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Gardner Law

Why Compliance Audits Are Non-Negotiable

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In today’s heightened enforcement environment, compliance auditing isn’t just a best practice—it’s a necessity. Federal and state laws and industry guidance, including the Office of Inspector General (OIG) Compliance Program...more

Mitratech Holdings, Inc

5 Legal Operations Trends to Have on Your Radar in 2025

The Forces Reshaping Legal Operations (and How You Can Stay One Step Ahead!) Legal teams are at an inflection point — while the legal technology market is predicted to soar to $50 billion by 2027 with increased spending and...more

Morrison & Foerster LLP

European Digital Compliance: Key Digital Regulation & Compliance Developments - February 2025

To help organizations stay on top of the main developments in European digital compliance, Morrison Foerster’s European Digital Regulatory Compliance team reports on some of the main topical digital regulatory and compliance...more

A&O Shearman

Global Foreign Exchange Committee publishes amended FX Global Code of Conduct

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The Global Foreign Exchange Committee (GFXC) has published the updated version of the FX Global Code of Conduct (dated December 2024), which supersedes the previous version (from July 2021). Updates have been made to...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FDA Issues Draft Guidance for the Use of Artificial Intelligence (AI) in Medical Devices and Drug Development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The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI in medical devices and drug and biological product development.These guidance...more

MoFo Life Sciences

FDA Draft Guidance on Artificial Intelligence-Enabled Device Software Functions

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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FDA Issues Artificial Intelligence-Enabled Device Software Functions Draft Guidance

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The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025....more

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

Foley & Lardner LLP

The Intersection of Agentic AI and Emerging Legal Frameworks

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The evolution of artificial intelligence (AI) has introduced systems capable of making autonomous decisions, known as agentic AI. While generative AI essentially “creates” – providing content such as text, images, etc. –...more

Mitratech Holdings, Inc

5 Trends Shaping Whistleblower Regulations in 2025

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In 2025, whistleblower regulations are poised for major evolution, reflecting a renewed commitment to transparency and accountability. The Ethics and Compliance Initiative (ECI) 2023 survey revealed a startling statistic:...more

Harris Beach Murtha PLLC

Key Considerations for Selling AI Software to the Government

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The federal government is the biggest purchaser in America and that extends to the SaaS space. On September 24, 2024, the Office of Management and Budget (OMB) released Memorandum M-24-18, offering updated guidelines for the...more

Ankura

EU’s AI Act: AI Risk Management System

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In December 2023, European Union (EU) lawmakers reached an agreement on the EU AI Act. In our prior article titled “An Introduction to the EU AI Act,” we focused on the applicability, timing, and penalties of the EU AI...more

Morrison & Foerster LLP - Government...

National Security And Government Contractor Implications Of Biden AI Executive Order

The Biden administration issued a widely anticipated executive order on artificial intelligence (“AI”) earlier this week. The Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence...more

Foley & Lardner LLP

NIST’s AI Risk Management Framework Helps Businesses Address AI Risk

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As we previously discussed, earlier this year the National Institute of Standards and Technology (NIST) launched the Trustworthy and Responsible AI Resource Center. Included in the AI Resource Center is NIST’s AI Risk...more

Gardner Law

Transatlantic Legal-Regulatory Update: Live from the Heart of Silicon Valley

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US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more

Fenwick & West LLP

SBIR and STTR Programs Renewed with New Foreign Risk Due Diligence Measures and Pilot Programs

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On September 29, 2022, Congress passed the SBIR and STTR Extension Act of 2022, renewing the U.S. Small Business Administration’s (SBA) Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR)...more

King & Spalding

FDA Issues Draft Guidance on Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

King & Spalding on

On April 8, 2022, FDA issued new, long-awaited draft guidance “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (Draft Cybersecurity Guidance). 1 This draft guidance...more

Ankura

5 Best Practices for Third Party Risk Management

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Organizations are becoming increasingly reliant on external parties to manage parts of their business. The centralized knowledge, expertise, and economies of scale that third parties provide enables organizations to focus...more

NAVEX

[Webinar] 2021 Top 10 Trends in a New World of Risk & Compliance Priorities - January 14th, 9:00 am - 10:15 am PT

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While hindsight may be 20/20, how can we use this to gain foresight into 2021? The last twelve months have permanently altered the role of risk and compliance—increasing it in scope and elevating the function to a...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2021 Managed Care Compliance Conference - February 1st - 3rd, 9:30 am - 3:45 pm CST

The first ever VIRTUAL Managed Care Compliance Conference will have the great speakers and content you have come to expect from the in-person event. Each year, we look forward to hosting compliance professionals at our...more

Hogan Lovells

UK Government calls for feedback on regulation of IoT device security

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Following the UK Government's announcement in January 2020 that it would be moving forwards with regulation on consumer IoT device security, the Government has now published its legislative proposals and is seeking feedback...more

Robins Kaplan LLP

Interview with Stacey Slaughter, Partner at Robins Kaplan LLP

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As Robins Kaplan’s COVID-19 Class Action Litigation Task Force practice lead, Ms. Slaughter describes for us COVID-19’s effect on class action litigation and how her practice is navigating these changing and uncharted times....more

Society of Corporate Compliance and Ethics...

Compliance Perspectives: Supply Chain Compliance Challenges

Supply chains are emerging as an increasingly complex risk area for compliance. The risk includes trade compliance, vendor management issues associated with cyber/privacy, product compliance, REACH, ROHS and California...more

Mitratech Holdings, Inc

For the CCPA, New AG Regulations Are a “How-To” Manual

Yes, the California Consumer Privacy Act is really happening. As the clock ticks down toward the January 1, 2020 effective dateof the California Consumer Privacy Act, many businesses are coming to grips with the fact that the...more

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