DIA 2015 - EMR/EHR Clinical Data Intergration with EDC Systems

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Glenn Keet

CEO

Clinovo Inc. @Clinovo

EMR/EHR CLINICAL DATA INTEGRATION WITH EDC SYSTEMS

PRESENTATION FOR THE 2015 DIA ANNUAL MEETING

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Challenges of Integrating EMR with EDC

Low Adoption Rates of EMRs in Practices and Hospitals

EDC Databases & CRFs Not Designed From Start With CDISC/C-DASH/ODM or Other Standards

Inability to Identify Clinical Study Subjects between Systems (Health Systems, EMRs, EDC)

Lack of Standardized Methods of Transport from EMR to EDC

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EMR Adoption Rates

What Kept EMR Adoption Low through late 2000s?

Training, Hosting, IT and Services Cost

Costly Conversion of Historic Paper

Records High Startup Costs

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The Obama’s HITECH Act

The HITECH Act

Paid Physicians to Achieve “meaningful use” of EMRs Required Hospitals to be compliant with HITECH Rules, and

obtain Certification of system capabilities

Meaningful Use of EMR

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Increase in Adoption Rates

The HITECH Act Soaring Adoption Rates

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InteroperabilityExport and Import Patient Medical Records Using a

Standardized Format

Create and Receive Records with a Common Data Set in Accordance with Consolidated Clinical Document Architecture (CCDA) Standard.

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Patient Medical Records

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Health Information ExchangeSafe and Secure Use of Technologies to Exchange

Data with Additional Systems

Federal Funding of State and Local HIEs; NHIN Improve Patient Safety by Reducing Medication and Medical Errors Reduce Health Related Costs Improve Healthcare Quality and Outcomes

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Direct TransportPoint to Point Delivery of Medical Records Using

Secure Email Technology

Physician to Email Patient’s Record to Another Registered Physician Without Breaking HIPAA Regulations

Laboratories to Send Diagnostic Results into an Ordering Physician’s EMR

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Patient Engagement Seamless Communication Between Provider and

Patient in Person or Virtually

HIEs Extend to Patients Increase Engagement Between Provider and Patient Ability to Send/Receive Reminders for Preventative or Follow-

Up Care, Patient Education Materials and More.

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Personal Health RecordsUsed to Collect, Track and Share Past and Current

Information on Health Records

Improve Patient Engagement Enhance Provider – Patient Communication Coordinate and Combine Information from Multiple Providers

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Patient Reported OutcomeSecure Way for Subjects to Enter Diary Information

Electronically

Quicker Access to Primary Efficacy Data of each Patient Reduced Data Cleaning Costs Increased Efficiency by Eliminating Double Data Entry

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Data Stewardship Manage, Collect, View, Store, Share, Disclose, or

Use of Patient-Oriented Health Information

Increase in the Use of Information and Communication Technology Enhanced Access to Information Efficient Access to More Comprehensive Data

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Systems Integration

EMRs Integrated to the HIEs

Hospital Lab Patient Physician

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EDC/EMR Integration

When Two Worlds Collide!

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Scenario 1 – Enroll Patient in EDC

Dr. OfficeEMR User

1. Enroll patient1.1 Check Patient Index

1.3 Create Subject ID1.2 Patient not found, enroll in EDC

1.6 Return Patient ID

1.4 Return Subject ID

1.5 Stores Subject ID in Patient Index

2.1 Check Patient Index

2.3 Store patient data2.2 Send Patient data, using Subject ID

2.5 Complete enrollment2.4 Complete store request

2. Enter patient data

HIE Server & Patient Index

EDCServer

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Scenario 2 – Patient Already Enrolled in EDC

Dr. OfficeEMR User

1. Enroll patient1.1 Check Patient Index

1.3 Locate Subject Record

1.2 Query Patient Using Subject ID

1.5 Return Patient ID 1.4 Send Patient Data

2.1 Check Virtual Health Record

2.5 Return CCD

2. Request Medical Records

HIE Server & Patient Index

EDCServer

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Glenn Keet

Chief Executive Officer

Clinovo

[email protected]

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