David Peloquin joined the corporate department in 2012. He works primarily on health care matters, particularly in the area of clinical research and health data privacy. Prior to attending law school, David worked as a project manager for a leading supplier of electronic medical records.
- Counsel multiple leading pediatric hospitals on matters related to “big data research collaborations”, receipt of research data from countries in the European Union, and design of biobanking research protocols and consent forms.
- Counsel a leading information technology firm regarding compliant strategies for obtaining data from health care organizations.
- Advised a university client in connection with a government investigation of its Select Agents research program.
- Advised a university client regarding requirements for tissue donation consent forms under various state laws.
- Assisted multiple clients in updating business associate agreements and research consent forms to comply with changes to HIPAA.
- Assisted multiple clinical trial sponsors and sites in drafting informed consent forms and reviewing subject recruitment processes.
- Advised a large pharmaceutical client regarding the permissibility of using clinical trials data and biospecimens for secondary research purposes.
- Advised multiple clients regarding transfers of clinical trials data from the European Union to the United States.
- Analyzed for a pharmaceutical client the potential implications of changes to European Union privacy law on the conduct of clinical trials in Europe.
- Analyzed for a major medical device company the pathway to seek reimbursement for its products in France, Germany and the United Kingdom.
- Assisted multiple health care providers in preparing and submitting self-disclosures of overpayments to the Centers for Medicare and Medicaid Services, Medicare Administrative Contractors, and the New York Office of the Medicaid Inspector General.
- Counseled hospital and clinical laboratory clients regarding the Medicare and New York Medicaid compliance implications of proposed billing practices.
- Assisted a clinical laboratory client in identifying possible fraud and abuse violations and drafting internal policies related to fraud and abuse compliance.
- Assisted a hospital client in filing administrative appeals of Medicare payment denials.
- 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)
- Ropes & Gray Roundtable Discussion, “Complying With the EU GDPR Requirements in Clinical Trials,” (December 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)