David Peloquin
Partner
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
- 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.
Publications
- Quoted, “ChatGPT Poses New Regulatory Questions for FDA, Medical Industry,” Bloomberg Law (June 21, 2023)
- Co-author, “End of the COVID-19 Single Institutional Review Board Exception: Considerations for Academic Medical Centers and Other Research Institutions,” American Health Law Association Bulletin (March 2, 2023) Copyright 2023, American Health Law Association, Washington, DC. Reprint permission granted.
- Co-author, “Clinical Trial Law Promotes Diversity and Modernization,” Law360 (January 24, 2023)
- Profiled, “Alumni Tackle Health Law Issues Facing Society Today,” Yale Law School Today (October 25, 2022)
- Quoted, “NIH Privacy Certificates Shield Reproductive Research,” Bloomberg Law (July 19, 2022)
- Quoted, “Global Trials Face Core Challenges From Privacy Laws,” BioWorld (June 27, 2022)
- Quoted, “State By State, Some Patients are Losing Telehealth Access to Doctors,” NBC News (June 19, 2022)
- Co-author, “Applying Civil Rights Law to Clinical Research: Title VI's Equal Access Mandate,” The Journal of Law, Medicine & Ethics (Spring 2022)
- Co-author, “Demystifying Schrems II for the Cross-Border Transfer of Clinical Research Data,” Journal of Law and the Biosciences (October 23, 2021)
- Co-author, “What Florida DNA Privacy Law Means For Health Providers,” Law360 (October 4, 2021)
- Co-author, “Emerging ethical issues raised by highly portable MRI research in remote and resource-limited international settings,” NeuroImage (September 2021)
- Co-author, “Mutual Recognition Of Physician Licensure By States Would Provide For Better Patient Care,” Health Affairs Blog (April 10, 2021)
- Co-author, “Health Info Blocking Rule Creates Opportunities For Research,” Law360 (March 8, 2021)
- Co-author, “HHS Opinions Signal Broad Immunity From COVID-19 Liability,” Law360 (November 6, 2020)
- Co-author, “Recent CCPA Amendment Brings Welcome Clarifications, But Also New Obligations Around De-Identified Patient Data,” Legaltech News and Law.com (October 20, 2020)
- Co-author, “How to fix the GDPR’s frustration of global biomedical research,” Science Magazine (October 2, 2020)
- Co-author, “Disruptive and Avoidable: GDPR Challenges to Secondary Research Uses of Data,” Nature publishing’s European Journal of Human Genetics (March 2, 2020)
- Co-author, “California Bill Clarifies Privacy Law’s Ambiguities for Medical, Research Communities,” Bloomberg Law (February 13, 2020)
- Quoted, “Lagging FDA Human Research Rules Draw Cures Law Architects’ Ire,” Bloomberg Law (December 13, 2019)
- Quoted, “Your Fitbit Data Means New Ethics Conundrums for Clinical Trials,” Bloomberg Law (August 30, 2019)
- Quoted, “Patchwork of Privacy Laws Muzzle Medical Studies Across States,” (May 28, 2019)
- Quoted, “GDPR: One Year Down, Forever to Go,” Legaltech News (May 1, 2019)
- Quoted, “EU’s Privacy Rule Impacts Sites, Sponsors Globally,” CenterWatch (April 8, 2019)
- Quoted, “DNA's Family Ties Poses Unique Personal Privacy Issue,” Legaltech News (April 8, 2019)
- Quoted, “As More Countries Seek Adequacy Decisions With EU, Will US Get Left Behind?“ Corporate Counsel (also appeared in Legal Week and The Asian Lawyer) (February 26, 2019)
- Co-author, “Guidance Regarding Interaction Between GDPR and EU Clinical Trials Regulation Leaves Several Questions Unanswered,” Bloomberg Law (February 14, 2019)
- Quoted, “Research Reg Changes Apply to 20 Agencies’ Grants—Half Are Closed (1),” Bloomberg Law (January 11, 2019)
- Co-author, “Insights On Right To Try Act And 'Expanded Access' Concerns,” Law360 (December 18, 2018)
- Co-author, “INSIGHT: The Right to Try Act and Its Implications for Pharmaceutical Manufacturers,” Bloomberg Law (July 24, 2018)
- Cited, “Returning Individual Research Results to Participants: Guidance for a New Research Paradigm,” National Academies of Sciences Consensus Study Report (July 2018)
- Co-author, “GDPR Complicates Admissions Applications for U.S. Universities,” Bloomberg BNA’s Privacy Law Watch (June 27, 2018)
- Co-author, “Will Consent Be Disfavored as Basis for Processing Personal Data in Clinical Research Under EU Data Protection Law?” Bloomberg Law’s Medical Law & Research Policy Report (June 15, 2018)
- Co-author, “Final Guidelines on Consent Requirements Under the EU General Data Protection Regulation: Implications for Scientific Research,” Bloomberg BNA’s Life Sciences Law & Industry Report (April 30, 2018)
- Co-author, “New Draft Guidelines on GDPR Consent Requirement’s Application to Scientific Research,” Bloomberg BNA’s Medical Law & Research Policy Report (January 17, 2018)
- Co-author, “Extraterritorial Effect of the GDPR and Implications for U.S. Academic Medical Centers Treating EU Patients,” Bloomberg BNA’s Medical Law & Research Policy Report (November 1, 2017)
- Co-author, “Certificates of Confidentiality After the 21st Century Cures Act” Bloomberg BNA’s Medical Research Law and Policy Report (October 4, 2017)
- Co-author, “Reconciling Personal Data Consent Practices in Clinical Trials with the EU General Data Protection Regulation,” Bloomberg BNA’s Medical Research Law & Policy Report (September 20, 2017)
- Co-author, “OIG’s Warranty Safe Harbor Opinion and Value-Based Care,” Law360 (September 14, 2017)
- Co-author, “What to Know About New FDA Informed Consent Guidance,” Law360 (August 11, 2017)
- Co-author, “New Frontiers in AMC Funding: Mission Support Alternatives Post-Halifax,” Member Briefing, American Health Lawyers Association (AHLA) AMCs and Teaching Hospitals Practice Group (May 2017)
- Co-author, “Using Biospecimens Collected Abroad in Future Research: Key Considerations,” Bloomberg BNA’s Medical Research Law & Policy Report (April 19, 2017)
- Co-author, “Recent Changes in French Law Affecting Clinical Research and Trials,” Bloomberg BNA Medical Research Law & Policy Report (February 15, 2017)
- Co-Author, “What To Know About HHS Revised 'Common Rule'” Law360 (February 13, 2017)
- Quoted, “New rules on trial subjects omit consent requirement, aiding test development,” S&P Global Market Intelligence (January 27, 2017)
- Co-author, “HHS Finalizes Comprehensive Revisions to the Common Rule,” Bloomberg BNA Life Sciences Law & Industry Report (January 26, 2017)
- Co-Author, The Biomedical Research Enterprise, The Oxford Handbook of U.S. Healthcare Law (2016) Edited by I. Glenn Cohen, Allison K. Hoffman, and William M. Sage
- Co-Author, “Impact of the European Union’s Approved General Data Protection Regulation On Scientific Research and Secondary Uses of Personal Data,” Bloomberg BNA Medical Research Law & Policy Report (February 17, 2016)
- Co-Author, “Impact of Proposed Federal Research Regulation Amendments (the Common Rule NPRM) on Life Sciences Companies,” Bloomberg BNA Life Sciences Law & Industry Report (November 13, 2015)
- Co-Author, “Single IRB Review: Legal and Policy Perspectives,” Bloomberg BNA Medical Research Law & Policy Report (November 4, 2015)
- Co-Author, “The CLIA/HIPAA Conundrum of Returning Test Results to Research Participants,” Bloomberg BNA Medical Research Law & Policy Report (July 15, 2015)
- Co-Author, “National Institutes of Health Issues a Notice of Proposed Rulemaking on Clinical Trials Registration and a Draft Policy on Registration and Reporting of Results for NIH-Funded Clinical Trials,” Bloomberg BNA Medical Research Law & Policy Report (December 17, 2014)
- Co-Author, “New EU Clinical Trials Regulation and its Interaction With Proposed EU Privacy Regulation and Proposed EMA Policy on Clinical Trials Data Transparency,” Bloomberg BNA Medical Research Law & Policy Report (August 20, 2014)
- Co-Author, “European Union's Proposed General Data Protection Regulation Promises Big Changes for Secondary Uses of Data from Clinical Trials,”Bloomberg BNA Medical Research Law & Policy Report (November 20, 2013)
- Co-Author, “EMA Draft Policy on Publication and Access to Clinical Trials Data Provides Broad Researcher Access to Participant-Level Data,”Bloomberg BNA Medical Research Law & Policy Report (July 17, 2013)
- Co-Author, “Rethinking America's Illegal Drug Policy,” NBER Chapter in Controlling Crime: Strategies and Tradeoffs (2011)
Presentations
- Presenter, U.S. Africa Leaders Summit Science Collaboration panel, Washington D.C. (December 16, 2022)
- Presenter, “Is This the End of Global Clinical Trials? How to Navigate Data Privacy and National Security Restrictions Affecting Cross-Border Data Transfers in the EU and China,” BIO International Convention (June 15, 2022)
- Presenter, “Applying Civil Rights Law to Clinical Research: Title VI's Equal Access Mandate,” University of Pennsylvania Law School Health Law and Anti-Racism Symposium (March 2022)
- Presenter, keynote address on “Navigating the Pandemic Research Landscape, Legal and Regulatory Perspectives,” The Feinstein Institutes for Medical Research at Northwell Health Virtual Conference (April 15, 2021)
- 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)
Education
- JD, Yale Law School, 2011; online editor, Yale Law Journal ; managing editor, Yale Journal on Regulation
- BA (Economics), summa cum laude, Carleton College, 2006; Phi Beta Kappa
Admissions / Qualifications
Qualifications
- Massachusetts, 2011
- New York, 2012
Awards
- Legal 500 (2021-2023)
- Best Lawyers in America (2023-2024)