The Challenges of Bridging HIS/EMRs and Research Information Systems James J. Cimino Chief, laboratory for Informatics Development NIH Clinical Center Bethesda, 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

OntologyOntology Data Acquisition Processes Coding Indexing De-Identifying Permission Setting BTRIS Data Repository Data Retrieval Functions Authorization Subject-Oriented Cross-Subject Re-Identification NLP Data Analysis Tools Subject 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 Inactive Protocols Active Protocols

BTRIS Data Use Policy Inactive Protocols Active Protocols PIs/AIs

BTRIS Data Use Policy Inactive Protocols Active Protocols PIs/AIs Blocked By PI

Identifiers Coded Data Active Protocols Inactive Protocols BTRIS Data Use Policy Blocked By PI PIs/AIs

Identifiers Coded Results Coded Events Active Protocols Inactive Protocols BTRIS Data Use Policy

Identifiers Coded Results Coded Events Active Protocols Inactive Protocols BTRIS Data Use Policy PI Only PI Only Restricted By PI Sharable Through PI

Identifiers Active Protocols Inactive Protocols Unencumbered By PI BTRIS Data Use Policy Coded Results Coded Events PI Only PI Only Restricted By PI Sharable Through PI No Access

Identifiers Active Protocols Inactive Protocols Sharable through PI Unencumbered By PI BTRIS Data Use Policy Coded Results Coded Events PI Only PI Only Restricted By PI Sharable Through PI No Access

Identifiers Active Protocols Inactive Protocols Sharable through PI Unencumbered By PI BTRIS Data Use Policy Coded Results Coded Events PI Only PI Only Restricted By PI Sharable Through PI No Access

Identifiers Active Protocols Inactive Protocols Sharable through PI Unencumbered By PI BTRIS Data Use Policy Coded Results Coded Events PI Only PI Only Restricted By PI Sharable Through PI No Access PIs/AIs

Identifiers Active Protocols Inactive Protocols Sharable through PI Unencumbered By PI BTRIS Data Use Policy Coded Results Coded Events PI Only PI Only Restricted By PI Sharable Through PI No Access Other Researchers

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 Access 1.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 Patient Accrual Publications IRB Approval Write Protocol Hypothesis Generation Reporting Data Gathering And Analysis B 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