Schedule

Kathleen Healy, Robinson & Cole
Robert Martin, Senior Legal Counsel, Mass General Brigham Incorporated

• Suggested steps to enable a health care compliance program to assess and monitor the use of AI in the enterprise
• Legal issues and ethical considerations raised by AI (e.g., informed consent, privacy and security including FTC and HIPAA breach rules, FDA approval, bias and discrimination, fraud and abuse)
• Practical considerations (e.g. governance and internal processes and controls)
• Legal trends to monitor
• Emerging laws and regulations

Tony Maida, McDermott Will Emery
Kirk Sripinyo, Deputy Branch Chief, Affirmative Litigation Branch, Office of the Inspector General, US Department of Health and Human Services

• Session description to follow

Vic Domen, DLA Piper US LLP
Joe Knight, FTI Consulting

• Session description to follow

Stephen D. Bittinger, Polsinelli PC
Maggie DiConstanzo, Offit Kurman
Jonathan M. Joseph, Christian & Barton

• The current tools, tasks, and disputes of in the use of AI in managed care
• Efforts by federal and state governments to regulate the use of AI in managed care
• The contracting strategies for the  use of AI in managed care
• Key issues to address with AI vendors using plans’ data
• Key issues being litigated against managed care plans for use of AI
• The vital legal issues that courts must determine on how AI will be valued as evidence

David Peloquin, Ropes & Gray, LLP
Gregory Stein, Senior Counsel, IT & IP, Cleveland Clinic
Allison Trimble, Associate General Counsel, BJC Health System

• Session description to follow

Julie Barnes, CEO, Maverick Health Policy

• Session description to follow

Mark Sendak, Population Health & Data Science Lead, Duke Institute for Health Innovation (DIHI)
Alya Sulaiman, Chief Compliance and Privacy Officer, Senior Vice President of Regulatory Affairs, Datavant

• Session description to follow

Alisa Chestler, Baker Donelson
Jumi Kassim, Global IT & Digital Enablement Counsel, Boston Scientific
Gregg Killoren, General Counsel, XSOLIS
Eric Setterlund, Bradley Arant Boult Cummings LLP

In this session we will discuss contracting approaches to unique issues raised by engaging Artificial Intelligence so that both the vendor and end-user are able to mitigate risk and maximize the benefits of the technology. At the conclusion of this program, you will have a better understanding of the following:

• Pre-negotiation strategies to set the stage for a successful negotiation
• Navigating AI governance committee requests
• The implications of AI on IP and data use rights and how to navigate and negotiate these issues
• Handling third-party terms (including discussion on click-through terms and related considerations)
• Strategies to manage and allocate risk

Elizabeth Hsieh Lee, Chief Privacy Officer, UCLA
Hillary Noll Kalay, Senior Principal Counsel, University of California Office of the President

This session will discuss the key considerations on negotiating terms relating to data sharing, primary use, and secondary uses of data. Presenters will discuss issues relating to:

• Privacy, security and data governance
• Data flow from health care provider, to AI vendor, and back, and the variations of data
• Downstream AI uses of data
• Industry benchmarking
• Marketing and optics

Clark Daniel, HeartFlow
Victoria Wallace, Hogan Lovells US LLP

• Background on Medicare benefit categories under the Social Security Act (SSA)
• The benefit categories that have applied to AI-based items and services under Medicare to date
• How the Centers for Medicare & Medicaid Services (CMS) has reimbursed for AI-based items and services
• Successes and challenges with obtaining payment for AI services when the concept of AI doesn’t fit neatly within the categories of the SSA
• The perspective of a company that has successfully obtained coverage and payment for its AI-based service, challenges along the way, and what challenges there might be on the horizon