Healthcare is undergoing a rapid, technology-driven evolution – reshaping how services are delivered, how data is used, and how patients and providers interact. Our digital health team is a market leader in guiding clients through this shifting landscape. 

We help companies leading healthcare innovation bring technology-enabled products and services to market, scale them, and defend them. We advise digital health, telemedicine, health technology, medical device, pharmaceutical, diagnostic, start-up and healthcare provider clients across the full product and business life cycle, combining deep regulatory, transactional, privacy, cybersecurity, reimbursement, and disputes experience. With extensive experience across the digital health ecosystem, our team helps organizations at every stage of growth anticipate and navigate the complex transactional, regulatory, and compliance challenges that define this space.

Our lawyers counsel clients on FDA and other regulatory issues before and after launch, including product development and pre-market strategy, software and app status, submissions and clearances, post-market compliance, advertising and promotion, telemedicine laws, licensure, corporate practice, consent and online documentation, interoperability, and billing and reimbursement structures.  We also guide clients through the regulatory landscape surrounding mobile health applications, wearables, connected devices, and emerging digital health tools that the FDA may consider regulated devices.

We offer guidance on all aspects of digital health transactions, including entity formation and governance, joint ventures, mergers and acquisitions, capital raising, strategic collaborations, technology and commercial agreements, and intellectual property protection and licensing. We also handle healthcare privacy and security compliance, HIPAA, risk assessments, investigations and breach response, fraud and abuse, antitrust, litigation, government investigations, and TCPA class actions.

Drawing on former FDA and other government insiders and working seamlessly across regulatory, healthcare, life sciences, technology, corporate, IP, privacy, and litigation teams, we deliver practical, business-focused advice that helps clients innovate confidently while managing legal and operational risk. By combining deep industry insight with a proactive approach to emerging trends, we help our clients overcome regulatory and operational hurdles, accelerate growth, and stay ahead in a rapidly evolving market.