Kathy Fitzgerald
Kathy Fitzgerald, JD, CHC, CHPC
Kathy Fitzgerald is a seasoned healthcare law and compliance executive with over 36 years of experience navigating the complex, fast-paced regulatory landscapes of the healthcare and life sciences industries, serving as a trusted compliance resource to Boards and C-Suite stakeholders, providing substantive expertise and guidance on complex regulatory matters.
Kathy specializes in designing robust compliance infrastructures, executing ground-up program implementations, and steering organizations through high-stakes regulatory crises. She frequently serves as an Interim Chief Compliance Officer, providing stability and guidance during times of transition. Kathy has established a stellar track record of transforming corporate cultures and stabilizing entities facing active federal investigations. Most recently, she led a pharmaceutical company under three federal government agreements. She has also built a comprehensive program from scratch and successfully negotiated a 5-Year Corporate Integrity Agreement with the Office of Inspector General (OIG) in lieu of debarment, successfully preserving enterprise viability.
She has held executive-level compliance roles at an American specialty pharmaceutical company and functioned as a Managing Director within a global business advisory firm’s Healthcare Risk & Advisory Practice. A highly sought-after interim leader, she has stepped into critical, high-impact roles including Interim Chief Compliance Officer for global pharmaceutical companies and Interim Compliance Leader for a university medical center.
Earlier in her career, Kathy honed her foundational healthcare legal acumen across an array of key roles, serving as VP of Compliance and In-House Counsel across healthcare and life sciences companies. She is a recognized, retained litigation expert witness in high-stakes HIPAA, data privacy, and data protection matters, bringing the firsthand compliance program experience that distinguishes credible expert testimony from academic analysis.
Kathy holds a BS in Business Administration with Honors from the University of Richmond, and a JD from William and Mary Law School. She is certified in Healthcare Compliance and in Healthcare Privacy Compliance, and is a member of the American Health Law Association, the Health Care Compliance Association, and the Society of Corporate Compliance and Ethics.