KATE GALLIN HEFFERNAN is a Member of the Firm in the Health Care and Life Sciences practice, in the Boston office of Epstein Becker Green. She advises academic medical centers, hospitals, research institutes, universities, and other research organizations and stakeholders on issues related to:
- Human subjects protection
- Research compliance and misconduct
- Research affiliations and contracting
- Investigator and institutional conflicts of interest
- Repositories for data, genomic, and tissue research and the downstream uses of stored materials
- FDA requirements for clinical investigations
- Treatment with investigational products pursuant to FDA's expanded access program and "Right to Try" laws
- Research involving human embryonic stem cells and induced pluripotent cells
- Multi-site global trials
- Privacy of research subjects' information
In addition to her research-focused practice, Ms. Heffernan advises clients on general patient care issues, including clinical informed consent and the protection of sensitive health information, as well as organ donation and transplantation.
Ms. Heffernan’s prior experience advising from both outside and within the institutional setting has given her an appreciation of the hurdles that health care organizations face not only in analyzing and understanding the complex regulatory scheme in which they pursue their mission, but also in developing and implementing solutions that work.
Ms. Heffernan is a frequent speaker and author on many issues related to the legal and ethical issues raised by academic and clinical research, and her writings have appeared in, among other places, the Journal of Clinical Oncology, the Journal of Medical Ethics, Transplantation, the Journal of the American Medical Association, Cell Stem Cell, The Hastings Center Report, IRB: Ethics and Human Research, BNA Medical Research Law & Policy Report, and Bloomberg Law's Pharmaceutical and Life Sciences News.
Ms. Heffernan is involved with policy and thought development on the national and international scene. Serving on a panel appointed to advise the Health Resources and Services Administration, she contributed to a proposed ethical framework for the conduct and oversight of organ donor intervention trials. The framework was subsequently endorsed in the National Academies of Sciences, Engineering, and Medicine’s report Opportunities for Organ Donor Intervention Research: Saving Lives by Improving the Quality and Quantity of Organs for Transplantation, for which she served as an invited reviewer. The Secretary's Advisory Committee on Human Research Protections (SACHRP), which advises the Secretary of the U.S. Department of Health and Human Services on challenging issues related to human subjects research, invited Ms. Heffernan to present to SACHRP on this topic in July 2019.
Ms. Heffernan serves as a member of the planning committee for the Advancing Ethical Research Conference, an internationally attended conference jointly sponsored by Public Responsibility in Medicine & Research (PRIM&R) and Boston University, at which she is a regular faculty member. She has also served as a member of several working groups of the Multi-Regional Clinical Trials Center at Harvard University's Global Health Institute, an interdisciplinary group of academics, health care providers, and industry convened to recommend concrete solutions for challenging ethical issues in international research. Ms. Heffernan has an enduring interest in bioethics, pursuing advanced study in June 2009 through a fellowship in medical ethics at Harvard Medical School, Division of Medical Ethics. She served on the Institutional Review Board of South Shore Hospital in Weymouth, Massachusetts, for several years.
Ms. Heffernan has been listed in Chambers USA: America's Leading Lawyers for Business in the Massachusetts – Healthcare category (2017-2020), selected by her peers for inclusion in The Best Lawyers in America© in the field of Health Care Law (2021), and included on the 2018 New England Super Lawyers list in the area of Health Care.
Before joining Epstein Becker Green, Ms. Heffernan was a partner, and served as the chair of the Academic and Clinical Research Group and vice chair of the Health Care & Life Sciences Group, at a New England regional law firm. She previously operated her own practice as the founder of KGH Advisors LLC, after having worked in the Research and Technology division of the Office of the General Counsel at a not-for-profit, integrated health care system in Massachusetts. Prior to that, she practiced in the health care group of an international law firm.
- New York University School of Law (J.D., magna cum laude, 2000)
- Order of the Coif
- Georgetown University (B.A., magna cum laude, 1996)
- Phi Beta Kappa
- New York