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1IHE Workshop – June 2007 What IHE Delivers
Nicholas SteblayNicholas Steblay
Boston ScientificBoston Scientific
Implantable Device Cardiac Implantable Device Cardiac Observations (IDCO) ProfileObservations (IDCO) Profile
2IHE Workshop – June 2007IHE Workshop – June 2007
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 2007IHE Workshop – June 2007
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 2007IHE Workshop – June 2007
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 2007IHE Workshop – June 2007
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 2007IHE Workshop – June 2007
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 2007IHE Workshop – June 2007
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 v2.5 ORU message ISO/IEEE 11073 Point of Care Medical Device
Communication Standards nomenclatureDefine actors, transactions and constraints consistent with existing and evolving IHE profiles and contexts
Align with EP Workflow and other related profiles
8IHE Workshop – June 2007IHE Workshop – June 2007
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 2007IHE Workshop – June 2007
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 2007IHE Workshop – June 2007
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.
12IHE Workshop – June 2007IHE Workshop – June 2007
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 2007IHE Workshop – June 2007
Potential ParticipantsPotential Participants
Observation Creator Implantable Cardiac Device Vendors
Observation Processor and Repository EMR, CIS or Device Clinic Management System
Vendors
HL7 Router Integration Engine Vendors
Others (?)
14IHE Workshop – June 2007IHE Workshop – June 2007
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 Observation values coded using ISO/IEEE 11073.1.1.3 IDC
nomenclature Option for embedded PDF report Audit Trail and Node Authentication (ATNA) profile
recommended for remote follow-ups across non-trusted networks
15IHE Workshop – June 2007IHE Workshop – June 2007
IDC NomenclatureIDC NomenclatureContainment TreeContainment Tree
1
1
Device
Session
1
1
System Lead
1 0..*
Information
1
1
Setting
10..1
Battery
1
0..*1
0..1
Capacitor Tachycardia Therapy
1
0..*
Episode Counter
1
0..*
Episode
1
0..*
High Voltage Channel
1
0..*
Channel
1
0..*
Counter
1
0..1
Tachycardia Therapy Counter
1
0..*
Information
1
1
16IHE Workshop – June 2007IHE Workshop – June 2007
HL7 2.5 ORUHL7 2.5 ORUOBX-4 Used for ContainmentOBX-4 Used for Containment
...
OBX|48|CWE|2314^MDC_IDC_SYS_DEV_TAC_THRPY_ZONE_NAME^MDC_IDC|1|Slow VT||||||F|||20070422170125||||DEV12359
OBX|49|CWE|2315^MDC_IDC_SYS_DEV_TAC_THRPY_ZONE_STATUS^MDC_IDC|1|Active||||||F|||20070422170125||||DEV12359
OBX|50|CWE|2312^MDC_IDC_SYS_DEV_TAC_THRPY_TYPE_ATP^MDC_IDC|1|Ramp||||||F|||20070422170125||||DEV12359
OBX|51|NM|2308^MDC_IDC_SYS_DEV_TAC_THRPY_PULSES_ATP^MDC_IDC|1|3||||||F|||20070422170125||||DEV12359
OBX|52|NM|2309^MDC_IDC_SYS_DEV_TAC_THRPY_SHOCK_ENERGY^MDC_IDC|1.1|25|J|||||F|||20070422170125||||DEV12359
OBX|53|NM|2309^MDC_IDC_SYS_DEV_TAC_THRPY_SHOCK_ENERGY^MDC_IDC|1.2|27|J|||||F|||20070422170125||||DEV12359
OBX|54|NM|2309^MDC_IDC_SYS_DEV_TAC_THRPY_SHOCK_ENERGY^MDC_IDC|1.3|29|J|||||F|||20070422170125||||DEV12359
OBX|55|NM|2309^MDC_IDC_SYS_DEV_TAC_THRPY_SHOCK_ENERGY^MDC_IDC|1.4|32|J|||||F|||20070422170125||||DEV12359
OBX|56|NM|2309^MDC_IDC_SYS_DEV_TAC_THRPY_SHOCK_ENERGY^MDC_IDC|1.5|35|J|||||F|||20070422170125||||DEV12359
OBX|57|NM|2310^MDC_IDC_SYS_DEV_TAC_THRPY_SHOCK_MAX_ADDITIONAL^MDC_IDC|1|4||||||F|||20070422170125||||DEV12359
OBX|58|NM|2311^MDC_IDC_SYS_DEV_TAC_THRPY_SHOCK_MAX_ENERGY^MDC_IDC|1|35|J|||||F|||20070422170125||||DEV12359
OBX|59|NM|2313^MDC_IDC_SYS_DEV_TAC_THRPY_ZONE_DETECT_RATE^MDC_IDC|1|120|1/min|||||F|||20070422170125||||DEV12359
OBX|60|CWE|2316^MDC_IDC_SYS_DEV_TAC_THRPY_ZONE_SVT_DISCR_STATUS^MDC_IDC|1|ON||||||F|||20070422170125||||DEV12359
OBX|61|CWE|2314^MDC_IDC_SYS_DEV_TAC_THRPY_ZONE_NAME^MDC_IDC|2|Fast VT||||||F|||20070422170125||||DEV12359
OBX|62|CWE|2315^MDC_IDC_SYS_DEV_TAC_THRPY_ZONE_STATUS^MDC_IDC|2|Active||||||F|||20070422170125||||DEV12359
OBX|63|CWE|2312^MDC_IDC_SYS_DEV_TAC_THRPY_TYPE_ATP^MDC_IDC|2|Ramp Scan||||||F|||20070422170125||||DEV12359
OBX|64|NM|2308^MDC_IDC_SYS_DEV_TAC_THRPY_PULSES_ATP^MDC_IDC|2|3||||||F|||20070422170125||||DEV12359
OBX|65|NM|2309^MDC_IDC_SYS_DEV_TAC_THRPY_SHOCK_ENERGY^MDC_IDC|2.1|25|J|||||F|||20070422170125||||DEV12359
OBX|66|NM|2309^MDC_IDC_SYS_DEV_TAC_THRPY_SHOCK_ENERGY^MDC_IDC|2.2|27|J|||||F|||20070422170125||||DEV12359
OBX|67|NM|2309^MDC_IDC_SYS_DEV_TAC_THRPY_SHOCK_ENERGY^MDC_IDC|2.3|29|J|||||F|||20070422170125||||DEV12359
OBX|68|NM|2309^MDC_IDC_SYS_DEV_TAC_THRPY_SHOCK_ENERGY^MDC_IDC|2.4|32|J|||||F|||20070422170125||||DEV12359
OBX|69|NM|2309^MDC_IDC_SYS_DEV_TAC_THRPY_SHOCK_ENERGY^MDC_IDC|2.5|35|J|||||F|||20070422170125||||DEV12359
…
17IHE Workshop – June 2007IHE Workshop – June 2007
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)
18IHE Workshop – June 2007IHE Workshop – June 2007
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)
19IHE Workshop – June 2007IHE Workshop – June 2007
What’s Next?What’s Next?
Scheduling / Orders
Waveforms
HL7v3 CDA
20IHE Workshop – June 2007IHE Workshop – June 2007
More info on www.ihe.netMore info on www.ihe.net
IDCO Profile in public comment June 18 – July 16
Final version for trial implementation available Aug 1st
21IHE Workshop – June 2007IHE Workshop – June 2007
ConclusionConclusion
With the increased use of EMR systems, the networking of in-clinic and remote follow-up systems for implanted cardiac devices, and the continued growth of the implantable cardiac device market, the importance of this profile to clinicians has become more acute.
Strong device vendor participation in the IDCO profile development this year is an acknowledgement of this importance.
As the IDCO Profile and associated standards continue to evolve there is little doubt that the use of this profile will be a critical component of comprehensive cardiac care.
22IHE Workshop – June 2007IHE Workshop – June 2007
QuestionsQuestions
Questions?
Nicholas SteblayBoston [email protected](651) 582-7316
23IHE Workshop – June 2007IHE Workshop – June 2007