In a redefined health tech and digital health landscape, Latham’s global cross-disciplinary group advises all types of stakeholders — from the innovators that develop new technologies, to the companies that are entering highly regulated healthcare markets or transforming with the integration of digital technologies, to the investors and private equity firms that are fueling industry inflection points. 

We help clients operating at a global scale and under intensifying scrutiny navigate unprecedented and consequential regulatory, corporate, commercial, litigation, and intellectual property matters facing industry players. Our market-leading healthcare and life sciences, technology, AI, as well as privacy and cyber practices seamlessly guide clients through all stages of the health tech lifecycle across markets in the US, Europe, and beyond.

With deep industry experience we are exceptionally well-positioned to advise clients grappling with the implications of three key forces: AI-powered digital health, the massive influx of connected medical devices and digital health data, and industry-specific regulation that simultaneously expands and fragments. We arm clients with insights to not only respond to market changes, but to anticipate and shape them.

Artificial Intelligence-Enabled Healthcare

AI embedded across digital health infrastructure, from product development and clinical workflows to diagnostics, operations, and drug and device lifecycles presents legal, regulatory, and strategic implications. We help clients optimally position products, including software as a medical device (SaMD), within regulatory frameworks, anticipate the post-market obligations of adaptive AI systems, and allocate liability amongst stakeholders. 

Data Strategy, Governance & Dynamic Regulation

Health data creates both competitive advantages and regulatory risks. We help clients strategize through multi-dimensional considerations, including data ownership and access, cross-border data flows and constraints, secondary use for research and AI, scalable data platforms, and data sharing and licensing arrangements.

As regulators impact the development of digital health, we bring expertise from jurisdictions with aggressive agencies and coordinated enforcement. Latham lawyers translate the firm’s market-leading experience into commercial, cross-border approaches to anticipate risks related to product compliance and safety, to respond to data and AI-related inquiries and regulatory investigations, and if necessary to defend clients in enforcement actions and cross-border, bet-the-company litigation. 

Transformative Transactions 

Amid this complexity, we interpret market changes and enforcement trends to develop clear sight lines to execute transactions. With a track record of evolving alongside our clients, Latham lawyers often develop novel structures to facilitate financing, strategic partnerships, licensing and collaboration, and other health tech transactions.  

As trusted advisors, we leverage market-leading legal insight and experience to help ambitious clients succeed in a landscape marked by AI integration, regulatory intervention, and the convergence of technology and innovative healthcare delivery.