nist medical device communication testing€¦ · nist medical device communication testing ......

NIST Medical Device Communication Testing Semantic interoperability of Medical Devices

Test Tool Update

HL7 Healthcare Devices WG / IEEE x73 Upper Layers

John J. Garguilo

National Institute of Standards and Technology

21 January, 2014 – San Antonio, TX

Contact: [email protected], 301-975-5248

mailto:[email protected]

2

NIST MDC Testing Staff

• John J. Garguilo

301-975-5248

[email protected]

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

• Art Griesser + Michael Faughn (Contractor -

Prometheus Computing, LLC ) – DIM Modeling +

MyDevice (next gen ICSGenerator plus)

Staff Notes:

• Julien left NIST Dec ’13 back to France

• Jing moved to new area (w/in NIST)

• Hoping to have new GR in April ‘14

Semantic Interoperability of Medical Devices


3

Discussion Topics • A few thoughts on testing…

• 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”

• IGAMT – Implementation Guide Authoring Management Tool

– Continue to develop PCD-01 (ORU^R01)…more after Connectathon…

• Rosetta Terminology Mapping Management System (RTMMS)

Overview + Update

– RTMMS Deployment Update and service status

• -10101a + 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)

4

IHE-PCD 2013/14 Pre-Connectathon + Connectathon

NIST Testing Support

State of the Union: How we are validating so far…

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

• Syntax and Semantic Content Validation

– Against HL7 conformance profile

– Against IHE-PCD Technical Frameworks/Supplements constraints

(e.g., PCD-01: ORU^R01, Communicate Device Data)

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

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

– Against ‘validation context’, including specific values

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

5

Refining Interoperability

• There are some resources which provide more

complex definitions of Interoperability which

include the concept of Interoperability Levels and

Dimensions.

• Discuss concepts from

– HL7

– *Turnitsa *Turnitsa, C.D. 2005. Extending the Levels of Conceptual Interoperability Model. Proceedings IEEE, Summer Computer

Simulation Conference, IEEE CS Press.

6

Interoperability Concept – HL7

• HL7 has categorized interoperability as:

– Technical Interoperability - ensures that systems can send and

receive data successfully. It defines the degree to which the

information can be successfully “transported” between systems.

– Semantic Interoperability - ensures that the information sent

and received between systems is unaltered in its meaning. It is

understood in exactly the same way by both the sender and

receiver.

– Process Interoperability - is the degree to which the integrity of

workflow processes can be maintained between systems. This

includes maintaining/conveying information such as user roles

between systems.

• These concepts build on each other.

http://cyrusxp.com/?page_id=18


7

HL7’s Interoperability Concept

8

Interoperability Model - Turnitsa

Turnitsa proposes a 7 level Interoperability Model: – Level 0 – No Interoperability

• The situation in which two systems have no need to, or cannot, interoperate.

– Level 1 - Technical interoperability

• Achieved when two systems have the means to communicate, but neither has

a shared understanding of the structure or meaning of the data communicated.

• For example a receiving system simply records what is received, not

understanding structure or meaning.

– Level 2 – Syntactic Interoperability

• Occurs when information is communicated with structure but without any

meaning.

– Level 3 – Semantic Interoperability

• Achieved when the data have meaning, but a full understanding of the

relationships between elements of data and the context of the data is missing.

*Turnitsa, C.D. 2005. Extending the Levels of Conceptual Interoperability Model.

Proceedings IEEE, Summer Computer Simulation Conference, IEEE CS Press.



9

Interoperability Model – Turnitsa

Continued

– Level 4 – Pragmatic Interoperability

• Encompasses a shared understanding of data, the relationships between

elements of the data, and the context of the data; however, pragmatic

interoperability cannot accommodate changing relationships or context.

– Level 5 – Dynamic Interoperability

• Allows for changing contexts and relationships over time or within the scope of

specific transactions.

– Level 6 – Conceptual Interoperability

• Complex concepts are exchanged and understood.

*Turnitsa, C.D. 2005. Extending the Levels of Conceptual Interoperability Model.

Proceedings IEEE, Summer Computer Simulation Conference, IEEE CS Press.



10

Turnitsa’s Model

None

Technical

Syntactic

Semantic

Pragmatic

Dynamic

Stand-alone

Common Physical and Transport Layers

Common Format

Meaning understood

Context understood

Dynamic Context understood

Level 0

Level 1

Level 2

Level 3

Level 4

Level 5

Incr

eas

ing

Cap

abili

ty f

or

Inte

rop

era

tio

n

Connectable

Integratable

Interoperable

11

Turnitsa’s Model - Adapted

None

Technical

Syntactic

Semantic

Pragmatic

Dynamic

Stand-alone

RS232, Ethernet, 802.11, USB, TCP/IP…

HL7, IEEE 11073, Continua…

Snomed, IHE-PCD RTM, IEEE 11073-10101, LOINC…

IHE PCD / Continua Use Case based Profiles…

Resource and Load Management

Level 0

Level 1

Level 2

Level 3

Level 4

Level 5

Incr

eas

ing

Cap

abili

ty f

or

Inte

rop

era

tio

n

Connectable

Integratable

Interoperable

12

Turnitsa’s Model – Adapted

Additional Requirements

None

Technical

Syntactic

Semantic

Pragmatic

Dynamic

Level 0

Level 1

Level 2

Level 3

Level 4

Level 5

Incr

eas

ing

Cap

abili

ty f

or

Inte

rop

era

tio

n

Connectable

Integratable

Interoperable

Asso

cia

tio

n

Au

then

ticati

on

Au

tho

rizati

on

Dis

co

very

Safe

ty

Secu

rity

Cert

ific

ati

on

13

Discussion Topics and Direction

• Goal of Improving rigor from “Context-Free” “Context-based”

• “Context Free” (up through “syntactic”, maybe low level “semantic”)

– HL7 2.6

– IHE-PCD Vol. 2 (base message profiles, e.g., DEC/PCD-01)

• Constraints on HL7

– 11073-10101:: Harmonized Rosetta

• Although related co-constraints (term code-units-body site-enumerations, not specialized to

device/modality level)

– 11073-10201:: (General) containment (e.g., MDSVMDChannelMetric)










14


• “Context-based” validation (above plus following)

start getting at “pragmatic” maybe even “dynamic”

– IHE-PCD Vol. 2 (base message profiles constrained to Integration Profile)

• E.g., Pulse Oximetry (POI ) Integration Profile, further constrains DEC

• Infusion Pump Event Communication (IPEC) – specific trigger (i.e., ORU^R42)

– IHE-PCD Vol. 3 constrained by device = device specialization

– 11073:: Harmonized Rosetta (groups)

• Constrained to device type/modality – set of terms appropriate for device type

– DIM (specific containment) for class of device

15


Going forward [Critical/Needed Considerations]

• To help get at common basis for a device “specialization”

(which is still a generalization)

– 11073-103xx

– 11073-104xx

• Pre and Post coordination

• Important when considering tools that can or must test to

dynamic operation

• This may/should consider behavior + functionality

16

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

_Profile.xml RTMMS

Reload Project X73 DIM

X73 (public terms)

hRTM (approved terms)

Rosetta (Proposed terms)

Semantic dB

DIM Editor (under development)

Transformation Key:

File Software/System

17

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_

Profile.xml RTMMS

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-PCD-

Conformance

-Profile.xml

MWB

IGAMT

IHE-PCD TFs

Vol. I Integration Profiles

Vol. II Transactions

Health IT Test Infrastructure

Context Validaton

Registry/

Reposito

ry

Test

Data

Aggrega

ted

Validatio

n

Proxy

Security

Generati

on

Logging Log

Analyzer

Servic

es

Time

Specializ

ed

Other

Services

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

STAKEHOLDE

RS

Vendors

Te

st

Ma

na

ge

me

nt

To

ols

an

d T

est

Sys

tem

s

Report

Test Environments

Supported

Peer-to-Peer

System Testing Test Analyzer

System

(s)

Under

Test

SUT

Real-Time Monitor

Test Framework Test Framework Test Framework

Test System

Instance

Instance Testing Isolated System

Testing

User Interface

Test System Control

Remote

Service

s

Existing

Tool

External

Service

Specification

(IG) Authoring

Tools

Context Validaton

Transformation Key:

File Software/System

18

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

19

‘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’

20

MyDevice: Early functional diagram w/ component process flows (draft – for discussion purposes only)

HL7 V2 Implementation Guide Authoring and Management Tool

Slides provided by Robert Snelick, NIST National Institute of Standards and Technology

Contact: [email protected]

22

IGAMT

• Productivity tool for creating profiles and implementation

guides

• Standardization of conformance rules, vocabulary and

structure

• Automation and Simplification of creation and editing of

profiles and guides

• Machine process-able profiles and conformance statements,

leading to integrated and quicker test tool development

23

Bigger Picture

Test System (Allow NIST/others to build tools quickly)

Implementation Guide Authoring Tools (Create more “testable” specifications!)

Test Cases and Testing Artifacts

Test Case Management Tool (Let domain experts help write the test cases!)

Implementation

Guides

(Number is

increasing rapidly—

no profile created

automatically)

HL7 v2 MU Syndromic

Surveillance Implementation

Guide

ELINCS HL7 v2

Lab Orders and Results

Implementation Guide

HL7 v2 MU incorporate Lab

Results & Reportable Lab

Results Implementation

Guides

HL7 v2 MU Immunization

Reporting Implementation

Guides

IHE HL7 v2 PCD

Technical Framework

IHE HL7 v2 PIX/PDQ Technical

Framework

HL7 v2 MU Lab Results

Interface (LRI) Implementation

Guide

IHE HL7 v2 Technical

Framework In General

HL7 v2

Implementation Guides in General (HL7, CDC, PHIN, ISDS, ONC, etc.)

20+ IHE

integration

profiles using

V2!

24

Implementation

Guide

Authoring &

Management

Tool

The Big Picture: HL7 V2 End-to-end Testing Support

HL7 v2 Standard Message Definition

General Transaction Constraints (e.g., IG , TF,

or user input)¹

HL7 v2 Standard

Value Sets

Test Case Requirements

Vocabulary Library (XML)

Conformance Profile (XML)

Test Case

Management

and Authoring

Tool

Message

Profiling

Test Plan Execution

Script (XML)

Test Plan Template

HL7 V2 Impl. Guide

Template

Test Plan English

Document

Data Sheets

Impl. Guide English

Document

Specification Validation

Context File

(XML)

¹ Support existing specifications

Use Cases

Vocabulary

Profiling

Use Case

Development

Disposition

Traceability

Utilities

IG Template

Wizard

Constraint

Generator

Test Case

Development

Test Script

Generator

Data Sheet and

Juror Document

Generator

Test Plan

Development

Document

Generator

Message Maker

Data

Management

Message

Generation

Testing

Infrastructure

Document

Generator

Execution

Engine

Validation

Engine

Test Agents

Report

Generation

Communication

Testing

Environments

Capabilities

Artifact

Repository

Testing

Tools

Web

Applications

Testing

Infrastructure

Components

Test Plan

Integration

Validation

Resource

Bundle

Management Message

Generation

Engine

Vocabulary Libraries

(XML)

Conformance Profiles (XML)

Test Case Specific Context

Files (XML)

Domain

Specific

Tools

Juror Documents

Utilities

Documentation

Communication

Resource Bundle

Test Plan Execution

Script (XML)

R. Snelick May 8th, 2012

Domain Experts

Domain Experts and Test Case Developers

User Input

Tool Generated

Software Engineers

Tool Developers

Import Value Sets

DITA XML

25

Current NIST process


Validation

Tool

Value Sets (XML)

MWB

Constraint

Generator

Test Case Specific

Validation Context File

(XML)

Analyze Manually Written Implementation Guide Document

Specification Validation

Context File

(XML)

Constraint

Generator Table Library (XML)

Table Library (XML)

Request clarification on conformance from authors and SMEs

Analyze SME responses, manually written addendum and conformance guides created based on inquiries, as well as original Implementation Guide

26

Proposed IGAMT process

Implementation

Guide

Authoring &

Management

Tool

HL7 v2 Standard Message Definition

General Transaction Constraints (e.g., IG , TF,

or user input)¹

HL7 v2 Standard

Value Sets

Vocabulary Library (XML)


Message

Profiling

HL7 V2 Impl. Guide

Template

Impl. Guide English

Document

Use Cases

Vocabulary

Profiling

Use Case

Development

Disposition

Traceability

Utilities

IG Template

Wizard

Document

Generator

Message Maker

Data

Management

Message

Generation

Domain Experts

User Input

Tool Generated

Import Value Sets

DITA XML

Code

Generator

Java Library - Parser - Validation

??

27

Benefits of IGAMT

Authors Implementers Testers

Automatic validation Standardized implementation guides Machine processable profiles

Templated format Standardized conformance

statements

Machine processable conformance

statements

Standardized conformance

statements

Ability to create guide from profile and

the profile components they choose.

(Individual views of specification)

Ability to start test tool development

as the guide is being created

Easily compare profiles, segments

and data type libraries (i.e. any

object).

Ability to automatically create own

implementation profiles off of IG

profiles.

Single source publication-

Automatic update of documents as

changes are being made

Ability to customize base IG to state

or local requirements.

Easily view different components and

sections of document as ballot

discussion is happening

Ballot tracking and comments (future)

HL7 V2.6 Validation Tooling IHE-PCD Pre-Connectathon Cycle 8 Semantic interoperability of Medical Devices

Test Tool Update

Joint HL7/IEEE 11073 Healthcare Devices Working Group National Institute of Standards and Technology




29

2013-14 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 (10)

– SPD – Filter (4)

– POI – Pulse Ox (3)

• PIV – Patient Infusion Verification (11)

• IPEC – Infusion Pump Event Communication (6)

• IDCO – Implantable Device Cardiac Observation (4)

• ACM – Alarm Communication Management (2)

• 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)

30

2013-14 IHE-PCD

Pre-Connectathon + Connectathon Status, Continued

• Cycle 8 - Test Cases/demographics being used as basis for

tooling at 2014 NA Connectathon next week in Chicago

• IHE-PCD F2F – week of April 1st in Cleveland at new

Interoperability center

• CPs documented and submitted (see PCD wiki) – Note: Two submitted in January 2014 – PCD members agreed to test using updates

(official ballot closes this week)

• Roadmap of activities updated… see PCD wiki

• Cycle 8 Revisions to TF Vols. I + II + III (IHE approved)

– Vol I: Revision 3, 11 October 2013

– Vol II: Revision 3, 11 October 2013

– Vol III: Revision 3, 11 October 2013

31

IHE-PCD 2013/14 Pre-Connectathon + Connectathon

NIST Testing Support










32

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

33

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)

34

HL7 V2 Tool Updates

• Test event results now stored and selectable

– Maintain (test management) data from test events

– E.g., “PreConnectathon 2013-2014 (Cycle 8)”

and “Cycles 1-7”.

• Profile Viewer (shows message structure attributes)

• Resource Management Capability Added

• Test Case Scenario Viewer (Sequence Diagrams)

• Updated in-tool documentation

– Release version + notes for each update

35

HL7 V2 Tool Updates, continued

• Documentation Tab (see coming slides)

– Conformance Profile Tab

– Patient Demographics

– IDCO Patient Demographics

– PIV Drugs

– Other Resources

– Cycle 9: Looking into capability to upload libraries +

demographics

• incorporated [automatically] into validation context files

used by tooling

36

New Tool Updates: Test Event Selection

37

New tool updates – Profile Viewer

38

New tool updates - Resource Management

39

New tool Updates - Resource

40

New tool Updates – Test Case Viewer

41

HL7 V2 Tool Updates (Starting with Cycle 8 test events)

• Current Version / Release Notes

– ‘About’ Tab (yellow ribbon)

42


• Documentation Tab

– Conformance Profiles

43



– Patient Demographics

44



– IDCO Patient Demographics

45



– PIV Drugs

46

Cycle 8 Organizations using NIST Pre-Connection Tooling

# of Organizations: Total 21, Unique 17

Organization Name Organization Name

USST Hospira

True Process Inc. Draeger Medical

*Carefusion Cardiopulmonary Corp.

B Braun Baxter

Smiths Medical *West Health

iSirona BIT Computer Co. Ltd.

Covidien Masimo

*GE Healthcare *Philips Healthcare

Fukuda Denshi *Multiple Users from same Org

47

IHE-PCD Cycle 8 2013-14 Pre-Connectathon

Test Result Statistics – Organizations and Tests Executed

• Total Organizations (by User Accounts): 21

(Cycle 7: 19)

• Total Organizations (by *unique Company Name): 17

(Cycle 7: 14)

Registered (stored) at NIST site (over Pre-Con 2013-14 Cycle 8)

• Total number of Tests Executed:116

(Cycle 7: 82)

• Total Number of Tests Passed: 108

(Cycle 7: 81)

• Total Number of Tests Failed: 8

(Cycle 7: 1)

48

IHE-PCD Cycle 8 2013-14 Pre-Connectathon

Test Result Statistics – by Actor

Cycle 7

Actor Total Pass Fail

DEC Reporter 18 17 1 17

DEC Consumer 2 2 1

DEC Filter 1 1 1

PIV Programmer 1 1 0

PIV Consumer 4 4 5

ACM Reporter 11 10 1 6

ACM Manager 2 2 1

IDCO Reporter 1 1 0

IDCO Consumer 1 1 0

IPEC Reporter 5 5 4

IPEC Consumer 1 1 0

RDQ Consumer 1 1 0

RDQ Responder 0 0 0

Cycle 8 213-2014 Cycle 8

Actors:

48 Total:

46 Pass

2 Fail

Cycle 7:

35 Total

Rosetta Terminology Mapping Management System - RTMMS Semantic interoperability of Medical Devices

Test Tool Update





51

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)

52

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

53

• 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

54

• 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

55

RTMMS by the numbers (as of 20 January 2014)

• 1615 (+19) Rosetta terms

• 670 (+16) hRTM terms

• 224 (+2) Groups

• 8 (0) Unit Groups – 445 (+3) Units (MDC)

– 429 (+3) Units (UCUM)

• 28 (+1) Enumeration

Groups – 273 (+12) Enumerations

• 42 (+5) Contributing

Organizations now

Registered!

56

RTMMS (as of 23 September 2013)

• 11073 Tab

Synched w/

Jan Wittenber’s

dBase

(23 Sept 2013)

ISO/IEEE

11073 Tab

57

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

5 – Description

Revised “term approval” Functionality

58

RTMMS Primary Updates – Signed Agreement 12/20/12

59

RTMMS Updates, cont.

• User can now download (an XML, HTML, and CSV) version of: – Rosetta [1615] – “hRTM” [670] – Units (MDC [445] + UCUM [429]) and Enumerations [273] – Term Approval::“Proposed terms” [189] – Term Approval::”Ready Terms” [285; +16] – 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)

60

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)

61

• “Ready to review terms” tab: 285 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.

62

• “Ready to review terms” tab: 285 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.

63

Terms being vetted (by the numbers)

• “Proposed Terms”: 189 rows • “Ready Terms Table”: 285 rows • “Mapped Terms”: 27 rows • “Proposed Units”: 101 rows • “Proposed Enumerations”: 133 rows

– 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, Proposed cont.

64

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


64

http://www.nist.gov/medicaldevices




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






Domain Information Model UML / DIM Editor, Progress Update Semantic interoperability of Medical Devices

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

Prometheus Computing


21 January, 2014 – San Antonio, MA

DIM Progress

Art Griesser, Ph.D.

Prometheus Computing LLC

67

Goals of Standard

68

Goals of Approach

• Minimize inconsistencies

– Between the standard and various artifacts

– Between the artifacts

• Traceability

– To smallest possible set of requirements

• Minimize maintenance effort

• Allow higher level of automation

• Make implementation easier

69

Traceability

70

Approach

• Semantics before Syntax

– Derive syntactic artifacts

• Fully object oriented

– Messages are marshalled object graphs

• Optimize backward compatibility

71

Semantics Vs Syntax

• Which conveys more information?

• “Colorless green ideas sleep furiously”

• “You don’t have no more troubles, Roscoe,” I tell him, “you

and me is just become business partners.”

72

Colorless Green Ideas Sleep Furiously

• Grammatically correct

• Meaningless

73

“You don’t have no more troubles, Roscoe,” I tell him, “you

and me is just become business partners.”

• Grammatically atrocious

• Meaningful

74

The Big Picture (Summary)

75

The Big Picture (Details)

76

Progress

• Made UML model from DIM standard

• Extended DIM model with models of:

– RTMMS (reverse engineered from NIST MySQL database)

– Profile and conformance statements (based on ICS Generator)

– Meta information

• Injected additional info into model

– Encoding values, clause numbers & titles, name binding, registered as,

description, update type, attribute IDs, comments

• Web based data browser / inspector / editor for aboveMade

API based on DIM section 8

– Layered on top of a more general distributed object API

• Generated artifacts

– ASN.1, XML Schema, C headers, RDB Schema, Java classes, JSON

version of meta information

• Generated LaTeX standard derived from model

– Using ISO styles

77

Project sites…

• 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

• Gap analysis –Gap Analysis Report

–http://mdcx73-working.wikispaces.com/file/view/DIM%20Gap%20Analysis%20v3b.docx/431746184/DIM%20Gap%20Analysis%20v3b.docx






DIM Gap Analysis v3-1.docx

79

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):


• 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


79

http://www.nist.gov/medicaldevices








