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Software Regulatory Requirements Risk Assessment

Pillsbury Winthrop Shaw Pittman LLP

The EU’s Cyber Resilience Act: New Cybersecurity Requirements for Connected Products and Software

The CRA will affect a broad range of digital products placed on the EU market (including by those based outside the EU), including connected hardware/devices, software and remote data processing solutions. The EU has adopted...more

Sheppard Mullin Richter & Hampton LLP

FedRAMP 20x – Major Overhaul Announced to Streamline the Security Authorization Process for Government Cloud Offerings

On March 24, 2025, the Federal Risk and Authorization Management Program (“FedRAMP”) announced a major overhaul of the program, which is being called “FedRAMP 20x.” The FedRAMP 20x announcement stated there are no immediate...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On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” which...more

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FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions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On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance was long-anticipated; it...more

DLA Piper

Navigating AI Liability Risks

DLA Piper on

Our webinar explored liability that can be incurred from the creation use or deployment of AI systems and raised some important questions around the current and future regulatory landscape applicable to AI and liability. We...more

Alston & Bird

What to Tell Your C-Suite About the EU AI Act

Alston & Bird on

Our Privacy, Cyber & Data Strategy Team highlights 11 common questions your company’s senior executives may have about the European Union’s Artificial Intelligence Act and how you can answer them....more

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