introduction

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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 Devices DomainPatient Care Devices DomainTest EffortTest Effort

September 2006

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IntroductionNIST PCD Team• John Garguilo ([email protected], 301-975-5248)• Sandra Martinez ([email protected], 301-975-3579)

Agenda• Meeting Goals• PCD background, IEEE 1073, IHE• Involvement in IHE PCD and IEEE 1073

– Year 1, Year 2+– High Level Diagram– IHE PCD Test Cases

• NIST Conformance Test Tools– HL7 Test Framework (including Message Maker)

• Input POC (HL7) XML message profiles• Data source (physiologic)• Output: HL7 test messages

– Test framework– ICSGenerator

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

– ValidatePDU• PDU syntax

• NIST 11073 XSchema• Issues and Open Discussion…

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Goals• Describe high-level test focus areas• Provide Tool Inventory/update:

– Brief description/demonstration of development enhancements

– Pointer/Links for more detail and contact information

• NIST XSchema– Provide status update– Discuss/resolve outstanding issues

• Call for vendor review/use of ICSGenerator• Discuss/Resolve any open issues…

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Integrating the Healthcare Enterprise IHE and NIST

• IHE defines a Technical Framework for the implementation of established messaging standards to achieve specific clinical goals.– Volume I: Integration Profiles– Volume II: Transactions

• NIST supports IHE fundamental objective:– To ensure that in the care of patients all required information for medical

decisions is both correct and available to healthcare professionals.

• NIST contributes to a rigorous testing process for the implementation of the Technical Framework.– Conformance claims by products must still be made in direct reference to

specific standards.– Vendors implementing IHE integration capabilities shall use an IHE

Integration Statement to describe the conformance of their product to the specifications in the IHE Technical Framework.

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IHE/PCD Year 1 Use Cases• The Patient Care Devices Domain is concerned with Use Cases in

which at least one actor is a regulated patient care device.

• Year One Profiles:- Profile 1: The Enterprise Communication of Patient Care Device Data Integration ProfileGoal: Communicate PCD data to enterprise information systems.IHE PCD Profile Name: Device Enterprise Communication (DEC)IHE PCD Transactions: PCD-01: Communicate PCD Data

PCD-02: Subscribe to PCD Data

IHE PCD Actors: Device Observation Consumer, Filter, and Reporter IHE ITI Actor: Time Client

- Profile 2: The Patient Identification Integration Profile Goal: Bind enterprise unique patient identification to the PCD Data which is

communicated to the enterprise

• PCD Test Cases

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ISO/IEEE 11073-60101 HL7(V2.x) ORI [IEEE P1073.6.1.1](Application Gateway)

1073Network

HL7Network

1073Device

11073/HL7Gateway

HL7System

HL7System

11073-based communications network where 11073 devices interact and

an HL7-based communications network, where HL7-based systems interact.

Problem: A communication gateway is needed between these two worlds!

Solution: ISO/IEEE 11073-60101 HL7(V2.x) ORI [IEEE P1073.6.1.1]

11073Device

11073Device

11073Device

IEEE 1073 System

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n

1073Standard

(DIM)

How the NIST Test Framework/Message Maker and ICS-Generator could contribute to the IHE/PCD year one Initiative…

(XSLT)

TestingFramework(Year 2+)

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 1073Standard

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

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Conformance Test Tools• NIST HL7 Test Framework

Message Maker– Message Maker dynamically constructs HL7 messages based on an

HL7 message profile.– Data values for the primitive elements (i.e., Field, Component, and

Subcomponent) defined in the profile are obtained from a number of data sources.

• NIST developed database of HL7 primitive data items, HL7 tables, User tables, External tables, local tables, example values from the profiles and default values.

– Test messages can be valid or invalid and contain variation from message to message.

• Example of invalid message is a missing data item for a required field. • A number of test parameters control the variation in the construction of a

message. – These may include segment and field cardinality, the usage of certain primitive

fields, value sets, data content, and more.– Data content variation is achieved by randomly selecting items from the HL7

items database.

– Framework to test HL7 implementations is under development

• http://www.nist.gov/messagemaker• Robert Snelick ([email protected])

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Conformance Test Tools (continued)(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 HL2 V2.x profile file) to build the test messages.]

• http://www.nist.gov/medicaldevices

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IEEE 11073

DIM

Nomenclature

ICSGenerator Valid XML File

XSLT

ICS

XSchema File

ICSGenerator Inputs/Outputs

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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.

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ICSGenerator Enhancements(since last WG meetings [San Antonio, May 06])(since last WG meetings [San Antonio, May 06])

• 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.

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ICSGenerator Enhancements(Continued…)

• 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.

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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 1073 syntax/structure/semantic testing

• http://www.nist.gov/medicaldevices

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DIM XSchema

• Checks common data types• Ensures DIM object definition (attributes, behaviors and

notifications)• Ensures containment association• Represents attributes/notification/behavior inheritance• Ensures object cardinality• Ensures term codes (Managed Objects, attributes,

behaviors and notifications)• Validates for proper XML structures• Checks syntax of XML instances• Allows for future extentions of the model

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Common data type

<xsd:element name="InstNumber“ type=“instNumber”/> <xsd:simpleType name="instNumber">

<xsd:restriction base="iNT-U16"/>

</xsd:simpleType>

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Containment/Object Definition<xsd:complexType name="Simple_MDS_Type">

<xsd:annotation><xsd:documentation>This type defines the Simple_MDS object including its containment tree.</xsd:documentation></xsd:annotation><xsd:choice minOccurs="0" maxOccurs="unbounded"><xsd:element name="OBJECT_NAME"> <xsd:complexType> <xsd:simpleContent> <xsd:extension base="Simple_MDS_Object_Name_Type">

<xsd:attribute name="Label" type="xsd:string"/> </xsd:extension> </xsd:simpleContent> </xsd:complexType></xsd:element><xsd:element name="OBJECT_ID" type="Simple_MDS_Object_Id_Type"/><xsd:element name="TERM_CODE" type="Simple_MDS_Term_Code_Type"/><xsd:element name="Reference" type="Simple_MDS_Reference_Type"/><xsd:element ref="MOC_RESTRICTIONS"/><xsd:element ref="MOC_APPLICATION_GUIDANCE"/><xsd:element ref="MOC_SERVICES_SUPPORTED"/><xsd:element ref="MOC_COMMENT"/><xsd:element name="Attribute_Info" type="Simple_MDS_Attribute_InfoType" maxOccurs="unbounded"/><xsd:element name="Behaviour_Info" type="Simple_MDS_Behaviour_InfoType" minOccurs="0" maxOccurs="unbounded"/><xsd:element name="Notification_Info" type="Simple_MDS_Notification_InfoType" minOccurs="0" maxOccurs="unbounded"/><xsd:element name="Alert" type="AlertType" minOccurs="0" maxOccurs="unbounded"/><xsd:element name="Alert_Monitor" type="Alert_MonitorType" minOccurs="0"/><xsd:element name="Alert_Scanner" type="Alert_ScannerType" minOccurs="0" maxOccurs="unbounded"/><xsd:element name="Alert_Status" type="Alert_StatusType" minOccurs="0"/><xsd:element name="Battery" type="BatteryType" minOccurs="0" maxOccurs="unbounded"/><xsd:element name="Bedside_Communication_Controller" type="Bedside_Communication_ControllerType" minOccurs="0"

…

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Attribute Definition<xsd:group name=“Simple_Mds_Attribute_InfoType">

<xsd:all> <xsd:element name="Mds-Status"> <xsd:complexType> <xsd:complexContent> <xsd:extension base="Mds_Mds-Status_Type"> <xsd:attributeGroup ref="System_Application_Attribute_Group"/> <xsd:attribute name="derivedFrom" type="xsd:string“ default="MDS"/> </xsd:extension> </xsd:complexContent> </xsd:complexType></xsd:element> …

</xsd:group>

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Attribute Definition (Cont.)<xsd:complexType name="Mds_Mds-Status_Type"> <xsd:sequence>

<xsd:element name="ATTRIBUTE_NAME" type="xsd:string" fixed="Mds-Status"/><xsd:element name="ATTRIBUTE_ID" type="xsd:string" fixed="MDC_ATTR_VMS_MDS_STAT"/><xsd:element name="ATTRIBUTE_TYPE" type="xsd:string" fixed="MDSStatus"/><xsd:element name="TERM_CODE" type="xsd:integer" fixed="2471"/><xsd:element name="Reference" type="Mds_Attribute_Reference_Type"/><xsd:element name="Qual" type="xsd:string" fixed="C"/><xsd:group ref="Attribute_Information"/>

</xsd:sequence></xsd:complexType>

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Attribute Groups

<xsd:attributeGroup name="System_Application_Attribute_Group"><xsd:attribute name="attrGrpId" type="xsd:string" default="MDC_ATTR_GRP_SYS_APPL"/><xsd:attribute name="attrGrpName" type="xsd:string" default="System Application Attribute Group"/><xsd:attribute name="attrGrpTermCode" type="xsd:string" default="2058"/></xsd:attributeGroup>

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Behavior Definition<xsd:complexType name="Simple_MDS_Behaviour_InfoType">

<xsd:sequence><xsd:element name="Mds-Set_Status" type="Mds-Set-Status_Type"/></xsd:sequence>

</xsd:complexType>

<xsd:complexType name="Mds-Set-Status_Type"><xsd:sequence><xsd:element name="METHOD_NAME" type="xsd:string" fixed="Mds-Set-Status"/><xsd:element name="METHOD_ID" type="xsd:string" fixed="MDC_ACT_SET_MDS_STATE"/><xsd:element name="BEHAVIOUR_ACTION_PARAMETER" type="xsd:string" fixed="MdsSetStateInvoke"/><xsd:element name="BEHAVIOUR_ACTION_RESULT" type="xsd:string" fixed="MdsSetStateResult"/><xsd:element name="TERM_CODE" type="xsd:integer" fixed="3087"/><xsd:element name="Reference" type="xsd:string" fixed="clause 7.5.2.2"/><xsd:element name="Qual" type="xsd:string" fixed="Confirmed"/><xsd:element ref="BEHAVIOUR_RESTRICTIONS"/><xsd:element ref="BEHAVIOUR_COMMENT"/></xsd:sequence>

</xsd:complexType>

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Notification Definition<xsd:complexType name="Simple_MDS_Notification_InfoType">

<xsd:sequence> <xsd:element name="System-Error" type="System-Error_Type"/> <xsd:element name="Mds-Create-Notification" type="Mds-Create-

Notification_Type"/> <xsd:element name="Mds-Attribute-Update" type="Mds-Attribute-

Update_Type"/> <xsd:group ref="Top_Notification_InfoType"/></xsd:sequence>

</xsd:complexType>

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Notification Definition (Cont.)

<xsd:complexType name="System-Error_Type"><xsd:sequence> <xsd:element name="NOTIFICATION_NAME" type="xsd:string" fixed="System-Error"/><xsd:element name="NOTIFICATION_ID" type="xsd:string" fixed="MDC_NOTI_SYS_ERR"/><xsd:element name="NOTIFICATION_EVENT_PARAMETER" type="xsd:string" fixed="MdsErrorInfo"/><xsd:element name="TERM_CODE" type="xsd:integer" fixed="3349"/><xsd:element name="Reference" type="xsd:string" fixed="clause 7.5.2.3"/><xsd:element name="Qual" type="xsd:string" fixed="Unconfirmed"/><xsd:element ref="NOTIFICATION_RESTRICTIONS"/><xsd:element ref="NOTIFICATION_COMMENT"/>

</xsd:sequence></xsd:complexType>

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XML INSTANCE FILE<?xml version="1.0" encoding="utf-8"?>

<DIM xmlns="http://www.nist.X73.gov">

<Simple_MDS>

<OBJECT_NAME Label="">Simple_MDS</OBJECT_NAME>

<OBJECT_ID>MDC_MOC_VMS_MDS_SIMP</OBJECT_ID>

<TERM_CODE>37</TERM_CODE>

<Reference>clause 7.5.3</Reference>

<MOC_RESTRICTIONS/>

<MOC_APPLICATION_GUIDANCE/>

<MOC_COMMENT/>

<Attribute_Info>

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XML Instance (cont.)<Mds-Status attrGrpId="MDC_ATTR_GRP_SYS_APPL" attrGrpName="System

Application Attribute Group" attrGrpTermCode="2058" derivedFrom="MDS"><ATTRIBUTE_NAME>Mds-Status</ATTRIBUTE_NAME><ATTRIBUTE_ID>MDC_ATTR_VMS_MDS_STAT</ATTRIBUTE_ID><ATTRIBUTE_TYPE>MDSStatus</ATTRIBUTE_TYPE><TERM_CODE>2471</TERM_CODE><Reference>clause 7.5.2.1</Reference><Qual>C</Qual><ATTRIBUTE_ACCESS/><ATTRIBUTE_VALUE_RANGE/><ATTRIBUTE_RESTRICTIONS/><ATTRIBUTE_APPLICATION_GUIDANCE/><ATTRIBUTE_COMMENT/>

</Mds-Status> …</Attribute_Info>

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Infusion Pump

Infusion pump

Electronic profile

introduction

Documents