Coppersmith Brockelman’s Kristen Rosati and Melissa Soliz co-authored a piece for Bloomberg Law’s Privacy and Data Security, sharing an overview of the privacy compliance issues associated with the use and disclosure of health information in human subjects research.
They discuss complying with the Health Information Portability and Accountability Act (HIPAA), the Common Rule, FDA regulations and federal and state health confidentiality laws in all stages of the research process. The piece includes a variety of samples and templates for forms, contracts, and agreements for human subjects research.
Kristen is one of the nation’s leading HIPAA compliance attorneys, with deep experience in data breaches, health information exchange, data sharing for research and clinical integration initiatives, clinical research compliance, clinical trials contracting, biobanking and genomic privacy, and all things “Big Data.”
Melissa’s practice focuses on HIPAA and 42 C.F.R. Part 2 compliance, data breaches and OCR investigations, electronic health records and information exchanges, data sharing for research and clinical integration, and clinical research compliance and contracting.