NIST

Medical Device Communication Testing

Semantic interoperability of Medical Devices

HIT Test Tool Update

National Institute of Standards and Technology

15 May, 2012 – Joint HL7/IEEE 11073 Healthcare Devices Working Group

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

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

2
3

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

3
4

Content Topics 

• RTMMS Deployment Update and Status

– User Membership Protocol

• Rosetta Terminology Mapping Management 

System (RTMMS) Overview 

• RTMMS & ICSGenerator - IHE-PCD V&V Testing

4
5

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 considering 

making the access to RTMMS freely available 

• IEEE requested June 2012 stakeholders’ meeting – likely final approval
6

RTMSS - Deployment Plan – Going Forward 

• RTMMS becomes the “master” version going forward

• 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

• Initially there may be a 3-5 business day turn-around

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

with approved account information.
7

RTMSS - Deployment Plan (continued) 

• NIST has in parallel performed initial evaluation ISO/IEEE 11073 

“SDO Database”

– Created, owned, and used by Jan Wittenberg (Philips Healthcare) as 

IEEE x73 Upper Layer Chair

• Tool used for moving to x73-10101 V2 

– NIST/x73 Co-chairs working on a procedure to integrate RTMMS data 

with Jan W’s/x73 database and enable additions to the standard 

vetted through the x73 ballot process.

• RTMMS X73 dBase has 5604 terms vs. 3803 terms in SDO 

dBase (+1801)

• There are 208 terms (RefIDs) not present in NIST database. 

• Overall there are (≈ 236 terms) terms in our database that are 

not in Jan’s SDO dBase. 
8

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

8
9

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 
10

• 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 proposed 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 
11

• 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 
12

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) 
13

Issues / Key Work Items 

•Term review/approval process to date - not yet finalized

- If approved, would this require a new type of user “RTM/ICE” that will 

approve terms with RTMP|ICEP status?
14

Issues / Key Work Items 

• If the term review/approval process is approved then,

- A list of suffix for each vendors (the VV in MDCVV_ ) must be provided.

- Are there rules for these/such suffixes? (e.g., max length, case, who decides 

new suffixes..) 
15

RTMMS Updates 

• 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
16

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
44

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)
45

ICSGenerator Status 

• 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
46

PCD-01 Infusion Pump - Vol2 (Annex D) 

Access to 

MDDbase(x73

, hRTM and 

Rosetta)
47

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
48

PDF generated from the Infusion Pump Device profile 
49

MD Semantic Dbase “Look-up” 
50

Physiological Monitor – “Compound Numeric” 

“MDC_DIM_C

M_H2O “, unit 

used in Vol3 is 

not in hRTM
51

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 if there is a mapping to OBX segment.
52

Thank YOU! For your attention 

• Discussion?