News & Analysis as of

Artificial Intelligence Draft Guidance

Mintz - Antitrust Viewpoints

NIST Releases Updated Draft Guidance for Federal Agencies’ Use of AI in Identity Verification Systems — AI: The Washington Report

On August 21, the National Institute of Standards and Technology (NIST) released the second draft of its revised Digital Identity Guidance, which NIST first published in 2004 and last revised in 2017. The draft guidance...more

King & Spalding

Predetermined Change Control Plans (PCCPs) for Medical Devices: FDA Issues Draft Guidance

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On August 22, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled, Predetermined Change Control Plans for Medical Devices. The draft guidance describes how FDA plans to implement new...more

Pillsbury Winthrop Shaw Pittman LLP

Department of Commerce Releases Five Products to Help Guide AI Development

The Department of Commerce released three final guidance documents incorporating public comments from earlier this spring which provide recommendations for managing AI risk, securing AI software development processes, and...more

Orrick, Herrington & Sutcliffe LLP

NIST, Department of Commerce announce new guidance to help AI developers

On July 26, the U.S. Department of Commerce announced new guidance and tools to enhance the safety, security, and trustworthiness of AI systems pursuant to President Biden’s Executive Order on AI (covered by InfoBytes here)....more

McDermott Will & Emery

Real-World Data Back in the Spotlight at FDA

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On July 25, 2024, the US Food and Drug Administration (FDA) announced the release of a final version of its Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making...more

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

Key Considerations When Using AI Tools to Draft and File Documents with the USPTO

The use of Artificial Intelligence (AI) tools in practice before the United States Patent and Trademark Office (USPTO) is changing how practitioners prepare and submit documents. The USPTO’s recent Guidance on Use of...more

Akin Gump Strauss Hauer & Feld LLP

Akin Intelligence - April/May 2024

Welcome to the April-May edition of Akin Intelligence. This edition is a double header, covering both months as we prepare for the launch of our new AI Hub—a one-stop resource for AI coverage that will launch soon. Starting...more

Manatt, Phelps & Phillips, LLP

NIST Releases New Draft Guidance to Improve Safety, Security and Trustworthiness of AI Systems

The flurry of AI-related activity has certainly begun. Earlier this week, the Department of Commerce’s National Institute of Standards and Technology (NIST) released new draft guidance to improve the safety, security and...more

Dechert LLP

Dechert Cyber Bits - Issue 54

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European Data Protection Board Publishes Strategy for 2024-27 - The European Data Protection Board (“EDPB” - the EU body tasked with promoting consistency and cooperation in enforcement of the GDPR) has outlined its...more

Hogan Lovells

U.S. National Institute of Standards and Technology issues draft guidance on AI safety and standards

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The U.S. National Institute of Standards and Technology (NIST) is seeking comment on four draft publications meant to promote safe, secure, and trustworthy artificial intelligence (AI) systems. Two drafts provide guidance to...more

Faegre Drinker Biddle & Reath LLP

Race Against the Clock: Federal Agencies Issue Their Six-Month Updates on AI Activities in Accordance With President Biden’s...

Since President Biden issued his sweeping Executive Order on the Safe, Secure and Trustworthy Development of AI on October 30 of last year (EO), federal agencies have been operating in high gear to meet the deadlines and...more

Akin Gump Strauss Hauer & Feld LLP

Timeline: Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence

On October 30, 2023, the Biden administration issued its long-awaited artificial intelligence (AI) executive order (EO), which issues directives to over 20 federal agencies, with the deadline for implementation spanning...more

Mintz - Antitrust Viewpoints

OMB Releases Draft Guidance to Agencies on Implementing Biden’s AI Executive Order — AI: The Washington Report

Welcome to this week's issue of AI: The Washington Report, a joint undertaking of Mintz and its government affairs affiliate, ML Strategies. The accelerating advances in artificial intelligence (“AI”) and the practical,...more

Seyfarth Shaw LLP

How the Federal Government’s AI Risk Management Practices Will Set the Standard: A Closer Look at Government Action Following...

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Seyfarth Synopsis: Following President Biden’s comprehensive Executive Order on AI, the White House announced the formation of the “US AI Safety Institute” within the Commerce Department’s technology arm, the NIST. The...more

BCLP

CNIL publishes ‘AI How-To Sheets’ on Aligning Artificial Intelligence Systems with GDPR

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A few days ago, the French Data Protection Authority (CNIL) published its first draft guidelines for the use of AI systems in the form of "AI How-To Sheets" with the aim to “help professionals reconcile innovation with...more

Wiley Rein LLP

Wiley Consumer Protection Download (October 2, 2023)

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Welcome to Wiley’s update on recent developments and what’s next in consumer protection at the Consumer Financial Protection Bureau (CFPB) and Federal Trade Commission (FTC). In this newsletter, we analyze recent regulatory...more

BCLP

Getting to Know Who: ICO Draft Guidance on Biometric Recognition

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On 18 August 2023, the UK’s Information Commissioner’s Office (“ICO”) published draft guidance on biometric recognition (the “Draft Guidance”) for public consultation. The Draft Guidance explains how data protection law...more

Ballard Spahr LLP

CPPA publishes new draft regulations addressing AI, risk assessments, cyber audits

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The California Privacy Protection Agency (CPPA) recently published two new sets of draft regulations addressing a range of cutting-edge data protection issues. Although the CPPA has not officially started the formal...more

Ballard Spahr LLP

CPPA Publishes New Draft Regulations Addressing AI, Risk Assessments, and Cyber Audits

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The California Privacy Protection Agency (CPPA) recently published two new sets of draft regulations addressing a range of cutting-edge data protection issues. Although the Agency has not officially started the formal...more

Arnall Golden Gregory LLP

[Webinar] FDA Tries to Keep Up: How FDA and Industry Are Trying to Keep Up With Artificial Intelligence - September 13th, 2:00 pm...

FDA has cleared or approved hundreds of products that work with artificial intelligence (“AI”) and acknowledges that the agency and industry need help navigating how FDA-regulated products engage with AI. In response to the...more

Dechert LLP

Dechert Cyber Bits - Issue 40

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FTC Settles with Experian for Alleged Customer Spamming - On August 14, 2023, the Federal Trade Commission (“FTC”) announced a proposed settlement involving Experian Consumer Services (“Experian”). A federal court entered...more

Proskauer Rose LLP

Providers of AI Systems Ten Steps Towards Future Compliance

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The global AI market was valued at $95.60 billion in 2021 and is predicted to reach $1.85 trillion by 2030, registering a compound annual growth rate of 32.9%. Alongside this growth and the proliferation of AI use cases...more

King & Spalding

FDA Finalizes Its Premarket Submissions Guidance for Medical Device Software Functions

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On June 14, 2023, FDA finalized its “Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff” (the “2023 Final Guidance”). The Final Guidance replaces the...more

Goodwin

FDA Issues Draft Guidance for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions

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The US Food and Drug Administration (FDA or the Agency) recently issued its draft guidance titled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning...more

Hogan Lovells

FDA promotes pre-approval for changes to AI devices via Predetermined Change Control Plans

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On March 30, the U.S. Food and Drug Administration (FDA) published draft guidance that proposes recommendations on the types of information that should be included in a Predetermined Change Control Plan (PCCP) in a marketing...more

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