Orrick helps disruptors scale, develop innovative business models and commercialize groundbreaking products and integrate AI, all while navigating a plethora of federal and state regulations. Our regulatory team is a key part of our multi-dimensional approach to supporting the life sciences, healthtech and healthcare ecosystem.
We represent digital health startups, emerging companies, venture capital and private equity investors, public healthtech companies, pharma and medical device companies, nationally recognized health systems and companies utilizing “click and mortar” models that leverage technology to transform the patient care experience.
We bring decades of experience helping hundreds of U.S. and international companies navigate the complex FDA regulatory and enforcement landscape. We counsel clients throughout the entire product lifecycle, from product approvals or premarket clearance to labeling and advertising strategies that maximize marketplace opportunities. We also counsel companies in FDA-adjacent spaces governed by the CPSC, USDA, and FTC.
Our team, led by Chambers-ranked healthcare advisors, brings expertise in anti-kickback and self-referral laws, patient privacy laws, and corporate practice of medicine and other professional services doctrines. Our lawyers have experience establishing and scaling “PC-MSO” arrangements across all fifty states and guiding 100+ digital health companies on the full scope of healthcare regulatory issues. We also regularly counsel on strategic affiliations, value-based care arrangements and other innovative business models.
We help clients incorporate privacy-by-design and secure design principles into their research, development and product launches. We advise on clinical trials, human subject protection, and state and federal laws that regulate the privacy and security of health data. In collaboration with our Chambers Band 1 Privacy & Data Security Litigation practice, we also defend clients in regulatory investigations, enforcement actions and litigation, often in matters connected to data breaches.
Our team, named an AmLaw 100 “Standout” for AI expertise, helps life sciences and healthtech companies leverage the power of AI and structure data-sharing arrangements. Our understanding of state regulatory frameworks enables us to counsel innovators on cutting-edge AI use cases, from “chatbot” and imaging solutions to clinical decision support, diagnostic and patient navigation tools.