applicable.– DIM_Data_Type.xsd containing classic x73 ASN.1 definition will
be included and redefined, when appropriate.
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“Classic” X73 DIM XSchema
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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PHD_DIM XSchema
PHD_MOC_Defs.xsd
PHD_MOC_Attr_Behav_Notif.xsd
PHD_Data_Types.xsd
(http://www.obj.sys.com/v1.0/XMLSchema)
asn1.xsd
(http://www.nist.gov/x73DIM)
PHD_DIM.xsd
include import
DIM_Data_Types.xsdPHD_Import.xsd
Enumerations_Bases.xsd
redefine
Qual_Bases.xsd
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ICSGenerator, DIM XSchema and PHD-DIM
ICSGenerator
• ICSGenerator generates X73 “Classic” device specializations using IEEE X73 baseline and polling application profiles.
– For PHD, ICSGenerator will use an XML IEEE P11073-104XXX device specialization configuration file to define implementation of a device specialization.
• ICSGenerator has been enhanced to allow the generation of X73-PHD 104xx XML configuration files in compliance with the IEEE P11073 20601.
– The tool will not allow to develop a configuration file that is not in compliance to IEEE P11073 20601. (ex. Trying to support an attribute as “conditional” or “optional” when the IEEE P11073 20601 states that it must be “mandatory”.
– Currently we have developed configuration files for:• 10415 Weighing Scale• 10404 Pulse Oximeter• 10441 Cardiovascular fitness and activity monitor• 10442 Strength fitness equipment
• ICSGenerator also generates ICS’s tables as required by IEEE P11073 20601.
• The tool must be enhanced to generate X73-PHD 104xx device specializations– XSchematron rules must be applied to achieve compliance to the IEEE P11073-104XXX
specification.
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ICSGenerator, DIM XSchema and PHD-DIM
X73-10441 (Cardiovascular fitness and activity monitor)
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ICSGenerator, DIM XSchema and PHD-DIM
X73-10441 (Cardiovascular fitness and activity monitor)
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ICSGenerator, DIM XSchema and PHD-DIM
X73-10441 (Cardiovascular fitness and activity monitor)
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ICSGenerator, DIM XSchema and PHD-DIM
X73-10441 (Cardiovascular fitness and activity monitor)
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ICSGenerator, DIM XSchema and PHD-DIM
X73-10404 (Pulse Oximeter)
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ICSGenerator, DIM XSchema and PHD-DIM
X73-10415 (Weighing Scale)
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ValidatePDU 2.0 and PHD-DIM
• Current version of ValidatePDU validates APDU syntax against X73 DIM specifications and the X73 Application Profiles – Base Standard and validates APDU semantic/content against device profile.
• ValidatePDU must be enhanced to support IEEE P11073-20601 specification:– Incorporate new and modified PHD data types.– Extract assertions from the PHD specifications.– Develop code to properly validate and parse PHD messages.
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Next Steps
• Enhance ICSGenerator to add the capability to generate implementations of IEEE-11073 PHD 104xx device specializations in XML including the ICS tables.– Incorporate XSchematron validation
• Enhance ValidatePDU to validate PHD type messages.
