Keo McKenzie
Biography
Keo McKenzie is a partner in Baker McKenzie's Intellectual Property and Technology Practice Group (IPTech), based in the Firm’s DC office.
Keo has a neuroscience degree from the University of Cambridge and is dual-qualified as a lawyer in the US and UK, bringing an international perspective to her practice. She is Co-Chair of the California Lawyers Association AI Steering Committee.
Practice Focus
Keo has significant experience advising multinational technology, life sciences, and healthcare companies with complex matters related to regulatory and transactional issues presented by digital health technologies. She regularly advises and publishes on legal issues arising from the application of novel medical technologies, including medical AI. Keo also advises a broad spectrum of clients on AI governance and generative AI tool red teaming.
Representative Legal Matters
- Advised various multinational companies on developing comprehensive responsible AI governance frameworks compatible with international regulation and best practices, including creating policies, oversight committee charters, risk assessment processes and documentation, and delivering training.
- Counseled a major global pharmaceutical company on development of digital therapeutics products and international rollout of generative AI enterprise tools.
- Conducted legal red teaming projects for life science and retail sector clients to identify legal risks posed by large language model tools under development and propose mitigations.
- Advised biotechnology companies on setting up clinical trials involving digital health technologies.
- Led FDA regulatory due diligence and transaction advice on acquisitions and investments involving AI and software solutions in the life science and health care space.
- Advised pharmaceutical, health technology, telehealth, and laboratory services clients on regulatory product classifications, risk assessments and implementation of digital health solutions, including smart wearables, clinical decision support software and AI/ML-enabled medical devices.
- Counseled a clinical trial services company on cyberattack response.
- Counseled a technology developer on product development strategy and post-market compliance issues related to health/medical mobile applications.
- Led multijurisdictional surveys to determine regulatory status of digital health products ahead of global launches.
- Advised Software as a Medical Device (SaMD) manufacturer on implementing clinical trials, including drafting and negotiating clinical trial agreements, reviewing informed consent forms and recruitment materials, addressing FDA regulatory issues with Investigational Review Boards and advising on clinicaltrials.gov publication issues.
- Counseled a multinational technology company on contributions to trade association position papers on smart devices and responses to public consultations on updates to medical device regulations.
- Advised a major US technology company on the cross-border acquisition of a health and sleep app and related devices.
- Led FDA regulatory advice in connection with US asset sale of non-steroidal anti-inflammatory products.
- Represented a large North American consumer goods company in employee non-compliance with FDA manufacturing and laboratory standards investigation and resolution.
Professional Associations and Memberships
- California Lawyers Association - Member and AI Steering Committee Co-Chair
- Food and Drug Law Institute (FDLI) - Member
- Health AI Partnership (HAIP) - Leadership team (2022 – 2024)
Admissions
- California~United States (2018)
- England & Wales~United Kingdom (2013)
Education
- University of Oxford (P.G.Dip in Intellectual Property Law and Practice) (2014)
- Nottingham Law School (LL.B) (2010)
- Cambridge University (M.A. in Natural Sciences) (2007)
Baker & McKenzie LLP is a Limited Liability Partnership organized under the laws of the State of Illinois (USA) and is a member of Baker & McKenzie International, a Verein organized under the laws of Switzerland.