CDASH, electronic medical records and ODM – status update

Jozef Aerts - XML4Pharma

The Standards

ODM: standard for clinical data

CDASH: standardized Forms - SDTM

EHR “standards”:

HL7: Continuity of Care Document (CCD)

OpenEHR

The challenge

Can we integrate EHR and EDC systems ?

Physicians/Investigators only need to use 1 system

eCRFs are prepopulated with EHR data

It is not only a technical problem

EHR vendors are not interested in EDC niche market 21 CFR Part 11

EDC vendors are afraid of EHR too big world complex

IHE: Integrating the Healthcare Enterprise

Defines “Integration Profiles”

Brings SDOs, vendors, developers and users together

Organizes “Connectathons”

2009: Vienna, Chicago

The IHE Process

IHE Connectathon

“Retrieve Form for Data Capture” profile (RFD)“Clinical Research Data Capture” profile (CRD)

Retrieve data from an EHR system

Populate eCRF with EHR data within EHR system or within EDC system

Submit completed form to EDC system or to EHR system

The RFD and CRD “Ingredients”

HL7 “Continuity of Care Document” HL7-v3 message in XML Generated from CDA

CDISC ODM 1.3

CDASH

XForms

The “integration” team(the geeks)

Kevin Powel – Cerner John Gedeon – Cerner Daemon Whittenburg - Greenway Medical Jason Colquitt – Greenway Medical Andrew Fowler – XClinical Gary Walker – Quintiles Chris Connor – Phoenix Data Systems Rhonda Facile – CDISC Jozef Aerts – XML4Pharma

Continuation of Care Document(CCD)

CDASH - ODM Metadata(a CDASH form in ODM)

The missing link ...

Must be vendor-neutral

Must be EHR-neutral Not limited to CCD

Must match with CDASH

The solution:ODM-CDASH ClinicalData“PrepopData”

The process

The result

The European situation

CEN 13606 for EHR extracts

HL7-v3-XML does not comply

OpenEHR extracts comply

CDISC, IHE and HL7 are US-centric

IHE-RFD should be extended to other EHR “standards” than HL7

RFD and CRD-profiles for OpenEHR

XSLT stylesheet for OpenEHR to PrepopData has been developed

Trying to interest OpenEHR vendors for demo application

CDISC seems to be open for integration with non-HL7 systems

The source: OpenEHR extract

The “PrepopData”(intermediate)

The result: prefilled eCRF

CDISC and EHRJozef's strong opinions CDISC thinks too US-centric

There is more in the world than HL7HL7 is not the only SDO in Healthcare

HL7-v3-XML is not the best basis for EHR(HL7-v3-XML datatypes rejected by CEN)

CEN, ISO, HL7 do talk to each otherfirst result: ISO-21090 datatypes

CDISC should have the same relationship with CEN-TC251 as it has with HL7

Europeans: raise your voice !