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Ballard Spahr LLP

FDA Issues Guidance on AI for Medical Devices

Ballard Spahr LLP on

The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...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

White & Case LLP

Newly passed Colorado AI Act will impose obligations on developers and deployers of high-risk AI systems

White & Case LLP on

The Colorado Artificial Intelligence Act will impose mounting obligations on developers and deployers of high-risk AI systems in an effort to protect consumers from discriminatory consequential decisions by such systems....more

DarrowEverett LLP

Prove It or Lose It: New York City Cracks Down on AI Hiring Software

DarrowEverett LLP on

Artificial Intelligence (“AI”) programs have gained notoriety by injecting ease into otherwise burdensome and difficult daily tasks. However, as with most innovative advancements, AI has also drawn concern from skeptics...more

McDermott Will & Schulte

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

McDermott Will & Schulte 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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