As AI-enabled technologies expand, life sciences companies face new challenges related to data rights, cybersecurity, cross‑border compliance, IP ownership, contracting, and promotional strategy. Our team helps clients build strong governance frameworks, protect proprietary assets, mitigate risk associated with complex datasets and third‑party tools, and structure collaborations that support sustainable AI innovation. We provide practical, forward‑looking guidance that allows organizations to use AI with confidence while maintaining the regulatory rigor required in healthcare and scientific environments.
AREAS OF FOCUS
Quality, Safety, and Post‑Market Obligations
- Integrating AI systems within GxP and quality‑system frameworks
- Managing model risk—including bias, drift, robustness, cybersecurity, and usability
- Establishing post‑market surveillance for AI performance, updates, and corrective actions
Data, Privacy, and Cybersecurity
- Securing lawful data sources, rights, consents, and provenance for clinical and real‑world datasets
- Addressing HIPAA and state privacy laws governing AI data use
- Building security‑by‑design safeguards for models, datasets, pipelines, and incident‑response plans
- Structuring compliant EU/UK and global data transfers in research and clinical settings
Intellectual Property, Data Rights, and Portfolio Strategy
- Coordinating patent strategies with regulatory exclusivities for AI‑enabled products
- Advising on ownership and inventorship for models, training data, improvements, and AI‑assisted research
- Evaluating freedom‑to‑operate risks for third‑party models, open‑source tools, and datasets
- Protecting models, datasets, and pipelines through trade secrets and tailored confidentiality frameworks
- Structuring data‑licensing agreements to support retraining, commercialization, and derivative works
Labeling, Promotion, and Market Access
- Ensuring promotional claims align with validated AI performance and explainability obligations
- Supporting payer engagement by demonstrating clinical utility and economic value of AI‑driven products
Strategic Contracting and Collaboration
- Drafting AI‑specific deal terms addressing data use, model ownership, updates, exclusivity, and audit rights
- Allocating validation, monitoring, SLAs, and clinical‑risk responsibilities in development partnerships
- Structuring research, licensing, MTA, CTA, and tech‑transfer agreements to secure key IP and data rights
- Supporting co‑development, co‑promotion, distribution, and supply arrangements for AI‑enabled products
