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Algorithms Draft Guidance

Morgan Lewis - As Prescribed

Key Takeaways from the AI Trends in Medical Devices Panel at the 2025 FDLI Annual Conference

Ariel Seeley served on the panel titled AI Trends in Medical Devices: Global Developments, FDA Policies, and Software as a Medical Device at the 2025 Food and Drug Law Institute (FDLI) Annual Conference. The panel provided an...more

Seyfarth Shaw LLP

How the Federal Government’s AI Risk Management Practices Will Set the Standard: A Closer Look at Government Action Following...

Seyfarth Shaw LLP on

Seyfarth Synopsis: Following President Biden’s comprehensive Executive Order on AI, the White House announced the formation of the “US AI Safety Institute” within the Commerce Department’s technology arm, the NIST. The...more

Ballard Spahr LLP

CPPA publishes new draft regulations addressing AI, risk assessments, cyber audits

Ballard Spahr LLP on

The California Privacy Protection Agency (CPPA) recently published two new sets of draft regulations addressing a range of cutting-edge data protection issues. Although the CPPA has not officially started the formal...more

Ballard Spahr LLP

CPPA Publishes New Draft Regulations Addressing AI, Risk Assessments, and Cyber Audits

Ballard Spahr LLP on

The California Privacy Protection Agency (CPPA) recently published two new sets of draft regulations addressing a range of cutting-edge data protection issues. Although the Agency has not officially started the formal...more

Gardner Law

The Evolving FDA Regulatory Landscape of Artificial Intelligence

Gardner Law on

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

Cooley LLP

Blog: General Wellness Products: Will the FDA Regulate Your Medical App or Device?

Cooley LLP on

In January 2015, the U.S. Food and Drug Administration (FDA) released its draft guidance on general wellness products, a reassuring indication that the FDA will focus its efforts on regulating higher risk products rather than...more

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