Keo Shaw

Representative Matters

• 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.

• Co-author, "Development and preliminary testing of Health Equity Across the AI Lifecycle (HEAAL): A framework for healthcare delivery organizations to mitigate the risk of AI solutions worsening health inequities," PLOS Digital Health (May 2024)
• Co-author, "Pharma & Medical Device Regulation 2024, Global Overview: the continued rise of digital health," Lexology Getting the Deal Through (October 2023)
• 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, Health AI Partnership Summit, "People, Process, and Technology for AI Product Lifecycle Management Within Healthcare Delivery Organizations", Washington, DC (September 19, 2024)
• Speaker, FMI (The Food Industry Association) Legal, Regulatory & Compliance Conference, "Application of AI in the Food Industry," Annapolis, MD (July 23, 2024)
• Speaker, UCSF Coordinating Center for Diagnostic Excellence (CoDEx) AI and Diagnosis Webinar Series, "Exploring the AI Implementation Life Cycle within Healthcare Organizations," virtual event (June 25, 2024)
• Speaker, Health Excellence Through Technology (HETT) North 2024, "Driving Innovation for Digital Maturity in a Global Context," Manchester, UK (February 28, 2024)
• Speaker, Food and Drug Law Institute (FDLI) Current Developments in Digital Health Technology and Regulation Conference, "Navigating Laws and Regulations Globally in the Artificial Intelligence and Machine Learning Era," virtual event (January 31, 2024)
• Speaker, Young Presidents' Organization (YPO) Healthcare Horizon Conference, "Data Ethics and Legal Frontiers: Navigating the Ethical and Legal Dimensions of Al in Healthcare," Singapore (October 14, 2023)
• Speaker, International Women’s Forum 2023 World Leadership Conference, "You're All I Need to Get By: The Artificial Intelligence Revolution," Detroit, MI (October 5, 2023)
• Speaker, Health Excellence Through Technology (HETT) Show 2023, "Considering Global Insights on Evidence for AI in Healthcare," London, UK (September 26, 2023)
• Speaker, Crosstown Showcase: AI in Healthcare, "Innovation in Healthcare," Chicago, IL (September 14, 2023)
• 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)