# Presentation: 358843

## Integrating the Healthcare Enterprise, IEEE 11073 and The National Institute of Standards and TechnologyPatient Care Medical Devices Test EffortJanuary 2007

## Introduction

- _Presenter_
- Jan Wittenber (for NIST Team)
- _NIST PCD Team_
- John Garguilo (_[john.garguilo@nist.gov](mailto:john.garguilo@nist.gov)__, 301-975-5248)_
- Sandra Martinez (_[sandra.martinez@nist.gov](mailto:sandra.martinez@nist.gov)__, 301-975-3579)_
- Rick Rivello (_[richard.rivello@nist.gov](mailto:richard.rivello@nist.gov)__, 301-975-3519)_
- _Outline_
- Meeting Goals
- NIST 11073 XSchema
- NIST Conformance Test Tools
- HL7 Test Framework (including Message Maker)
- ICSGenerator
- Implementation Conformance Statements
- Capabilities and Enhancements (since last WG meeting...)
- ValidatePDU
- Next Steps...
- Call for Help...

## Meeting Goals

- Describe high-level IEEE/IHE PCD test focus areas
- NIST XSchema
- Provide status update
- Provide Tool Inventory/update:
*ICSGenerator*
- Brief description of development capabilities and enhancements
*ValidatePDU*
- Next Steps
- Gather Feedback...
- Call for vendor/clinical engineers and WG members to review/use the NIST XSchema and *ICSGenerator*

## How the NIST Test Framework/Message Maker and ICSGenerator could contribute to the IHE/PCD Initiative...

- n

- 1073
- Standard
- (DIM)

- How the NIST Test Framework/*Message Maker* and *ICSGenerator* *could* contribute to the IHE/PCD Initiative...

- (XSLT)

***NIST***

*******HL7 v2.x Message Profile: **Captures and describes a set of HL7v2.x messages used to solve a Use Case.

***(Year 2+***** )**

***NIST IHE Test Framework***

- NIST XSchema

- 11073 Standard
- (DIM + Nomenclature)

**Notes:**
The IHE Technical Framework identifies the transactions and the standards that it references.
NIST could develop HL7v2.x test messages for an IHE (HL7v2.x) message profile that was based on a transaction that uses HL7 Messaging Standard v2.x or a transaction that uses 11073 medical device data that was mapped to HL7v2.x using the HL7v2.x ORI (gateway) specification. 

Year 2 and beyond:  The ICSGenerator could potentially generate a data set based on users/vendors/implementers selected conformance attributes.
The Testing Framework would be developed to enable test messages (produced from Message Maker) to be utilized as test cases/suites within the enterprise environment.

## ICSGenerator Inputs/Outputs

- IEEE 11073

- DIM

- Nomenclature

***ICSGenerator***

- Device Profile(Valid XML File)

- ICS

- XSchema File

*ICSGenerator* Inputs/Outputs

## DIM XSchema Status

- XSchema modifications:
- Added capability to associate values with data types
- Created DIM_Values.xsd library containing textual object information such as reference, object id, object name, etc.
- Reason:
- Facilitates access and manipulation of this type of information.
- Reduces size of DIM.xsd.
- Facilitates upgrades to DIM.xsd.
- Created separate schema library for DIM data types
- Reason:
- Facilitates access and manipulation of data types.
- Makes data types reusable by other application.
- Facilitates upgrades to DIM.xsd
- Reduces size of DIM.xsd
- Optimized XSchematron rules in DIM.xsd.
- Applied XML Schema best practices for optimization purposes in different areas of the DIM.xsd.
- Developing draft IEEE 11073 DIM XML Schema document
- Used IEEE 11073.1.1.2 aECG Nomenclature template as example.

## Conformance Test Tools(based on 11073 DIM Schema)

- Conformance Test Tools(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 HL7 V2.x profile file) to build the test messages*.]
**http://www.nist.gov/medicaldevices**

## 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.

## ICSGenerator Capabilities (cont.)

- 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.

## ICSGenerator Capabilities(cont.)

- 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.
- Code added to ICSGenerator that enables users to add/delete Composite MDS to the containment tree

## ICSGenerator Enhancements(since last WG meetings [Boca Raton, Sept 06])

- Interface upgrades
- Added menu bar to re-start application
- Added PDF report generation for ICS Tables.
- Added pop-up menu to MOC in JTree to manipulate the objects.
- Improved JTree collapsing behavior when manipulating the objects.
- Created an installer to automatically install *ICSGenerator*.

## ICSGenerator Work-in-Progress

- Value/Data type association
- Creating a DIM data type library
- Adding value input dialog
- Mapping observation values to HL7 OBX segments
- OBX-2, OBX-3, OBX-4, OBX-5, OBX-6 and OBX-7
- Updating *ICSGenerator* code to compile and run under Java 1.5
- Updating Users Guide to include latest *ICSGenerator* changes

## Conformance Test Tools (continued)(based on 11073 DIM Schema)

- 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 11073 syntax/structure/semantic testing
**http://www.nist.gov/medicaldevices**

## Next Steps

- NIST 11073 DIM XSchema
- Document IEEE 11073 Normative Standard
- PAR approved 9/15/06?
- Project Plan under development
- Maintenance issue of electronic file (versus paper documentation) in Standard
- ICSGenerator
- Add Remaining Transport Profiles
- Continue Enhancing Interface and Usability; Documentation
- Work w/ IHE PCD Team and Medical Device Vendors
- Unit of Measurement (e.g., convert IEEE units of measurement to UCUM, if adopted)
- Mapping IEEE x73-10101 (Nomenclature) ‘Unit Codes’ to Reference Identifiers
- Look into issue of Unit Attribution Semantics (long range)

## Next Steps                     (continued...)

- IHE PCD Test Case Development (Year 2)
- Support HL7 Profile Development (using MWB and Message Maker)
- Output test messages
- Obtain data values
- To be used w/ Message Maker test generation
- Research potential link of IEEE X73-basedICS files (XML) into MWB and Message Maker

## Call for Help...

- IEEE X73/IHE WGs, Vendors/Clinical Engineers
- Validate NIST XSchema
- Install and evaluate *ICSGenerator*
- Provide feedback on utility and functionality
- Recommendations for enhancements
*NIST* Contacts: John Garguilo (_[john.garguilo@nist.gov](mailto:john.garguilo@nist.gov)__)__Sandra Martinez (__[sandra.martinez@nist.gov](mailto:sandra.martinez@nist.gov)__)__Richard Rivello (richard.rivello@nist.gov)_