Artificial Intelligence, Software Developers, Manufacturers

The EU Updates its Products Liability Directive to Include AI

Fenwick & West LLP on 12/13/2024

On Dec. 8, the European Union (EU) updated its Product Liability Directive (PLD) to, inter alia, specifically address AI software. This directive must next be “transposed,” or written into law by each of the 27 member states....more

Evolution of FDA regulation of AI-based technology

Hogan Lovells on 6/15/2022

Hogan Lovells partners Kelliann H. Payne and John J. Smith, M.D., J.D. recently joined Richard Frank, MD, PhD, Chief Medical Officer, Siemens Healthineers, and other industry leaders in person and virtually at the Health Care...more

FDA’S Plan For AI/ML-Based Software As Medical Devices: Progress And Concerns

MoFo Life Sciences on 3/4/2021

U.S. Food and Drug Administration (FDA) has acknowledged the prevalence of Artificial Intelligence/Machine Learning (AI/ML)-Based Software as Medical Devices (SaMDs) and has been taking steps towards advancing its regulatory...more

Code Red: The FDA’s Artificial Intelligence/Machine Learning Action Plan Poses Potential Risks for Medical Device Makers

Nutter McClennen & Fish LLP on 2/5/2021

Q: The FDA’s stance on a regulatory framework for artificial intelligence and machine learning (AI/ML) software as a medical device is continuously evolving. Could you explain the history? A: Artificial intelligence (AI) is...more

Reviewing Key Principles from FDA's Artificial Intelligence White Paper

McDermott Will & Emery on 8/28/2019

In April 2019, the US Food and Drug Administration (FDA) issued a white paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device,”...more

Mitigating Product Liability for Artificial Intelligence

Jones Day on 3/23/2018

The Situation: New technologies incorporating AI create questions about how product liability principles will apply and adapt. The Issue: Legislatures and courts have not addressed how product liability laws apply to new...more