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Artificial Intelligence Machine Learning New Guidance

Morgan Lewis - As Prescribed

FDA’s AI-Assisted Review: The Next Stage of Regulated Product Evaluation

On June 2, 2025, FDA announced the launch of Elsa, a generative AI tool designed to “help employees—from scientific reviewers to investigators—work more efficiently.” Per FDA, the tool “modernizes agency functions and...more

Jones Day

U.S. Copyright Office Issues Guidance on Generative AI Training

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To address the legal issues presented by artificial intelligence ("AI"), the U.S. Copyright Office ("Office") launched a multi-part Copyright and Artificial Intelligence Report ("Report") (see our Commentaries on Part One and...more

Epstein Becker & Green

Copyright Infringement Liability for Generative AI Training Following the Copyright Office’s AI Report and Administrative Shakeup

Epstein Becker & Green on

When multiple forces act on an object, its direction of motion is determined by the net force, which is the vector sum of all individual forces. When this happens within our federal government, we call it “interesting times.”...more

Wiley Rein LLP

Copyright Office Issues Key Guidance on Fair Use in Generative AI Training

Wiley Rein LLP on

On May 9, 2025, the U.S. Copyright Office (the Office) released the third and final report in its “Copyright and Artificial Intelligence” series, offering its most comprehensive guidance to date on one of the most contested...more

BCLP

HK Releases Guideline Concerning Generative AI

BCLP on

On 15 April 2025, the Hong Kong Government’s Digital Policy Office published the Hong Kong Generative Artificial Intelligence Technical and Application Guideline (“Guideline”), which aims to provide operational guidance for...more

Kaufman & Canoles

AI and Copyrights

Kaufman & Canoles on

Hours before the Register of Copyrights, Shira Perlmutter, was unceremoniously fired, the U.S. Copyright Office published long-awaited guidance on the use of copyrighted content for training artificial intelligence (AI)....more

Sheppard Mullin Richter & Hampton LLP

Copyright Office Report on Training AI and Fair Use

The Copyright Office released a “Pre-publication” version of Part 3 of its Report on Copyright and AI. Coincidentally (?) Shira Perlmuter, the Register of Copyrights, was fired amid a shakeup at the Copyright Office. The...more

Jones Day

OMB Directs Agencies to Accelerate AI Adoption and Devise Governance Strategy

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The Office of Management and Budget releases highly anticipated guidance to federal agencies on the use and deployment of artificial intelligence and how to manage its risks....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

Womble Bond Dickinson

USPTO's AI Patent Eligibility Guidance, Vincent Look

Womble Bond Dickinson on

In 2024, the USPTO published guidance on whether an AI-based invention is patent eligible. The guidance includes three hypothetical inventions, including one relating to using an artificial neural network for data anomaly...more

Jones Day

Blurring the Line Between the Dry and Wet Lab: Joint Inventorship in AI-Assisted Life Science Inventions

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In 2024, not one but two Nobel Prizes (in Chemistry and Physics) were awarded to researchers for their work in artificial intelligence ("AI"). Particularly noteworthy for the life science community is the Nobel Prize in...more

McDermott Will & Emery

FDA Reveals AI Development Cheat Sheet in Highly Anticipated Draft Guidances

McDermott Will & Emery on

Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more

Littler

AI in the Garden State: New Guidance on Algorithmic Discrimination and the New Jersey Law Against Discrimination

Littler on

On January 9, 2025, the New Jersey attorney general and the Division of Civil Rights (DCR) announced that the DCR has launched a new Civil Rights and Technology Initiative to address the risks of discrimination stemming from...more

ArentFox Schiff

FDA Issues New Recommendations on Use of AI for Medical Devices, Drugs, and Biologics

ArentFox Schiff on

In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on the use of artificial intelligence (AI) in the context of drugs, biologics,...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

AI IP Year in Review - AI Developments at the USPTO

Navigating Inventorship of AI-Assisted Inventions: USPTO’s Guidance and Implications - The USPTO issued guidance on AI-assisted inventions on February 13, 2024. This guidance is part of the USPTO’s ongoing efforts to address...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

IP Hot Topic: USPTO Publishes FAQs on Inventorship Guidance for AI-Assisted Inventions

Following the Inventorship Guidance for AI-Assisted Inventions, the United States Patent & Trademark Office (USPTO) has published a set of frequently asked questions (FAQs) and answers regarding the guidance...more

DLA Piper

EU: EDPB Opinion on AI Provides Important Guidance Though Many Questions Remain

DLA Piper on

A much-anticipated Opinion from the European Data Protection Board (EDPB) on AI models and data protection has not resulted in the clear or definitive guidance that businesses operating in the EU had hoped for. The Opinion...more

Jones Day

FDA's Final Guidance Provides Practical Approach for AI-Enabled Devices Implementing Post-Market Modifications

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As a streamlined method for obtaining U.S. Food and Drug Administration ("FDA") authorization of post-market functionality, FDA issued final guidance recommending the information to include in a Predetermined Change Control...more

Brooks Pierce

Counting Down to the New Year: Ten “Need-to-Know” Labor and Employment Developments of 2024

Brooks Pierce on

2024 was yet another active year in the labor and employment landscape. While 2025 and the new administration could bring any number of changes to workplace laws and enforcement, the timing and extent of such changes is...more

Sheppard Mullin Richter & Hampton LLP

FDA Releases Long-Anticipated Guidance on Predetermined Change Control Plans for Devices That Utilize AI/ML Software

FDA’s primary challenge in regulating AI-enabled device software functions (“AI-DSF”) has been that the self-modifying nature of these functions simply does not fit within the Agency’s long-standing framework for medical...more

A&O Shearman

EDPB adopts EU-U.S. DPF report, issues Biometrics Guidelines mandate and other updates

A&O Shearman on

On November 5, 2024, the European Data Protection Board (EDPB) issued its first report under the EU-U.S. Data Privacy Framework (DPF) and released a statement on the access to data for law enforcement. Both documents were...more

A&O Shearman

Australia’s privacy regulator, the Office of the Australian Information Commissioner, publishes new guidance on privacy...

A&O Shearman on

The Office of the Australian Information Commissioner (OAIC) has published AI guidance articulating how Australian privacy law applies to AI and the OAIC’s overall expectations on AI governance and privacy safeguards for...more

Baker Botts L.L.P.

Department of Labor Releases "Best Practices" Guide for Employers Using Artificial Intelligence

Baker Botts L.L.P. on

The U.S. Department of Labor (DOL) recently released new non-binding guidelines for employers and developers using artificial intelligence (AI). These guidelines build on the DOL’s May 2024 release of eight AI “principles”...more

Jones Day

DOJ Updates Corporate Compliance Program Guidance With a Focus on AI and Emerging Technologies

Jones Day on

The Situation: In September 2024, the U.S. Department of Justice ("DOJ" or "Department") announced updates to its Evaluation of Corporate Compliance Programs guidance covering three primary areas: (1) the risks of artificial...more

BCLP

AI in the Workplace: Using Artificial Intelligence Intelligently

BCLP on

Ready or not, artificial intelligence (“AI”) is here, and even if your company hasn’t introduced or approved the use of AI, chances are your employees are already using it....more

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