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Lighthouse

Cloud Attachments: What Every Legal and GRC Team Needs to Know

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From our M365 Academy Series, learn about the current state of cloud attachments, their behavior in Teams and OneDrive, and why you may need to update your traditional preservation strategies to manage them. ‍...more

Osano

How to Shift Data Privacy Left

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The 1:10:100 rule—coined in 1992 by George Labovitz and Yu Sang Chang, the rule describes how much bad data costs. Preventing the creation of bad data at its source costs $1. Remediating bad data costs $10. Doing nothing...more

Ankura

Remediation Happens: How To Identify, Mitigate and Resolve Related Risks

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Remediation occurs for a host of reasons. You may identify remediation risk from internal activities (e.g., an audit, a control break) or external activities (e.g., a complaint, a regulatory exam, a lawsuit). Sometimes a...more

Osano

Multi-Hyphenate Privacy Professionals: 3 Strategies for Success

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When we write about data privacy, it’s easy to default to talking to “privacy professionals.” But take a look at the privacy management industry: The privacy program managers, chief privacy officers, and other purely...more

Lighthouse

A Less is More Strategy for Data Risk Mitigation

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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

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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

Osano

Privacy Governance: A Framework for Data Privacy Protection and Compliance

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Responsible organizations understand that privacy governance is essential for the systematic and compliant management of personal data and for maintaining customer and stakeholder trust. In a world where people increasingly...more

McDermott Will & Emery

FDA Reveals AI Development Cheat Sheet in Highly Anticipated Draft Guidances

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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 

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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...

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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

Mayer Brown

Um Olhar Retrospectivo Sobre a ANPD e a Proteção de Dados no Brasil em 2024

Mayer Brown on

O ano de 2024 representou um período de grande amadurecimento institucional e regulatório para a Autoridade Nacional de Proteção de Dados (ANPD). Em um cenário marcado por avanços tecnológicos acelerados e discussões...more

Knobbe Martens

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

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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

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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

Hogan Lovells

FDA warns of “important” clinical trial protocol deviations

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The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for sponsors, investigators, and...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

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

A&O Shearman

DORA: Get ready, get set, take action

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The Digital Operational Resilience Act 2022/2554 (DORA) is a European regulation that will come into force on January 17, 2025. The regulation aims to strengthen the digital operational resilience of the financial sector...more

Carlton Fields

CPPA Advances New Privacy Rules for Businesses

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The California Privacy Protection Agency (CPPA), at its board meeting on November 8, 2024, voted 4–1 to advance proposed regulations to a formal rulemaking. As currently drafted, these regulations would, among other things...more

Guidepost Solutions LLC

How to Build a Strategy to Mitigate AI Risks

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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

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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

White & Case LLP

AI Watch: Global regulatory tracker - Brazil

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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

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