The Challenges of Bridging HIS/EMRs and Research Information Systems
James J. CiminoChief, laboratory for Informatics Development
NIH Clinical CenterBethesda, Maryland
Bridging Patient Care and Research at NIH
• The NIH Clinical Center and research
• The Biomedical Translational Research Information System (BTRIS)
• Technical Issues
• Policy Issues
The NIH Clinical Center
The Clinical Research Information System (CRIS)
• Patient data stored in EHR (Eclipsys)
• Need to extract individual data for analysis
• Need cross-patient queries for additional analysis
• Data may require transformation:– De-identification and Re-identification– Indexing– Aggregation by time– Abstraction by classification
What is BTRIS?• Biomedical data
– Research data collected using clinical information systems
– Clinical data collected using clinical information systems
– Research data from research information systems– Non-human data
• Reuse of data to support translational research
• Hence: Biomedical Translational Research Information System
The National Institutes of Health
BTRIS
BTRIS
O n t o l o g y
Data Acquisition ProcessesCoding Indexing De-Identifying Permission Setting
BTRISData Repository
Data Retrieval FunctionsAuthorization Subject-Oriented Cross-Subject Re-Identification NLP
Data Analysis ToolsSubject Recruitment Hypothesis Generation Hypothesis Testing
Technical Issues
• Data sources
• Data model integration
• Queries that are:– Cross-patient– Cross-protocol– Cross-source– Concept oriented
Data Sources
• Order entry system
• Ancillary systems
• Archived clinical data
• Institute and Center (IC) systems
• Individual researchers’ systems
• Notebooks
Data Model Integration
• Events and details
• Entity-relation vs entity-attribute-value
• Denormalization
Research Entities Dictionary (RED)
• Apelon’s Terminology Development Editor
• NCI/caBIG Thesaurus
• Apelon’s Terminology Development Editor
• NCI/caBIG Thesaurus
Research Entities Dictionary
• Content
• Organization
Access Policies
• Privacy Act, not HIPAA
• Policy Working Group
• Intellectual property vs. public domain
• Identifiers
• Unlinked, coded data
BTRIS Data Storage Policy
InactiveProtocols
ActiveProtocols
BTRIS Data Use Policy
InactiveProtocols
ActiveProtocols
PIs/AIs
BTRIS Data Use Policy
InactiveProtocols
ActiveProtocols
PIs/AIsBlockedBy PI
Identifiers Coded Data
ActiveProtocols
InactiveProtocols
BTRIS Data Use Policy
BlockedBy PI
PIs/AIs
Identifiers CodedResults
CodedEvents
ActiveProtocols
InactiveProtocols
BTRIS Data Use Policy
Identifiers CodedResults
CodedEvents
ActiveProtocols
InactiveProtocols
BTRIS Data Use Policy
PIOnly
PIOnly
RestrictedBy PI
SharableThrough PI
Identifiers
ActiveProtocols
InactiveProtocols
UnencumberedBy PI
BTRIS Data Use PolicyCodedResults
CodedEvents
PIOnly
PIOnly
RestrictedBy PI
SharableThrough PI
NoAccess
Identifiers
ActiveProtocols
InactiveProtocols
Sharablethrough PI
UnencumberedBy PI
BTRIS Data Use PolicyCodedResults
CodedEvents
PIOnly
PIOnly
RestrictedBy PI
SharableThrough PI
NoAccess
Identifiers
ActiveProtocols
InactiveProtocols
Sharablethrough PI
UnencumberedBy PI
BTRIS Data Use PolicyCodedResults
CodedEvents
PIOnly
PIOnly
RestrictedBy PI
SharableThrough PI
NoAccess
Identifiers
ActiveProtocols
InactiveProtocols
Sharablethrough PI
UnencumberedBy PI
BTRIS Data Use PolicyCodedResults
CodedEvents
PIOnly
PIOnly
RestrictedBy PI
SharableThrough PI
NoAccess
PIs/AIs
Identifiers
ActiveProtocols
InactiveProtocols
Sharablethrough PI
UnencumberedBy PI
BTRIS Data Use PolicyCodedResults
CodedEvents
PIOnly
PIOnly
RestrictedBy PI
SharableThrough PI
NoAccess
OtherResearchers
BTRIS Policy WG: Data Inclusion
1. All Data from CC (including historical archives) will be included
2. Data from institutes, centers, laboratories and investigators will be included on a voluntary basis
3. Other intramural data to be included as per NIH policy
BTRIS Policy WG: Data Access1. Investigators will have access to data in
their active protocols as per current policies and practices
2. All NIH personnel will have access to de-identified data for research purposes
3. Investigators will retain on-going rights to some data
BTRIS in the Research Process
Recruitment
PatientAccrual
Publications
IRBApproval
Write Protocol
HypothesisGeneration
Reporting
Data GatheringAnd Analysis
B RISB RIS
BTRIS Will:
• Be the preferred system to analyze NIH clinical and non-clinical data
• Aggregate and standardize disparate and isolated data sets
• Automate and streamline processes that are traditionally manual and cumbersome
• Prioritize data sources and functionality based on needs of user community
Remaining Challenges
• Can we scale up to handle all sources:– Data– Terminologies
• Incentive for researchers to contribute data
• Access to “involuntarily contributed” data
