Gabrielle Goldstein provides regulatory and transactional counsel to health care providers, research and educational institutions and biotechnology companies.
Today, my practice focuses on three main areas at the crossroads of health care and life sciences.
I work with institutional review boards, hospitals, research institutions, academic medical centers and biotechnology companies on regulatory and compliance matters related to clinical trials and other biomedical research. This includes counsel regarding FDA, HHS, NIH, OHRP and state level requirements for the protection of human subjects, the conduct of stem cell research, the storage and use of human biospecimens and compliance with federal regulations related to financial conflicts of interest in research.
I provide transactional support to the technology transfer and research operations of hospitals, research institutions, and academic institutions through structuring collaborative arrangements between industry, government and health care institutions, including sponsored research agreements, collaboration agreements, clinical trial agreements and material transfer agreements.
I counsel hospitals, health systems, medical groups, academic medical centers, fertility clinics and clinical laboratories regarding federal and state fraud and abuse laws; informed consent requirements; health information privacy matters, including HIPAA and California confidentiality laws; facilities and professional licensing requirements; and health reform matters, including formation and operation of accountable care organizations.
Health care providers are increasingly focused on clinical research and technology transfer opportunities. We’re working with providers to identify opportunities and strategies to integrate and streamline compliance and minimize risks in these areas.
Boston University School of Law, J.D., Certificate in Health Law, with honors
University of California, Berkeley, B.A.