Subject: Artificial Intelligence

Significant Drug & Device Developments of 2025

Share

As we welcome the new year, it is time to reflect on some of the most significant legal developments in the drug and device space in 2025.

1. Navigating a New Skepticism in Science

Not long ago, the average American likely could not name the U.S. secretary of health and human services. Yet, following this year’s change in administration and major shakeup in the regulatory landscape, skepticism in science has become the elephant in the room for anyone working in the drug and device sphere. Practitioners should start thinking about how to present scientific evidence to juries in 2026 as the old norms may no longer apply.

Read the full article on the Faegre Drinker website.

ChatGPT As Your New Testifying Expert Under Proposed Federal Rule of Evidence 707? Maybe Not.

Share

Artificial intelligence is taking the world by storm, and the legal community is no exception. Tools that can reduce the time and cost of litigation have long been in high demand by both clients and counsel. But the tool must be fit for its purpose, and tools that generate evidence or other outputs that will be submitted to the court must pass judicial scrutiny. As video cameras became smaller and less expensive, there were fights over the admissibility of deposition videos that attorneys had recorded themselves to avoid videographer fees. Practitioners who focus on e-discovery can tell stories of hotly litigated technology-assisted review protocols. One of the newer fights concerns the admissibility of machine-generated “expert” opinions.

The U.S. Courts Advisory Committee on the Federal Rules of Evidence (the “Committee”) proposes to address the issue by adding a new rule, Federal Rule of Evidence 707. The prospect of adding a new rule to regulate the admissibility of machine-generated evidence was first raised at the Committee’s November 2024 meeting. Since then, the Committee has proposed the following language for Rule 707:

Continue reading “ChatGPT As Your New Testifying Expert Under Proposed Federal Rule of Evidence 707? Maybe Not.”

FDA Publishes New Artificial Intelligence & Medical Products White Paper

Share

On March 15, the United States Food & Drug Administration published a white paper entitled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” FDA announced the paper by sharing a short letter from Commissioner Califf, where he reaffirmed the Agency’s commitment to “promoting the responsible and ethical development, deployment, use, and maintenance of safe and effective medical products that incorporate or are developed with AI.” The white paper does not contain any new pronouncements of FDA position, but refers to existing guidance and serves as a reinforcement for existing FDA policy regarding AI.

Continue reading “FDA Publishes New Artificial Intelligence & Medical Products White Paper”

5 Major Drug and Device Developments of 2022

Share

As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702 updates that took place this year, which will carry over into 2023?), but provides a brief recap and assessment of five of the most interesting and consequential developments affecting drug and device law in 2022.

Continue reading “5 Major Drug and Device Developments of 2022”

Responsible AI: Managing Risk in an Evolving Regulatory and Legal Landscape

Share

Artificial Intelligence (“AI”) is driving innovation across industries and is playing an increasing role in everyday life. AI (and, more broadly, algorithms) is being used in diagnostics, enabled medical devices, device manufacturing, drug discovery and manufacturing, industrial manufacturing, smart home and wearable devices, and vehicles. AI has the potential to benefit society in a number of ways, including by boosting efficiency, providing invaluable insights, and informing decisions. But to borrow from the likes of Winston Churchill (or Spider-man), with great AI capabilities comes great responsibility.

Many of the risks and benefits of AI systems are unique in comparison to other technologies. Regulators, governmental agencies, and consumer advocates are keenly focused on addressing unintended consequences that may result from the development and use of algorithms and AI. These issues, like the technology, are complex, and policymakers, stakeholders, and regulators are grappling with how best to address them.

Continue reading “Responsible AI: Managing Risk in an Evolving Regulatory and Legal Landscape”

European Commission Updates Liability Rules to the Digital Age

Share

The European Commission adopted two proposals that adapt liability rules to the digital age, circular economy and the impact of global value chains. These proposals are related to the Revised Product Liability Directive, fit for the green and digital transition and global value chains, and the AI Liability Directive to provide easier access to redress.

Continue reading “European Commission Updates Liability Rules to the Digital Age”