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

7 May, 2013 – Atlanta, GA

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

• Julien Deshayes (Guest Researcher) – HL7 V2 Tools

• Nicolas Crouzier(GR) - RTMMS

• Jing Gao (GR) – ICSGenerator

• Art Griesser + Michael Faughn (Contractor -

Prometheus Computing, LLC ) – DIM Modeling

• Sandra Martinez  working on MU 

Semantic Interoperability of Medical Devices

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Discussion Topics 

• HL7 V2 (2.6) IHE-PCD Validation Tools

– Cycle 7 – 2012-13; Fall/Winter Pre-Connectathon [completed] + 

Virtual Testing, January/February 2013 Connectathon, March 

2013 HIMSS13

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

– IHE-PCD Connectathon, “Instance Environment

– Cycle 8 Enhancements

• Rosetta Terminology Mapping Management System 

(RTMMS) Overview 

– RTMMS Deployment Update and service status

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

• ISO/IEEE 11073 ‘Domain Information Model Editor’

– Progress Updates

– UML Defined x73 DIM, Activity Diagram, Goals 

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HL7 V2.6 Validation Tooling

IHE-PCD Pre-Connectathon Cycle 7

Semantic interoperability of Medical Devices

Test Tool Update

HL7 Healthcare Dev / IEEE WGs

National Institute of Standards and Technology

7 May, 2013 – Atlanta, GA

Contact: john.garguilo@nist.gov, 301-975-5248
5

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)

• 28 Test Cases

• 60+ existing User Accounts 

– In total since tool made available
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2012-13 IHE-PCD 

Pre-Connectathon + Connectathon Status, 

Continued 

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

Tuesday calls

• IHE-PCD F2F – week of April 15th in San Diego at WHI

– Notable: Alarm Comm Mgmt  Alert Comm Mgmt

• CPs documented and submitted

• Roadmap of activities updated... see PCD wiki

• JG + JR addressing revisions to TF Vol II
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IHE-PCD 2012/13 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 Cycle 7 2012-13 Pre-Connectathon 

 Test Result Statistics – Organizations and Tests Executed 

• Total Organizations (by User Accounts): 19

• Total Organizations (by *unique Company Name): 12

*Org No. followed by dash indicates more than one account 

from same organization in following slide

Registered (stored) at NIST site (over Pre-Con 2012-13 cycle)

• Total number of Tests Executed:82

• Total Number of Tests Passed: 81

• Total Number of Tests Failed: 1

Connectathon Test Monitors for IHE-PCD (North America @ 

Chicago, Jan 2013)

• Garguilo, Martinez, Deshayes, Crouzier
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Organization running DEC Reporter: 16

Organization running DEC Consumer: 1 (1 Test Case) – OZ Systems

Organization running DEC Filter: 1 (1 Test Case) – B Braun 

Organization running PIV Programmer: 0

Organization running PIV Consumer: 5

Organization running ACM Reporter: 6

Organization running ACM Manager: 1 (1 Test Case) – Philips Medical

Organization running ACM Archiver: 0 (out of scope 2012-13)

Organization running IDCO Reporter: 0

Organization running IDCO Consumer: 0

Organization running IPEC Reporter: 4

Organization running IPEC Consumer: 0

Organization running RDQ Reporter: 0

Organization running RDQ Consumer: 0

Organizations running DEC Option POI: 1 (3 Test Cases) - Massimo

IHE-PCD Cycle 7 2012-13 Pre-Connectathon 

 Test Result Statistics – by Actor 

 (does not include supportive role participants – recorded /committed on NIST site) 
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HL7 V2 Tool Updates (post cycle 7 test events) 

• Version / Release now shown on tool

• Needs to be added (see example slide below)

• Maintain (test management) data from test events

– E.g., 2012, 2013, etc.

– Not an executable site (yet!) – just results data + reports

• Documentation Tab (see coming slides)

– Conformance Profile Tab

– Patient Demographics

– IDCO Patient Demographics

– PIV Drugs

– Other Drug Libraries tab?

– Way to upload libraries + demographics (future) – incorporated 

[automatically] into validation context files used by tooling
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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
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HL7 V2 Tool Updates (post cycle 7 test events) 

• Documentation Tab

– Conformance Profiles
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HL7 V2 Tool Updates (post cycle 7 test events) 

• Documentation Tab

– Patient Demographics
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HL7 V2 Tool Updates (post cycle 7 test events) 

• Documentation Tab

– IDCO Patient Demographics
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HL7 V2 Tool Updates (post cycle 7 test events) 

• Documentation Tab

– PIV Drugs
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HL7 V2 Tool Update, Continued 

• Profile Viewer

• Need to review/update/synch w/ TF Vols. II + III
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

7 May, 2013 – Atlanta, GA

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

• Linked to RTMMS

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 / exported to ‘DIM Editor’

RTMMS Key Features 
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• 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 
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RTMMS (as of 6 May 2013) 

• 1587 Rosetta terms

• 644 hRTM terms

• 35 Contributing 

Organizations now 

Registered!
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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
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RTMMS Primary Updates – Signed Agreement 12/20/12 
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Term Approval 

Revised “term approval” tables/tab

“New proposed terms” tab (192 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) 
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• “Ready to review terms” tab: 259 rows:

– Terms with MDC_ prefix and null or 0 term code 

– The ‘Register’ button allows to register a term 

(define a Block, partition, code, systematic name etc...) to the x73 database

 These processed terms would become / be added to the 

harmonized Rosetta terms (hRTM) upon approval by SDO user 

and balloting 

Term Approval, cont. 
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RTMMS Updates, cont. 

• User can now download an HTML version of:

– “hRTM”

– “New proposed terms” 

– “New proposed terms” table, 

– Note: hope is users find this version to be easier to work with when working 

outside the tool

• “Standard Table”

– A new column “Standard table” 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.
Domain Information Model

UML / DIM Editor, Progress Update

Semantic interoperability of Medical Devices

Test Tool Update – Art Griesser

Joint HL7/IEEE 11073 Healthcare Devices Working Group

National Institute of Standards and Technology

7 May, 2013 – Atlanta, GA

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

• Made UML model from DIM standard

• Made XML Schema from UML model of DIM

• Made web-based editor for DIM data

• Added to DIM UML and web app:

– RTMMS data

– Conformance statements

– Meta-information

• Demonstrated an example (non-DIM) standard 

derived from a model
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Progress II 

• Created interface for DIM section 8

• Finished testing framework document

• Injected additional meta information into UML

– Encoding values, clause numbers & titles, name 

binding, registered as, description, update type, 

attribute id

• Discussed semantics of DIM groups

• Discussed ASN.1 representation of inheritance

• Generated JSON and YAML files of meta-info
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Progress III 

• Created Java code to parse JSON meta-info

• Derived complete ASN.1 schema from UML

• NIST Face-to-Face meeting

– Created model of goals (next slide)

– Resolved some questions about UML mappings

• Added tree view of containment to MyDevice

• Reverse engineered UML of NIST XML Schema

• Finished first draft of DIM gap analysis
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Progress III 

• Determine “Golden Repository”

– See Meta Information Management Model

– Further progress documentation (from Jan Wittenber) in coordination with 

11073 work... [discussed earlier @ Spring F2F in April]

• 2-Day F2F Summit at NIST (26-27 March)

– Project Plan de/revised for DIM work

• Aimed at scoping logical (and doable tasks based on priorities 

identified

– Summit Outcome Goals

– DIM Activity Diagram

• Integrating ICSGenerator into new tooling...

– Via Cucumber tool / use cases
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Proposed x73 DIM UML (from Art Greisser) 
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Goals for DIM – outcome from 2-day Summit @ NIST (March ‘13) 
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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 
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Current Foci 

• Create executable use cases for 

ICSGenerator

– Use them to prove MyDevice has all functionality

• Normative text

– Extract from DIM standard

– Inject into UML

– Use to generate next version standard from UML

• Possibility of describing operational state
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Disconnected State Machine 

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 ??
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Open Questions (from Action item list of January 2013) 

From Monday, May 6, 2013:

• Art --> what's the status of DIM UML --> generation of 

standard 10202?

– Inject into Word Doc (Todd has example)

– Tied to IEEE new publications formats as identified

• 10202 (electronic version of DIM): Equivalent XML (withdrawn)

– New Par: UML + Companion Standards for syntactic 

representations (e.g., XML, JSON) + automated tooling(?)

– Jan noted current “open window” w/in IEEE publication (e.g., 

repository IEEE is looking at to facilitate this kind of publication 

process...)

• Tiger Team

– Art work w/ IEEE (Kathryn + Dom Messina(?))

– Get Todd’s example (word doc infusion)
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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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