News & Analysis as of

Regulatory Oversight Manufacturers Artificial Intelligence

Ballard Spahr LLP

FDA Issues Guidance on AI for Medical Devices

Ballard Spahr LLP on

The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more

Dorsey & Whitney LLP

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

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

Baker Donelson

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

Baker Donelson on

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

K&L Gates LLP

Brussels Regulatory Brief: February 2024

K&L Gates LLP on

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

Hogan Lovells

A brave new world of AI liability in the EU

Hogan Lovells on

Manufacturers and other stakeholders contemplating the use of AI-enabled products and services should be mindful of new rules proposed by the European Commission (EC) to address product liability claims related to AI systems....more

Hogan Lovells

Evolution of FDA regulation of AI-based technology

Hogan Lovells on

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

MoFo Life Sciences

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

MoFo Life Sciences on

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

Robins Kaplan LLP

Financial Daily Dose 12.02.2019 | Top Story: US Restores Metal Tariffs on Argentina and Brazil

Robins Kaplan LLP on

The White House will again slap tariffs on steel and aluminum imports from Argentina and Brazil in an apparent reaction to “massive devaluation” of  currencies in both South American nations....more

McDermott Will & Schulte

Reviewing Key Principles from FDA's Artificial Intelligence White Paper

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

Jones Day

Driverless, Networked Vehicles on the Rise, French Liability Regulations Lag Behind

Jones Day on

The Situation: Autonomous cars with incorporated artificial intelligence ("AI") are now a reality whereas French regulations have yet to adjust. The Issue: The phenomenon of new autonomous cars using AI gives rise to...more

Hogan Lovells

How the Internet of Things could redefine product safety and liability in the EU

Hogan Lovells on

How big is the Internet of Things (IoT)? It’s likely that there will be tens of billions of connected devices in use by 2020. As this massive network of “things” keeps expanding, so do the number of questions about...more

11 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide