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Rethinking Records Retention
Work This Way: A Labor & Employment Law Podcast | Episode 48: Opportunities & Risks with Artificial Intelligence in HR with Chingwei Shieh of GE Power
Compliance Needs are Alive and Well: FTC's Recent Enforcement Activity
From Dashboards to Data-Driven Decisions – The Evolving Role of Technology in Legal Marketing & BD
Regulatory Rollback: Inside the CFPB's FCRA Guidance Withdrawal — FCRA Focus Podcast
No Password Required: Reginald “Andre” Andre, CEO of ARK Solvers and Builder of Human + AI-Driven Culture
AI on the Job: How to Stay Ahead of Employment and Data Privacy Risks
Meet Phil Leslie, Cornerstone Research's New Chief Technology and Innovation Officer
Upping Your Game: Harnessing AI to Revolutionize Third-Party Risk Management
The Future of Supply Chains: Chris Andrassy on Using AI to Predict & Prevent Disruptions
Compliance and AI: Using AI for Data Loss Prevention Systems with Vinay Goel
Tenant Tales and Reseller Realities: Inside the FCRA Arena With Eric Ellman — FCRA Focus Podcast
Law School Toolbox Podcast Episode 505: Breaking ADHD Barriers with the Help of AI (w/Lindsay Scola)
Compliance and AI: Revolutionizing Risk Management with John Byrne
New Executive Order Targets Disparate Impact Claims Nationwide - #WorkforceWednesday® - Employment Law This Week®
Constangy Clips Ep. 10 - 3 Ways the GDPR Is Evolving with Today’s Tech Landscape
Harnessing AI in Litigation: Techniques, Opportunities, and Risks – Speaking of Litigation Video Podcast
Upping Your Game: Episode 3 - Embedded Compliance: From Gatekeeper to Business Enabler
Evolving AI Legislation: Federal Policies, Task Forces, and Proposed Laws — The Good Bot Podcast
Artificial intelligence is transforming the medical device industry, offering unprecedented opportunities to enhance patient care. However, this technological leap comes with significant regulatory challenges. Across the...more
Trial lawyers, especially defense lawyers in the pharmaceutical and medical device arena, strive to ensure that “junk science” stays out of the courtroom. Unfortunately, that is often wishful thinking. When I spoke with an...more
Artificial intelligence (AI) is transforming the medical technology (“medtech”) and healthcare industries through the integration of advanced AI agents. Unlike traditional AI systems that perform discrete, predefined tasks,...more
In recent years, the rapid advancement of artificial intelligence (AI) and machine learning (ML) technologies has sparked a wave of innovation across various sectors, particularly in life sciences. ML technologies have...more
Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more
The 2025 SCOPE Conference (Summit for Clinical Ops Executives), held last week in Orlando, FL, brought together more than 4,500 industry leaders, innovators, and experts in the clinical operations field. ...more
In the waning days of the Biden administration, the FDA released a flood of new guidance documents and other agency actions, including several important items related to digital health. On January 7, FDA published two new...more
The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. ...more
The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI in medical devices and drug and biological product development.These guidance...more
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
In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on the use of artificial intelligence (AI) in the context of drugs, biologics,...more
The FDA has shared its first draft guidance on how sponsors should assess the credibility of artificial intelligence (AI) models to support FDA decisions regarding drug safety, effectiveness or quality. The agency noted an...more
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
Last week, the U.S. Food and Drug Administration (FDA) issued two significant draft guidance documents concerning the use of artificial intelligence (AI) in medical devices and in drug and biological product development....more
FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support a regulatory decision about a drug or biological product’s safety, effectiveness, or...more
The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations and...more
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
In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a regulatory framework that allows medical device manufacturers to implement certain pre-approved...more
U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, M.D., and other senior FDA officials recently published a “Special Communication” in JAMA describing FDA’s concerns with the use of AI in medical product...more
On January 7, 2025, FDA published “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff”...more
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
On December 3, 2024, the US Food and Drug Administration (FDA) published final guidance titled, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software...more
Amid continued rapid development of novel software products that present new opportunities in the health care space, FDA has yet to grant marketing authorization to a medical device incorporating artificial intelligence (AI)...more
Investment in artificial intelligence (AI) is rising fast. The International Data Corporation projects global spending on AI R&D will reach $632 billion by 2028, more than twice the expected total for 2024....more