Legal Aspects of Conducting Clinical Trials Boot Camp/ Symposium Session 7: Privacy and HIPAA (2019)


Topics

  1. Key Concepts
  2. The Concept of Privacy
  3. Global Privacy
  4. United States: Health Insurance Portability and Accountability Act (HIPAA)
  5. HIPAA is… Complex
  6. United States: State Laws
  7. European Union: Rise of General Data Protection Regulation “GDPR”
  8. Patient/Subject Protections Under GDPR
  9. GDPR Basics
    1. Report, Report, Report
    2. Penalties
    3. Removal of “Contingent Permissions”
  10. Key mandates: Eight Data Subject Rights
  11. Personal Identifying Information Under GDPR
  12.  About Brexit
  13. Clinical Trials: Privacy Pitfalls
  14. Clinical Trials, Sample Management
  15.  Breach, Disclosure Obligations
  16.  If there is a Breach, What Next?
  17.  Things to Take Away…
  18. Case Studies
  19. Job Opportunities in Privacy

Acknowledgement

Accompanying text created by Ashwini Tambe | Graduate Student, Regulatory Science, USC School of Pharmacy | atambe@usc.edu


NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.