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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: john.garguilo@nist.gov, 301-975-5248
2
NIST MDC Testing Staff
• John J. Garguilo
301-975-5248
john.garguilo@nist.gov
• 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
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.
http://cyrusxp.com/?page_id=18
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.
http://cyrusxp.com/?page_id=18
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)
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)
14
Discussion Topics and Direction
• “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
Discussion Topics and Direction
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: rsnelick@nist.gov
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
Conformance Profile (XML)
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)
Conformance Profile (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
21 January, 2014 – San Antonio, TX
Contact: john.garguilo@nist.gov, 301-975-5248
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
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)
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
41
HL7 V2 Tool Updates (Starting with Cycle 8 test events)
• Current Version / Release Notes
– ‘About’ Tab (yellow ribbon)
42
HL7 V2 Tool Updates (Starting with Cycle 8 test events)
• Documentation Tab
– Conformance Profiles
43
HL7 V2 Tool Updates (Starting with Cycle 8 test events)
• Documentation Tab
– Patient Demographics
44
HL7 V2 Tool Updates (Starting with Cycle 8 test events)
• Documentation Tab
– IDCO Patient Demographics
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
Joint HL7/IEEE 11073 Healthcare Devices Working Group National Institute of Standards and Technology
21 January, 2014 – San Antonio, TX
Contact: john.garguilo@nist.gov, 301-975-5248
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
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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)
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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)
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• “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.
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• “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.
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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.
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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
• DIM Work
– http://mdcx73-working.wikispaces.com/_NIST-ArtG
Semantic Interoperability of Medical Devices
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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
21 January, 2014 – San Antonio, MA
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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
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Approach
• Semantics before Syntax
– Derive syntactic artifacts
• Fully object oriented
– Messages are marshalled object graphs
• Optimize backward compatibility
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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.”
73
“You don’t have no more troubles, Roscoe,” I tell him, “you
and me is just become business partners.”
• Grammatically atrocious
• Meaningful
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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
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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
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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
• DIM Work
– http://mdcx73-working.wikispaces.com/_NIST-ArtG
Semantic Interoperability of Medical Devices
79
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