News & Analysis as of

Artificial Intelligence Regulatory Agenda Draft Guidance

Sheppard Mullin Richter & Hampton LLP

FDA Dumps Trio of Device-Related Guidances Prior to Administration Change

Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were three notable draft guidance documents pertaining to medical devices (together, the...more

MoFo Life Sciences

FDA Releases Draft Guidance on Evaluating the Risk and Credibility of AI Used in Establishing Drug and Device Safety,...

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

A&O Shearman

EDPB calls for alignment between GDPR and EU digital legislation; adopts draft Guidelines on data transfers to third country...

A&O Shearman on

On December 2 – 3 2024, the European Data Protection Board (EDPB) met for its 99th plenary session. It subsequently issued several documents, one of which calls for the need for greater alignment between the GDPR and EU...more

Pillsbury Winthrop Shaw Pittman LLP

Department of Commerce Releases Five Products to Help Guide AI Development

The Department of Commerce released three final guidance documents incorporating public comments from earlier this spring which provide recommendations for managing AI risk, securing AI software development processes, and...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

Nelson Mullins Riley & Scarborough LLP

FDA Publishes Groundbreaking AI/ML Medical Device Draft Guidance

The U.S. Food and Drug Administration (“FDA”) has announced its first-ever draft guidance specifically addressing the use of artificial intelligence/machine learning (“AI/ML”) in medical devices (“Draft Guidance”).This...more

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