Overview

Kate Hardey is a corporate partner in the Washington, D.C., office of Kirkland & Ellis LLP. Kate is an experienced attorney with a focus in a broad range of healthcare transactions and regulatory matters. With her extensive law firm, in-house and healthcare industry experience, Kate has a deep understanding of the complex regulatory landscape affecting companies in the healthcare provider and life science space including pharmaceutical and medical device manufacturers, laboratories, pharmacies, physician groups and hospital systems.

Kate has extensive experience providing transaction and regulatory compliance advice to companies with FDA-regulated products including, human and animal pharmaceutical products, medical and digital health devices, cosmetics, over-the counter (OTC) and dietary supplement products, and food and beverage products. Kate routinely evaluates FDA compliance requirements for all aspects of drug and device product life cycle including product development and clinical trials, product classification, product sales and marketing, manufacturing and product recalls. Kate also routinely advises clients on a broad range of healthcare-related issues including pharmacy compliance, corporate practice of medicine and dentistry and general fraud and abuse matters, such as the Anti-Kickback Statute and the Stark Law and other related regulatory matters.

Kate's in-house experience includes serving as Senior Regulatory Counsel at a leading middle-market healthcare lender where she advised on healthcare regulatory risks for a wide range of pharmaceutical, medical device, technology and provider transactions. Kate also served as in-house legal counsel in a large health system, where she served on hospital boards and leadership teams. In this role, Kate counseled hospital clients on a wide range of legal issues including physician contracting, medical staff compliance, pharmacy compliance, patient privacy and patient care matters.

Kate's healthcare industry experience includes managing physician practices where she oversaw all aspects of the practice's billing and coding compliance and managed care contracting. In addition to her physician practice management experience, Kate served as the emergency department administrator at a major academic medical center where she was responsible for the department's EMTALA compliance, physician contracting, financial and strategic planning and hospital emergency preparedness.

Kate was recognized in the 2023 Southeastern Legal Awards as one of the Most-Effective Deal-Makers. In September 2022, she received the M&A Advisor award for Healthcare/Life Sciences Deal of the Year. Kate is regularly called upon to advise on large corporate transactions in connection with major acquisitions and mergers undertaken by private equity and strategic acquirers in the healthcare provider, healthcare services and life sciences platforms.

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Thought Leadership

Press Mentions

Quoted, “Healthcare Policies to Watch in the New Trump Administration,” The Wall Street Journal, November 14, 2024

Recognition

Recognized in American Lawyer Media as a “Most Effective Deal-Maker,” June 2023

Received the M&A Advisor’s Healthcare/Life Sciences Deal of the Year Award 2022 for advising Canadian cannabinoid investment company Cronos Group on its strategic investment in PharmaCann Inc., one of the largest privately held and vertically integrated cannabis multistate operators in the United States

Recognized in North Carolina Lawyers Weekly as “Leaders in the Law,” November 2020

Recognized in The National Law Journal as a “Cannabis Law Trailblazer,” September 2020

Credentials

Admissions & Qualifications

  • 2004District of Columbia
  • 2018North Carolina
  • 2003Virginia

Education

  • Catholic University of AmericaJ.D.cum laude
  • Marymount UniversityM.S., Healthcare Administration
  • George Mason UniversityB.A., English