Gabrielle Goldstein provides regulatory and transactional counsel to health care providers, research and educational institutions and biotechnology companies.
What do you focus on?
Today, my practice focuses on three main areas at the crossroads of health care and life sciences.
Biomedical Research Compliance
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.
Technology Transfer and Research Transactions
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.
Operational Counsel and Health Reform
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.
What do you see on the horizon?
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.
Publications and Presentations
- “Experimentalist Governance in Global Public Health: The Case of UNAIDs,” Ariz. J. Int'l & Comp. L. 35 (2018): 219 (with Christopher Ansell)
- Institutional Review Boards: A Primer, Third Edition, American Health Lawyers Association, 2018 (contributing author)
- “Regulatory Basics for Healthcare and Biotech Entrepreneurs,” LA BioStart Legal Basics Program, Los Angeles, August 2018
- “Regulatory Basics for Healthcare and Biotech Entrepreneurs,” LA BioStart Legal Basics Program, Los Angeles, February 2018
- “Moving Beyond the Federal Funding Hook: Management-Based Regulation in Biomedical Research,” Drexel L. Rev. 10 (2017): 127
- “Regulatory Basics for Healthcare and Biotech Entrepreneurs,” LA BioStart Legal Basics Program, Los Angeles, July 14, 2017
- “HHS’ Notice of Proposed Rulemaking: Implications for Secondary Use of Biospecimens in Research,” AHLA e-Alert, April 7, 2016
- “Health Reform: Legal Issues for Employers and Healthcare Providers,” American Bar Association Annual Meeting, Business Law Section, San Francisco, August 9, 2013
- “The Good News and Not So Good News about Health Care Reform,” UCSF Vascular Symposium, San Francisco, April 18, 2013
- “Science Policy and Stem Cell Research” (2008–2012) and “Human Subjects Research and IRB Oversight” (2009–2012), Guest Lecturer, UC Berkeley School of Public Health, PH 225 (Legal Basis for Health Care Delivery)
- “Health Policy and the Courts” (2012-2013), Guest Lecturer, UC Berkeley School of Public Health, PH220 (Health Policy Decision Making)
- “Law Review: Social Media Primer,” American Marketing Association, Marketing Health Services, August 2010
- California Hospital Association EMTALA Manual, 7th Edition, Editorial Assistance, October 2009
- “Research Misconduct—Institutional Responsibility and an Invisible Crisis,” AHLA Life Sciences, Vol. 2, No. 3, December 2008
- “Don’t Ask, Don’t Tell? Transfer and Sale of De-identified Patient Data,” Journal of Clinical Research Best Practices, April 2008
- “FDA Amendment Act of 2007: Changes for the Future,” AHLA Life Sciences, Vol. 2, No. 1, March 2008