Overview
When academic medical centers, hospitals, universities, research institutes, start-up biotechnology companies, and other research stakeholders need advice on a comprehensive range of issues affecting biomedical research, they turn to attorney Kate Gallin Heffernan.
Kate counsels clients on issues related to the following:
- Human subjects protection
- Research noncompliance and misconduct proceedings
- 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, Kate 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.
Clients benefit from Kate’s prior experience advising from inside the institutional setting, which has given her insight into 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.
Focus Areas
Services
- Academic and Clinical Research
- Corporate Compliance Program Development, Implementation, and Effectiveness
- FDA Inspections and Enforcement
- Federal Research Grants: Compliance, Investigations & Enforcement
- Health Care
- Health Care and Life Sciences Investigations and Enforcement
- Industry Research and Clinical Trials
- Life Sciences
- Privacy, Cybersecurity & Data Asset Management
- Product Marketing and Compliance
- Regulatory Strategy, Product Development, and Product Approvals
Experience
Recognition
- The Best Lawyers in America©: Health Care Law (2021 to 2025)
- Chambers USA: America's Leading Lawyers for Business: Massachusetts—Healthcare, "Leader in Their Field" (2017 to 2024)
- New England Super Lawyers Health Care (2018)
Credentials
Media
Events
Insights
Insights
- Media Coverage
Epstein Becker Green's Health Law Advisor Cited in “Old Laws, Supreme Court May Stymie HHS Plan to Fast-Track Policy” ...
2 minute read - Media CoverageKate Heffernan Featured in “Can NIH Overturn a Court Order Blocking It from Slashing Overhead Payments? Unlikely, One ...5 minute read
- Media CoverageKate Heffernan, Robert Wanerman Quoted in “HHS Comment Reversal Sets Stage for Quick Policy Changes”2 minute read
- BlogsHHS Reverses Its Longstanding Policy and Limits Public Participation in Rulemaking7 minute read
- BlogsThe NIH IDC – Where Are We Now6 minute read
- Media CoverageKate Heffernan Quoted in “Colleges Get More Leeway to Handle Research Misconduct”2 minute read
- Media CoverageKate Heffernan Quoted in “The Rise of the Science Sleuths”5 minute read
- Firm Announcements
Epstein Becker Green Attorneys Honored for Excellence in the Legal Profession by Best Lawyers 2025
14 minute read - PublicationsFDA Issues Long-Anticipated Draft Guidance on Diversity Action Plans16 minute read
- Firm Announcements
Epstein Becker Green Honored for Exceptional Performance in Key Practice Areas by Chambers USA 2024
5 minute read - Media Coverage
Kate Heffernan Featured in AHLA’s Speaking of Health Law Podcast, “Trends Related to Research Misconduct” ...
1 minute read - Media Coverage
Epstein Becker Green Attorneys Elected to Law360’s 2024 Editorial Advisory Boards
3 minute read - BlogsUnpacking Averages: Sample Size for Clinical Trials Used to Obtain FDA Medical Device Clearance13 minute read
- PublicationsORI Releases Notice of Proposed Rulemaking to Update 2005 Public Health Service Policies on Research Misconduct ...7 minute read
- BlogsFDA Issues Final Guidance on Informed Consent for IRBs, Clinical Investigators, and Sponsors4 minute read
- Firm Announcements
Epstein Becker Green Attorneys Recognized by 2024 Best Lawyers for Excellence in the Legal Profession
12 minute read - PublicationsFDA Issues Draft Recommendations for Implementing Decentralized Clinical Trials20 minute read
- Firm Announcements
Epstein Becker Green Recognized for Focused Excellence Across Core Practice Areas in Chambers USA 2023
5 minute read - Media CoverageCarrie Valiant, Kate Heffernan Quoted in “Scuba Diving Scientist Underscores DOJ Focus on NIH Dollars”2 minute read
- Firm Announcements
Epstein Becker Green Attorneys Recognized by 2023 Best Lawyers for Excellence in the Legal Profession
11 minute read - Firm AnnouncementsChambers USA 2022 Recognizes Epstein Becker Green's Focused Excellence in Core Practice Areas: Distinguished in ...4 minute read
- PublicationsOSTP Releases Highly Anticipated Guidance on National Security Strategy for Federally Funded Research6 minute read
- Firm AnnouncementsFifty-Eight Epstein Becker Green Attorneys Recognized for Professional Excellence–Three Attorneys Distinguished as ...7 minute read
- Firm Announcements
Epstein Becker Green’s Focused Excellence Lauded by Chambers USA in 2021 Edition of Leading Law Firms and Attorneys ...
3 minute read - Media CoverageEpstein Becker Green Becomes Boston Bar Association Sponsor2 minute read
- Media Coverage
Epstein Becker Green’s Latest Health Hires in Boston Featured in Law360
2 minute read - PublicationsEpstein Becker Green’s Boston Health Care and Life Sciences Practice Featured in “Hire Up: This Week’s Lateral ...2 minute read
- Firm AnnouncementsEpstein Becker Green Adds Group of Health Care & Life Sciences Attorneys in Boston6 minute read
- PublicationsIncorporating Ethical Principles into Clinical Research Protocols: A Tool for Protocol Writers and Ethics Committees ...
- PublicationsThe NFL-NIH Research Partnership: Why Congress Is Worried
- PublicationsA Framework for Conducting Deceased Donor Research in the United States