Data Sharing and Intellectual Capital Working Group (DSIC WG)

1
Data Sharing and Intellectual Capital Working
Group (DSIC WG)

• Accomplishments and Goals

2
The DSIC WGs Mission

• Consider issues presented by caBIG activities
  related to data sharing, intellectual property,
  and intellectual capital
• Recommend best practices, develop guidance, and
  draft white papers
• Sponsor two Special Interest Groups (SIGs)
• Regulatory SIG
• Proprietary SIG

3
Regulatory and Proprietary SIGs

• The Regulatory SIG is focused on legal and policy
  issues relating to study participant consent, IRB
  and HIPAA authorization, and confidentiality and
  data security.
• The Proprietary SIG is concerned with
  intellectual property matters such as software
  licensing, data sharing and biospecimen resources
  and intellectual capital (e.g., authorship and
  attribution).

4
DSIC WG Previous Accomplishments

• caBIG Publication Policy
• Documents the process for review and provides
  guidelines for authorship, attribution, and
  acknowledgement in caBIG Publications
• caBIG Publications are those funded by the
  National Cancer Institute (NCI) in connection
  with the caBIG initiative
• Preliminary feedback has been received and will
  be addressed once all participants have had a
  full opportunity to comment

5
DSIC WGPrevious Accomplishments

• Security Administration Recommendation
• Recognizes that access to some data via caBIG
  must be controlled to meet privacy and security
  needs
• Recommends development of common set of security
  administration tools and services as part of
  overall caBIG architecture
• Tools and services should be flexible,
  extensible, interoperable and scalable since
  security requirements can change at any time
• Draft recommendation currently pending for review
  before Strategic Planning SLWG

6
Regulatory Issues HIPAA Covered Entities

• Only certain institutions
• Health care plans
• Health care providers
• Health care clearinghouses
• Many cancer centers are health care providers
• Hybrid entities can isolate HIPAA- and
  non-HIPAA covered functions

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Regulatory IssuesDe-Identification

• Covered entities are required to de-identify
  information transmitted to other entities for
  research purposes
• Safe Harbor method
• Statistical Method
• Limited data set An alternative to
  de-identification

8
Regulatory IssuesPatient Identifiers

• A code or other means of record identification
  (patient identifier) may be assigned
• Code may not be derived from PHI, or otherwise be
  usable to re-identify the patient
• The means or code of generating the patient
  identifier is not disclosed

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Regulatory SIG Next Steps Statement on
De-Identification Tools

• Automated De-Identification Tools
• May be an effective method of lowering the burden
  related to complying with the safe harbor
  method
• Need to be coordinated with manual review to
  minimize error rate
• May not address certain safe-harbor data
  elements if they are entirely text-driven

10
Regulatory SIGUpcoming Issues

• Building awareness that
• collection of data for de-identification requires
  notification or waiver
• IRB approval is necessary for submitting data to,
  and also for retrieving data from, a repository
• Expedited IRB review for research on
  de-identified data may be appropriate

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Regulatory SIG Next Steps Solicitation of Use
Cases

• Request for use case that
• describe the ways in which health information
  will be used in caBIG
• Address both identifiable and de-identified
  information
• Include information on how data will be
  collected, stored, used, and/or exchanged
• Extensive detail not necessary

12
Next Steps IRB and HIPAA Issues

• White paper on best practices
• FAQs for caBIG DSIC WG Web page

13
Proprietary SIGPrevious Accomplishments

• Open Source Software (OSS) Licensing Guidelines
  and Model Agreement
• Source code for all caBIG software tools will be
  available to end-users no restrictions on how
  source code modified by end users is distributed
• Use of model agreement is not mandatory guidance
  document will assist caBIG institutions in
  formulating alternatives
• Draft documents discussed at caBIG Annual
  Meeting Breakout Session

14
Proprietary SIGFuture Activities

• Model Data Sharing Agreement
• Samples are being collected by SIG Subcommittee
• Model Materials Transfer Agreement (Biospecimens)
• Samples are being collected by SIG Subcommittee
• Investigate role of industry collaborators and
  proprietary software vendors
• Explore institutional and individual investigator
  concerns about sharing data

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Communications

• Working Group Facilitator (NCI)
• Wendy Patterson, J.D.
• [phone]
• pattersw_at_mail.nih.gov
• Working Group Coordinator (BAH)
• Dan Steinberg, J.D.
• [phone]
• steinberg_daniel_at_bah.com