Health Care AI & Pharma
Artificial intelligence is increasingly embedded in how health care organizations deliver care, manage operations, and engage with patients, payors, and regulators. As AI and digital health technologies move beyond pilot programs and into routine clinical and operational use, organizations face legal questions that extend well beyond technology selection, including regulatory compliance, data governance, accountability, and enterprise risk management.
FBT Gibbons advises health care and life sciences organizations on the legal and governance considerations that arise when artificial intelligence is deployed in highly regulated health care environments. Our approach treats AI as a health care issue first, recognizing that its use often intersects with clinical judgment, reimbursement structures, patient safety, privacy obligations, and regulatory oversight. We work across legal, compliance, clinical, IT, and operational functions to help organizations align AI adoption with existing compliance programs, clarify accountability, and reduce fragmentation across internal stakeholders. Our guidance is grounded in health care regulatory analysis, privacy and security considerations, and defensible governance frameworks rather than technical system design or model development.
Key Issues We Help Address
- Determining when AI and digital health use triggers regulatory, enforcement, or audit risk.
- Aligning AI deployment with HIPAA, state privacy, and data security requirements.
- Establishing clear governance and accountability for AI‑enabled clinical or operational decisions.
- Managing vendor risk and contractual responsibility for third‑party AI tools.
- Supporting compliant and defensible AI adoption in the event of audits, investigations, or inquiries.
- Integrating AI oversight into existing compliance, quality, and enterprise risk programs.
Areas of Focus
We assist organizations in establishing governance structures that define accountability for AI enabled tools and outcomes across clinical, operational, and administrative settings. This includes policies, approval workflows, documentation standards, and oversight mechanisms that integrate AI into existing compliance, quality, and enterprise risk programs.
AI applications in health care and digital health may implicate overlapping federal and state regulatory regimes depending on their function, data inputs, and role in decision making. We help clients assess regulatory exposure, monitor evolving guidance, and implement documented, good faith compliance strategies designed to withstand regulatory review.
AI systems often rely on large volumes of clinical, operational, and consumer data. We advise on data sourcing, permitted and secondary uses, model training considerations, and alignment with HIPAA, state privacy laws, and federal consumer protection requirements, including consistency with privacy notices, consents, and authorizations.
Many health care organizations rely on external vendors for AI and digital health tools. We counsel clients on structuring contracts to address data rights, security obligations, audit and transparency provisions, allocation of regulatory and litigation risk, and ongoing compliance responsibilities throughout the vendor relationship.
We advise on legal considerations associated with AI tools used in clinical decision support and other high impact operational settings. Our guidance focuses on appropriate use limitations, human oversight requirements, documentation practices, and alignment with patient safety, professional judgment, and reimbursement expectations.
Key Contacts
Partner
Washington, D.C.
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