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

2. Bridging Patient Care and Research at NIH The NIH Clinical Center and research The Biomedical Translational Research Information System (BTRIS) Technical Issues Policy Issues

3. The NIH Clinical Center

4. 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

5. 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

6. The National Institutes of Health

7. BTRIS

9. 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

10. Technical Issues Data sources Data model integration Queries that are: –Cross-patient –Cross-protocol –Cross-source –Concept oriented

11. Data Sources Order entry system Ancillary systems Archived clinical data Institute and Center (IC) systems Individual researchers’ systems Notebooks

12. Data Model Integration Events and details Entity-relation vs entity-attribute-value Denormalization

13. Research Entities Dictionary (RED) Apelon’s Terminology Development Editor NCI/caBIG Thesaurus

15. Apelon’s Terminology Development Editor NCI/caBIG Thesaurus Research Entities Dictionary Content Organization

20. Access Policies Privacy Act, not HIPAA Policy Working Group Intellectual property vs. public domain Identifiers Unlinked, coded data

21. BTRIS Data Storage Policy Inactive Protocols Active Protocols

22. BTRIS Data Use Policy Inactive Protocols Active Protocols PIs/AIs

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

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

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

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

27. 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

28. 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

29. 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

30. 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

31. 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

32. 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

33. 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

34. BTRIS in the Research Process Recruitment Patient Accrual Publications IRB Approval Write Protocol Hypothesis Generation Reporting Data Gathering And Analysis B RIS

35. 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

36. Remaining Challenges Can we scale up to handle all sources: –Data –Terminologies Incentive for researchers to contribute data Access to “involuntarily contributed” data