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FDA Draft Guidance on Artificial Intelligence-Enabled Device Software Functions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FDA Issues Artificial Intelligence-Enabled Device Software Functions Draft Guidance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The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025....more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FDA Issues Draft Guidance on AI-Enabled Medical Devices

The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices.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

Akin Gump Strauss Hauer & Feld LLP

Guidelines on the Export of Cyber-surveillance Items Under Article 5 of Regulation 2021-821

In 2021, the European Union (EU) updated the EU Dual-Use Regulation, setting unified standards for EU member states to control exports of dual-use items. A key addition in Regulation (EU) 2021/821 is Article 5’s “catch-all...more

Clark Hill PLC

Right To Know - October 2024, Vol. 22

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Cyber, Privacy, and Technology Report - Welcome to your monthly rundown of all things cyber, privacy, and technology, where we highlight all the happenings you may have missed....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

Mitratech Holdings, Inc

Streamlining Global Immigration Processes: How Effective Case Management Ensures Efficiency & Compliance

Mitratech Holdings, Inc on

As businesses expand their operations across continents, navigating the complex web of immigration processes becomes essential. However, these processes can often be a daunting maze filled with paperwork, deadlines, and...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

The Evolving FDA Regulatory Landscape of Artificial Intelligence

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As artificial intelligence technology evolves on a seemingly minute-by-minute basis, the U.S. FDA’s regulatory approach continues to evolve in an effort to keep pace. “The promise of artificial intelligence in medicine is...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

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