caBIG Crosscutting Regulated Information Exchange SIG

1
caBIG Cross-cuttingRegulated Information
ExchangeSIG

• Shanbhag Krishnakant (Avinash) - NCICB Arch. WS
  Facilitator
• Arumani Manisundaram - Architecture Workspace
  Lead
• Christo Andonyadis -NCICB Facilitator
• Frank Manion , Identity, Security and Access
  Management SIG Lead
• Warren Kibbe, RIE SIG Lead

2
Regulated Information Exchange

• Review of RIE SIG mission
• This SIG will provide recommendations for
  infrastructure that will support the exchange and
  management of regulated information, such as
  identifiable patient data, within and between
  sites.

3
Regulated Information Exchange

• Goal
• Recommend an infrastructure to handle the
  exchange and management of regulated information
  and de-identification
• Scope of mission
• All applicable federal patient privacy and
  security regulations and policies including, but
  not limited to, HIPAA
• All applicable regulations with regard to
  handling and management of clinical, protocol and
  other data submitted to the FDA including, but
  not limited to, CFR 21 Part 11
• All additional requirements for protection of
  Intellectual Capital, as identified by the Data
  Sharing and Intellectual Capital (DSIC) of caBIG

4
Use Cases

• Lab Interfaces SIG
• CTMS/CDUS Reporting SIG
• Use the Recommendations White Paper
• Financial Billing SIG
• Adverse Events SIG
• NCI-FDA Inter-Agency Operational Task Force
  (IOTF)
• CRIX (Private-Public Collaboration)
• Other domain workspaces
• DSIC working group

5
Projects

• De-identification whitepaper
• Highlighting the use cases and architectural
  implications of de-identification
• Security whitepaper
• This is now part of the security whitepaper
  project headed by Gary Daemer and Ken Lin and the
  merged Security and Access Control SIG and the
  RIE SIG

6
Regulated vs. Research Environment Vision
Clinical Trials (Patient Identifiable) Environment
Clinical Research (De-identified Patient)
Environment
External Agencies
Analytical Applications
OLTP Applications
caBIG
Analytical and Reporting Tools (SAS, WebSDM,
ToxViewer, I-Review, etc.)
Ad Hoc Query Tool
Excel w/ caBIO driver
AE Module
CT Registry
Financial Module
etc.
caGRID
Study Specific Analysis Data

caBIO/CT
caSPR/DSAM/DAM

caBIO/CT
HL7 RIM
JDBC 2
caSPR/DSAM/DAM
HL7 v3
HL7 RIM
HL7 Transactional Database
Secure Transport Between Sites
Translational Service
Master Index
HL7 v3
HL7 v3
Extensions (CDUS/CTMS)
Base Janus Model
HL7 v3
HL7 v3
DRAFT
Electronic Medical Record (EMR)
Labs
Clinical Research Database (Janus Repository)
Tissues
HL7 v3
etc.
De-Identification/ Re-Identification Service
HL7 SDK
Proprietary, Excel, Text, HL7 v1, HL7 v2
HL7 v3
Source S. Dubman, NCICB
Clinical Data Sources
Common Security Module (CSM)
Enterprise Vocabulary Service (EVS)
Data Standards Repository (caDSR)