News & Analysis as of

Data Management Artificial Intelligence Regulatory Requirements

EDRM - Electronic Discovery Reference Model

Illumination Zone: Episode 204 | Bennett Borden of Clarion AI Partners sits down with Kaylee & Mary

Bennett Borden, founder and CEO of Clarion AI Partners, sits down with Kaylee and Mary to share his journey from the CIA to law school and BigLaw eDiscovery, to his decision to refresh his data skills at NYU. Bennett...more

Lighthouse

A Less is More Strategy for Data Risk Mitigation

Lighthouse on

With new collaboration features, AI tools, and work technology developing at a dizzying pace, we know that the volume of data organizations must manage will only increase faster. What are the risks and costs involved with...more

Frost Brown Todd

Managing Data Security and Privacy Risks in Enterprise AI

Frost Brown Todd on

Artificial intelligence (AI), particularly generative AI, thrives on vast amounts of data, fueling AI capabilities, insights, and predictions. But with this reliance on data comes potential privacy and security risks. And...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Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more

NAVEX

Artificial Intelligence and Compliance: Preparing for the Future of AI Governance, Risk, and Compliance 

NAVEX on

Artificial Intelligence has rapidly moved from theoretical to transformational, profoundly changing how businesses operate across industries. While the benefits of AI, particularly Generative AI (genAI), are monumental, these...more

Ropes & Gray LLP

The Biden Administration’s Swan Song on Digital Health: Two FDA Guidances on Artificial Intelligence and FDA’s Defense of its...

Ropes & Gray LLP on

In the waning days of the Biden administration, the FDA released a flood of new guidance documents and other agency actions, including several important items related to digital health. On January 7, FDA published two new...more

Knobbe Martens

FDA Issues Draft Guidance for the Use of Artificial Intelligence (AI) in Medical Devices and Drug Development

Knobbe Martens on

The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI in medical devices and drug and biological product development.These guidance...more

American Conference Institute (ACI)

[Event] Advanced Forum on Global Export Controls - February 25th - 26th, Arlington, VA

Looking for something more advanced than your average export controls conference? Go beyond the basics at ACI’s 2nd Annual Advanced Forum on Global Export Controls. This premier event offers cutting-edge insights and...more

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

FDA Issues Draft Guidance Documents on Artificial Intelligence for Medical Devices, Drugs, and Biological Products

FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support a regulatory decision about a drug or biological product’s safety, effectiveness, or...more

Fenwick & West LLP

FDA Issues Draft Guidances on AI in Medical Devices, Drug Development: What Manufacturers and Sponsors Need to Know

Fenwick & West LLP on

The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations and...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

Faegre Drinker Biddle & Reath LLP

FDA Makes Draft Guidance Available on Lifecycle Management and Marketing Submission Recommendations for AI-Enabled Device Software...

On January 7, 2025, FDA published “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff”...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

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

Guidepost Solutions LLC

How to Build a Strategy to Mitigate AI Risks

Guidepost Solutions LLC on

In the rapid evolution of artificial intelligence, companies are often enticed by the numerous benefits that AI can offer, from improving efficiency and productivity to gaining a competitive edge....more

A&O Shearman

Data Governance: Strategic Convergence, Opportunities and Risks

A&O Shearman on

AI is accelerating digital transformation for companies and data governance is a key pillar in this change, enabling data strategies that unlock the potential of AI, and mitigate the risks associated with its use. Data...more

Reveal

AI in eDiscovery: Highlights from the ACEDS Benelux Chapter Event

Reveal on

On May 30, 2024, the Benelux Chapter of the Association of Certified eDiscovery Specialists (ACEDS) hosted a highly anticipated event in collaboration with Reveal and Houthoff in Amsterdam. This exclusive gathering brought...more

White & Case LLP

AI Watch: Global regulatory tracker - Brazil

White & Case LLP on

The enactment of Brazil's proposed AI Regulation remains uncertain with compliance requirements pending review. Laws/Regulations directly regulating AI (the “AI Regulations”) Brazil intends to regulate AI through Bill...more

Society of Corporate Compliance and Ethics...

The EU AI Act: A comprehensive guide for organizations

The EU recently introduced the AI Act, landmark legislation aimed at regulating artificial intelligence (AI) technologies. This article provides an in-depth overview of the EU AI Act, its implications for organizations, and...more

McDermott Will & Emery

The Impact of the New EU AI Act on the Medtech and Life Sciences Sector

McDermott Will & Emery on

As technology continues to advance almost every aspect of healthcare, so the use of AI has become an increasing focus for developers and the regulators who are racing to keep pace with rapid advancements in technology. ...more

Skadden, Arps, Slate, Meagher & Flom LLP

Hot Topics: AI and ESG

The US Government Is Using AI To Detect Potential Wrongdoing, and Companies Should Too With agencies such as the SEC and DOJ using AI and other data analytics tools extensively to detect wrongdoing, companies need to adopt...more

Society of Corporate Compliance and Ethics...

Creating an AI governance function: Part 2

This is Part 2 of a two-part series. Part 1 addressed the risks and restrictions organizations face in deploying artificial intelligence (AI) and the key elements of an AI strategy. This part details how to develop an AI...more

Epstein Becker & Green

California Privacy Protection Agency Grapples with Cybersecurity Audit, Risk Assessment, Automated Decisionmaking Technology...

Epstein Becker & Green on

On December 8, 2023, the California Privacy Protection Agency (“CPPA”) Board (the “Board”) held a public meeting to discuss, among other things, regulations addressing: (1) cybersecurity audits; (2) risk assessments; and (3)...more

Faegre Drinker Biddle & Reath LLP

UK AI Regulation Bill Proposes New AI Regulator

While the focus of attention in the world of AI has been the EU AI Act: EU AI Act Agreed – Discerning Data in recent weeks, there have also been some other noteworthy legislative developments. On 22 November 2023, the...more

Epstein Becker & Green

California Privacy Protection Agency Public Board Meeting Sheds Light on Upcoming Risk Assessment and Cybersecurity Audit...

Epstein Becker & Green on

The five-member Board of the California Privacy Protection Agency (the “CPPA”) held a public meeting on September 8, 2023, to discuss a range of topics, most notably, draft regulations relating to risk assessments and...more

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