Privacy and HIPAA: Concerns in Global Clinical Trials
Full course description
The Georgia Clinical & Translational Science Alliance- Georgia CTSA and Southern California Clinical and Translational Science Institute -SC-CTSI have collaborated to provide free, high quality educational programs for clinical research professionals at novice to expert levels of experience. At the completion of each course or program, participants earn contact hours recognized by a certificate and/or badge.
This explores core concepts of privacy in clinical research including similarities and differences between the U.S. and E.U. Privacy protections under the U.S. Health Insurance Portability and Accountability Act (HIPAA) and the European Union General Data Protection Requirements (GDPR) will be discussed. Additional complex considerations such as privacy breaches, disclosure obligations, penalties for non-compliance, state-specific laws, and the impact from Brexit will be examined.
- Key concepts around privacy
- Global privacy
- United States: Health Insurance Portability and Accountability Act (HIPAA)
- Covered entities vs business associates
- Accessing personal health information (PHI) for clinical research
- De-identified data standards
- United States: State Laws
- California Consumer Protection Act (CPPA)
- Children’s Online Privacy Protection Act (COPPA)
- Patient/Subject Protections under General Data Protection Regulation (GDPR)
- GDPR basics
- Reporting a data breach or loss
- Personal identifying information under GDPR
- Brexit impact to EU clinical trials
- Clinical trials: Privacy pitfalls
- Breach, disclosure obligations
- If there is a breach, what next?
- Potential damages
Terence J. Hogan, Esq. Partner is subject matter expert within RGP’s Healthcare practice, with extensive background and expertise in Legal, Regulatory and Compliance matters. Terence has 20+ years of experience both within industry, leading functional business performance improvement projects related to the acquisition and development of regulated drug and device products, audit and inspection of GMP facilities, litigation support for product liability, transactional services, and data protection in the US, EU and Asia. Terence has experience developing tailored client solutions and implementing transformative initiatives with clients across many industry sectors. Terence served as executive-level in-house counsel for several Fortune 500 companies. In these roles, he has provided counsel on ANDA patent litigation, R&D regulation and compliance, import/export regulation and compliance, and privacy breaches of varying sizes. Terence also has a strong background in transactional support, as well as intellectual property prosecution and litigation. Terence began his consulting career with RGP in 2015. He has spoken internationally at various industry & professional events, on various topics pertaining to healthcare and life sciences, and currently resides in Orange County, California. firstname.lastname@example.org
Learner Level: Intermediate
This symposium is designed for Clinical Research Associates or Clinical Research Coordinators in academia, clinics, hospitals, industry, or CRO with at least 3 years of clinical research experience. Individuals should be experienced with research study coordination, IRB submission process, budgeting, research compliance, recruiting, enrolling, financial management, data collection and analysis.
Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation. Attendees to this CNE activity will be awarded 1.5 Continuing Nursing Education contact hours from ENPDC.
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Program Information: This is the sixth course in a six session program. To complete the entire program and earn badge Click Here.