Manufacturers, Regulatory Oversight, Machine Learning

AI regulation introduced in Europe - setting the way forward for the rest of the world or slowing down the adoption of new tech?

Dorsey & Whitney LLP on 3/25/2024

The EU AI Act, which was passed by the European Parliament on 13 March and is set to become law later this year, will probably be the world’s first legislation to introduce a general regulatory framework for artificial...more

Who's Who under the EU AI Act: Spotlight on Key Actors

Baker Donelson on 3/15/2024

Who will play the leading role if we make a new series about AI? If you interview Steven Spielberg, Sundar Pichai, and Sam Altman, you might receive three distinct ideas ranging from the 2001 classic "AI: Artificial...more

Brussels Regulatory Brief: February 2024

K&L Gates LLP on 3/5/2024

Antitrust and Competition - The European Commission Carried Out Unannounced Inspections in the Tires Sector - On 30 January 2024, the Commission conducted dawn raids at the premises of several companies active in the tires...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

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