News & Analysis as of

Software Regulatory Requirements

Hogan Lovells

AI Health Law & Policy: Complying with FDA GMP rules for AI-enabled diagnostic devices

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter citing a failure to obtain marketing authorization via a premarket approval (PMA) or 510(k) clearance as well as Good Manufacturing Practice (GMP)...more

Orrick, Herrington & Sutcliffe LLP

EU Commission Clarifies Definition of AI Systems

The European Commission published guidelines that clarify the definition of AI systems under the AI Act, analyzing each component of the definition of AI system, providing examples and specifying which systems should be...more

Pillsbury Winthrop Shaw Pittman LLP

The EU’s Cyber Resilience Act: New Cybersecurity Requirements for Connected Products and Software

The CRA will affect a broad range of digital products placed on the EU market (including by those based outside the EU), including connected hardware/devices, software and remote data processing solutions. The EU has adopted...more

Akin Gump Strauss Hauer & Feld LLP

Updating Permitting Technology for the 21st Century (Trump EO Tracker)

Directs agencies to streamline environmental review and permitting processes for infrastructure projects by leveraging modern technologies. The Council on Environmental Quality (CEQ) must establish an interagency Permitting...more

Sheppard Mullin Richter & Hampton LLP

FedRAMP 20x – Major Overhaul Announced to Streamline the Security Authorization Process for Government Cloud Offerings

On March 24, 2025, the Federal Risk and Authorization Management Program (“FedRAMP”) announced a major overhaul of the program, which is being called “FedRAMP 20x.” The FedRAMP 20x announcement stated there are no immediate...more

Holland & Knight LLP

A Regulatory Assessment of AI Performance Guarantees

Holland & Knight LLP on

With the warranty industry evolving in the U.S., companies seeking to modernize conventional warranties by leveraging advanced technologies such as artificial intelligence (AI) are faced with unique regulatory questions and...more

Morgan Lewis

Investment Opportunities and Regulatory Framework in Kazakhstan

Morgan Lewis on

The Republic of Kazakhstan, having vast reserves of natural resources and being located at the intersection of Europe and Asia, competes for investments in the region. As such, and as laid out in this article, the government...more

Goodwin

Crossing Administrations: The Focus on Federal Cybersecurity Continues

Goodwin on

Federal contractors, including defense contractors, should prepare for the emergence of new requirements in the coming months that are designed to strengthen software supply chain security, impose more stringent cybersecurity...more

Warner Norcross + Judd

Lessons from CES 2025: The Legal Side of Product Innovation — What Every Manufacturer and Supplier Needs to Know

Warner Norcross + Judd on

The 2025 Consumer Electronics Show (CES) — one of the world’s most influential tech events — once again showcased groundbreaking innovations that are shaping the future of technology. I was among the over 141,000 attendees of...more

DLA Piper

How Many Neurons Must a System Compute Before You Can Call It AI? Unpicking the Guidelines on the AI Act’s Definition of...

DLA Piper on

Bob Dylan famously asked, “How many roads must a man walk down, before you can call him a man?”. The power of the question is that there is no answer – and comparing the tribulations of one person’s journey through life to...more

Vinson & Elkins LLP

From Cloud to Compliance: Legal Essentials for Building and Operating AI-Ready Data Centers

Vinson & Elkins LLP on

Driven by the demand for AI-ready cloud infrastructure, the market cap for global data center construction, currently valued at more than $250 billion, is set to double in less than ten years, reaching half a trillion dollars...more

MoFo Life Sciences

FDA Draft Guidance on Artificial Intelligence-Enabled Device Software Functions

MoFo Life Sciences on

This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more

DLA Piper

FDA Issues Artificial Intelligence-Enabled Device Software Functions Draft Guidance

DLA Piper on

The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025....more

Venable LLP

AI On the Prize: Decoding FDA's Latest Guidance

Venable LLP on

Last week, the U.S. Food and Drug Administration (FDA) issued two significant draft guidance documents concerning the use of artificial intelligence (AI) in medical devices and in drug and biological product development....more

Hogan Lovells

New guidance on AI-enabled device software functions clarifies information FDA expects in marketing applications

Hogan Lovells on

On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” which...more

Pillsbury - Internet & Social Media Law Blog

The Importance of Opting In: Pitfalls of AI Enablement Without Client Buy-In

Imagine you’re an associate at a consulting firm. You’re surprised to see a new “AI Assist” button appear in your email application one morning. Without any training or guidance from your firm’s IT department, you decide to...more

Morrison & Foerster LLP - Government...

SHARE IT Act Requires Agencies to Share Custom-Developed Source Code Throughout the Government

On December 23, 2024, President Biden signed the Source Code Harmonization and Reuse in Information Technology Act (“SHARE IT Act” or “the Act”), which provides a formal mechanism for federal agencies to store and share...more

Fox Rothschild LLP

Investments in Chinese Technology Companies Limited by New US Outbound Investment Rule

Fox Rothschild LLP on

U.S. investors interested in investing in advanced Chinese technology companies may now be constrained by the U.S. Government’s first-ever outbound investment rule (Final Rule) which took effect on Jan. 2, 2025. The Final...more

King & Spalding

FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions

King & Spalding on

On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance was long-anticipated; it...more

Foley & Lardner LLP

Foley Automotive Update - January 2025.

Foley & Lardner LLP on

Foley & Lardner announced the 2024 installment of its Auto Trends series—A Year in Review: Updates, Trends and the Road Ahead. This series delves deep into the transformative forces shaping the automotive world by providing...more

Orrick, Herrington & Sutcliffe LLP

FDA Issues Draft Guidance on AI-Enabled Medical Devices

The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices. The Importance of Engaging Early Sponsors of AI-enabled devices should engage with the...more

Husch Blackwell LLP

State AI Update: December 30, 2024

Husch Blackwell LLP on

Welcome to the second edition of Byte Back AI, a weekly newsletter providing updates on proposed state AI bills and regulations, an AI bill tracker chart, summaries of important AI hearings, and special features....more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 10, December 2024

Happy Holidays and welcome to our year-end issue of Decoded. We hope you enjoyed reading our technology law insights e-newsletter this year. We are already planning for 2025. ...more

Baker Botts L.L.P.

China Bans Exports to U.S. of Critical Minerals Used in High Tech “Dual-Use” Materials

Baker Botts L.L.P. on

On December 3, 2024, the Chinese Ministry of Commerce announced strict export restrictions on “dual-use” technologies. Dual-use technologies are those that are developed for civilian markets but also have military utility or...more

Jones Day

Radical Changes to Europe's Product Liability Rules Adopted

Jones Day on

Dramatic changes to EU product liability rules are expected to drive an increase in litigation....more

53 Results
 / 
View per page
Page: of 3

"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