Compliance

This is the second in a series of blog posts focused on AI and clinical trials/research space, highlighting topics to be discussed at the upcoming BIO International convention on June 22-25, 2026.

Introduction

Your latest trial sponsor is using AI to accelerate protocol development and patient recruitment,[1] cutting timelines that once took months down to weeks. The efficiency gains are undeniable. Then your quality assurance team asks a simple question: “Can you reproduce these AI-generated inclusion criteria?” You realize you can’t. The same prompts produce different outputs each day. When you ask the AI vendor how to validate their tool under ICH E6(R2), they send you marketing materials about “cutting-edge technology,” not validation documentation.

Register for our webinar, AI in Your Organization: Are Your Contracts Keeping Up?, on May 19 at noon CT, presented by Kris Kappel and Maggie Mannebach.

Artificial intelligence is no longer an emerging technology—it is embedded in the mainstream enterprise software, platforms, and vendor services that organizations rely on every day. In many cases, organizations are already using AI without realizing it because vendors have quietly integrated it into existing products. That reality raises an urgent question: are your contracts keeping pace?

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A Final Rule updating Section 504 of the Rehabilitation Act of 1973 recently published by the Department of Health and Human Services (HHS) issued new mandates stipulating that every facility, program, or activity with 15 or more employees that receives HHS funding will need to comply with new digital accessibility guidelines.

To align its requirements…

Digital tablet computer close up man using tablet hands man multitasking with isolated screen

On April 24, 2024, the Department of Justice (DOJ) published a final rule to adopt the Web Content Accessibility Guidelines, version 2.1 Level AA (WCAG 2.1) as the compliance standard for web and mobile app accessibility for Title II entities under the Americans with Disabilities Act (ADA).

After our recent presentation, Physician Owner Mindset, Compliance Guardrails: Growth Without the Gotchas, at the American Alliance of Orthopaedic Executives on April 21, we wanted to share some practical insights on incentive design, deal structure, and how these issues surface in transactions and enforcement—key topics we touched on in our discussion. We think you will find these articles beneficial in navigating the ever-changing landscape you face (alternate: the industry faces) today.

This is the first in a series of blog posts focused on AI and clinical trials/research space, highlighting topics to be discussed at the upcoming BIO International convention on June 22-25, 2026.

A major research institution combines 15 years of patient genomic data with metabolomic profiles and clinical outcomes, feeding it into an AI model for drug target discovery. The resulting insights are groundbreaking—until the legal department asks: “Did any of those consent forms authorize AI analysis? Or data sharing across these datasets? Or commercial drug development?”

Blurred image of business people walking in modern office with sunlight.

This is the sixth and final installment in a six-part series on incentive design, deal structure, and how these issues surface in transactions and enforcement. Other relevant topics will be discussed in our upcoming presentation, Physician Owner Mindset, Compliance Guardrails: Growth Without the Gotchas, to be given at the American Alliance of Orthopaedic Executives on Tuesday, April 21.

Close-up of a neatly organized stack of insurance documents with a magnifying glass on top, showcasing professionalism and attention to detail in a modern office setting.

This is the fifth in a six-part series on incentive design, deal structure, and how these issues surface in transactions and enforcement. Other relevant topics will be discussed in our upcoming presentation, Physician Owner Mindset, Compliance Guardrails: Growth Without the Gotchas, to be given at the American Alliance of Orthopaedic Executives on Tuesday, April…

AdobeStock_1539387488

This is the fourth in a six-part series on incentive design, deal structure, and how these issues surface in transactions and enforcement. Other relevant topics will be discussed in our upcoming presentation, Physician Owner Mindset, Compliance Guardrails: Growth Without the Gotchas, to be given at the American Alliance of Orthopaedic Executives on Tuesday, April 21.