Software and Systems Division

HL7/Healthcare Devices WG

(Orlando, Florida)

NIST Tooling Activities 

John Garguilo and Sandra Martinez

16-19 May, 2011
Software and Systems Division

HL7/x73 and IHE-PCD Testing

IHE-PCD Testing – Key Objectives

• Increase test comprehensiveness & quality 

• Support both conformance & interoperability testing

• Support for pre- & virtual- connectathons, actual connectathon & 

enable year round testing

• Remain in alignment with IHE-PCD integration profile 

development road map and underlying standards (e.g. HL7,x73)

• Establish single framework for PCD covering increasing 

complexity and technologies over next 5 years

• Coordinate with IHE “Gazelle Project” and NIST’s HIT Test 

Infrastructure

• Generate work products that companies can use in their 

regulatory submissions or help in product evaluation
Software and Systems Division

HL7 / Healthcare Devices WG

(Orlando, Florida)

NIST Tooling: HL7 V2.6 Test Tool

For Cycle 6 (2011-12) 

17 May, 2011

3
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

• Pre-Connectathon

Coming in August...

• Connectathon Web site:

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

• 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)

– ISO/IEEE 11073 device specialization/profile builder

 Private Term implementation considerations being added to tool

• What’s still needed

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

– Web Services
Software and Systems Division

HL7 v2 Transaction Validation Process

• HL7 v2 Syntax Validation

– Ensure the message structure is valid with respect to the HL7 v2 

message definition and the HL7 v2 conformance profile

– Ensure that the conformance requirements such as usage, cardinality, 

data type usage, etc. are valid with respect to the standard and the HL7 

v2 conformance profile that constrains the message, in accordance with 

the IHE technical framework for a given transaction

• Value Set Semantic Validation

– Ensure that elements that refer to a table are valid with respect to the 

value set it references. The value set is given by the HL7 v2 standard or 

as constrained by the IHE technical framework. An example includes 

confirming that the administrative sex element (PID.8) of the PID 

segment contains a value that is given in the HL7 v2 Administrative Sex 

table (HL70001).

– Identify conformance violations of constraints implied by the IHE 

Integration Profile. These constraints are captured in a validation context 

file. An example of such a test includes an element that is fixed in the 

IHE integration profile (e.g., RCP.1 = I).

• Terminology (and associated co-constraints) Semantic 

Validation (see RTM)

• Test Case Specific Validation

– Verify element content against a validation context file that captures test 

values as defined in the Pre-Connectathon test cases. 

• NEXT: HL7 v2 MLLP Validation

– Ensure the message is valid with respect to the HL7 v2 MLLP 

specification for wrapping and unwrapping HL7 v2 messages. This is an 

implied test.
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 DOC and DOR Test Agents
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

IHE-PCD Face-to-Face

(Boca Raton, Florida)

“Rosetta Terminology Mapping

Management System”

(RTMMS) 

12 May, 2011

33
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 P. Barclay(Guest Researcher)

Project Web site: 

www.nist.gov/medicaldevices

Semantic Interoperability of Medical Devices
Software and Systems Division

Discussion Topics 

• Rosetta Terminology Mapping (RTM) 

Overview

• Rosetta Terminology Mapping Management 

System (RTMMS) Overview 

• RTMMS DEMO

• Issues

– IEEE copyright issues

• Against NIST Policy to maintain proprietary data 

– Integration of LOINC Terms

• We have no documentation on LOINC.

• Mapping must be provided

– PHD added new refIds under x73 Alert partition. The 

term codes assigned to these events are not in 

within the range specified in the alert block
Software and Systems Division

IHE PCD Profile: RTM Overview

• RTM is an IHE PCD Profile that addresses the 

problem of medical device semantic interoperability 

by proposing a mapping to a standard 

nomenclature.

– Identifies the core set of semantics appropriate for 

medical devices

– Maps vendors terminology to standard terminology

– Maps numeric parameters to their associated units-ofmeasure and enumerated values

• ftp://ftp.ihe.net/Patient_Care_Devices/TechnicalFra

meworkforTrialImplementation/IHE_PCD_TF_Suppl

ement_Rosetta_Terminology_Mapping_RTM_TI_20

08-08-22.pdf
Software and Systems Division

• Rosetta Table

– Maps vendor supported observations, units and 

enumerations to ISO/IEEE x73 nomenclature

• Units Table

– Defines allowed units-of-measure

– Defines groups of related units-of-measure

• Enumerations Table

– Defines groups of enumerated values

• hRTM Table

– Generated from the original Rosetta 

RTMMS Tables
Software and Systems Division

RTMMS Overview

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/Appendix. 

• 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
Software and Systems Division

• General user

– Views Rosetta Tables

• Reviewer

– Participates in discussions

• Vendor

– Modifies Vendor Rosetta Table

– Suggests new terms

• SDO (Standard Development Organization)

– Modifies Units and Enumerations Table

– Register new terms

• Admin

– Manages User Accounts

• Potential IEEE-Member User 

RTMMS Users
Software and Systems Division

RTMMS Features

• 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

• hRTM, units and enumeration download in XML format

• User registration

– Email confirmation, approval...

• Filtering based on regular expressions

• Rosetta validation against hRTM

• Management capabilities for SDO users
Software and Systems Division

• Integrated PHD nomenclature into the IEEE 11073-10101 NIST 

Nomenclature database 

– Provided by UL Chair (Jan W.) in January 2011 F2F.

– PHD nomenclature includes; terms under new PHD partitions, terms 

already in the nomenclature and new terms under existing x73 

nomenclature partitions.

• New terms under PHD partitions were added to the IEEE 11073-10101 

Nomenclature dbase:

– MDC_PART_PHD_AI (aging independently )

– MDC_PART_PHD_DM (disease management)

– MDC_PART_PHD_HF (health and fitness)

• Terms already in the existing X73 nomenclature partitions

– Association done using the block and partition id 

• New terms (PHD) under existing X73 nomenclature partitions.

– These terms are not captured yet we need some clarifications.

– No association between specialization and terms – RTM dbase and X73 

dbase does not handle these associations. 

RTMMS Updates 

(since last F2F in January)
Software and Systems Division

• Integrated PHD nomenclature into the IEEE 11073 Nomenclature 

database (Cont.)

– Need clarification:

• PHD added new refIds under x73 Alert partition. The term codes assigned to these 

events are not in within the range specified in the alert block :

MDC_PART_EVT MDC_EVT_PEF_MED 21106

RTMMS Updates 

(since last F2F in January)
Software and Systems Division

Ongoing Work

• Implementing Backup cycle

• Developing XML2DB Module

– Adding Import XML Rosetta Data feature

• Implementing synonym terms

– Support synonyms in Nomenclature Database

– Support synonyms in RTM Database

• Adding new data to hRTM table

– Support Vendor_VMD, and Vendor Description in hRTM
Software and Systems Division

Next Steps

• Update RTMMS database access/update 

mechanism.

• Add aECG into X73 Nomenclature Dbase.

• Edit hRTM Table

– Add new entry

– Edit an entry

– Deprecate an entry 

– Support multiple versions

– Ability to set current version to use for validation

• Implement versioning system

• Add logging history capabilities

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

who made them...
Software and Systems Division

Issues

• IEEE copyright issues

– Against NIST Policy to maintain proprietary data 

• Integration of LOINC Terms

– We have no documentation on LOINC.

– Mapping must be provided. 
Software and Systems Division

IHE-PCD Face-to-Face

(Boca Raton, Florida)

“ICSGenerator”

(Implementation Conformance Generator) 

12 May, 2011

66
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

• Working on the following enhancements:

– Update ICSGenerator to have access to the latest X73 

Nomenclature dbase version (containing IDC, PHD and 

Appendix B.)

– Support PHD standards

• Update specializations with published versions

– Private Terms support

ICSGenerator Next Steps 
Software and Systems Division

PTB

RTMMS

(Harmonization Tool)

ICSGenerator

Rosetta

Units

Enum

hRTM

RTMdb

<MDC>

MDCP

PTdb

X73db <MDC>

<MDCX>

<MDCP>

<MDCP*>

Private Term Support (Private Term Builder)
Software and Systems Division

Private Term Builder Status

– Developed an initial “Private Term Builder” application 

(PTB) with the following goals:

• Capture vendor private terms

• Associate a private term to an x73 object – facilitating integration 

to the modeling tool (ICSGenerator)

– Initial PTB application includes the following features:

• Imbedded database for private term storage.

• Import/export capabilities in RTM xml formats.

• Ability to enter vendor ref ids – not in compliance with x73 

nomenclature

• Ability to enter vendor term code – if available, nothing to do with 

x73 private space.

• Ability to enter a common name (display name) – vendor name

• Ability to enter a description for the term

Note: This is a private vendor application, vendor chooses to share 

terms for harmonization.
Software and Systems Division

Private Term Builder Status