Software and Systems Division

HL7/Healthcare Devices WG

(San Diego, California)

NIST Tooling Activities 

John Garguilo and Sandra Martinez

11-16 September, 2011
Software and Systems Division

Our Team and Project Web Sites...

Contacts

• John Garguilo (john.garguilo@nist.gov)

• Sandra Martinez (sandra.martinez@nist.gov) 

Tools and Project Sites

NIST’s IHE-PCD HL7 V2

• Static ‘Instance Testing’

Pre-/Connectathon Web site:

http://xreg2.nist.gov:8080/PCD-HL7WebCon/

• Pre-Connectathon Cycle 6 (2011-12)

 ‘Isolated Testing’ Coming in October...

(URL coming soon...)

MDC Testing Web site: www.nist.gov/medicaldevices
Software and Systems Division

NIST Supported Test Tools

Overview/Status Update

• HL7 V2 Validation (IHE-PCD)

– Instance-type Environment (at message level)

– http://xreg2.nist.gov:8080/PCD-HL7WebCon/

– http://hit-testing.nist.gov:8080/HL7Web/

• Cycle 6 (2011-12)

– Isolated-type Environment 

– Scenario based

– Actor centric

– One System Under Test (SUT)

• RTMMS – Rosetta Terminology Mapping Management System

– No version available to public – yet...

• ICSGenerator (ICS = Implementation Conformance Statement)

• Next Steps and What’s still needed...

– Envelope/Message wrappers (WS, SOAP, SAML?) validation

– Web Services
Software and Systems Division

HL7 / Healthcare Devices WG

(San Diego, California)

NIST Tooling: HL7 V2.6 Test Tool

For Cycle 6 (2011-12) 

13 September, 2011

4
Software and Systems Division

Test Environments

• Instance Testing

– Conformance (e.g., against HL7 V2.x or CDA)

• Implementation conforms to Spec. on which it is based

• Isolated System Testing

– Includes Instance Testing Activities

– Protocol Conformance 

– Functional Behavior Conformance

• Features and Operational behavior correspond to Specs.

• Peer-to-Peer System Testing

– Includes Isolated System Testing Activities

– Interoperability Testing

• Testing complete application environment 

• May include interacting w/ Database, using Network 

Communications, or interacting w/ other hardware, apps, 

or systems if appropriate

NIST HIT Test Infrastructure
Software and Systems Division

Conformance Testing of an HL7 V2 Message

Report

Test Artifacts

• Conformance Profile

• HL7 Tables

• ‘Device’ Test Agents

• ISO/IEEE 11073/Rosetta 

Terminology

HL7 V2

Message

Validation

Services Test Management

HL7 V2 

Message

Validation 

Test Case

Results

HL7 V2 

Message

Validation 

Report

Test Harness

(Java Code)

Test 

Execution

User

Web 

Application

Client

HL7 V2 

Message

Registry/

Repository

Instance System Test Environment
Software and Systems Division

IHE-PCD Pre- and -Connectathon Tool

http://xreg2.nist.gov:8080/PCD-HL7WebCon/
Software and Systems Division

Validation Report (Example)
Software and Systems Division

Test Environments

• Instance Testing

– Conformance (e.g., against HL7 V2.x or CDA)

• Implementation conforms to Spec. on which it is based

• Isolated System Testing

– Includes Instance Testing Activities

– Protocol Conformance 

– Functional Behavior Conformance

• Features and Operational behavior correspond to Specs.

• Peer-to-Peer System Testing

– Includes Isolated System Testing Activities

– Interoperability Testing

• Testing complete application environment 

• May include interacting w/ Database, using Network 

Communications, or interacting w/ other hardware, apps, 

or systems if appropriate

NIST HIT Test Infrastructure
Software and Systems Division

IHE-PCD Testing using a Web Application Client

Report

IHE-PCD

DOR/DOF

Test Agent

HL7 V2

Message

Generation

IHE-PCD

DOC

Test Agent

HL7 V2

Message

Validation

Services

Test Management

Router/Logger/Proxy

Vendor

System Under Test

Test Artifacts

•Conformance Profiles

•HL7 Tables

•Validation Context Files

•Generation Context Files

IHE-PCD Client

Test Scenario

Results

HL7 V2 Message 

Validation 

Reports

Test Harness

(Java Code)

Test Execution

Web 

Application

Client

IHE-PCD

IOR

Test Agent

IHE-PCD

AM

Test Agent

IHE-PCD

IOC

Test Agent

IHE-PCD

AR

Test Agent

IHE-PCD

IDCC

Test Agent

IHE-PCD

IDCR

Test Agent

Isolated System Test Environment
Software and Systems Division

Isolated / Scenario Testing

• Demonstration of a ‘user’ or System Under Test 

(SUT) [acting as a device observation reporter –

DOR] interacting with the NIST Test System [acting 

as a device observation consumer – DOC] ‘Test 

Agent’
Software and Systems Division

IHE-PCD HL7 V2 Isolated Test Tool
Software and Systems Division

IHE-PCD HL7 V2 Isolated Test Tool

Select Version and Actor
Software and Systems Division

IHE-PCD HL7 V2 Isolated Test Tool

DOR – select test case
Software and Systems Division

IHE-PCD HL7 V2 Isolated Test Tool

Test Case and Step Descriptions
Software and Systems Division

IHE-PCD HL7 V2 Isolated Test Tool

Configuration
Software and Systems Division

IHE-PCD HL7 V2 Isolated Test Tool

Waiting for DOR/SUT...
Software and Systems Division

IHE-PCD HL7 V2 Isolated Test Tool

Parse ORU^R01; Send ACK^R01
Software and Systems Division

IHE-PCD HL7 V2 Isolated Test Tool

Transaction Processing, with result
Software and Systems Division

IHE-PCD HL7 V2 Isolated Test Tool

Test Result Summary
Software and Systems Division

IHE-PCD HL7 V2 Isolated Test Tool

Validation Report
Software and Systems Division

IHE-PCD HL7 V2 Isolated Test Tool

Validation Report, Continued
Software and Systems Division

IHE-PCD HL7 V2 Isolated Test Tool

Submit Report (to Test Management)
Software and Systems Division

IHE-PCD HL7 V2 Isolated Test Tool

Test Management – Vendor Summary
Software and Systems Division

IHE-PCD HL7 V2 Isolated Test Tool

Test Management – Vendor Dashboard
Software and Systems Division

IHE-PCD HL7 V2 Isolated Test Tool

Validation Report
Software and Systems Division

IHE-PCD HL7 V2 Isolated Test Tool

Validation Report, Cont
Software and Systems Division

HL7/Healthcare Devices WG

(San Diego, California)

“Rosetta Terminology Mapping 

Management System”

(RTMMS) 

Activities 

John Garguilo and Sandra Martinez

11-16 September, 2011
Software and Systems Division

NIST Contacts

• John J. Garguilo

301-975-4248

john.garguilo@nist.gov

• Sandra Martinez

301-975-3579

sandra.martinez@nist.gov

• Isabelle Barclay (Guest Researcher) – term ends 

this month

• Nicolas Crouzier (Guest Researcher)

Project Web site: 

www.nist.gov/medicaldevices

Semantic Interoperability of Medical Devices
Software and Systems Division

• RTMMS was developed to support the IHE-PCD 

Rosetta Terminology Mapping (RTM) :

– A web application that allows vendors and reviewers:

• access, retrieval, and reporting of Rosetta Tables over 

the internet in conformance to IHE RTM Profile.

• saving the data in the xml format as defined by RTM 

Profile. 

– Aids in The harmonization process by:

• Identifying missing terms. 

• Automatic generation of the “Harmonized Rosetta 

Table”

• Viewing and downloading latest hRTM table.

– Facilitates the proposal of New Terms to x73 

Nomenclature

RTMMS Overview
Software and Systems Division

• Models RTM data and relationships

• Stores RTM data

– Rosetta table

– Units and Unit Groups

– Enumerations and Enumeration Groups

– hRTM table

• Uses IEEE 11073 Nomenclature database

– REFIDs

– Term codes

– Partition numbers

Database
Software and Systems Division

• General user

– Views Rosetta Tables

• Reviewer

– Participates in discussions

• Vendor

– Modifies Vendor Rosetta Table

– Suggests new or mapped terms

• SDO (Standard Development Organization)

– Modifies Units and Enumerations Table

– Register new or mapped terms

• Admin

– Manages User Accounts

• Potential IEEE-Member User ??

RTMMS Users
Software and Systems Division

• Access to NIST IEEE 11073 Nomenclature database 

– Appendix A terms

– Appendix B terms

– IDCO terms

– PHD terms

• Access to RTM database

• Ability to proposed terms in Rosetta

• Download in XML format hRTM, units and enumerations 

tables

• User registration

– Email confirmation, approval...

• Filtering based on regular expressions

• Rosetta validation against hRTM

• Management capabilities for SDO users

RTMMS Features
Software and Systems Division

RTMMS Updates (since May 2011)

• Database management capabilities implemented.

• Versioning system implemented.

– Possibility for the SDO to view previous Rosetta versions.

• Logging history capabilities implemented.

– To identify occurred changes, time they were made, users who 

made them...

• New menu on top of login screen for the user guide

• Differentiation between mapped terms and new terms

• Access to Vendor, Groups and Rules tables.

• Harmonized Rosetta is now generated in real time from 

Rosetta table

• Import directly Paul’s XML files
Software and Systems Division

Ongoing Work

• RTM database re-structuring to facilitate management.

• Implementing synonym terms

– Support synonyms in Nomenclature Database

– Support synonyms in RTM Database

• SNOMED interface.

• Resolved bugs identified in functionality testing exercise.

– Add unit filtering

– Improve registration e-mail content

– Allow to add units or enumeration, not both at the same time.
Software and Systems Division

Next Steps

• Add aECG into X73 Nomenclature Dbase. 

• hRTM table updates

– Support Vendor_VMD, and Vendor Description

• Populate X73 Nomenclature dbase systematic name, common term, 

acronym and term description tables. 

– Waiting for electronic files, if available. 

• SDO ability to set Rosetta versions. 
Software and Systems Division

Issues

• IEEE copyright issues

-Displaying of copyrighted information...

-Maintenance issues...

-Hosting/Server issues...

-Access control issues...

• Integration of LOINC Terms

– We have no documentation on LOINC.

– Mapping must be provided.

• Waiting for SNOMED mapped terms.

• Clarification of new/private terms adoption process 
Software and Systems Division

All users capabilities:

• View/Download Rosetta Table

• View/Download Units Table

• View/Download Enumerations Table

• View logging history

• Filter Rosetta Table

– By Vendor ID (Philips)

– Using Regular Expressions (MDCX_.*)

– Viewing Discussed Entries

RTMMS Scenario and DEMO
Software and Systems Division

Rosetta Table
Software and Systems Division

Units Table
Software and Systems Division

Enumeration Table
Software and Systems Division

Download Table in XML
Software and Systems Division

Logging history
Software and Systems Division

Filter Rosetta table

Filter Vendor_ID
Software and Systems Division

Filter Rosetta table

Filter Vendor_Discussion
Software and Systems Division

All users capabilities:

• Account management

• User Guide

RTMMS Scenario and DEMO
Software and Systems Division

Account Management
Software and Systems Division

User Guide
Software and Systems Division

RTMMS Scenario

‘Reviewer’ Type User Capabilities

• Contribute to Discussions

– Adding Comments
Software and Systems Division

Comment Dialog
Software and Systems Division

‘Vendor’ Type User Capabilities

• Add a new Rosetta entry

– REFIDs lookup from x73 Nomenclature

– Group lookup from RTM tables

– Units/Unit Groups and Enumerations/Enumeration Groups 

lookup from RTM tables

– Term codes completion from x73 Nomenclature

– Suggesting new terms to the standard

– Validating Required fields

• Edit a Rosetta entry

• Deprecate a Rosetta entry

RTMMS Scenario
Software and Systems Division

Rosetta : Philips vendor
Software and Systems Division

Edit Entry
Software and Systems Division

‘SDO’ Type User Capabilities

• Register a Proposed Term

– Assigning term code

– Automatically updating Vendor tables

RTMMS Scenario
Software and Systems Division

Register new terms
Software and Systems Division

‘Admin’ Type User Capabilities

• Save/Load/Delete selected database

• User management

• Import XML files provided by Paul Schluter

RTMMS Scenario
Software and Systems Division

Database Management
Software and Systems Division

User Management
Software and Systems Division

Import Rosetta XML files
Software and Systems Division

HL7/Healthcare Devices WG

(San Diego, California)

“ICSGenerator”

Tool Activities 

John Garguilo and Sandra Martinez

11-16 September, 2011
Software and Systems Division

NIST Contacts

• John J. Garguilo

301-975-4248

john.garguilo@nist.gov

• Sandra Martinez

301-975-3579

sandra.martinez@nist.gov

• Jing Gao (Guess Researcher)

Project Web site: 

www.nist.gov/medicaldevices

Semantic Interoperability of Medical Devices
Software and Systems Division

ICSGenerator Overview 

ICSGenerator was developed to:

• Support IEEE 11073 Conformance Testing.

– Generate Implementation Conformance Statements 

(ICSs) 

– Build Device Profile (XML) 

– Provide validation against DIM Schema

– Provide high level semantic interoperability

• Ensures correct containment relationship and terminology at 

the object class and related attribute, notification, and 

behavior level

• Provides access to Rosetta Dbase and X73 dbase
Software and Systems Division

• Access to latest hRTM version (3q 2011-05-07T10)

• Access to the latest X73 Nomenclature dbase version 

(containing IDC, PHD and Appendix B.)

• Private Terms support

– Capability to enter private objects using a “blank” object 

template.

– Capability to import private terms using a Rosetta-based xml file. 

• "File" menu  “import private terms” 

– Capability to access MDC-<vid> private terms from hRTM, if 

available.

– Capability to enter private attributes to a private object or to 

already defined objects.

(This is based on the x73 DIM allowance of extension (section 6.1.4) to 

the model that states: “In other cases, it may be necessary to define 

completely new objects or to add new attributes, new methods, or 

new events to already defined objects. These extensions are 

considered private or manufacturer-specific extensions”.)

ICSGenerator Enhancements 
Software and Systems Division

ICSGenerator Updates 

Capability to enter private objects using a “blank” object template
Software and Systems Division

ICSGenerator Updates 

Capability to enter private objects using a “blank” object template
Software and Systems Division

ICSGenerator Updates 

Capability to import private terms using a Rosetta-based xml file
Software and Systems Division

ICSGenerator Updates Capability to access private terms from hRTM.
Software and Systems Division

ICSGenerator Updates Capability to enter private attributes to a private object or to 

already defined objects.
Software and Systems Division

User Interface improvements:

• "Profile Overview" display 

– By clicking “DIM” on tree root, profile information is 

displayed on the right side panel.

• Dim Object changeable 

– By clicking on the DIM Object Name an object can be 

changed to a different object.

ICSGenerator Enhancements (Cont.) 
Software and Systems Division

• Support PHD standards

– Update specializations with published versions

• Access to MCD-<vid> private terms via hRTM, 

when available.

ICSGenerator Future Enhancements 
Software and Systems Division

Thank You!

• Questions

• Discussion