AI in Healthcare

A Market Leader in Healthcare AI

Wilson Sonsini defined the internet era with its representation of Silicon Valley’s digital giants since their earliest start-up days—and this legacy continues today with the firm as a pioneer in the healthcare artificial intelligence (AI) sector.

Just as the firm has been an integral part of the tech scene for decades, its commitment to client service has grown through its representation of the most impactful AI companies, including a third of the Forbes 2025 AI 50. Wilson Sonsini advises clients—including healthcare clients—on some of the biggest deals in AI, which totaled over $50 billion in 2024, and takes on precedent-setting cases in AI-related law.

At the same time, the firm has built a highly experienced Digital Health practice, with a sharp focus on AI, representing clients ranging from cutting-edge healthcare technology start-ups to hospital systems. The firm’s cross-disciplinary team blends its market-leading representation of the world’s most influential technology companies with deep digital healthcare regulatory experience. Due to this unique combination, hundreds of healthcare innovators consider Wilson Sonsini to be their go-to strategic advisor when it comes to harnessing AI innovation in their business.

Wilson Sonsini’s Healthcare AI Clients

Wilson Sonsini’s clients include healthcare companies and investors that use AI to fundamentally reshape care delivery, clinical decision-making, and the use of healthcare data. The firm counsels on business strategy, helps its clients understand the law and its gaps, and predicts where future legal developments are likely to create significant risks or opportunities. Because Wilson Sonsini represents the full range of participants in the healthcare AI ecosystem, it has a holistic view of the current business and regulatory realities of this sector, as well as the distinct ability to foresee the concerns and requests that potential clients and partners may present to companies and investors. The firm’s central position in the tech and healthcare industries helps facilitate significant and beneficial relationships that drive innovation and growth, and smooth the way to the adoption of AI in healthcare.

Wilson Sonsini advises healthcare AI companies on the full legal and regulatory landscape governing the development, training, deployment, and commercialization of AI in healthcare. This includes compliance with emerging state healthcare AI laws across all U.S. jurisdictions; HIPAA compliance and patient data protections; managing risks related to patient care and the influence of clinical outcomes; and FDA regulatory oversight. In addition to our firm’s advisory services, we represent clients in regulatory inquiries and investigations related to healthcare AI.

Data Privacy, Security, Access, and Use

Data is the key to the development and deployment of innovative AI-enabled technologies in healthcare, but its use, security, and sharing present unique challenges in the healthcare context. Wilson Sonsini advises on issues related to the access, exchange, and use of health data for AI development and deployment. Our firm provides AI-related advice in contract negotiations and transactions, as well as during disputes and investigations. In addition, we help clients shape this rapidly developing area of the law through robust and effective advocacy.

Wilson Sonsini’s AI healthcare team includes a former HHS and ONC executive who helped draft and implement foundational healthcare data privacy and interoperability rules, including the HIPAA Privacy Rules that are a key consideration in every AI-related healthcare decision. This unique experience informs our approach to regulatory issues we routinely handle for our clients, including issues related to health information exchange, interoperability, TEFCA, information blocking, and data rights. We also counsel health AI innovators on health data protections, including state and federal privacy and security requirements such as HIPAA, FTCA, and state laws. In addition, we provide strategic advice on business arrangements that implicate data access, as well as the right to use and exchange health information and other data.

AI Healthcare-Centered Deals

Wilson Sonsini is consistently ranked by Bloomberg, Thomson Reuters, and Capital IQ as a leading deal advisor to companies and underwriters in the tech space. The firm is also consistently ranked No. 1 by LSEG for the number of company-side venture capital deals it handles each year, including AI healthcare deals. Together with the firm’s corporate attorneys, the team represents AI healthcare clients in a wide range of deals, including venture financings, private equity capital raises, M&A, strategic ventures, and IPOs.

In addition, Wilson Sonsini understands that intellectual property (IP) is an innovative company’s most valuable asset, driving its valuation and ability to raise capital and enter into strategic partnerships. At the same time, protection of AI-related innovation poses new and unique challenges. Our AI healthcare team routinely collaborates with the firm’s IP professionals to define the scope of available protection and help clients obtain patents, trademarks, and copyrights where appropriate, as well as provide practical advice on trade secret protections.

AI in Healthcare Regulatory Compliance

Wilson Sonsini helps healthcare AI companies innovate in one of the most highly regulated industries in the United States. The use of AI in healthcare raises novel legal and regulatory questions about clinical decision-making and patient-specific recommendations, which require guidance on structuring AI tools and workflows to distinguish between clinical care and wellness guidance, and to address the implications of AI on compliance with the corporate practice of medicine (CPOM) and associated requirements for a management services organization (MSO) and professional corporation (PC) structure. The legal and regulatory framework for the application of AI in healthcare is fluid and fragmented, with a patchwork of state and federal laws and regulations that demand careful synthesis. The firm’s AI healthcare team counsels clients on both state-specific healthcare AI laws and broader healthcare and technology laws that do not explicitly address AI, but nonetheless govern healthcare AI businesses.

The AI healthcare team also helps clients manage liability risk in an evolving regulatory environment where the laws and legal standards are changing rapidly and still developing. Further, it advises on complex healthcare regulatory frameworks implicated by AI-enabled healthcare, including fee-splitting, the Anti-Kickback Statute, the Stark Law, CPOM, reimbursement, value-based care, licensing, and professional responsibility.

FDA Regulatory Strategy

Wilson Sonsini advises healthcare AI companies on how the U.S. Food and Drug Administration (FDA) regulates AI/ML-enabled products and platforms and strategic regulatory considerations for commercializing those technologies, including risk mitigation strategies, negotiations with FDA-regulated partners such as biopharmaceutical or medical device companies, quality agreements with suppliers, and post-market regulatory compliance. Our team helps clients analyze their product development and the use of AI in the context of their business model to determine potential go-to-market strategies, including pathways outside of FDA regulation or subject to FDA enforcement discretion, as well as FDA regulatory requirements pre- and post-market for FDA-regulated products, software functions, and/or SaaS platforms, including those that interface or connect with other medical devices, including wearables and remote monitoring products.

AI Policy and Engagement

Wilson Sonsini is actively engaged with federal agencies and policymakers on AI policy and its applicability to health care. The AI healthcare team partners with clients to advise them on shaping policy and advancing business goals related to healthcare AI. The team’s senior federal agency experience and Washington, D.C., presence contribute to its unique judgment and understanding of policy development, enabling our attorneys to provide exceptional advice and direction to clients seeking to track and understand policy development and engage with policymakers on rapidly developing AI policy and advancements in technology. We work with leaders at HHS, including ONC, CMS, OCR, and FDA, as well as the FTC.

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