David Peloquin is a partner in the health care group who advises clients on a wide range of legal and regulatory issues in the area of clinical research and related activities. David counsels academic medical centers, life sciences companies, information technology companies and other clients that sponsor, support and conduct research. With a broad client base and knowledge of a range of laws and regulations, from the Common Rule and FDA regulations, to HIPAA and GDPR, to state and federal fraud and abuse laws—David offers clients clear, practical advice on how the complex legal landscape intersects with an array of research activities.
In an area that is constantly evolving, David advises clients on the latest guidance across a range of issues. With the onset of COVID-19, he helped clinical laboratories, universities and diagnostic test developers navigate the regulatory implications of testing, assisted companies that were creating diagnostic tests for the very first time, and counseled employers in setting up back-to-work testing programs and, most recently, vaccination programs. In addition to his advisory work, David collaborates with the private equity group to conduct regulatory diligence of clinical research investments, and works with the firm’s litigation practice on government and civil investigations involving clinical research.
David’s interest and advocacy in health care is far-reaching, extending to the broader community. He speaks and writes frequently on issues in health care law and data privacy, and has been published in Science magazine and the legal press. As part of his pro bono practice, he advises the Multi-Regional Clinical Trials Center of Harvard and Brigham & Women’s Hospital and leads the team that advises Vivli, a nonprofit organization that collects and shares participant-level anonymized data from clinical trials. David also serves as a Community Member of the Mass General Brigham Institutional Review Board. Before his legal career, David was a project manager for Epic Systems, a leading supplier of electronic medical records.
- Counsels numerous U.S.-based academic medical centers, universities and life sciences companies on the application of the European Union’s General Data Protection Regulation (GDPR) to their research and health care operations.
- Counsels multiple leading health systems and specialty hospitals on matters related to “big data research collaborations” and design of biobanking research protocols and consent forms with respect to compliance with state and federal research regulations and data privacy laws.
- Served as regulatory counsel to multiple diagnostics companies in their initial public offerings.
- Counsels numerous nonprofit and for-profit clinical laboratories on issues related to licensure, CLIA and equivalent state regulations, data privacy and compliance with human subjects research regulations, particularly in the area of genetics.
- Counsels life sciences companies, information technology companies and academic medical centers on issues arising from the enrollment of a company’s or institution’s own employees or students in research studies.
- Advises multiple pharmaceutical companies regarding the application of HIPAA, CCPA, and other state and federal privacy laws to patient support programs.
- Conducted regulatory diligence for numerous private equity and life sciences clients regarding their planned investments in companies that participate in the clinical research enterprise, including contract research organizations, pharmaceutical companies, biobanks, institutional review boards and clinical trial support software.
- Led multiple internal investigations at a leading pharmaceutical company regarding allegations of misconduct in the research setting, including allegations of inappropriate patient care at a pharmaceutical company’s wholly-owned clinical trials unit.
- Led internal investigation of a medical device client’s CLIA-certified laboratory following the return of inaccurate results to test subjects.