1IHE Workshop – June 2006 What IHE Delivers
Nicholas SteblayNicholas Steblay
Boston ScientificBoston Scientific
Implantable Device Cardiac Implantable Device Cardiac Observations (IDCO) ProfileObservations (IDCO) Profile
2IHE Workshop – June 2006IHE Workshop – June 2006
Implantable Cardiac DevicesImplantable Cardiac Devices
Pacemakers – therapy for heart rate problems
Defibrillators – therapy for life threatening heart rhythms
Cardiac Resynchronization – therapy for congestive heart failure
3IHE Workshop – June 2006IHE Workshop – June 2006
Device InterrogationsDevice Interrogations
Implant
Clinic
Home
The act of retrieving data from The act of retrieving data from implanted cardiac devices. implanted cardiac devices. Done at implant or during Done at implant or during patient follow-ups.patient follow-ups.
Information includes Patient and Information includes Patient and Device Observations, andDevice Observations, andTherapy SettingsTherapy Settings
4IHE Workshop – June 2006IHE Workshop – June 2006
Clinical Process – Device Follow-upClinical Process – Device Follow-up
3.1 Schedule Follow-ups
3.2 Exam Patient & Interrogate Device
3.3 Analyze Information
3.1.1 Schedule In Clinic Follow-ups
3.1.2 Schedule Remote Follow-ups
3.2.1 Exam Patient (Physical & Lab Tests If Needed)
3.2.2 Interrogate Device In Clinic
3.2.3 Interrogate Device Remote
3.3.1 Review Exam and Interrogation Information
Determine New or Adjusted Therapies
3.4 Adjust Therapy and Configure Device
3.3.1 Pharmalogical3.3.2 Configure and
Test Pulse Generator
3.5 Update Medical Record
3.5.1 Record and Follow-up Process and Outcomes
3.5.2 Record Pertinent Data Concerning Device and Pharmalogical
3.5.4 Sign-Off Procedure
3.5.5 Create Follow-up Summary (Referral Letter) for Following Physician
1.0 Diagnosis
2.0 Implant
3.0 Device Follow-up
4.0Patient Follow-up
5.0 Acute Events
Explants
Level 0
Level 1
Level 2
5IHE Workshop – June 2006IHE Workshop – June 2006
Implantable Cardiac Device Follow-up Implantable Cardiac Device Follow-up Problems and OpportunitiesProblems and Opportunities
Electrophysiologists follow patients with implantable cardiac devices from multiple vendors
For each patient follow-up information that is stored in the implantable device is electronically collected by an “interrogating” device In-Clinic – Programmer Remote – Communicator / Data Collector
Each “interrogating” device is vendor proprietary
The follow-ups can occur in-clinic or remotely in the home healthcare environment
Access to follow-up information often requires clinicians to use multiple vendor specific systems and interfaces, complicating efficiency and quality of workflows
Aggregation of data into a central EMR or device clinic management systems requires manual and paper processes
6IHE Workshop – June 2006IHE Workshop – June 2006
IDCO Value PropositionIDCO Value Proposition
Enable management of follow-up information in a central system such as an Device Clinic Management System or EMR
Improve efficiency and quality of related clinical processes Single point of access for information Automation of current manual processes for data
collection, aggregation and analysis Standardization of workflow processes Enabling of analytics
7IHE Workshop – June 2006IHE Workshop – June 2006
IDCO Profile ApproachIDCO Profile Approach
Rally domain vendors around a profile that defines a standard approach to integrating implantable cardiac device follow-up information into a receiving clinic system
Enable the needed systems integration by profiling the use of standard, domain applicable messaging protocols, structures and data semantics
HL7 Therapeutic Device Domain – Implantable Device Cardiac messaging standards
ISO/IEEE 11073 Point of Care Medical Device Communication Standards nomenclature
Define actors, transactions and constraints consistent with existing and evolving IHE profiles and contexts
Align with future EP Workflow and other related profilesKeep it simple for first year – trial implementation
8IHE Workshop – June 2006IHE Workshop – June 2006
IDCO Profile Use CasesIDCO Profile Use Cases
In-Clinic Implants or Follow-ups Patients present themselves in-clinic for implantation or
follow-ups Information is collected using vendor specific “programmers” Information is sent from interrogation system to a central
Device Clinic Management System or EMR
Remote Follow-ups Patients devices are interrogated in the home health care
environment Information is collected using vendor specific communication
devices and systems Information is sent from interrogation system to a central
Device Clinic Management System or EMR
IDCO ProfileIDCO ProfileSystems ModelSystems Model
Home Healthcare Environment
Inductive or RF Interrogation
In-Clinic Healthcare Environment
Inductive or RF Interrogation
IHE
TR
AN
SA
CT
ION
IHE TRANSACTION
IHE
TR
AN
SA
CT
ION
Programmer
Device Vendor Environment
IHE TRANSACTION
SecuredNetwork
Transmissions
SecuredNetwork
Transmissions
Another ClinicSecuredNetwork
Transmissions
EHR or DeviceManagement System
Vendo
r Dat
a Tra
nsfe
r
Device Data Information Management System
InterrogationDevice
10IHE Workshop – June 2006IHE Workshop – June 2006
IDCO Actors and TransactionIDCO Actors and Transaction
Observation Processor
Observation Repository
Send Observation[CARD - 12]
Send Observation[CARD - 12]
PIX Consumer
ObservationCreator
PIX Consumer
Patient Demographics
Consumer
11IHE Workshop – June 2006IHE Workshop – June 2006
IDCO ActorsIDCO Actors
Observation Processor
Observation Repository
Send Observation[CARD - 12]
Send Observation[CARD - 12]
PIX Consumer
ObservationCreator
PIX Consumer
Patient Demographics
Consumer
Observation Creator - A system that creates and transmits diagnostic or therapeutic observational data.
Observation Processor and Repository – Systems that receive clinical observations and further process them or store them for retrieval and display.
Grouped with PIX and PAM actors for patient identification and demographics management (not required first year).
12IHE Workshop – June 2006IHE Workshop – June 2006
IDCO ActorsIDCO Actors
Alternative Actor configuration
HL7 Router - A system that receives HL7 messages, routes them to one or more configured actors, and handles transport level acknowledgements.
Router will manage patient identification cross-referencing
Observation Processor
Observation Repository
Send Observation[CARD - 12]
ObservationCreator
Patient Demographics
Consumer
HL7 RouterSend Observation
[CARD - 12]
Send Observation[CARD - 12]
PIX Consumer
13IHE Workshop – June 2006IHE Workshop – June 2006
Potential ParticipantsPotential Participants
Observation Creator Implantable Cardiac Device Vendors
Observation Processor and Repository EMR or Device Clinic Management System
Vendors
HL7 Router Integration Engine Vendors
Others (?)
14IHE Workshop – June 2006IHE Workshop – June 2006
IDCO TransactionIDCO Transaction
Observation Processor
Observation Repository
Send Observation[CARD - 12]
Send Observation[CARD - 12]
PIX Consumer
ObservationCreator
PIX Consumer
Patient Demographics
Consumer
CARD-12
Unsolicited HL7 v2.5 ORU message OBX contains XML payload based on HL7 v3 IDC message XML payload coded using ISO/IEEE 11073.1.1.3 IDC nomenclature
containing Device Observations, Patient Observations, Device Therapy Settings
Options for standard v2.5 OBX and embedded PDF report Audit Trail and Node Authentication (ATNA) profile recommended
for remote follow-ups across non-trusted networks
15IHE Workshop – June 2006IHE Workshop – June 2006
Embedded XML Data Payload in OBXEmbedded XML Data Payload in OBXBased on v3 IDC RMIMBased on v3 IDC RMIM
Implantable Cardiac Device Summary(POTD_RM000001)
Description: Implantable Cardiac Device Summary report.This report contains a subset of current programmed settingsand device observations
ObservationclassCode*: <= OBSmoodCode*: <= EVNid*: SET<II> [1..*]code*: CD CWE [1..1] <=DeviceInterrogation (The capturing or reading out of datastored in the medical device)statusCode: CS CNE [0..1] <=ActStatuseffectiveTime*: TS [1..1]
CMET: (PAT) R_Patient
[identified/confirmable](COCT_MT050002)
0..1 roleName 1..1 patient *
typeCode*: <= RCTcontextControlCode: CS CNE [0..1] <= "OP"
recordTarget
DeviceTherapySettingclassCode*: <= OBSmoodCode*: <= EVNcode*: CE CWE [1..1] <= ImplantedCardiacDeviceControlVariable (Externally defined subset of IEEE 1073 vocabulary)text: ED [0..1]value: ANY [0..1]
1..* assignedEntity
typeCode*: <= AUTtime*: TS [1..1]signatureCode: CE CNE [0..1] <= XsignatureText: ED [0..1]
author
0..* assignedEntity
typeCode*: <= PRFperformer
CMET: (ASSIGNED) R_AssignedEntity
[identified/confirmable](COCT_MT090002)
0..1 roleName
0..1 externalCardiacInterrogationDevice
typeCode*: <= RDVreusableDevice
0..1 assignedInterrogationDevice
ExternalCardiacInterrogationDeviceclassCode*: <= ASSIGNEDid: II [0..1]code: CE CWE [0..1] <= DedicatedServiceDeliveryLocationRoleType
InterrogationDeviceclassCode*: <= DEVdeterminerCode*: <= INSTANCEid: II [0..1] (e.g. Serial Number)desc: ED [0..1]manufacturerModelName: SC CWE [0..1] <= ManufacturerModelNamesoftwareName: SC CWE [0..1] <= SoftwareName
OrganizerclassCode*: <= ORGANIZERmoodCode*: <= EVN
CMET: (ASSIGNED) R_AssignedDevice
[universal](COCT_MT090300)
0..1 roleName
Note:Participant who assists inperforming the interrogationof the implanted device
Note:Implantable CardiacDevice or identified lead
1..1 assignedDevice *
typeCode*: <= SBJcontextControlCode: CS CNE [0..1] <= "OP"
subject
PatientObservationclassCode*: <= OBSmoodCode*: <= EVNid: II [0..1]code*: CD CWE [1..1] <= CardiacDevicePatientObservationTypetext: ED [0..1]effectiveTime: IVL<TS> [0..1]value: ANY [0..1]interpretationCode: CE CNE [0..1] <= ObservationInterpretationNormality
1..1 patient
typeCode*: <= SBJcontextControlCode: CS CNE [0..1] <= OP "ContextControlOverriding"
subject
MedicalDeviceActclassCode*: <= ACTmoodCode*: <= EVNid: SET<II> [0..*]code*: CD CWE [1..1] <= MedicalDeviceActtext: ED [0..1]effectiveTime: TS [0..1]
0..* medicalDeviceAct
typeCode*: <= SUBJcontextControlCode: CS CNE [1..1] <= "ON"contextConductionInd: BL [0..1] "true"
subject
0..* deviceTherapySetting
typeCode*: <= CTRLVcontextControlCode: CS CNE [0..1] <= "AN"contextConductionInd: BL [0..1] "false"
controlVariable
1..1 assignedDevice
typeCode*: <= PPRFcontextControlCode: CS CNE [0..1] <= "OP"
primaryPerformer
0..* organizer
typeCode*: <= COMPcontextControlCode: CS CNE [0..1] <= "AN"contextConductionInd: BL [0..1] "true"
component1
DeviceTherapyclassCode*: <= PROCmoodCode*: <= EVNid: II [0..1]code*: CE CWE [1..1] <= ImplantedCardiacDeviceTherapy (IEEE 1073)text: ED [0..1]activityTime: TS [0..1]
DeviceObservationclassCode*: <= OBSmoodCode*: <= EVNcode*: CD CWE [1..1] <= CardiacDeviceSelfObservationType (IEEE1073)text: ED [0..1]effectiveTime: IVL<TS> [0..1]value: ANY [0..1]interpretationCode: CE CNE [0..1] <= ObservationInterpretationNormalitymethodCode: CE CWE [0..1] <= ObservationMethod (IEEE 1073)
0..* deviceObservation
typeCode*: <= COMPcontextControlCode: CS CNE [0..1] <= "ON"contextConductionInd: BL [0..1] "true"
component
0..* patientObservation
typeCode*: <= COMPcontextControlCode: CS CNE [0..1] <= "AN"contextConductionInd: BL [0..1] "true"
component2
0..* deviceTherapy
typeCode*: <= COMPcontextControlCode: CS CNE [0..1] <= "AN"contextConductionInd: BL [0..1] "true"
component3
Note:E.g.: Brady SettingsPacing Output SettingsAtrial Tachy SettingsVentricular Tachy Settings
OrganizationclassCode*: <= ORGdeterminerCode*: <= INSTANCEid: SET<II> [0..*]name: BAG<EN> [0..*]
Note:This ACT changes thesubject from patient tothe device.
0..1 encounter *
typeCode*: <= COMPcontextControlCode: CS CNE [1..1] <= "OP"contextConductionInd: BL [1..1] "false"
componentOf CMET: (ENC) A_Encounter
[universal](COCT_MT010000)
component
0..* deviceObservation
typeCode*: <= COMPcontextControlCode: CS CNE [1..1] <= ContextControlPropagating "AP"contextConductionInd: BL [0..1]sequenceNumber: INT [0..1]priorityNumber: INT [0..1]
component
0..* patientObservation
typeCode*: <= COMPcontextControlCode: CS CNE [0..1] <= ContextControlPropagating "AP"contextConductionInd: BL [0..1]sequenceNumber: INT [0..1]priorityNumber: INT [0..1]
component
0..* deviceTherapySetting
typeCode*: <= COMPcontextControlCode: CS CNE [0..1] <= ContextControlPropagating "AP"contextConductionInd: BL [0..1]sequenceNumber: INT [0..1]priorityNumber: INT [0..1]
Option for Standard OBX SegmentOption for Standard OBX SegmentELEMENT NAME SEQ COMP DT LEN USAGE CARD TBL# ITEM # Fixed Ex. Values
Set ID - OBX 1 SI 4 R [1..1] 00569 1
Value Type 2 ID 2 R [1..1] 0125 00570 DTM
Observation Identifier 3 CE 250 R [1..1] 00571
Identifier 1 ST 80 R [1..1] MDC_IDC_DEVICE_IMPLANT_DATE
Text 2 ST 256 R [1..1] The implant date of the device
Name of Coding System 3 ST 20 R [1..1] IEEE P10731.1.3
Observation Sub-ID 4 ST 20 C [1..1] 00572 3.1
Observation Value 5 varies * RE [0..1] 00573 20060317
Units 6 CE 250 RE [0..1]
Observation Result Status 11 ID 1 R [1..1] 0085 00579 Y F
Date/Time of the Observation 14 TS 26 RE [0..1] 00582
20060317170000+0006
Observation Method 17 CE 250 00936
Identifier 1 ST 80 R [1..1] MDC_IDC_SESSION_TYPE
Text 2 ST 256 R [1..1] In Clinic
Name of Coding System 3 ST 20 R [1..1] IEEE P10731.1.3
Equipment Instance Identifier 18 EI 256 O [0..*] 01479 Programmer XXXX
17IHE Workshop – June 2006IHE Workshop – June 2006
Observations Coded UsingObservations Coded UsingISO/IEEE 11073 IDC NomenclatureISO/IEEE 11073 IDC Nomenclature
IEEE 1073.1.1.3 IDC terms - nomenclatureDevice ObservationsPatient ObservationsDevice Therapy SettingsDevice TherapiesData TypesUnitsEnumerated Value TablesDiscriminators
Device Observations - [top]
Automatic Manual
1 Device Type MDC_IDC_DEVICE_TYPE The type of device
2 Device Manufacturer MDC_IDC_DEVICE_MANUFACTURER MDC_IDC_DEVICE_TYPE The manufacturer of the device
3 Device Name MDC_IDC_DEVICE_NAME MDC_IDC_DEVICE_TYPE The marketing name given to a device by the manufacturer
4 Device Model MDC_IDC_DEVICE_MODEL MDC_IDC_DEVICE_TYPE The model of a device
6 Device Serial Number MDC_IDC_DEVICE_SERIAL_NUMBER MDC_IDC_DEVICE_TYPE The serial number for a device
7 Device Implant Date MDC_IDC_DEVICE_IMPLANT_DATE MDC_IDC_DEVICE_TYPE The implant date of the device
8 Device Explant Date MDC_IDC_DEVICE_EXPLANT_DATE MDC_IDC_DEVICE_TYPE The explant date of the device
9 Device Abandon Date MDC_IDC_DEVICE_ABANDON_DATE MDC_IDC_DEVICE_TYPE The date the device was abandoned (still implanted but not functioning)
10 System Status MDC_IDC_SYSTEM_STATUS Overall status of the system
17 Lead State MDC_IDC_LEAD_STATE The state of lead
18 Lead Polarity Type MDC_IDC_LEAD_POLARITY_TYPE The type of lead polarity
20 Lead Heart Anatomy Location Modifier MDC_IDC_LEAD_ANOTOMICAL_LOCATION_MODIFIER
MDC_IDC_LEAD_ANOTOMICAL_LOCATION The site within the heart anatomy where the lead is fixated
26 Lead Pace Threshold at Implant Amplitude MDC_IDC_LEAD_PACE_THRESHOLD_IMPLANT_AMPLITUDE
MDC_IDC_LEAD_PACE_THRESHOLD_IMPLANT 1 The minimum Chamber Pulse Amplitude needed for capture
27 Lead Pace Threshold at Implant Pulse Width MDC_IDC_LEAD_PACE_THRESHOLD_IMPLANT_PULSE_WIDTH
MDC_IDC_LEAD_PACE_THRESHOLD_IMPLANT 2 The minimum Pulse Width needed for capture
29 Lead DFT at Implant MDC_IDC_LEAD_DFT_IMPLANT For each high voltage lead, the measured defibrillation threshold (DFT) at implant.
31 Date/Time of Communication Session MDC_IDC_SESSION_DATE_TIME Date of the current in-clinic or remote interrogation.
32 Previous Session Date MDC_IDC_PREVIOUS_SESSION_DATE_TIME Date of most recent in-clinic or remote interrogation.
33 Session Type MDC_IDC_SESSION_TYPE The type of device interaction that generated the current data set. If the specific cause of a remote data transmission is unknown, use the "Remote" value. If the specific cause is known, use the values of Remote-Scheduled, Remote-Patient Initiatied or Remote-Device Initiated.
# Display Name Reference ID Parent ID SeqNr Discriminator Description
19 Lead Heart Anatomy Location MDC_IDC_LEAD_ANOTOMICAL_LOCATION MDC_IDC_discriminator_LeadLocationType The heart anatomy where the lead is located
21 Lead Intrinsic Amplitude at Implant MDC_IDC_LEAD_INTRINSIC_AMPLITUDE_IMPLANT MDC_IDC_discriminator_HowMeasured Intrinsic Amplitude (P-Wave) measured during an Intrinsic Amplitude Test at implant
22 Lead Intrinsic Amplitude Configuration at Implant MDC_IDC_LEAD_INTRINSIC_AMPLITUDE_CONFIGURATION_IMPLANT
MDC_IDC_discriminator_ElectrodeType For each low voltage lead, the sensing configuration used during implant to measure the intrinsic amplitude
23 Lead Pace Impedance at Implant MDC_IDC_LEAD_PACE_IMPEDANCE_IMPLANT MDC_IDC_discriminator_HowMeasured Lead Impedance measured during a Lead Impedance Test at implant
24 Lead Pace Impedance Configuration at Implant MDC_IDC_LEAD_PACE_IMPEDANCE_CONFIGURATION_IMPLANT
MDC_IDC_discriminator_ElectrodeType For each low voltage lead, the pacing configuration used during implant to measure the lead impedance
25 Lead Pace Threshold at Implant Amplitude @ Pulse Width
MDC_IDC_LEAD_PACE_THRESHOLD_IMPLANT MDC_IDC_discriminator_HowMeasured The minimum electrical stimulation (pacemaker output pulse) required to consistently initiate chamber depolarization and cardiac contraction, as determined by a clinician-interpreted threshold test at implant.
28 Lead Pace Threshold Configuration at Implant MDC_IDC_LEAD_PACE_THRESHOLD_CONFIGURATION_IMPLANT
MDC_IDC_discriminator_ElectrodeType For each low voltage lead, the pacing configuration used during implant to measure the capture threshold
30 Lead DFT Configuration at Implant MDC_IDC_LEAD_DFT_CONFIGURATION_IMPLANT MDC_IDC_discriminator_ElectrodeType For each high voltage lead, the shock configuration used during defibrillation threshold (DFT) measurement at implant.
18IHE Workshop – June 2006IHE Workshop – June 2006
Example Transaction FlowExample Transaction FlowDevice Interrogator Observation Creator Observation Processor Observation Repository
Query Device (1)
Send Interrogation
Send Interrogation (2)
Validate and Review (3)
Translate Information (4)
Send Observation [CARD-12] (5)
Process Observation (7)
Send Observation [CARD-12] (8)
Store Observation (10)
PIX Manager
PIX Query [ITI-9] (6)
PIX Query [ITI-9] (9)
19IHE Workshop – June 2006IHE Workshop – June 2006
Potential Extended Actor GroupingsPotential Extended Actor Groupings
ObservationRepository
Information Source
Display
Retrieve Document for Display [ITI - 12]
Retrieve Specific Info for Display [ITI - 11]
ObservationProcessor
ReportCreator
Report Manager
Encapsulated Report Submission [CARD - 7]
ObservationProcessor
EvidenceCreator
Image Manager
Storage Committment [CARD - 3]
Modality Images/Evidence Stored [CARD - 2]
Store Evidence Documents [RAD - 43]
Storage Committment [CARD - 7]
ObservationProcessor
Document Source
Document Repository
Provide and Register Document Set [ITI - 15]
Basic IDCO Report Display using Retrieve Information for Display Profile (RID)Basic IDCO Report Display using Retrieve Information for Display Profile (RID)
IDCO Data Incorporation into a Report using Displayable Reports Profile (DRPT)IDCO Data Incorporation into a Report using Displayable Reports Profile (DRPT)
IDCO Discrete Data Storage using Evidence Documents Profile (ED)IDCO Discrete Data Storage using Evidence Documents Profile (ED)
IDCO Submission to an EHR using Cross Domain Document Sharing Profile (XDS)IDCO Submission to an EHR using Cross Domain Document Sharing Profile (XDS)
20IHE Workshop – June 2006IHE Workshop – June 2006
What’s Next?What’s Next?
PIX and PAM groupings required
Waveforms
Episodes
Scheduling / Orders
21IHE Workshop – June 2006IHE Workshop – June 2006
More info on www.ihe.netMore info on www.ihe.net
Profile for trial implementation
SDK (available July 1) containing Schema for embedded XML payload Example HL7 2.5 messages
• Wrappers• Standard OBX
Example OBX XML payload based on v3 IDC message
Spreadsheet / XML, Schema, Style Sheets for ISO/IEEE 11073.1.1.3 Nomenclature
22IHE Workshop – June 2006IHE Workshop – June 2006
QuestionsQuestions
Questions for me?
A few for you …
To claim this profile you need to support OBX embedded XML data payload. How does this impact your ability to participate? Do potential participating vendors prefer a standard v2.5 ORU message OBX or one with an embedded v3 data payload? Why or why not? Comment soon!
Nicholas SteblayBoston [email protected](651) 582-7316
23IHE Workshop – June 2006IHE Workshop – June 2006