Keo ShawOf Counsel
Keo Shaw advises life sciences, technology, and healthcare clients on a range of regulatory, compliance, and transactional issues. She has particularly rich experience advising on regulatory issues presented by digital health technologies.
Keo has a neuroscience degree from the University of Cambridge and is dual-qualified as a lawyer in the US and the UK, bringing an international outlook to her practice. She is part of DLA Piper’s FDA Regulatory and AI practices, regularly advising, speaking, and publishing on legal issues arising from the application of novel medical technologies. Keo is also part of the Health AI Partnership Leadership Team along with individuals from Duke Health, the Mayo Clinic, UC Berkeley and others.
Before joining DLA, Keo was senior health products counsel at a multinational technology company. In that role Keo advised business teams and executive management on complex legal and regulatory risks in the digital health space, including human subjects research and clinical trials, regulatory authorization for medical devices, product marketing, distribution, and post-market issues.
- Counseled a major global pharmaceutical company on development of digital therapeutics products and governance of AI within its business.
- Advised a biotechnology company 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.
- M.A., Neuroscience, Cambridge University 2007
- L.L.B., Nottingham Trent University 2010
- P.G.D., University of Oxford 2014
- Co-author, "Organizational Governance of Emerging Technologies: AI Adoption in Healthcare," In Proceedings of Conference on Fairness, Accountability, and Transparency (FAccT '23) (April 2023)
- Co-author, "Pharma & Medical Device Regulation 2023, Global Overview: the continued rise of digital health," Lexology Getting the Deal Through (October 2022)
- Co-author, "Regulate your thoughts: the age of brain-machine interfaces and the neural lace is almost here," Society for Computers and Law (October 2022)
- Speaker, American Health Law Association (AHLA) webinar, "Data Privacy and Security Enforcement for Health and Wellness Apps," (June 13, 2023)
- Speaker, eMerge Americas Conference, "Unlocking Innovation and Collaboration Through Digital Health and Technology," Miami, FL (April 21, 2023)
- Speaker, Association of University Technology Managers (AUTM) 2022 Software Course, "FDA: Digital Therapeutics & Regulation," Baltimore, MD (September 19, 2022)
- Mentioned, "A research team airs the messy truth about AI in medicine — and gives hospitals a guide to fix it," Stat News, April 27, 2023
Memberships And Affiliations
- Health AI Partnership (HAIP) – Leadership team
- Food and Drug Law Institute (FDLI) - Member
- Association for Computing Machinery (ACM) - Member
My latest insights
FDA is embracing AI for its own purposes. Are you keeping pace?
5 September 2023 .8 minute read