Regulatory Science Symposium: Legal Aspects of Conducting Clinical Trials Session 7: Privacy and HIPAA (2019)


  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


Accompanying text created by Ashwini Tambe | Graduate Student, Regulatory Science, USC School of Pharmacy |

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