Ioana Singureanu Greg Staudenmaier Detailed Clinical Models for Medical Device Domain Analysis Model 1 Overview Detailed Clinical Model DCM Atomic clinical information Promote semantic clarity and reuse ID: 262986
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Catherine HoangIoana SingureanuGreg Staudenmaier
Detailed Clinical Models for Medical Device Domain Analysis Model
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Overview
Detailed Clinical Model (DCM)Atomic clinical informationPromote semantic clarity and reuseStandard Terminology is built-in rather than an afterthought (e.g. primary and secondary standard-based coding system)Structured information to supportProcess improvement Interoperability
and automation
Reusable in many contexts
New standardsProfiling existing standardsApplication developmentInteroperability
Domain Analysis Model (DAM)Describe the stakeholders requirements to a integrators, developers, vendors, etc.Assist communication among stakeholder groupsUses a Std. modeling language (UML) improves communication, identifies main concepts, and leads to consensusModels can be used to generate code or other models (e.g. ontology)Methodology that supports the development of DCMsContext for DCMs
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Glossary
DAM: Domain Analysis ModelUML: Unified Modeling Language – a standard developed by the Object Management GroupDCM: Detailed Clinical Model – reusable information models, standardizedLOINC: Logical Observation Identifiers Names and Codes – standard codes for laboratory
SNOMED-CT
: Systematized Nomenclature of Medicine--Clinical Terms – Terminology System
ISO: International Organization for Standardization – standards development organization
HL7: Health Level Seven- healthcare interoperability standards development organizationIHE: Integrating the Healthcare Enterprise – standards-related consortiumContinua Health Alliance – standards-related consortium specialized in personal healthcare devices3Slide4
May 2011: Ballot DetailsThis ballot is informative and will expanded as new requirements and use cases are identified
The ballot artifacts are intended to be used: by providersTo express semantic interoperability requirements (e.g. RFP)by consortia (e.g. IHE, Continua Health Alliance)To develop Integration and Content Profileby standard development organizations (e.g. HL7, ISO)
To develop new standards for interoperability
Ballot: V3 Ballot
Domain Analysis Models:http://www.hl7.org/v3ballot/html/dams/uvdmd/uvdmd.htmlProject Site:
http://gforge.hl7.org/gf/project/dcmmd/Releases: http://gforge.hl7.org/gf/project/dcmmd/frs/Latest project artifacts 4Slide5
Specification history
September 2010 - Draft for CommentInitial version documenting the Domain Analysis for the following use cases: Intubate Patient - UnplannedManage Patient on VentilatorLiberate Patient from Ventilator, Planned
May 2011 -
Informative
In addition to addressing the ballot comments, this ballot includes additional use cases that are a high priority for the project stakeholders.:
Post-Operative Patient TransportPatient-to-device AssociationTime Synchronization for Networked Devices and for Legacy Devices5Slide6
Approach
Gathered requirements illustrated by scenarios, standard operating procedures, and stakeholder requirementsUse cases that were derived from clinical scenario illustrate the requirements in a precise way. Use cases identify the capabilities and user or system roles involved .Next we elaborated the use cases as workflows, step by step, identify the type of information produced or required by each step
Refine the information structures (correspond to device data) required to support workflow
Includes
standard terminology bindings
Interoperability requirements with the information systemsbetween devices Consistent, repeatable approach/methodology 6
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3
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Ballot Document Structure and ProcessSlide7
Actors to specify roles for business users relative to the use cases in scope
Identify the users roles and/or system roles for users and systems involved in the clinical scenario(s)
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Is a Care Team Member…
Clinician
roles
Is a Clinician…
Care Team Member
rolesSlide8
Business Use Case Analysis to specify…
Use CasesActive verb
Based on
requirements and
clinical scenariosNarrative descriptionPreconditionsSteps
WorkflowPostconditionsActorsParticipants in use casesA role relative to the use caseUsers, systems 8
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Actor participation
…based on
Workflow
Use Case
Business Use Case
Reference to workflow
Technical Use Case
Technical Use CaseSlide9
Device State
Transition
Condition
Device to Patient Association
– State Transitions
Patient associated to one more devices
Device undergoes state changes
connected/disconnected to patient
settings configured
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Patient
Ready
Patient Not Available
Device Assigned to a PatientSlide10
Clinical Workflow
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Role
Process Step
Information as input into a step
Information produced by a step
Trigger
Device Data produced by a step
DecisionSlide11
Post-0perative Transport
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EHR DataSlide12
Post-0perative Transport
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Device Data
Device DataSlide13
Post-0perative Transport
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Information
ReceivedSlide14
Technical Use Case
Actors: System RolesThe process steps are described as system interactionsSynchronize Time is a high-priority requirements
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System role
Technical Use Case
System role
Technical Use CaseSlide15
Time Synchronization for Legacy Devices
Legacy Devices are unable to synchronize time automatically Missing network connectionMissing support for protocol (SNTP)Device Manager required toreport device observation and parameters
Synchronized
It supplies time correction information (synchronized time)
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Device Manager
Medical Device
Network Time ServerSlide16
Time Synchronization +Time Correction
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Time correction
Synchronization
Use case is realized differently for legacy devices vs. networked/interoperable devicesSlide17
Patient to Device Association – Interoperable Medical Device
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Choice 1: Using Hospital Info System (ADT)
Choice 2: Enter at point-of-careSlide18
Patient to Device Association –
Legacy Medical Device18
Choice 1: Location based
Choice 3:
Patient association using Device Manager
Device Manager
Choice 2:
Patient assigned at point-of-careSlide19
Information Derived from Workflow Analysis
High-level, identifies the information
used or produced, precursors to DCMs
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Device Observation
Device Configuration
Common/
Shared Information
EHR Data Required Slide20
Focus of the analysis: Medical Device Interoperability
Emphasis on device-to-device and device-to-system interoperability and automation
We specify the structure of relevant types of data
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Device Observation
Device Configuration
Common/
Shared InformationSlide21
Information Analysis to specify context for DCMs
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attribute
class
association
repetitions
data type for date/timeSlide22
DCMs provide the final level of detail : Standard Terminology
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DCM Candidate
Parameter properties
Terminology Constraints
Inherited Constraints
Is a “Ventilator Setting”
Reusable data that may be used in information exchanges