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Software Regulatory Requirements Cybersecurity

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

Goodwin

Crossing Administrations: The Focus on Federal Cybersecurity Continues

Goodwin on

Federal contractors, including defense contractors, should prepare for the emergence of new requirements in the coming months that are designed to strengthen software supply chain security, impose more stringent cybersecurity...more

Warner Norcross + Judd

Lessons from CES 2025: The Legal Side of Product Innovation — What Every Manufacturer and Supplier Needs to Know

Warner Norcross + Judd on

The 2025 Consumer Electronics Show (CES) — one of the world’s most influential tech events — once again showcased groundbreaking innovations that are shaping the future of technology. I was among the over 141,000 attendees of...more

MoFo Life Sciences

FDA Draft Guidance on Artificial Intelligence-Enabled Device Software Functions

MoFo Life Sciences on

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FDA Issues Artificial Intelligence-Enabled Device Software Functions Draft Guidance

DLA Piper on

The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025....more

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

Fox Rothschild LLP

Investments in Chinese Technology Companies Limited by New US Outbound Investment Rule

Fox Rothschild LLP on

U.S. investors interested in investing in advanced Chinese technology companies may now be constrained by the U.S. Government’s first-ever outbound investment rule (Final Rule) which took effect on Jan. 2, 2025. The Final...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

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 10, December 2024

Happy Holidays and welcome to our year-end issue of Decoded. We hope you enjoyed reading our technology law insights e-newsletter this year. We are already planning for 2025. ...more

DLA Piper

EU: Cyber Resilience Act published in EU Official Journal

DLA Piper on

On 20 November 2024, the EU Cyber Resilience Act (CRA) was published in the Official Journal of the EU, kicking off the phased implementation of the CRA obligations....more

Jones Day

EU Enacts Broad Cybersecurity Requirements for Hardware and Software Products

Jones Day on

On October 10, 2024, the EU Cyber Resilience Act ("CRA") was adopted by the Council of the European Union....more

Reveal

What is Corporate Law? And How It Will Evolve in 2023

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Corporate lawyers are held in high regard in the business world, and for good reason. Corporations rely on their lawyers to perform an ever-wider variety of functions. This increased reliance is due, in part, to...more

Polsinelli

EU Cyber Resilience Act

Polsinelli on

On September 15, 2022, the European Commission published its Proposal for a Cyber Resilience Act (CRA) which sets out new requirements for hardware and software products in the EU.  The CRA applies to hardware and...more

McDermott Will & Emery

To Market, To Market: FDA’s Digital Health Precertification Program

McDermott Will & Emery on

In response to the rapid pace of innovation in the health and life sciences arena, the US Food and Drug Administration (FDA) is taking a proactive, risk-based approach to regulating digital health products. Software...more

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