NIST

Medical Device Communication Testing

Semantic interoperability of Medical Devices

Test Tool Update

HL7 Healthcare Devices WG / IEEE x73 Upper Layers

John Garguilo

National Institute of Standards and Technology

24 September, 2013 – Cambridge, MA

Contact: john.garguilo@nist.gov, 301-975-5248
2

NIST MDC Testing Staff 

• John J. Garguilo

301-975-5248

john.garguilo@nist.gov

• Julien Deshayes (Guest Researcher) – HL7 V2 Tools

• Nicolas Crouzier(GR) – RTMMS, HL7 V2 Tools

• Jing Gao (GR) – ICSGenerator

• Art Griesser + Michael Faughn (Contractor -

Prometheus Computing, LLC ) – DIM Modeling

Staff Notes:

• Julien will be leaving NIST in Dec; 

• Jing will be shortly moving to new area (w/in NIST)

Semantic Interoperability of Medical Devices
3

Discussion Topics 

• HL7 V2 (2.6) IHE-PCD Validation Tools

– Enhancements

Cycle 8 – 2013-14; Fall/Winter Pre-Connectathon + Virtual Testing, 

January/February 2014 Connectathon, March 2013 HIMSS14

– IHE-PCD Pre-Connectathon, “Isolated Environment”

– IHE-PCD Connectathon, “Instance Environment”

• Rosetta Terminology Mapping Management System (RTMMS) 

Overview + Update 

– RTMMS Deployment Update and service status

• IEEE Agreement to make available the “Works” + latest numbers...

• ISO/IEEE 11073 ‘Domain Information Model Editor’ -> “MyDevice”

– Progress/Roadmap Updates (Art Griesser + Michael Faughn)

– UML Defined x73 DIM, Activity Diagram, Goals 

– Auto producing ISO/IEEE documentation (to meet SDO’s templates)

• IGAMT – Implementation Guide Authoring Management Tool

– Later this morning Q2 – to aid user in communizing development and use of IGs
4

 

ICSGenerator

IHE-PCD 

HL7 V2 Testing

•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 (enum values) – ICSGenerator access to hRTM

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

OBX-7(value range) if provided

Cardinality at object level ??? 

Attribute, behaviour and notification information could also be added if there is a mapping to OBX segment.

ICSGenerator and IHE-PCD V&V testing artifacts: Phase I

Includes co-constraints

(units & enum. values)

(PCD TF- Vol. III)

Semantic 

Content

MDS_OBX_Encoded

_Dev_Profile.xml

X73_Device RTMMS _Profile.xml

Reload Project X73 DIM

X73

(public terms)

hRTM

(approved terms)

Rosetta

(Proposed terms)

Semantic dB

DIM Editor

(under development)

Key: Transformation

Software/System File
5

By Hand

 

ICSGenerator

IHE-PCD 

HL7 V2 Testing

MyDevice and IHE-PCD V&V testing artifacts: Phase II

Includes co-constraints

(units, body sites & enum. values)

IHE-PCD TF

Vol. III Semantic Content

MDS_OBX_Encoded

_Dev_Profile.xml

X73_Device_ RTMMS Profile.xml

Reload Project

X73 DIM

(UML)

X73

(public terms)

hRTM

(approved terms)

Rosetta

(Proposed terms)

HL7

(Conf Profiles)

Semantic dB

DIM Editor +

(under development)

MyDevice IHE-PCDConformance

-Profile.xml

MWB

IGAMT

IHE-PCD TFs

Vol. I Integration Profiles

Vol. II Transactions

Health IT Test Infrastructure

Context Validaton

Registr

y/ 

Reposit

ory

Test

Data

Aggreg

ated

Validati

on

Proxy

Securit

y

Generat

ion

Loggin

g

Log

Analyze

r

Servi

ces

Time

Speciali

zed

Other

Service

s

Test Agent

Evaluation 

Agent

NIST TEST INFRASTRUCTURE 

SYSTEM

Test Harness Workflow 

Management 

/Execution Engine

Resource 

Repository

Templates, 

Common File 

Format 

Specifications

Test Cases, 

Machine-Readable 

Test Scripts

Test System 

Development 

Components

Test Case Creation

Test Initiation and 

Test Identification 

Management 

Configuration 

Settings 

Management

User Repository 

Management

 Certification 

Body

 NHIN

Other Industry

Consortia

Implementers

 HITSP

STAKEHOLD

ERS

 Vendors

Test Management Tools and Test Systems

Report

Test Environments 

Supported

Peer-to-Peer 

System Testing

Test Analyzer

System

(s) 

Under 

Test

SUT

Real-Time Monitor

Test FrameworkTest FrameworkTest Framework

Test System 

Instance

Instance Testing

Isolated System 

Testing

User Interface

Test System 

Control

Remot

e

Servic

es

Existing

Tool

External

Service

Specification 

(IG) Authoring 

Tools

Context Validaton

Key: Transformation

Software/System File
HL7 V2.6 Validation Tooling

IHE-PCD Pre-Connectathon Cycle 8

Semantic interoperability of Medical Devices

Test Tool Update

HL7 Healthcare Devices / IEEE WGs

National Institute of Standards and Technology

24 September, 2013 – Cambridge, MA

Contact: john.garguilo@nist.gov, 301-975-5248
7

2013-14 IHE-PCD 

Pre-Connectathon + Connectathon Status, Continued 

• Cycle 8 - Test Cases being reviewed with IHE-PCD 

Tuesday calls

• IHE-PCD F2F – week of October 7th in Boca Raton at 

Philips Healthcare

– Notable: Alarm Comm Mgmt  Alert Comm Mgmt

• CPs documented and submitted

• Roadmap of activities updated... see PCD wiki

• Revisions to TF Vols. I + II (PCD submitted, pending IHE 

approval), 

– Vol I: Revision 3, July 2013

– Vol II: Revision 3, August 2013
8

2012-13 IHE-PCD Pre-Connectathon Status 

• IHE-PCD: NIST “Isolated Environment” Test Tools required

– HL7 V2.6

– Supports 6 Integration Profiles (number of test cases)

• DEC – Device Enterprise Communication (9)

– SPD – Filter (4)

– POI – Pulse Ox (3)

• PIV – Patient Infusion Verification (7)

• IPEC – Infusion Pump Event Communication (6)

• IDCO – Implantable Device Cardiac Observation (4)

• ACM – Alarm Communication Management (1)

• RDQ – Retrospective Data Query (1)

• OMS, RTLS/CMS white papers/WGs

• 30+ Test Cases

• 60+ existing User Accounts 

– Contributing Orgs, SDO (leads/Co-chairs), Reviewers

– In total since tool made publically available (2011)
9

IHE-PCD 2013/14 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)
10

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
11

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)
12

HL7 V2 Tool Updates (continued) 

• Test event results now stored and selectable

– Maintain (test management) data from test events

– E.g., 2012, 2013, etc.

– Not a live site (yet!) – updated release in Oct 2013

• Profile Viewer (shows message structure attributes)

• Resource Management Capability Added

• Test Case Scenario Viewer (Sequence Diagrams)

• New Directions (tool component research/work)

– Constrains definition and generation methodologies and utilities
13

HL7 V2 Tool Updates (post cycle 7 test events) 

• Documentation Tab (see coming slides)

– Conformance Profile Tab

– Patient Demographics

– IDCO Patient Demographics

– PIV Drugs

– Other Resources

– Looking into capability to upload libraries + demographics (future) 

– incorporated [automatically] into validation context files used by 

tooling
14

New Tool Updates: Test Event Selection 
15

New tool updates – Profile Viewer 
16

New tool updates - Resource Management 
17

New tool Updates - Resource 
18

New tool Updates – Test Case Viewer 
19

HL7 V2 Tool Updates (post cycle 7 test events) 

• Current Version / Release Notes

– Needs to be added – to be added soon...

– Example shown from MU Lab Reporting Interface Tool
20

HL7 V2 Tool Updates (post cycle 7 test events) 

• Documentation Tab

– Conformance Profiles
21

HL7 V2 Tool Updates (post cycle 7 test events) 

• Documentation Tab

– Patient Demographics
22

HL7 V2 Tool Updates (post cycle 7 test events) 

• Documentation Tab

– IDCO Patient Demographics
23

HL7 V2 Tool Updates (post cycle 7 test events) 

• Documentation Tab

– PIV Drugs
24

New tool directions 

• Predicate Project

– assertion language to capture message value constraints

– Needed in addition to the conformance profile, which does not 

capture all the HL7 constraints

– Eg: MSH[1]-3[1].2[1]="sender“

• DataLibraryExpander project

• Resource Generator project
25

New tool directions 

• DataLibraryExpander project

– Generate any conformance profile by specifying an HL7 Profile + 

data that user wants to override

– only the static definition

Example code snippet:
26

New tool directions 

• Resource Generator project

– Reads an HTML document which contains all the constraints, 

identified as <Code> tags in the document, and translates them 

into HTML tags

Example code snippet:
27

New tool directions 

• Resource Generator, 

continued

• Generates the static 

definition table:
Rosetta Terminology Mapping Management 

System - RTMMS

Semantic interoperability of Medical Devices

Test Tool Update

Joint HL7/IEEE 11073 Healthcare Devices Working Group

National Institute of Standards and Technology

24 September, 2013 – Cambridge, MA

Contact: john.garguilo@nist.gov, 301-975-5248
29

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)
30

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

• Linked to RTMMS

Security DB - Stores users information

RTMMS Key Tables 
31

• 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 / exported to ‘DIM Editor’

RTMMS Key Features 
32

• General user

– Views Rosetta Tables

• Reviewer

– Participates in discussions

• Contributing Organizations

– Vendor/Contributer ‘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 
33

RTMMS by the numbers (as of 23 September 2013) 

• 1596 Rosetta terms

• 654 hRTM terms

• 222 Groups

• 8 Unit Groups

– 442 Units (MDC)

– 426 Units (UCUM)

• 27 Enumeration Groups

– 261 Enumerations

• 37 Contributing 

Organizations now 

Registered!
34

RTMMS (as of 23 September 2013) 

• 11073 Tab

• Synched with Jan Wittenber’s dBase (Spring 2013)
35

RTMMS (as of 23 September 2013) 

• 11073 Tab ISO/IEEE 

11073 Tab
36

RTMMS Primary Updates 

 Agreement finalized between IEEE and NIST (Dec 2012)

• Allows users free and public access of terminology attributes that were 

formally ‘pay-for’ via the NIST tool

• The “Works”

Definition of the “Works” [from IEEE/NIST Agreement]

The following data items within the approved standards , existing and future 

versions, currently designated as:

1 – IEEE 11073-10xxx

2 – IEEE 11073-20xxx

Limited to the following data items within, currently designated as:

1 – Ref ID

2 – Code

3 – Description

4 – Systematic Name

 Revised “term approval” Functionality
37

RTMMS Primary Updates – Signed Agreement 12/20/12 
38

RTMMS Updates, cont. 

• User can now download (an XML, HTML, and CSV) version of:

– Rosetta [1596]

– “hRTM” [654]

– Units (MDC [442] + UCUM [426]) and Enumerations [261]

– Term Approval::“Proposed terms” [189]

– Term Approval::”Ready Terms” [269]

– Note: Basis from prior WG discussions - this version enables greater flexibility to 

work with when working outside the tool

• “Standard Table”

– A new column “Standard Tbl” is now present in all Rosetta, hRTM and review 

tables 

– Provides association of the term with corresponding table in the base standard 

– Only the terms given by Jan W. (275) REFIDs are currently linked

– NIST can add more if community provides the/additional mapped terms.

• Term Approval Updates (see subsequent slides)
39

Term Approval 

Revised “term approval” tables/tab

“Proposed terms” tab (189 rows)

Re-groups all the newly proposed terms with “MDCX_” prefix

The ‘Assign REFID’ button allows to change the REFID from an “MDCX_” term 

to a “MDC_ term” (or anything else) 
40

• “Ready to review terms” tab: 269 rows:

– Terms with MDC_ prefix and null or 0 term code 

 Term being worked on by SDOs/MDC experts

 These processed terms would become / be added to the harmonized 

Rosetta terms (hRTM) upon approval by SDO user and balloting 

Term Approval, cont. 
41

• “Ready to review terms” tab: 269 rows:

– The ‘Edit RefID’ button allows approved user to edit a term and it’s attributes

– Edit a REFID, Standard Table, Block, Partition, Code(base 10), Systematic Name, 

Common Term, Acronym, and Description to the x73 database

– Pull down menus available (where enumerations provided/exist)

Term Approval, cont. 
42

• “Ready to review terms” tab: 269 rows:

– The ‘Register RefID’ button allows to register a term

– Register a REFID, Standard Table, Block, Partition, Code(base 10), Systematic 

Name, Common Term, Acronym, and Description to the x73 database

– Pull down menus available (where enumerations provided/exist)

Term Approval, cont. 
Domain Information Model

UML / DIM Editor, Progress Update

Semantic interoperability of Medical Devices

Test Tool Update – Art Griesser, Ph.D., 

 Prometheus Computing 

Joint HL7/IEEE 11073 Healthcare Devices Working Group

National Institute of Standards and Technology

24 September, 2013 – Cambridge, MA
44

Status 1/2 

• http://mdcx73-working.wikispaces.com/_NIST-ArtG 

• Goal model

• Gap analysis

• Clause 8 API

• Complete UML model from DIM standard, with

– RTMMS data

– Conformance statements

– Meta-information
45

Status 2/2 

• Programmatically derived from UML:

–XML Schema

–ASN.1 schema

–Relational database schema

–Web-based editor

–JSON meta-information

•Java parser for JSON meta-information

•Gap analysis

–Gap Analysis Report

–http://mdcx73-

working.wikispaces.com/file/view/DIM%20Gap%20Analysis%20

v3b.docx/431746184/DIM%20Gap%20Analysis%20v3b.docx
46

Progress 

• Containment tree browser added

• Resolved many questions at NIST face-to-face

• Now generating LaTeX from UML

• Draft of MyDevice functional requirements
47

PDF Snippet From LaTeX 
48

PDF Snippet From LaTeX 
49

PDF Snippet From LaTeX 
50

PDF Snippet From LaTeX 
51

Goals for DIM 
52

Plan 

• Standard generation

– LaTeX meeting ISO publication requirements

– Add UML diagram snippets

• Enhance usability of MyDevice

– Simplify profile construction, viewing

– Profile & conformance statement import/export

– Help text (snippets from the standard)

– Stand alone desktop version

• Should we describe operational state?
53

State Machine 

Disconnected

Connected

Transport connect indication

Transport disconnect indication

Unassociated

Associating

+ entry / TxAssocReq

assocReq

RxAssocAbort

Or

TxAssocAbort

RxAssocRsp

(rejected)

Associated

RxAssocAbort

TxAssocAbort

RxAssocRelReq/

TxAssocRelRsp

RxAssocRsp

(accepted-unknown-config)

RxAssocRsp

(accepted)

Operating

Configuring

Sending Config

TxConfigEventReportReq

RxConfigEventReportRsp

(accepted-config)

Waiting Approval

Disassociating

+entry / TxAssocRelReq

assocRelReq

RxAssocAbort

TxAssocAbort

RxAssocRelRsp

RxConfigEventReportRsp

(unsupported-config)

RxAssocRelReq/

TxAssocRelRsp

??
‘MyDevice’ Progress Update

Semantic interoperability of Medical Devices

Test Tool Update – Art Griesser/Michael Faughn

Joint HL7/IEEE 11073 Healthcare Devices Working Group

National Institute of Standards and Technology

24 September, 2013 – Cambridge, MA

Contact: Arthur Griesser, Ph. D. a.griesser@prometheuscomputing.com, Prometheus Computing, LLC
55

MyDevice 1.0 

• A tool to create device profiles and 

conformance statements.

• An application built directly from the DIM UML 

model.

• Outputs: device profiles, conformance 

statements

• Output formats: JSON, PDF

– Java API to parse JSON
56

‘MyDevice’ Now 

• ICSGenerator functionality analyzed with 

assistance from Jing Gao (GR @ NIST).

• Initial documentation and discussion of 

requirements – we have enough to start 

writing code.

• Prototype application demonstrated in March 

2013 showing interface to all DIM objects, 

ability to construct and store profiles, and 

containment tree view.
57

‘MyDevice’ v1 in FY2014 

• Implement and improve capabilities of 

ICSGenerator – integrated into ‘MyDevice’

• Continue discussions to clarify stakeholder 

needs

• Improve application, collect feedback from 

stakeholders, repeat

• In use by stakeholders before end of FY2014 

(September 30, 2014)
58

‘MyDevice’ after v1.0: 

Possibilities 

• Facilitate the construction of messages

• Participate in message verification

• Verify profiles with respect to device 

specializations

• Package as a stand-alone application

• Produce useful artifacts - C headers, HL7 PDUs, 

others

• Expand the scope of ‘device profile’ 
59

Outcomes from 2-day Summit @ NIST (March ‘13) 

• DIM Activity Diagram

Aimed at automatically 

generating -10201 + 

communicating standard Aimed at providing encodings 

(directly?) consumable for 

processing (by device 

manufactures / vendors)

Aimed at providing 

device specializations)

Aimed at generating 

messages/PDUs 

MyDevice / DIM Editor
60

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

• DIM Work

– http://mdcx73-working.wikispaces.com/_NIST-ArtG 

Semantic Interoperability of Medical Devices

60