Patient Care Devices DPI White Paper Discussion (Updated: 2009.08.20)

Patient Care DevicesPatient Care Devices

DPI White Paper DiscussionDPI White Paper Discussion(Updated: 2009.08.20)(Updated: 2009.08.20)

22

DPI White PaperDPI White Paper

Section Detail Discussion:Section Detail Discussion:

OrganizationOrganization

33

DPI WP OrganizationDPI WP Organization• Major WP SectionsMajor WP Sections

– Front Matter (Intro/Definitions/References)• Include sections / point to Appendix E & F

– Executive Summary– PoC Integration

• “Device Integration @ Point-of-Care” (vs. POC-T)

– Use Context & Clinical Workflow– Stakeholder Benefits & Risks Assessment– Device Reporting– Plug-and-Play– Device Identification & Association– Symmetric / Bi-directional Communication

44

DPI WP OrganizationDPI WP Organization

• Major WP Sections (cont’d)Major WP Sections (cont’d)– Configuration & Deployment– PCD TF DPI Roadmap

– Appendix A: Use Cases / Clinical Scenarios– Appendix B: Support for U.S. ONCHIT/HITSP– Appendix C: Support for ASTM “ICE”– Appendix D: ISO/IEEE 11073 Examples– Appendix E: Glossary w/ Acronyms– Appendix F: Bibliography / References

55



Front MatterFront Matter

66

IntroductionIntroduction

• General Front Matter….General Front Matter….– Introduction

• Scope• Goals• Overview• Audience• Expected Knowledge and references• Request for Feedback• Open Issues and Questions

– Definitions & Acronyms (ref. appendix)– References (ref. appendix)

77


IHE-PCD CharterIHE-PCD Charter

The Patient Care Device Domain is The Patient Care Device Domain is concerned with concerned with use casesuse cases in which at in which at least one actor is a least one actor is a patient-centric point-patient-centric point-of-care medical deviceof-care medical device. …. …

88

DPI: Scope –

Device Point-of-care Integration (DPI) is concerned with use cases that include care contexts that fall within the stated charter of the IHE PCD, namely where "at least one actor is a one actor is a regulated patient centric point-of-care medical regulated patient centric point-of-care medical devicedevice," and that require device-to-device device-to-device communicationcommunication.


99


Device Point-of-Care IntegrationDevice Point-of-Care Integration• Discovery and Association (PnP)Discovery and Association (PnP)• Real-Time Data ReportingReal-Time Data Reporting• Bi-Directional / SymmetricBi-Directional / Symmetric• External ControlExternal Control

Enterprise IntegrationEnterprise Integration

Semantic InteroperabilitySemantic Interoperability

Monitored ParametersMonitored ParametersAlarms & LimitsAlarms & LimitsWaveforms (Real-Time)Waveforms (Real-Time)Control ParametersControl Parameters

Semantic InteroperabilitySemantic Interoperability

Monitored ParametersMonitored ParametersAlarms & LimitsAlarms & LimitsWaveforms (Real-Time)Waveforms (Real-Time)Control ParametersControl Parameters

Device Reporting, Device Reporting, Management & Management &

ControlControl

Device Reporting, Device Reporting, Management & Management &

ControlControl

Real-TimeClinical Decision Support

Point-of-Care

Applications Real-Time

Closed / OpenLoop Control

DPI Manager / Enterprise

Gateway

DPI Manager / Enterprise

Gateway

Include in the intro. Section w/ description

Include in the intro. Section w/ description

(incl. “technical” interop w/ semantic)

(incl. “technical” interop w/ semantic)

1010


• Heterogeneity – … coexistence in a multi-vendor & multi-modality world, leveraging shared infrastructure

• Semantic Interoperability – … from the sensor to the EHR

• Real-time Availability – … facilitating more timely clinical decisions

PCD Profile Primary Objectives:PCD Profile Primary Objectives:

Ultimately providing improved – … safety, quality of care & workflow efficiency

Reprise in the Intro section & Relate to DPI

Reprise in the Intro section & Relate to DPI

1111



Executive SummaryExecutive Summary

1212

Executive SummaryExecutive Summary

Include the summary sectionInclude the summary section Keep to 2 pagesKeep to 2 pages Base summary on FINAL content of the Base summary on FINAL content of the

documentdocument Focus on …Focus on …

• Concise overview• Compelling need for DPI• Roadmap• …

Major Components / Issues:Major Components / Issues:

1313



Point-of-Care IntegrationPoint-of-Care Integration

1414


Define: Point-of-Care!Define: Point-of-Care! PoC Architectural AlternativesPoC Architectural Alternatives ……


1515

HIMSS Showcase ’09 - ProductsHIMSS Showcase ’09 - Products

DPI!DPI!

1616


NIST TOOL

[Device]Intermediary

Device.xml

Device

MDIB

Agent

Device

Rosetta.xml

HL7 DPI

DPI[x73, incl. PHD]

Legacy [incl. HL7v2x]

Emulator [“test harness”]

MDIB Mgr [Sym]

Transformer

Interface (See next slide)

Emulate.xml

(From 2009.05 PCD F2F @ NIST / Wittenber)

1717


(From 2009.05 PCD F2F @ NIST / Wittenber)

1818



Use Context & Clinical Use Context & Clinical WorkflowWorkflow

1919

Use Context & Clinical WorkflowUse Context & Clinical Workflow

Summarize DPI use cases – point to Summarize DPI use cases – point to Appendix A Appendix A (where the details are kept)(where the details are kept)

Include overview diag’s for contexts, Include overview diag’s for contexts, topologies, data flow types, etc.topologies, data flow types, etc.

……


2020


2121


2222


2323


2424



Stakeholder Benefits & Stakeholder Benefits & Risks AssessmentRisks Assessment

2525


Identify Stakeholders & DPI Value PropositionsIdentify Stakeholders & DPI Value Propositions• MDMMDM• Providers (clinical e.g., “workflow”, biomed, purch., HIT, …)Providers (clinical e.g., “workflow”, biomed, purch., HIT, …)• Gov’t/RegulatoryGov’t/Regulatory• Patient? (safety, quality of care, improved health care costs, Patient? (safety, quality of care, improved health care costs,

…)…)• Purchasers (GPOs – group purch. org’s)Purchasers (GPOs – group purch. org’s)• Payers? (e.g., insurers & impact on risks)Payers? (e.g., insurers & impact on risks)

Identify major business risks/blocks to DPI integrationIdentify major business risks/blocks to DPI integration• Include Paul’s list…Include Paul’s list…

Identify major technical risksIdentify major technical risks• DPI key technical problems to be resolved• 80001-1 Key Properties (P/S, Effec., Data & system security)

Look forward to Roadmap discussion (to address risks)Look forward to Roadmap discussion (to address risks)


2626


Primary focus should be on stakeholder Primary focus should be on stakeholder VPs / opportunities and the roadmap.VPs / opportunities and the roadmap.

……


2727



Device ReportingDevice Reporting

2828

Device ReportingDevice Reporting

Describe & characterize requirements Describe & characterize requirements around basic device out-bound around basic device out-bound reportingreporting

Motivate and detail the contents of the Motivate and detail the contents of the proposed DPI-DR profile …proposed DPI-DR profile …


2929



Device Identification & Device Identification & AssociationAssociation

3030

Device ID & AssociationDevice ID & Association

Review PoC device / entity identification Review PoC device / entity identification issues and requirements (incl. FDA/UDI)issues and requirements (incl. FDA/UDI)

Factor in need for discovery mechanisms & Factor in need for discovery mechanisms & architectural approachesarchitectural approaches

Factor in the PCD profile proposal for ID Factor in the PCD profile proposal for ID management @ PoC (by infusion pump WG management @ PoC (by infusion pump WG participants)participants)

Motivate & detail the contents of the Motivate & detail the contents of the proposed DPI-DnA (Discovery & Association) proposed DPI-DnA (Discovery & Association) profile…profile…

……


3131



Plug-and-Play ConnectivityPlug-and-Play Connectivity

3232

Plug-and-Play ConnectivityPlug-and-Play Connectivity

Define PnPDefine PnP Describe varilous “levels” of PnP (vs. Describe varilous “levels” of PnP (vs.

pre-coordination)pre-coordination) ……


3333



Symmetric / Bi-Directional Symmetric / Bi-Directional CommunicationCommunication

3434

Symmetric/Bi-directional Comm.Symmetric/Bi-directional Comm.

Detail scenarios & requirements behind Detail scenarios & requirements behind devices not only reporting (-DR) but devices not only reporting (-DR) but consuming information from other devicesconsuming information from other devices

Incl. wireless / infusion pump U/C’s?Incl. wireless / infusion pump U/C’s? Address discovery & parameter Address discovery & parameter

“subscription” w/ QoS requirements“subscription” w/ QoS requirements Indicate relationship to PCLC algorithms/ICEIndicate relationship to PCLC algorithms/ICE Motivate the DPI-SYM profile.Motivate the DPI-SYM profile. ……


3535



Device ControlDevice Control

3636


Define types / categories of controlDefine types / categories of control Review X73 PnP external control modelReview X73 PnP external control model Motivate the DPI-XDC profileMotivate the DPI-XDC profile Look forward to “ICE” requirementsLook forward to “ICE” requirements ……


3737


3838


3939



Configuration & DeploymentConfiguration & Deployment

4040

Configuration & DeploymentConfiguration & Deployment

Detail device configuration semantic Detail device configuration semantic layerlayer

DPI Deployment architecturesDPI Deployment architectures MEM – Remote Maintenance Support?MEM – Remote Maintenance Support? MEM – Device config mgmt support?MEM – Device config mgmt support? ……


4141

Test Tool Support – HL7 v2Test Tool Support – HL7 v2

Actor

Actor

2

Specification Tool (e.g. MWB)

IHE/PCD-01Validation

Criteria(XML)

HL7 Test

Messages

HL7 Test

Messages

MsgMappingProfile

TestReports

HL7 TestMessages

Message Generation(X73 + HL7 Partial Messages)

IHE-PCD MessageSpecifications

(IHE-PCD TF Vol 2)

HL7 V2 Profile(XML)

NIST Data Repository(HL7 Ref. DB,Table Values,

Sample Values,From Profiles,

Default Values,X73 Device Profiles)

(XML)

Device Table Values

[Rosetta Stone Terms]

(Manufacturer Specific)[e.g., B.Braun, Draeger, GE, Philips, Spacelabs,

Welch Allyn, etc.]

NIST HL7 V2.xTesting Tool

(Web Services)

Message Specification

Profiles

1

Device Content

HL7 Msgs

Msg Specifications

Arrow Key:

4242

Test Tooling Support - NISTTest Tooling Support - NIST• NIST Test ToolsNIST Test Tools

– ICSGeneratorICSGenerator • Medical Device Profiles (specializations)• Implementation Conformance Statements

– ValidatePDUValidatePDU • X73 Application Layer Message Syntax and Semantic Validation

• NIST Medical Device Standards WorkNIST Medical Device Standards Work– ISO/IEEE 11073 Standard (X73): Medical Device Communication

• XML SchemaXML Schema: NIST P11073-10202 Domain Information Model

• CollaborationsCollaborations– Integrating Health Enterprise - Patient Care Devices (IHE-PCD)– IEEE 11073 Personal Health Devices (PHD) Working Group (WG)– ISO/IEEE 11073 WG

• On-going Work and Future Direction…On-going Work and Future Direction…– IHE-PCD profile and message generation and testing (includes enterprise – e.g.,

HL7 V2 & V3HL7 V2 & V3)– PHD X73 profile and message testing (ContinuaContinua)– X73 Java Class LibraryX73 Java Class Library

• NIST Team MembersNIST Team Members– John Garguilo ([email protected] 301-975-5248), Sandra Martinez,

Maria Cherkaoui (guest researcher), and Richard Theimer (contractor)

http://www.nist.gov/medicaldeviceshttp://www.nist.gov/medicaldevices

4343



PCD TF & DPI RoadmapPCD TF & DPI Roadmap

4444


Show relationship of DPI profile Show relationship of DPI profile components to the PCD TFcomponents to the PCD TF

Establish a roadmap for Establish a roadmap for phased phased developmentdevelopment of DPI components of DPI components

……


4545


RTMRTM DECDEC DEC-PIB (& ID binding management)DEC-PIB (& ID binding management) DEC-SPDDEC-SPD ACMACM PIV / Infusion Pump IntegrationPIV / Infusion Pump Integration MEMMEM WCM … ?

DPI & Existing enterprise-oriented profiles:DPI & Existing enterprise-oriented profiles:

Factor in Jan’s Table from New Directions +

Factor in Jan’s Table from New Directions +

Annotate diagrams on subsequent slides

Annotate diagrams on subsequent slides

4646

PCD TF: DPI & RosettaPCD TF: DPI & Rosetta

Migrating Toward True PCD Semantic Interoperability

Today HIMSS ’10!

ISO/IEEE 11073Semantic Standards

Vendor Semantics

IHE PCD TF Content

Vendor A

Vendor C

Vendor B

RosettaMappingTables(RTM)

11073PnP Comm

HL7 v3CDA/CCD

HL7 v2Messages

DPI Semantics are DPI Semantics are 100% in the “Gold” 100% in the “Gold” Semantic DatabaseSemantic Database

4747

Device Enterprise Communication (DEC)Device Enterprise Communication (DEC)

4848

(DEC-PIB) Patient ID Binding(DEC-PIB) Patient ID Binding

ITI-PAMITI-PAM

ITI-PDQITI-PDQ

Note: Note: This is an option to DEC for coordinating authenticated patient IDs.This is an option to DEC for coordinating authenticated patient IDs.

No Significant Changes


4949

SPD - Subscribe to Patient DataSPD - Subscribe to Patient Data

Note: Note: This is an option to DEC for configuring PCD-01 content & frequency.This is an option to DEC for configuring PCD-01 content & frequency.



5050

SPD - Subscribe to Patient DataSPD - Subscribe to Patient Data

5151

ACM Data FlowsACM Data Flows

AlarmSource

AlarmAggregator

AlarmReceiver

AlarmCoordinator

AlarmDisseminator

AlarmCommunication

AlarmEndpoint

AlarmCommunication

AC

AlarmCommunication

AC

AlarmManagement

AM

AlarmManagement

AM

AlarmReporter

AR

AlarmReporter

AR

AlarmReporter

AlarmCache

Communication detailed in ACM profileCommunication detailed in ACM profile

Communication not detailed in ACM profileCommunication not detailed in ACM profile

.

.

.

.

.

.......

PCD Inputs(PM, NC, Resp,

Pump, etc.)

PCD Inputs(PM, NC, Resp,

Pump, etc.)

Output Devices(Marquee Sign, Pager,

Wi-Fi Phone or Badge, etc.)

Output Devices(Marquee Sign, Pager,

Wi-Fi Phone or Badge, etc.)

HIS, EMRHIS, EMRAlarm

ArchiverAA

AlarmArchiver

AA

Report Alarm Report Alarm

Alarm StatusAlarm Status**Alarm StatusAlarm Status**

*Note: Implementation TBD*Note: Implementation TBD

Subscribe to AlarmSubscribe to Alarm **Subscribe to AlarmSubscribe to Alarm **

** Disseminate Alarm ** Disseminate Alarm Dissemination StatusDissemination Status **Dissemination StatusDissemination Status **

Report AlarmReport AlarmReport AlarmReport AlarmSubscribe to Alarm Subscribe to Alarm ** Subscribe to Alarm Subscribe to Alarm **

GapGap!!

5252

PIV ActorsActors

DEC!DEC!

5353

MEMMEM

DEVICE MANAGEMENT

REPORTER

Patch ManagementPending patchesPatch history

Location ServicesCurrent locationPrevious locations (Trending)Boundary controls (Alarm when

device leaves area)

Device Configuration Management

Recall ManagementUnique device identificationHardware configuration (serial numbers, etc)Software configuration (revision numbers, etc)

Device ReconfigurationUse profiles (NICU vs. CICU)

Operational Status and Monitoring

Is the device currently in useUsage historyAlarms – which are active, what the trigger

levels, how long has the alarm been onDay/time of last self check and its resultEvent log recordingPreventative Maintanence

Last PMNext scheduled PMLast repair time/date

Battery ManagementOn A/C or D/C? Charge level (% of full)/Est.

operating time left. Charging / Discharging historyBattery type and installation date Est. battery life

IHE

PC

D

Sta

nd

ard

s b

ased

T

ran

sac

tio

ns

DEVICE MANAGEMENT

CONSUMER

DPIDECACM

Risk ManagementSupport for IEC 80001-1 ...

v Activities (incl. configuration and network performance monitoring)

v Risk Management Filev ...

5454

WCMWCM

WCM will cover the following prioritized WCM will cover the following prioritized Use Cases:Use Cases:

1.1. Current Multi-Channel Waveform (MCW) Current Multi-Channel Waveform (MCW) snapshotsnapshot as defined by the source is created/pushed by as defined by the source is created/pushed by alarm source based on alarm source based on eventevent occurrence occurrence

2.2. Current MCW Current MCW snapshotsnapshot as defined by source on as defined by source on requestrequest to source to source

3.3. Continuous MCW Continuous MCW streamsstreams4.4. MCW snapshot MCW snapshot archivearchive query query5.5. Periodic Periodic trendtrend data on request data on request

It is not expected that all Use Cases will be It is not expected that all Use Cases will be covered during the first cycle.covered during the first cycle.

5555

WCMWCM In addition to defining the waveform representation In addition to defining the waveform representation

scheme, scheme, attributesattributes will need to be defined, including: will need to be defined, including:

Sampling RateSampling Rate RangeRange and and OffsetOffset FilteringFiltering DisplayDisplay AttributesAttributes AnnotationsAnnotations (time points and time intervals) (time points and time intervals)

Beat identificationBeat identification Breath identificationBreath identification Optional parametric data (e.g. HR, IBP, …)Optional parametric data (e.g. HR, IBP, …) Etc.Etc.

StatusStatus Out-of-rangeOut-of-range Leads OffLeads Off ZeroZero Artifact, NoiseArtifact, Noise Etc.Etc.

Etc…Etc…

5656



General DPI Use CasesGeneral DPI Use Cases

5757

Appendix: General DPI Use CasesAppendix: General DPI Use Cases

Detail the use cases / clinical scenarios Detail the use cases / clinical scenarios identified in DPI proposalsidentified in DPI proposals

Format? Level of Detail?Format? Level of Detail? Include scenario diags from 2008/10 DPI Include scenario diags from 2008/10 DPI

F2F in Boston?F2F in Boston? ……


5858



Support for ONCHIT / HITSPSupport for ONCHIT / HITSP

5959

PCD & HITSPPCD & HITSP

(from HITSP TC Orientation 2009.02.17)

6060

Appendix: ONCHIT / HITSP SupportAppendix: ONCHIT / HITSP Support

Indicate DPI support for the NHIN & Indicate DPI support for the NHIN & HITSP Deliverables (incl. CmDC)HITSP Deliverables (incl. CmDC)

Sync with proposed HITSP CmDC Sync with proposed HITSP CmDC Technical NoteTechnical Note

Include diag’s from HITSP discussion Include diag’s from HITSP discussion earlier in 2009earlier in 2009

……


6161



Support for ASTM “ICE”Support for ASTM “ICE”

6262

Appendix: “ICE” SupportAppendix: “ICE” Support

Show how DPI components can support ICE-Show how DPI components can support ICE-based implementations / arch’sbased implementations / arch’s

Include ICE-PAC analysis w.r.t. DPIInclude ICE-PAC analysis w.r.t. DPI Note: See Rhoads draft appendix.Note: See Rhoads draft appendix. Start with ICE overview & ICE-PAC work Start with ICE overview & ICE-PAC work

reviewreview Include requirements for DPI + how this Include requirements for DPI + how this

relates to the PCD TF roadmap (main section)relates to the PCD TF roadmap (main section) ……


6363

Appendix C: ICE SupportAppendix C: ICE Support

(From ICE-PAC Overview Update 2009.06.22 to IHE PCD)

6464



ISO/IEEE 11073 ISO/IEEE 11073 Messaging ExamplesMessaging Examples

6565

Appendix: 11073 ExamplesAppendix: 11073 Examples

Worked examples from the MDCIG Demo II Worked examples from the MDCIG Demo II efforteffort

Update per Infusion Pump modelsUpdate per Infusion Pump models ““Examples” … not duplication of the Demo II Examples” … not duplication of the Demo II

document!document!• Information ModelInformation Model• Sequence / Interaction DiagsSequence / Interaction Diags• Message ExamplesMessage Examples

……


6666


General Issues:General Issues:

……..

6767

Date post:	16-Jan-2016
Category:	Documents
Upload:	phyllis-alexander
View:	218 times
Download:	0 times

Patient Care Devices DPI White Paper Discussion (Updated: 2009.08.20)

Documents