David Peloquin

Partner

David Peloquin

Partner

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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.

Experience

  • Counsel 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.
  • Counsel multiple leading pediatric 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 a diagnostics company in its initial public offering.
  • Counsel numerous nonprofit and for-profit clinical laboratories on issues related to licensure, data privacy and compliance with human subjects research regulations.
  • Counsel 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 in research studies.
  • Advise multiple pharmaceutical companies regarding the application of HIPAA, CCPA, and other state and federal privacy laws to patient support programs.
  • Conduct regulatory diligence for numerous private equity clients regarding their planned investments in companies that participate in the clinical research enterprise, including contract research organizations, pharmaceutical companies, 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.

Presentations

Publications

Presentations

  • Speaker, “Current Issues in Technology Transfer,” Ropes & Gray Roundtable (November 8, 2019) 
  • Presenter, “Decentralized Clinical Trials,” Research, Development and Regulatory Roundtable (R3) of the Multi-Regional Clinical Trials Center of Brigham & Women’s Hospital and Harvard (MRCT), Washington, DC (November 7, 2019)
  • Presenter, “Consent for Future Use of Biospecimens Under the Revised Common Rule,” International Society for Biological and Environmental Repositories Regional Meeting, Minneapolis, MN (November 5, 2019)
  • Presenter, “General Data Protection Regulation: Impact on International Biobanking,” International Society for Biological and Environmental Repositories Regional Meeting, Minneapolis, MN  (November 4, 2019)
  • Presenter, “Secondary Uses of Health Data for Research and Development Purposes,” Privacy + Security Forum, Washington, DC  (October 16, 2019)
  • Presenter, “New York Human Subjects Protection Updates and EU General Data Protection Regulation: Application to Research at U.S. Institutions,” Greater New York Hospital Association, New York, NY (September 25, 2019)
  • Presenter, “General Data Protection Regulation: Impact on Research Conducted by U.S. Entities,” Harvard School of Public Health, Ethical Issues in Global Health Research, Boston, MA  (September 23, 2019)
  • Presenter, “Informed Consent and Secondary Use of Data,” Vivli, Inc. annual meeting (September 18, 2019)
  • Speaker, “CCPA/GDPR/Compliance Updates for Pharmaceutical Companies,” Ropes & Gray Small Pharma Compliance Roundtable (September 13, 2019) 
  • Research, Development and Regulatory Roundtable (R3) of the Multi-Regional Clinical Trials Center of Brigham & Women’s Hospital and Harvard (MRCT), presentation entitled “Legal and Ethical Issues in the Enrollment of a Company or Institution’s Own Employees and Students in Research Studies,” Boston, MA (August 1, 2019) 
  • U.S. Department of Health & Human Services, Secretary’s Advisory Committee for Human Research Protections, Full Committee Meeting, presentation entitled “The Intersection of End User License Agreements and Terms of Service with Informed Consent,” The National Institutes of Health, Bethesda, MD (July 30, 2019)
  • Speaker, “Clinical Trials and Human Research: Complying With New Regulatory Obligations," Strafford Webinar (July 18, 2019) 
  • Trial Scope, TrialBlazers Executive Forum, presentation entitled “One Year On: GDPR and its Implications for Data Disclosures and Data Sharing,” New York, NY (June 17, 2019)
  • U.S. Department of Health & Human Services, Secretary’s Advisory Committee for Human Research Protections, Joint Subpart A Subcommittee and Subcommittee on Harmonization Meeting, presentation entitled “The Intersection of End User License Agreements and Terms of Service with Informed Consent,” Rockville, MD (June 6, 2019)
  • New York State Bar Association, Committee on Medical Research and Biotechnology, presentation entitled “General Data Protection Regulation: Impact on Research Conducted by U.S. Entities,” New York, NY (June 5, 2019)
  • Association of American Medical Colleges, Compliance Officers Forum, “Impact of the European Union’s General Data Protection Regulation on U.S. Academic Medical Centers,” Washington, DC (June 5, 2019) 
  • North Carolina Healthcare Information and Communications Alliance AMC Security & Privacy Conference, presentation entitled “Impact of the European Union’s General Data Protection Regulation on U.S. Academic Medical Centers and Other Healthcare Facilities,” Durham, NC (June 4, 2019)
  • Association for the Accreditation of Human Research Protection Programs, presentation entitled “General Data Protection Regulation: Impact on Research Conducted by U.S. Entities,” New Orleans, LA (May 22, 2019)
  • The Petrie-Flom Center at Harvard Law School, Consuming Genetics Pre-Conference, presentation entitled “State of the Current Regulatory Framework,” American Academy of Arts and Sciences, Cambridge, MA (May 16, 2019)
  • MAGI East Conference, presentation entitled “Recent Developments in Data Privacy and Security,” Boston, MA (May 7, 2019)
  • Stanford Law School, The Future of Healthcare Symposium, panelist on “Emerging Issues in AI and Healthcare,” Palo Alto, CA (April 27, 2019) 
  • Harvard Catalyst Regulatory Foundations, Ethics and Law Meeting, presentation entitled “General Data Protection Regulation: Impact on Research Conducted by U.S. Entities,” Boston, MA (April 17, 2019)
  • Northeastern University Law School, 2019 Annual Health Law Conference, panelist on “Artificial Intelligence,” Boston, MA (April 12, 2019)
  • The Harvard-MIT CRS Regulatory Science Symposium, presentation entitled “Legal and Ethical Challenges in International Clinical Trials,” Cambridge, MA (April 2, 2019)
  • Speaker, “The EU GDPR: Implications for Researchers,” MAGI/CenterWatch Webinar (April 1, 2019)
  • National Council of University Research Administrators, presentation entitled “The EU GDPR: Implications for Research at U.S. Universities,” Las Vegas, NV (March 11, 2019)
  • Research, Development and Regulatory Roundtable (R3) of the Multi-Regional Clinical Trials Center of Brigham & Women’s Hospital and Harvard (MRCT), presentation entitled “Secondary Uses of Health Care Data for Clinical Trial Recruitment: Legal and Regulatory Ambiguities + GDPR Update,” Washington, DC (March 7, 2019) 
  • Speaker, “Informed Consent & Data Sharing,” Vivli Webinar (February 14, 2019) 
  • American Health Lawyers Association (AHLA) AMCs and Teaching Hospitals Conference, presentation entitled “Application of the European Union’s General Data Protection Regulation to Research Conducted at U.S. Academic Medical Centers,” Alexandria, VA (January 2019)
  • Speaker, “Current Issues in Technology Transfer,” Ropes & Gray Roundtable (November 2, 2018) 
  • Virginia Institutional Review Board Consortium, Annual Conference, presentation entitled “Big Data and Confidentiality,” Charlottesville, VA (October 2018) 
  • Association for the Accreditation of Human Research Protection Programs, Annual Conference, Presentation on Big Data & Confidentiality, Denver, CO (April 2018) 
  • Panelist, “The Importance of Data in Value-based Health Care,” Will Value-based Care Save the Health Care System? Conference at Harvard Law School Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics (March 2, 2018) 
  • Speaker, “Clinical Trials and Human Research: Complying With New Regulatory Obligations,” Strafford Webinar (January 17, 2018) 
  • Ropes & Gray Roundtable Discussion, “Complying With the EU GDPR Requirements in Clinical Trials” (December 2017)
  • Ropes & Gray Teleconference, “The EU GDPR: Implications for U.S. Academic Medical Centers Treating EU Patients and Conducting Other Activities in the EU” (November 2017)
  • Children’s Hospital Pediatric Research Alliance Conference, Presentation on Legal and Practical Considerations in the Sharing of Data and Biological Specimens for Research, Boston, MA (October 2017)
  • National Academies of Sciences, Engineering and Medicine, Panelist for Presentation on Laws and Regulations Governing the Return of Results to the Consensus Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories, Washington, DC (September 2017)
  • International Association of Privacy Professionals, KnowledgeNet Presentation on Privacy and Research, Cambridge, MA (September 2017)
  • DIA, Clinical Trial Disclosure and Transparency Conference, Panelist for Discussion on Preparing for Results Submission Under the ClinicalTrials.gov Final Rule and Other Global Requirements, Rockville, MD (September 2017)
  • MAGI East Conference, “Recent Developments in Data Privacy and Security,” Philadelphia, PA (May 2017)
  • International Society for Biological and Environmental Repositories (ISBER), Annual Meeting, “Legal, Ethical and Structural Considerations in Biobanking Involving Academic and Commercial Entities,” Toronto, Canada (May 2017)
  • University of Connecticut, Annual Combined IRB Panel Meeting, talk entitled “Recent Developments in the Laws and Regulations Governing Human Subjects Research,” Farmington, CT (May 2017)
  • Jackson Heart Study, Workshop on Return of Results, University of Mississippi Medical Center, “Considerations for Institutional Review Boards,” Jackson, MS (April 2017)
  • Strafford Webinar:  “Complying With Final Rule Revising the Common Rule for Clinical Trials and Human Research” (February 2017)
  • Strafford Publications, webinar entitled “Clinical Trials and Human Research: Complying with New Regulatory Obligations” (January 2017)
  • Children’s Hospitals Pediatric Research Alliance Conference, presentation entitled “Consortium Collaborations: Contractual Considerations,” Philadelphia, PA (November 2016)
  • MAGI West Conference, presentation entitled “Recent Developments in Research Subject Data Privacy,” Las Vegas, NV (October 2016)
  • Biorepositories & Sample Management Conference, presentation entitled “Impact of Changes in European Union Data Privacy Law on Biorepositories,” Boston, MA (October 2016)
  • American Health Lawyers Association, Academic Medical Center & Teaching Hospitals Conference, presentation entitled “Hot Topics in Genomics Care and Research,” Washington, DC (March 2016)
  • Petrie-Flom Center, Harvard University, Specimen Science Conference, presentation entitled “Legal and Regulatory Issues in Biospecimen Research: National and International Perspectives,” Cambridge, MA (November 2015)
  • American Society for Bioethics and Humanities, Annual Meeting, presentation entitled “Engaged in the Conduct of Research? How to Keep the Government from Finding Violations and What to do When They Do,” Houston, TX (October 2015) 
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