Technology & Information Systems

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).

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?”

Earlier this month, Judge Rakoff of the Southern District of New York issued a first-of-its-kind ruling in United States v. Heppner. The case involved a criminal defendant, Heppner, who used a public generative AI platform (Claude) to “prepare reports that outlined his defense strategy (what he might argue with respect to the facts and the law that [his attorneys] anticipated that the government might be charging”). Although the defendant prepared the documents on his own, he later shared them with his attorneys. Heppner argued that these AI-generated documents should be protected by attorney-client privilege and the work product doctrine.

Blog SeriesConference Post (1)

This is the fourth in a series of articles designed to provide SXSW and LSI USA ’26 attendees and other MedTech professionals with practical considerations for efficiently executing mission-critical life science deals.

Many MedTech companies begin with one important relationship.

A health system agrees to test the product.
A strategic customer agrees to move first.
A commercial partner helps validate the market.

That is often how the first traction happens.

This post is part of our The Top 2025 Privacy and Security Issues Still Shaping Healthcare series, in which our team of attorneys provides essential strategies and insights for healthcare privacy and security.

In December 2024, the FTC announced two separate settlements against Mobilewalla, Inc. and Gravy Analytics, Inc., asserting that the two companies were unlawfully tracking and selling sensitive location data from users without consent, including data related to visits to health centers. 

Blog SeriesConference Post (1)

This is the third in a series of articles designed to provide SXSW and LSI USA ’26 attendees and other MedTech professionals with practical considerations for efficiently executing mission-critical life science deals. On March 15, during SXSW, Husch Blackwell’s healthcare team will host two panels, bringing together founders and investors from healthcare, technology, and early-stage companies for candid discussion, practical insights, and plenty of time to connect.

Register here.