NIST

Medical Device Communication Testing

Semantic interoperability of Medical Devices

HIT Test Tool Update 

Joint HL7/IEEE 11073 Healthcare Devices Working Group

National Institute of Standards and Technology

11 September, 2012 – Baltimore, Maryland

Contact: john.garguilo@nist.gov, 301-975-5248
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NIST MDC Testing Staff 

• John J. Garguilo

301-975-5248

john.garguilo@nist.gov

• Sandra Martinez 

301-975-3579

sandra.martinez@nist.gov

• Julien Deshayes (Guest Researcher) – HL7 V2 Tools

• Nicolas Crouzier(GR) - RTMMS

• Jing Gao (GR) - ICSGenerator

Semantic Interoperability of Medical Devices

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Content Topics 

• HL7 V2 (2.6) IHE-PCD Validation Tools

– Cycle 7 – 2012-13; Fall Pre-Connectathon, Virtual Testing, 

January/February 2013 Connectathon, HIMSS13

• Rosetta Terminology Mapping Management System 

(RTMMS) Overview 

– RTMMS Deployment Update and service status

• User Membership Protocol / pending IEEE decision

• ICSGenerator

– Implementation Conformance Statement Generator

– Device Profile/Specialization

• ISO/IEEE 11073 ‘Domain Information Model Editor’

– UML Defined x73 DIM

– Provides DIM Objects

– Art Griesser + Jun Ho Shin (“Shin”) [see presentation]

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NIST MDC Testing Project 

Web Sites 

• Project Web site: www.nist.gov/medicaldevices

• NIST HL7 V2 Test Tooling Web sites:

IHE-PCD Pre-Connectathon:

http://hit-testing.nist.gov:13100/PCD-HL7WebPreCon/

 IHE-PCD Connectathon: 

http://hit-testing.nist.gov:13100/PCD-HL7WebCon/

• NIST Medical Device Terminology Service:

 Rosetta Terminology Mapping Management System (RTMMS): 

http://hit-testing.nist.gov:13110/rtmms/

• NIST Implementation Conformance Statement 

Generator (ICSGenerator):

– http://hit-testing.nist.gov/medicaldevices/ICSGenerator/ics_download.html

Semantic Interoperability of Medical Devices

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IHE-PCD 2012 Pre-Connectathon + Connectathon 

 NIST Testing Support 

The NIST V2 (2.6) Tools perform the following validation:

• Syntax and Semantic Content Validation

– Against IHE-PCD Technical Frameworks/Supplements (e.g., 

PCD-01, Communicate Device Data)

– Against HL7 conformance profile

– Against HL7 and/or user [local] provided tables

• Example of user provided table is RTM for Ref_IDs, Units, etc.

– Against ‘validation context’, including specific values

• Defined in XML (e.g., specific test case values)
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Testing Environments 

• Instance Testing

– Conformance (e.g., against HL7 2.x or CDA)

• Test object conforms to specification on which it is based

• IHE Model: ~Virtual and Pre-Connectathon 

• NIST IHE-PCD v2 Message Validation Test Tool

• Isolated System Testing

– Includes Instance Testing Activities

– Protocol Conformance 

– Functional Behavior Conformance

• Features and operational behavior correspond to specifications

• IHE Model: ~Virtual and Pre-Connectathon

• NIST IHE-PCD v2 Test Tool

• Peer-to-Peer System Testing

– Includes Isolated System Testing Activities

– Interoperability Testing

• Testing complete application environment 

• May include interacting with Database, using Network Communications, or interacting with 

other hardware, applications, or systems if appropriate

• IHE Model: ~Connectathon
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NIST V2 HL7 IHE-PCD Test Tool: Operational Process 

END-USER

(VENDOR)

SYSTEM UNDER TEST 

(SUT)

NIST IHE-PCD 

HL7 v2/v3 TEST TOOL

SPECIFICATIONS

(test material that defines test assertions)

INTERACTION/REPORTS

MESSAGES (TEST OBJECTS)

MANUAL OR AUTOMATED SUT

Web Application 

Interface

(via the communication protocol

currently only MLLP)

V3 – Future Work

STIMULUS OR RESPONSE (MESSAGES)
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IHE-PCD Pre-Connectathon ‘Isolated Environment’ Tool

http://hit-testing.nist.gov:13100/PCD-HL7WebPreCon/
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IHE-PCD Connectathon ‘Instance Environment’ Tool

http://hit-testing.nist.gov:13100/PCD-HL7WebCon/
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NIST Pre-Connectathon + Connectathon: 

Test Case Updates Cycle 7 
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RTMMS: Update 
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RTMSS - Deployment Status 

• RTMMS went live on May 1, 2012. 

• http://hit-testing.nist.gov:13110/rtmms/

• Beta-Test version was available from mid January – April 2012 

– any data/change was not committed (i.e., discarded)

• Beta version of RTMMS was available for ~2 months to a select 

few (~15) individuals of varying roles (e.g., vendor, SDO, Admin)

– NIST received feedback on functionality, capability, usability, and 

interface and subsequently updated the on-line RTMMS 

• NIST continues to work out IEEE membership issues w/ IEEE

– Full presentation and proposal made to IEEE by NIST in Dec 2011

– Presentation and Q&A session with IEEE ‘systems people’ 

– Kathryn Bennett (IEEE) indicated IEEE-SA Senior Management agreed to 

RTMMS DIM + Nomenclature freely available  (June 2012)

– IEEE formal announcement pending – likely final approval soon! (Sept 2012)
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RTMSS - Deployment Plan – Going Forward 

• RTMMS becomes the “master” version going forward

• [Today] RTMMS is now available to various user types and 

domain groups (e.g., IHE-PCD members) and select others (but 

only if IEEE members) 

– If interested in obtaining an RTMMS system id and password

• Go to Web Applications (URL below) and request and account 

• http://hit-testing.nist.gov:13110/rtmms/

– NIST will perform the appropriate background checks

• Typically same day turn-around

• If/Once approved (vetted with IEEE) - NIST will provide a corresponding 

email with approved account information.
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RTMMS Overview 

• A web application* that allows vendors and reviewers access, 

retrieval, and reporting of Rosetta Tables over the internet in 

conformance to IHE-PCD RTM Profile

• An electronic resource/tool providing the capability of saving 

data in xml format (as defined by RTM Profile)

• Aids the harmonization process by:

– Identifying missing terms

– Automatic generation of the “Harmonized Rosetta Table”

– Providing latest up-to-date view of hRTM table

• Facilitates the proposal of New Terms to IEEE 11073 

Nomenclature standard

• Facilitates Conformance Tooling

– Message verification and conformance (syntax and semantics)

– Leading to interoperability...

– *developed by and currently hosted at NIST

– Integrated with ICSGenerator Tool (hRTM also imported into DIM Editor)

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Rosetta Terminology Mapping Data Base

• 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 

X73 Nomenclature DB

Security DB - Stores users information

RTMMS Key Tables 
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• Access to NIST IEEE 11073 Nomenclature database

– Appendix A terms (from ISO/IEEE 11073 10101: Nomenclature)

– Appendix B terms (from ISO/IEEE 11073 10101: Nomenclature)

– IDCO terms (ISO/IEEE 11073-10301 – implantable device cardiac)

– aECG (annotated Electrocardiography)

– PHD terms (personal health domain)

• Access to RTM database

• Ability to propose terms in Rosetta

• hRTM, units, and enumeration download-able in XML format

• User registration

– Email confirmation, approval process... controlled through ‘admin’

• Filtering based on regular expressions

• Rosetta validation against hRTM

• Management capabilities for SDO users

 Integrated w/ ICSGenerator

RTMMS Features 
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• General user

– Views Rosetta Tables

• Reviewer

– Participates in discussions

• Vendor (includes Organizations)

– Vendor ‘sandbox’

– Modifies Vendor Rosetta Table

– Suggests new terms

– Modifies Units and Enumerations Table

• SDO (Standard Development Organization)

– Modifies Units and Enumerations Table

– Register new terms

• Admin

– Manages User Accounts

RTMMS Users 
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Issues / Key Work Items 

• Synching membership from IEEE to NIST (issue may go away 

in June)

• IEEE copyright issues

– Against NIST Policy to maintain proprietary data or public displaying of 

copyrighted information...

• Long-term – who owns and maintains RTMMS

• Maintenance issues...

• Hosting/Server issues...

• Access control issues...

• Integration of SNOMED-CT Terms

– Expertise needed – mappings provide equivalence between SNOMED 

CT/x73 (e.g., Norman Jones IHTSDO)

• Integration of LOINC Terms

– Mapping must be provided by exerts (e.g., Clem McDonald – NLM) 
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RTMMS Updates 

• Updates and focus on Rosetta term after search (results)

• Allow user to download only the current terms / Clearer label 

for download buttons 

• New/better format for xml download

• Better icons for enumeration group/ unit groups

• Focus on edited term after edit or new comment 

• Vendors can create group in group panel

• Allow group sorting 

• Duplicate Rosetta term button

• Use of views for "quick" SQL queries

• Add project on Hudson server (eliminates NIST firewall 

issues)

• Major code cleanup / doc
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RTMMS Updates (Continued) 

• From Last Time (May 2012, Vancouver WG Mtgs.)

• Vendors can now propose units and enumerations

• Fixed interface glitches found during testing period

• Rosetta terms can now have multiple groups 

• Mouse-over help on table headers 

• Improved PDF reports for x73

• Wrapped text in x73 tables

• Global search in x73 tab

• SDOs can now create/propose a Rosetta term

• Improved new account request process

• RTMMS is now compatible with IE7, although it works best 

with Firefox, Chrome or Safari

• Updated user’s guide
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RTMMS Functionality Demo 

• Viewing the RTM Tables (all user types)

• Mapping X73 and UCUM units (SDO)

• Mapping a Term (Vendor and SDO)

• Proposing new terms (Vendor and SDO)

• Term Review (SDO, Vendors and Reviewers)

• Term approval (SDO)

http://www.youtube.com/watch?v=rP_Tsb6wlF8&hd=1
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ICSGenerator Overview 

• Model Devices in compliance with the X73 DIM, capturing;

– object relationship (containment)

– object attributes, behavior and notifications

– Objects and parameters term codes from hRTM and X73 Nomenclature

– Device profile generated in XML in compliance to the DIM schema

• Generates Implementation Conformance Statements (device supported 

features) in a tabular and XML format.

– General ICS

– Service Support ICS

– Transport ICS 

– DIM MOC ICS

– MOC Attribute ICS

– MOC Behavior ICS

– MOC Notification ICS

• Uses an embedded DIM database originated from the DIM Schema

• Provides access to IEEE 11073 nomenclature, hRTM and Rosetta 

(proposed terms)

• Generates a PDF file that includes only object containment and 

parameters.

• Generates simplified version of the device profile (xml)
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ICSGenerator Status 

• In this year, we have been challenged by three major 

problems,

– Data Synchronization

– Quick Delivery

– Private Owned Terms

• Several improvements and new functionality (focus areas):

– New Model for ICSGenerator

– More outputs (Device Profiles [DP] in XML, and device reports in PDF file)

– Integration of Rosetta proposed terms and associated Unit/Enumeration

– Web based API including terminology search engine

– DP database

– Object level and term level cardinality

– Misc (security, UML diagram, cache, UI, OBX)
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ICSGenerator Status 

• From Last Time/WG Mtgs (Vancouver)

• Object cardinality support

• Access to RTMMS Rosetta “proposed terms” including units 

and enumerations

– Connecting to NIST RTMMS web service

• Automatic generation of device profile in PDF format

• “compound numeric” support

• Dbase lookup (X73 nomenclature, DIM and hRTM)

• In the process of developing a web application
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PCD-01 Infusion Pump - Vol2 (Annex D) 

Access to 

MDDbase(x73

, hRTM and 

Rosetta)
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ICSGenerator XML Profile content 

 

ICSGenerator XML PCD-01 Infusion Pump 

Profile

• The ICSGenerator profile 

contains: 

– All the objects involved

– object attributes

– Behavior and Notifications

– Object term codes

– Containment

– Units and enumerations
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PDF generated from the Infusion Pump Device profile 
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MD Semantic Dbase “Look-up” 
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Physiological Monitor – “Compound Numeric” 

“MDC_DIM_C

M_H2O “, unit 

used in Vol3 is 

not in hRTM
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ICSGenerator and IHE-PCD V&V testing artifacts

 

ICSGenerator

IHE-PCD 

HL7 V2 Testing

Includes co-constraints

(units & enum. values)

(PCD TF- Vol. III)

Semantic 

Content

MDS_OBX_Encoded

_Dev_Profile.xml

X73_Device_

Profile.xml

Key: Transformation

RTMMS

X73 DIM Reload Project

X73

(public terms)

hRTM

(approved terms)

Rosetta

(Proposed terms)

Semantic dB

•X73_Device_Profile.xml

 Main testing artifact, this file will be transformed to an HL7 OBX encoded file. ICSGenerator OBX encoded X73 device profile,

MDS_OBX_Encoded_Device_Profile.xml includes:

OBX-2(data types)  could develop for partial data type testing

OBX-3 (OBX-3.1= <term code> ,OBX-3.2= <refid> and OBX-3.3=“MDC”)

OBX-4 (containment), dotted notation

OBX-5 (enumeration values) – ICSGenerator access to hRTM

OBX-6(units) – ICSGenerator access to hRTM

OBX-7(value range) if provided

Cardinality at object level ??? 

Attribute, behavior and notification information could also be added as a mapping to OBX segment is defined.
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Thank YOU! For your attention 

• DIM Work w/ Art and Shin...(reference associated slide set)

• Discussion?