ihe workshop

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


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


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


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


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


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


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


IDCO Actors and TransactionIDCO Actors and Transaction

Observation Processor

Observation Repository

Send Observation[CARD - 12]


PIX Consumer

ObservationCreator

PIX Consumer

Patient Demographics

Consumer


IDCO ActorsIDCO Actors





PIX Consumer

ObservationCreator

PIX Consumer


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.


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




ObservationCreator


Consumer

HL7 RouterSend Observation

[CARD - 12]


PIX Consumer


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 (?)


IDCO TransactionIDCO Transaction





PIX Consumer

ObservationCreator

PIX Consumer


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


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


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|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






…


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)


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]


EvidenceCreator

Image Manager

Storage Committment [CARD - 3]

Modality Images/Evidence Stored [CARD - 2]

Store Evidence Documents [RAD - 43]

Storage Committment [CARD - 7]


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)


What’s Next?What’s Next?

Scheduling / Orders

Waveforms

HL7v3 CDA


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


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.


QuestionsQuestions

Questions?

Nicholas SteblayBoston [email protected](651) 582-7316

ihe workshop – june 2007what ihe delivers 1 nicholas steblay boston scientific implantable device...

Documents

device remote

device observations

interrogating device

patient followup information

clinic followups

followup process

patient followups