caBIG Overview

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HL7 SDK A Software Development Kit for v3
messaging Clinical Trials Management Workspace
Washington, D.C. February 19 20
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Contents

• Introduction and Overview of HL7 v3
• HL7 SDK Architecture and Components
• HL7 SDK Development Status
• caCORE Integration
• Benefits to the community

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HL7 Overview

• Heath Level Seven (HL7) is an ANSI- accredited
  Standards Developing Organization (SDO) operating
  in healthcare arena
• Provides standards for data exchange to allow
  interoperability between healthcare information
  systems.
• HL7 focuses on the clinical and administrative
  data domains
• It is a not-for-profit organization made up of
  volunteers providers, payers, vendors, govt.
• Version 3 is under development

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HL7 v3 as a Messaging Standard at NCICB

• Why HL7?
• Recommended by the Health and Human Service (HHS)
  as the messaging standard for electronic exchange
  of clinical data.
• Over 90 of US hospitals have implemented some
  version of HL7 messages
• Why HL7 v3?
• V3 is based on three fundamental principles a
  Common Reference Model Well-defined data types,
  and Standardized Vocabulary Domains.
• V3 specification is a robust, well defined
  process designed to support a structured
  methodology for development of interoperable
  messages.
• Why HL7 v3 at NCICB?
• Support for translational research requires
  integration of research data with the clinical
  data. V3 offers the computable semantic
  interoperability to make this possible

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HL7 v3 Overview

• HL7 v3 is not just a new version. V 3 message
  development is a paradigm shift from v 2.x
• Follows object oriented developmental methodology
  based on UML model. All v3 messages derived from
  Reference Information Model (RIM)
• V3 follows a structured message development
  process where the RIM classes are further refined
  for specific domains of healthcare Refinement
  of classes are represented by different
  information models.
• The HL7 v3 messaging methodology provides the
  much needed common definition to the data that is
  exchanged and computed upon between systems. It
  provides the syntactic (structural) as well as
  semantic (meaning-based) interoperability
• Current Status
• Clinical Trials area and following messages are
  under development Annotated ECG, Drug Product
  Stability Report and Adverse Event Reporting.
  Periodic Reporting of Clinical Trial Lab Data is
  an approved HL7 standard and is moving towards
  ANSI approval.
• HL7 for its first implementation has chosen XML
  based message specification

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HL7 v3 activities at NCICB

• Registered with HL7 as an Early Adopter of v3
  implementation
• Active participation in Clinical Trials, Java,
  XML, Patient Administration, Public Health
  Reporting and Clinical Genomic domains of HL7
• Leveraged HL7 Java SIG API (in pre-alpha release
  Open Source) to build HL7 SDK
• Identifying new requirements in Clinical Trials
  and Patient Administration domains
• Building the HL7 v3 Adverse Event Reporting
  message from NCICB AE database in Phase I of HL7
  SDK

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HL7 SDK Architecture - Java SIG API Component
Overview
HL7 v3 XML file

• Provides Java API for HL7 v3 artifacts
• Parses HL7 v3 XML message(s)
• Takes Metadata and XML file as input
• Instantiates RIM classes data types (object
  graph)
• Populates RIM objects w/ data
• Uses SAX Parser
• Library uses open source saxon
• Builds HL7 v3 XML message(s)
• Takes RIM object graph and meta data as input
• XML Transformer to transform from SAXSource to
  XML Stream
• Outputs a HL7 v3 XML document

JavaSIG Software
HMD
Meta Data (MessageTypeLoader)
Parser(MessageContentHandler)
Data types
RIM Objects
Builder (Transformer)
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HL7 SDK Architecture Java SIG API as a component

• requires upgrade
• - not provided by HL7
• - requires integration

HL7 SDK
JavaSIG Software
HMD
Meta (MessageTypeLoader)
HL7 v3 XML File
caDSR
Parser(MessageContentHandler)
Validation
EVS
Data Types
RIM Objects
Vocabulary
CSAERS
HL7 Data Warehouse
Builder (Transformer)
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HL7 SDK Architecture - Description
HL7 SDK

• A J2EE based reference implementation of HL7 RIM
  v3 components
• Contains HL7 RIM Interface Classes that can be
  leveraged by
• Clinical Decision Support Systems
• Applications Supporting Translational Research
• Utilizes HL7 Java SIG tools message
  builder/parser
• Similar to the caBIO API, the HL7 SDK will
  provide a language and platform independence via
  Java, SOAP and HTTP APIs
• Similar to caBIO, will provide an efficient
  search and retrieval

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HL7 SDK Development Status

• Phase I Analysis (complete)
• HL7 v3 specifications and all of its associated
  components/artifacts
• Data types and Vocabulary components
• HL7 clinical domains including
• Regulated Studies (Clinical Trials)
• Public Health (Adverse Event)
• Patient Administration
• Infrastructure and implementation artifacts
• Evaluation HL7 Java SIG API

Continued ?
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HL7 SDK Development Status

• Phase I Tasks (on-going)
• Develop a strategy for leveraging the HL7 SIG API
  in the HL7 SDK effort
• Evaluate vocabulary (Common Terminology Services
  CTS) objects/interfaces
• Develop a methodology to produce RIM based object
  graphs for interfacing with clinical applications
  
• Will allow mapping of application business
  objects with RIM objects
• Build a prototype using the NCICB Adverse Event
  Reporting Application (CSAERS)
• Phase I - Timeline
• Design (April 2004)
• Implementation (August 2004)
• Testing (September 2004)
• Deployment (October 2004)

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caCORE Integration

• Use Case
• Retrieve adverse events associated with a
  particular agent
• Planning to build a proof-of-concept that
  demonstrates
• Integration between the caCORE infrastructure and
  the HL7 based repository via the HL7 SDK
• Persistence of a de-identified HL7 message
• Incorporation of the HL7 SDK into the NCICB
  infrastructure
• Query between caCORE data sources and
  de-identified HL7 data via the caCORE API

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Clinical Trials Architecture Overview
Clinical Research Support Systems and
Translational Research Applications
Clinical System(s)
NCICB Infrastructure
HL7 SDK
caBIO
caDSR
Java SIG API
HL7 SDK
EVS
HL7 V3
HL7 V3
Java SIG API
Message Exchange
Security
De-Identification Service
HL7 V3
HL7 V3
HL7 Data Warehouse
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Benefits to the Community

• Can contribute back to the HL7 v3 Java community
  by extending the functionality of the Java SIG
  API
• Developers can download this open source SDK to
  implement v3 messaging services
• Can contribute to the HL7 v3 emerging standards
  by identifying new message requirements and use
  cases