Healthcare Link Web and
Flow
CDISC Interchange
November 4, 2010
Landen Bain
Healthcare Link + eSDI
November 2005, Libertyville, Illinois
© 2010
Agenda
1. The focus: data capture, not data mining
2. Finding healthcare partners: IHE
3. The approach: web service...
4Photos courtesy of Women’s Clinic of Lincoln, NE
Start with the nitty-gritty world of the study
coordinator, not the rare...
© 2010 5
Integrating the Healthcare Enterprise (IHE) is an
initiative by healthcare professionals and industry to improve ...
© 2010
The approach: Web and Flow
• Web Services: Set up a direct conversation
between the healthcare system (EMR) and the...
7
I’ve got Mrs. Jones here for
her research visit and I need
to retrieve her form so that I
can do the data capture.
And h...
8
OK, here’s the completed
form. Thanks for inserting
the data I sent you. I’ve
completed the rest and
filed a copy.
OK, g...
9
Case Report Form
EHR
Clinical Research
QualityPublic Health
Quality Measure
Outbreak Report
IHE-CDISC Retrieve Form
for ...
© 2010
Specifications
1. ‘make the connection’ - Retrieve Form for Data-
capture (RFD)
2. ‘pre-populate the data’ - Clinic...
11
RFD Profile
Retrieve
Form
Submit
Form
Archive
Form
Form Manager
B
Form Receiver
C
Form Filler
A
Form Archiver
D
14
15
Pre-population Problem
Post-approval Study
EMR
Legacy
Disease Registry
AE Report
To Regulatory AgencyICHICSR
CDASH
16
• EMRs speak a standard language (HL7 CCD)
• Form Managers translate from this common language
Pre-population Solution
...
17
• If all EMRs agree to send CCD,
then each Form Manager only
has to support one data format.
• A transformation is stil...
18
• RFD Integration Profile:
specifies actors and
transactions (Retrieve,
Submit, Archive)
• CRD Content Profile:
further...
19
RFD and eSource
19
EHR
Investigator sphere
of control
FA
20
eSource Data Interchange (eSDI) Initiative
• Goals
– to make it easier for physicians to conduct clinical
research,
– c...
21
HITSP Clinical Research IS
21
22
Identified Gap
• The data sent from the EHR to the EDC must conform to
the protocol. Currently there is a gap in the ab...
23
Redaction Services - 2010
1. Export
Document (CRD)
2. Retrieve
Extraction
Specification
4. Send
Redacted
Document
Redac...
25
RPE 2.0 Transactions
ProcessDefinitionManager
ProcessActivityExecutor
ProcessStateManager
InitiateActivity
ReceiveProce...
2626
SHARP Service Bus
Orchestration Engine
(RPE)
Step-based Knowledge Acquisition
Graphical User
Interface
Demographics L...
© 2010 27
Strength through collaboration.
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2010 11-04 interchange-bwi

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2010 11-04 interchange-bwi

  1. 1. Healthcare Link Web and Flow CDISC Interchange November 4, 2010 Landen Bain
  2. 2. Healthcare Link + eSDI November 2005, Libertyville, Illinois
  3. 3. © 2010 Agenda 1. The focus: data capture, not data mining 2. Finding healthcare partners: IHE 3. The approach: web services and workflow automation – Web and Flow 4. The specifications: RFD, CRD, eSDI, Redaction, RPE 3
  4. 4. 4Photos courtesy of Women’s Clinic of Lincoln, NE Start with the nitty-gritty world of the study coordinator, not the rarefied world of data
  5. 5. © 2010 5 Integrating the Healthcare Enterprise (IHE) is an initiative by healthcare professionals and industry to improve the way computer systems in healthcare share information. IHE promotes the coordinated use of established standards such as DICOM and HL7 to address specific clinical need in support of optimal patient care. Systems developed in accordance with IHE communicate with one another better, are easier to implement, and enable care providers to use information more effectively.
  6. 6. © 2010 The approach: Web and Flow • Web Services: Set up a direct conversation between the healthcare system (EMR) and the research system (EDC). • Collaborative Workflow Automation: Enable the two systems to initiate actions and exchange information. 6
  7. 7. 7 I’ve got Mrs. Jones here for her research visit and I need to retrieve her form so that I can do the data capture. And here’s some data on her to start off. Sure, here’s the form we need for Mrs Jones. I’ve inserted the data you sent me, and you do the rest. Electronic Health Record Research System
  8. 8. 8 OK, here’s the completed form. Thanks for inserting the data I sent you. I’ve completed the rest and filed a copy. OK, got it. Electronic Health Record Research System
  9. 9. 9 Case Report Form EHR Clinical Research QualityPublic Health Quality Measure Outbreak Report IHE-CDISC Retrieve Form for Data Capture (RFD) = key common workflow integration profile (easy for EHRs to implement) RFD RFD RFD Safety Integrating Workflow: EHRs and Clinical Research
  10. 10. © 2010 Specifications 1. ‘make the connection’ - Retrieve Form for Data- capture (RFD) 2. ‘pre-populate the data’ - Clinical Research Data (CRD) 3. ‘comply with source documentation requirements’ - eSource 4. ‘tailor the pre-population’ - Redaction Services 5. ‘broaden the scope’ - Retrieve Process for Execution (RPE) 10
  11. 11. 11 RFD Profile Retrieve Form Submit Form Archive Form Form Manager B Form Receiver C Form Filler A Form Archiver D
  12. 12. 14
  13. 13. 15 Pre-population Problem Post-approval Study EMR Legacy Disease Registry AE Report To Regulatory AgencyICHICSR CDASH
  14. 14. 16 • EMRs speak a standard language (HL7 CCD) • Form Managers translate from this common language Pre-population Solution Post-approval Study EMR CCD Disease Registry AE Report To Regulatory Agency
  15. 15. 17 • If all EMRs agree to send CCD, then each Form Manager only has to support one data format. • A transformation is still necessary to bridge from CCD to the world of research. Transformations 17
  16. 16. 18 • RFD Integration Profile: specifies actors and transactions (Retrieve, Submit, Archive) • CRD Content Profile: further defines the Retrieve transaction, specifying exactly what the Form Filler can send to the Form Manager Clinical Research Data Capture (CRD) 18 Retrieve Form Transaction Form Manager B Form Filler A Prepopulation Data (CRD) Form
  17. 17. 19 RFD and eSource 19 EHR Investigator sphere of control FA
  18. 18. 20 eSource Data Interchange (eSDI) Initiative • Goals – to make it easier for physicians to conduct clinical research, – collecting data only once in an industry standard format for multiple downstream uses, and thereby – to improve data quality and patient safety • Product (2 year development process) – Version 1.0 document posted at http://www.cdisc.org/eSDI/eSDI.pdf 20
  19. 19. 21 HITSP Clinical Research IS 21
  20. 20. 22 Identified Gap • The data sent from the EHR to the EDC must conform to the protocol. Currently there is a gap in the ability to redact the CCD to conform to the protocol-required data as specified in the case report form • Resolution: – A new IHE profile called Redaction Services has been accepted for inclusion in the Quality, Research, and Public Health (QRPH) domain for development in 2010
  21. 21. 23 Redaction Services - 2010 1. Export Document (CRD) 2. Retrieve Extraction Specification 4. Send Redacted Document Redactor B Extraction Def. Mgr. C Document Source A Document Receiver D 3. Return Redacted Document Healthcare Research
  22. 22. 25 RPE 2.0 Transactions ProcessDefinitionManager ProcessActivityExecutor ProcessStateManager InitiateActivity ReceiveProcessStateAlert RetrieveProcessDefinitions Subscribe ReceiveProcessDefinitions ReceiveProcessDefinitions DeployProcessDefinition RetrieveProcessDefinitions Subscribe InitiateProcess RetrieveActivities UpdateActivity ReceiveProcessStateAlert • Transactions broadly concerned with: – Access to process definitions – Runtime management of process state and activities
  23. 23. 2626 SHARP Service Bus Orchestration Engine (RPE) Step-based Knowledge Acquisition Graphical User Interface Demographics Labs Text (UIMA) Coded Diagnoses
  24. 24. © 2010 27 Strength through collaboration.

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