As AI becomes embedded in clinical workflows, healthcare organizations and technology innovators face growing challenges in deploying and scaling these tools safely and effectively. Please join us for Part Two of our series, which covers the practical business, legal and regulatory challenges vendors face when bringing AI tools into clinical settings.

This webinar will provide practical guidance on structuring AI-enabled products for the healthcare market, from defining defensible usage limits and transparent metering, to addressing customer concerns around data retention, model memory, and the boundaries of what AI "knows" about a patient across sessions.

Topics include:

• Regulatory Positioning for AI-Enabled Devices: Aligning product design and vendor agreements with state and federal guidance and HIPAA, software-as-a-medical-device (SaMD) guidance, state AI disclosure laws and evolving CMS reimbursement frameworks.
• Customer-Facing Risk Allocation: Structuring indemnities, warranties and limitation-of-liability provisions that account for the unique risk profile of AI outputs in clinical decision-making.
• Tracking Context and Model Memory: Navigating the technical and legal implications of how AI tools retain, discard or reprocess patient data across sessions, including implications for necessary minimum HIPAA standards, data minimization and patient consent.
• Usage Limits, Metering, Token Economics and Pricing Transparency: How to define, communicate, and draft contracts that align with usage thresholds, while managing customer expectations around performance, availability, and the relationship between tokens, inference costs, and contract pricing.

Attendees will leave with actionable information for navigating the regulatory, contractual and commercial challenges unique to vendors deploying AI in clinical settings.

Speakers:
Elizabeth G. Litten, Partner, Chief Privacy and HIPAA Compliance Officer, Fox Rothschild
Nicholas Sarokhanian, Partner, Fox Rothschild
Jonathan H. Stechmann, Partner, Fox Rothschild

Fox Rothschild LLP is an Accredited Provider of Continuing Legal Education in California, Nevada, New Jersey, New York, Pennsylvania, and Texas. This program is eligible for a maximum of 90 minutes of CLE instruction in these states. Credit is pending in Colorado, Georgia, and North Carolina. Attorneys seeking credit in other jurisdictions may apply individually for accreditation. We will provide a uniform certificate of attendance and timed agenda upon request.