KIM TYRRELL-KNOTT* is a Member of the Firm in the Health Care and Life Sciences practice, based in San Diego and Washington, DC and serves on the firm's National Health Care and Life Sciences Steering Committee. She has significant experience advising investors and companies on a broad range of health care regulatory issues and developing and implementing comprehensive compliance programs. Ms. Tyrrell-Knott also has extensive experience assisting new entrants to the FDA regulated environment, from mobile app developers to compounding pharmacies, in understanding and complying with the applicable regulatory requirements.
- Assists medical device and health care technology companies with FDA-regulation compliance throughout the product life cycle—from product development to post-market compliance
- Conducts health care regulatory due diligence for transactions involving health care technology or medical devices companies
- Advises private equity and financial services firms on the regulatory issues associated with corporate transactions
- Counsels clients on clinical research issues, including drafting and negotiating clinical research agreements
- Assists clients in creating and implementing compliance programs addressing FDA, clinical research, data privacy, and fraud and abuse regulatory requirements
- Advises health care and technology companies on complex commercial transactions, including strategic technology partnerships and software licensing arrangements
- Advises clients on regulatory requirements for compounding pharmacy operations, including FDA warning letter responses
In addition, Ms. Tyrrell-Knott has extensive experience negotiating clinical research agreements, managing privacy and regulatory product reviews, and advising on advertising and promotional activities.
Ms. Tyrrell-Knott was formerly an Associate General Counsel of a $1+ billion division of a global health care company, where she served as strategic legal partner to the executive management team of various software- and technology-based global business units, including mobile applications and cloud-based offerings. In addition, she oversaw all legal aspects of business strategy and operations, including business development, commercial initiatives, and product development.
Ms. Tyrrell-Knott also worked previously in the technology and services industry, advising on novel regulatory issues associated with emerging technologies and the development of a global cloud computing platform.
Actively involved in policy development in the health IT industry, Ms. Tyrell-Knott serves as General Counsel to the mHealth Regulatory Coalition and the Clinical Decision Support Coalition. She also teaches a graduate course on regulatory policy and regulations for Case Western Reserve University’s Case School of Engineering. This course is part of the school’s Wireless Health graduate program.
*Application pending in California and the District of Columbia.
- Boston College Law School (J.D., 1996)
- Georgetown University (B.A., 1992)
- cum laude
- California (application pending)
- District of Columbia (application pending)
- Vermont (inactive)
- American Health Lawyers Association
- Health Care Compliance Association