Electronic Health Record Initiatives
Mitra Rocca
Outline of the Presentation
 Health Record Terms and Definitions
 Current Status of Health Information Networks and Electronic
Health Record (EHR) Systems
• US
• EU
 Role of EHR/Health Information Technology (HIT) in Clinical
Research
 Ongoing EHR Initiatives
2 | EHR| 09 October 2008 | Presentation to PRIMS Forum
Outline
Health Records Terms and Definitions
(EMR, EHR, PHR)
Why Implement an EHR System?
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Electronic Medical Record (EMR)
 An electronic record of health-related information on an
individual used by healthcare providers and residing within a
system or organization.
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Electronic Health Record (EHR)
CPOE: Computerized Physician Order Entry
CDR: Clinical Data Repository
CMV :Controlled Medical Vocabulary
CDSS: Clinical Decision Support System
 Interoperability distinguishes EHR from EMR
 It’s ability to be shared across organizations.
Documentation
Interface Engine
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CMV*
CDSS*
Web Portal
Interface Engine
NHIN
CDR*
Pharmacy
• Laboratory
Enterprise Master Patient Index (EMPI)
• Radiology
CPOE*
• PACS
• Transcription
Workflow
• Departmental
Systems
• Pat. Access
• Billing/Coding
• HR
• Scheduling
• ERP
• Resource
Management
EHR
Environment
NHIN
Personal Health Record (PHR)
 Contains lifelong health information that is entered and
owned by the patient, usually accessible over the
Internet.
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Why implement an EHR System?
 Improves Performance (Safety, Quality)
 Clinical Decision Support
 Reduces undesirable variation
 Increases Efficiency
 Reduces transcription, redundant tests
 Facilitates Data Reporting
 Enhances Value
 Pay for Performance
 Safety
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Outline
US Landscape
Current Status of the Nationwide Health
Information Network (NHIN)
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US: Office of the National Coordinator (ONC) for HIT
American Health Information Community (AHIC)
Executive Order Most Americans to have an EHR by 2014…
President Bush
Four Goals of ONC Strategic Framework
1.Inform clinical practice
3. Personalize care
• Incentivize EHR adoption
• Encourage use of PHRs
2.Interconnect clinicians
4. Improve population health
• Unify public health surveillance
• Develop a nationwide health
information network
architecture
American Health Information Community (AHIC)
Provide Recommendation to public and private sectors to accelerate HIT
AHIC Members:
 Public Sector (CDC, VA, DoD, NIST, …)
 Private Sector (Intel, …)
 Non-for-Profit Organizations (National Patient Advocate Foundation, …)
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American Health Information Community
(AHIC) Ongoing Projects
Workgroups:
1.
2.
3.
4.
5.
6.
7.
Chronic Care
Confidentiality, Privacy and Security
Consumer Empowerment
EHR
Personalized Healthcare
Population Health
Quality
Main Contracts:
 Standards Harmonization – Health IT Standards Panel (HITSP)
 EHR, IT Infrastructure Certification – Certification Commission for HIT
 Over 100 EHR systems certified as of Jan. 2008
 Nationwide Health Information Network (NHIN) pilots
 Security and Privacy Policies
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Why are these national efforts important to
Biopharmaceutical industry?
 Investigate the Pharma-specific use cases that could
leverage Health Information Exchanges (HIE) and the
Nationwide Health Information Network (NHIN)
 Improve development, administration, safety and
surveillance of drugs and medical products
 Define the obstacles and key enablers to the
pharmaceutical industry realizing the benefits of this
emerging infrastructure
 Legal and Policy
 Standards
 Data Ownership
 Financial
 Technical
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NHIN Significance to Pharma:
The NHIN Slipstream Project
 Why:
•
Pharma can help to define the key HIT use cases for enabling
clinical research and monitoring the safety and effectiveness of
medicines
•
Assessment that the Pharma industry would have greater impact
if it were able to speak with a unified voice in national, regional,
and local HIT efforts
 Who:
•
4 pharmaceutical companies: AstraZeneca, Bristol-Myers Squibb,
Pfizer, and Wyeth
 What:
•
List of use cases relevant to Pharma, prioritized down to the top
three
•
Three detailed use cases, including value propositions and proof
of 09concept
opportunities
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October 2008 | Presentation
to PRIMS Forum
Slipstream Use Cases:
The Pharmaceutical value chain and priority Use Cases
Clinical
Research
1. Genetic
Clinical
Development
3. Clinical Trial
Association
and Linkage
Analysis
10. Post-
Execution
2. Clinical
Validation –
Target,
Biomarker,
and
Diagnostic
Regulatory /
Safety
Marketing
a.
Connect Patients to Trials
b.
Data Collection & Mgmt
c.
Investigator Services
d.
Compliance
e.
Placebo Populations
a.
Safety /
Adverse
Event
Monitoring
b.
Pharmacovigilance
c.
P-Epi & Data
Mining
Prioritized High-Level Use Cases
4.
Clinical Trial Simulation11. Manufacturer’s
5.
New Indication
Identification
6.
Interim analyses
Recall
Commercial
12. Pharmacoeconomics
13. Marketing
Comparative
Studies
14. Pharmaceutical/
Disease
Management
Programs
15. e-Prescribing
7. Personalized Medicine – Pharmacogenomics
8. Outcomes Studies
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9. Disease and Care Management Modeling
EU eHealth IT Initiatives: 2005-2010
Health Information Network
Connecting for Health (UK)
Elektronische Gesundheitskarte
National Institute for ICT in Health
(NICTIZ)
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Deliver better, safer care to patients,
via new computer systems and
services, that link GPs and community
services to hospitals
Electronic health cards which will
eventually contain the patients'
complete health history in digital
format
The National IT Institute for
Healthcare in the Netherlands - is the
national coordination point and
knowledge centre for IT and
innovation in the healthcare sector.
Health Information Networks:
Canada Health Infoway
 Independent, not-for-profit organization, Members from
Canada's 14 federal, provincial and territorial Deputy
Ministers of Health.
 Canada Health Infoway’s 2007-09 Corporate Business
 Plan focuses on accelerating the implementation of
electronic records across Canada.
 $1.6 Billion of investment capital
 Goal: 50% of Canadians will have Interoperable Electronic
Health Records (iEHR) by 2010
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Outline
Role of EHR/HIT in Clinical Research
Why are EHRs important for Clinical Research?
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Clinical Care and Clinical Research
2 separate “electronic” worlds….
Technology
GP’s Office
GP’s Office
Data standards
GP’s Office
GP’s Office
Semantics
Pharma Industry
Quality & completeness
of data
Pharma Industry
Hospital
Hospital
GP’s Office
GP’s Office
GP’s Office
Hospital
Hospital
Governance structures
& processes
GP’s Office
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Pharma Industry
Clinical Care and Clinical Research
.. That could interoperate
Study Setup
GP’s Office
GP’s Office
Patient recruitment
GP’s Office
GP’s Office
Electronic data capture
Submission and Reporting
Pharma Industry
Hospital
Hospital
Pharmacovigilance
GP’s Office
Pharmaco-economics
Pharma Industry
GP’s Office
ePrescribing
GP’s Office
Hospital
Hospital
GP’s Office
Predictive safety
Pharma Industry
Pharmaceutical/disease management
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Why are EHRs important for Clinical Research?
Trial Step
EHR potential role
Study
Setup
 Query EHR database to establish number of potential
study candidates. (Protocol Feasibility)
 Incorporate study manual or special instructions into EHR
“clinical content” for study encounters
Patient
 Implement study screening parameters into patient
Recruitment registration and scheduling.
 Query EHR database to contact/recruit potential subjects
and notify the patient’s healthcare provider(s) of potential
study eligibility.
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Why are EHRs important for Clinical Research?
Trial Step
EHR potential role
Study
 Incorporate study-specific data capture as part of routine
Execution
clinical care / clinical documentation workflows
 Auto-populate study data elements into case report forms
(Merging
from other parts of the EHR database.
EHR & EDC)
 Embed study-specific data requirements (case report
forms) as special tabs/documentation templates using
structured data entry.
 Implement rules/alerts to ensure compliance with study
data collection requirements
 Create range checks and structured documentation
checks to ensure valid data entry
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Why are EHRs important for Clinical Research?
Trial Step
EHR potential role
Submission
 Document and report adverse events
& Reporting
 Risk management plan requirements (FDA)
Evidence
based
 Implement study findings as clinical documentation,
clinical care
 Monitor changes in care and outcomes in response to
orders sets, point-of-care rules/alerts
evidence-based clinical decision support
 Provide easy access to detailed clinical care data for
motivating new clinical trial hypotheses
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EHR-Clinical Research Ongoing Projects
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HIMSS 2007 / IHE Five Life Sciences Use Cases
Drug Safety (Pfizer, AllScripts)
Physician investigator, using an EHR, discovers a suspected adverse drug event and
summons a data-capture form from the drug manufacturer to provide information on the
event.
Clinical Trial Implementation (Eli Lilly, Cerner)
A physician investigator, using an EHR, summons a clinical research data capture form
from an EDC, establishes context, then fires off an EDC session for further data
capture.
Local Labs and Images (Novartis, Siemens)
Clinical Investigator schedules, reviews, and submits clinical trial lab results and images
to directly to Novartis via internet
Disease Registry (Genzyme)
EHR user completes a guest form for disease registry.
Biosurveillance (Centers for Disease Control and Prevention)
A physician using an EHR discovers a suspected outbreak of a disease. Using RFD, the
physician summons a data-capture form from CDC, completes the form, and returns.
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EHR/EDC - Integration – HIMSS 2007
Novartis Received
Status Alerts
Completed Data
Start
Novartis Protocol Visit
Schedule with Detailed
Data Elements Approved
CDISC RFD or
HL7 Message
EDC/EHR
Integration Vision
Investigator & Novartis
is notified what is
scheduled/completed
HL7
Standards Based
HL7
CDISC/IHE - RFD
DICOM
LOINC
RDF or HL7
Message
DICOM
Workflow is updated &
Novartis is notified what
is/not completed
HL7
LOINC
HL7
Integrated EHR
Data Collected as per Health Record
work flow stored for System
investigator review
Labs process order
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Novartis Research Server
generates eCRF and/or
Visit Schedule using
CDISC RFD or HL7
message
EHR Vendor
receives Novartis
information &
Creates EHR
Workflow
Investigator identifies
patient in the Clinical
Trial & Visit Schedule
workflow creates orders
for Labs & PET/CT
(Radiology) etc.
PET/CT
Scanner
a component
of PACS/RIS
Radiologist to review
PET/CT Scan
images
EHR Clinical Research Project Vision
“Roadmap” to Connect Healthcare and
Clinical Research
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Project Sponsors & Participants
Sponsors:
Global Participants:
• Bayer
• Boehringer Ingelheim
EDC/eSource Task Group
• Bristol Myers Squib
• Cerner Corporation
In Cooperation With:
HL7 EHR & RCRIM Workgroups
CDISC
• ClinPhone Inc.
• Eli Lilly and Company *
• FDA
• Glaxo SmithKline
• Hoffman La Roche
• Lundbeck
• Millennium
• National Cancer Institute
• Northrop Grumman
• Novartis
• Pfizer *
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• Procter & Gamble *
EHR CR Project Overview
 Develop a Global EHR/Clinical Research Functional Profile
(EHR/CR-FP)
 Identify critical requirements for clinical research utilizing
EHR systems through:
• Expansion of the HL7 EHR FM R1 to include clinical research
requirements
• Mapping to EuroRec EHR Requirements Repository and
identifing Clinical Research-specific requirements
• Providing the profile to both CCHIT and EUROREC
Outcomes:
 EHR Vendors: provide with requirements for
incorporating clinical research functions into their
systems
 Sponsors: provide basis for evaluating EHR systems as
source
data systems
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27
HL7 EHR Clinical Research Status

HL7 EHR Clinical Research Functional Profile
passed the HL7 May 2008 ballot cycle

Conducted a proof-of-concept assessment of a
large EHR system (Cerner Millennium) against our
requirements/profile, results assisted us with profile
reconciliation and stakeholder awareness

Currently mapping user requirements to EuroRec

Formed a CCHIT roadmap planning committee
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HL7 EHR/CR Functional Profile Example
New Conformance Criteria for
Clinical Research
IN 1.1.1
User
Authentication
Statement: Authenticate
EHR-S users before allowing
access to an EHR-S.
1. The system SHALL prevent access to
EHR-S applications or EHR-S data to all
non-authenticated principals
2. The system SHALL prevent access to
EHR-S applications or EHR-S data to all
non-authenticated principals
3. The system SHALL limit the number of
log-in attempts and record failed log-in
attempts
4. IF username/password is used, the
system SHALL allow and enforce
password to be changed at established
intervals
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EU EHR Clinical Research Profile Approach
Global Clinical Research User Requirements…
User Requirement
Tier 1 (Core)
Relevance
International
International
Regs
Regulations
System and
Data Security
Requirements
HL7 EHR CR
Functional Profile
Conformance
Criteria
System shall have an
audit trail to include
recording
date/time/author of any
data creation, change,
or deletion
… and reason …

Regulatory Link
CSUCI: D2b, D2c,
D2f, D2g
Part 11: 11.10 e
Essential
Optional (future)
ICH GCP: 4.9.3,
5.5.4

21 CFR: 312.62
…Mapped to Existing Criteria
Conformance Criteria
EuroRec
Conformance Criteria
GS002183.02
The audit log contains
create/edit/ deleted events.
HL7
Shall provide the ability…
GS002188.01
Audit log records include date
and time of recordable events.
Should provide the ability
GS002191.01
An audit log record includes
the user identity associated with a recorded
event.
May provide the ability …
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EuroRec
Fine
Grained
Statements
…New Criteria
Needed to Meet
Clinical
Research Needs
GS002192.01
An audit log record contains
the outcome status of a recorded event.
GS003652.01
The system registers in an
audit log what has been accessed by the patient
when consulting his/her own EHR.
30
Objective
Create a Clinical Research Functional Profile based
upon EuroRec EHR criteria
By…
Drawing upon…
• EHR/CR user requirements
• HL7 EHR/CR Functional Profile Standard
• EuroRec EHR criteria to identify potential candidates for mapping to
EHR/CR user requirements
• EuroRec EHR labelling proposal
Delivering
• A submission of a proposed functional profile and a proposal for use to
EuroRec
for “standards”
acceptance
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2008 | Presentation
to PRIMS Forum
31
Mapping in Progress
Categories of Relevance
Core – must have to meet minimum requirements
Future – future need or nice to have
Maybe – needs discussion
Not relevant – not relevent now or ever
New – a new criteria being proposed by EHRCR to
meet Clinical Research User Requirements
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13-Apr-15
Copyright EHR/CR Project 2007
32
Next Steps
1. Publish the HL7 EHR CR as an Informative Standard
2. Resubmit for Normative Standard after CDISC CDASH
R1 standard is finalized
3. Identify services based on the HL7 EHR Clinical
Research requirements:
•
Authorization
•
Consent management
•
Authentication
•
Clinical Decision Support
•
Verify Inclusion/Exclusion Criteria
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33
CCHIT & Clinical Research

Created a multi-stakeholder planning committee
(Single Voice of the clinical research community), in
order to get on the Certification Commission for
Health Information Technology (CCHIT) Roadmap

Participation by Academic Medical Centers clinical
informatics researchers helps strengthen our case
and provide a broader base.
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CCHIT EHR CR Planning Committee Members
•
eClinical Forum EHR CR Team Members
•
Biopharmaceutical Industry
•
PhRMA (Pharmaceutical Research and Manufacturer of
America)
•
EHR Vendors
•
FDA
•
NCI
•
HIMSS LifeSciences Roundtable
•
HL7
•
CDISC
•
AMIA Clinical Research Informatics Workgroup
•
AHIMA
•
CCHIT
•
Clinical and Translational Science Awards (CTSA)
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35
American Health Information Technology (AHIC)
•
Met on July 29th, 2008
•
Panel on Supplemental Priority Development Pathway
for Clinical Research Applications of Electronic Health
Information
- Gregory Downing, ONC
- Rebecca Kush, CDISC
- Kenneth Buetow, NCI
- Greg Simon, FasterCures
- Amy Miller, Personalized Medicine Coalition
•
AHIC to authorize exploration of a “supplemental”
pathway to use case development, standards
harmonization, and support interoperability of electronic
health information to support clinical
research information needs
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36
Global EHR initiatives/activities
(EFPIA EHR Taskforce)
 Build a common understanding of EHR and potential
challenges for clinical research (EU focus)
 Define EFPIA consolidated position related to EHR and
identify critical use cases to push forward
 Collaborate with
• European Commission in the context of eHealth initiative
 Support/push data standardization activities related to EHR
in clinical care in Europe
 Build business case: why would we invest into EHR
integration ?
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eHealth Workstream Initiatives within PhRMA
 Vision: Collaborate within PhRMA to raise awareness and explore
opportunities for eHealth in focused areas including:
- integration with Clinical Research
- improvement of drug safety capabilities
- to enable clinical decision support
- improved drug selection/prescribing Published a White Paper on
HIT
Ongoing Inititiatives:
 HIT Portfolio:Captures HIT related initiatives aimed at optimizing
clinical research design and conduct
 PhRMA White paper on HIT
 HIT Monitoring Sources: HIT Bills, ListServs, NHINWatch, Meetings,
Membership to various healthcare informatics associations, SDOs
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Key Messages
 EHR systems have capabilities that facilitate data
capture and trial monitoring
 Clinical research should share health care data
standards where possible
 There are many different data standards in Health
Care but HL7 is emerging as the “de facto” world
wide standard
 Integrating EHR data requires semantic
interoperability (i.e. same meaning of data)
between EHR systems and clinical research
systems
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Thank you!
Questions?
Mitra Rocca
Mitra.Rocca@novartis.com
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40
Backup Slides
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Novartis Initiative:
Clinical B2B Hub Proof-of-Concept Project
Imaging
Partner
Personal Medical Device Partner
EHR Partner
HL7
XML
HL7
Internet
B2B HUB
NOVARTIS
Canonical
Enterprise Service Bus
Canonical
NOVDD
CT4
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Canonical
Any Format
Any System
Purpose of DAM for Business Domain Experts
 Systematically analyze common data required by the
Novartis business across business processes and clinical
trials, and promote consistency with/extend evolving
industry data models (BRIDG etc.)
 Bridge the gap between the clinical research and the
healthcare domain, in order to exchange information
externally with electronic health record systems
 Agree on common data elements, based on standard
terminologies or vocabularies where appropriate (Ex:
SNOMED, LOINC, …) to be used across applications
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Developing the Novartis DAM
1. Develop
Content
(clinical domain)
Data submission
2. Create
Storyboards and
validate with
Domain Experts
Use Case Model
Storyboard
Use Case
7. Design
Class Diagrams,
Interaction
Diagrams
BRIDG Model
SB
5. Identify
classes that can
be re-used from
BRIDG
Activity Diagram
8. MDR Data Entry
Specification
3. Design AD and
Validate them with
Domain Experts
6. Model New
Concepts
4. Conduct Gap Analysis
Harmonization
DE_AM
New Concepts
Modeling
Class Diagram
Interaction Diagram
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MDR
DE_DE
9. Extend
DE_DE
implementation
guide
10. Harmonize
With BRIDG
and Provide
recommendatio
ns
Refine SOPs
Outline
Role of Standards and Interoperability in Integration
of EHR and Clinical Research
45 | EHR| 09 October 2008 | Presentation to PRIMS Forum
Role of Standards in Health Information Networks
EHR
Enterprise
Portal
HIS
CDISC
Data
W/H
Hospital
Pharmaceutical
CDISC & HL7
Lab
HL7
Radiology
DICOM
HL7
Health
Information
Network
NCPDP HL7
X12
Federal / State
Government
X12
Health Plan
Pharmacy
46 | EHR| 09 October
Primary Care
2008 | Presentation to PRIMS
Forum
Physician
X12
Employer