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 | atambe@usc.edu