(Podcast) The Briefing: The Wrong Argument – Why Authors Lost Against Meta and What Comes Next
The Briefing: The Wrong Argument – Why Authors Lost Against Meta and What Comes Next
Lawyers Beware: There Could Be Serious Ethics Issues With The New AI Browsers
From OCR to AI The Future of Media and Image Analysis in eDiscovery
LathamTECH in Focus: Navigating National Security: The Impact of FDI Reviews on Tech M&A
Podcast - Tips for Maintaining FTC Compliance When Using AI
Compliance Tip of the Day: Rethinking Corporate AI Governance Through Design Intelligence
Julie Mortimer of Mills & Reeve on The Right Way to Kickstart Your CRM Strategy - Passle's CMO Series Podcast EP176
Law School Toolbox Podcast Episode 513: Grappling with AI as a Law Student and Lawyer (1L Summer Series)
(Podcast) The Briefing: Anthropic, Copyright, and the Fair Use Divide
The Briefing: Anthropic, Copyright, and the Fair Use Divide
SkadBytes Podcast | Tech’s Shifting Landscape: Five Trends Shaping the Conversation
Hospice Insights Podcast - AI in Action: Exploring How AI Is Helping Hospices Do Things in New Ways
How to Rank in the Age of AI Search: On Record PR
AI in eDiscovery Today: An Open Conversation
Innovation in Compliance: Allison Lagosh on Proactive Compliance Planning for Regulatory Changes
FCPA Compliance Report: Ethical Challenges in AI, Data Protection, and Sports with Andre Paris
Work This Way: An Employment Law Video Podcast | Episode 51: Smarter Recruiting Strategies with Rhiannon Poore of Forge Search
Daily Compliance News: July 9, 2025, The TACO Don Caves Again Edition
CMO Series Live Special: The AI Revolution and What it Means for CMOs
Private Equity focused on investment and operations within the Life Science industry faces significant compliance, operational and business risk due to the heavily regulated nature of the investment targets and portfolio...more
Innovation in life sciences isn’t just about scientific breakthroughs—it’s about making the right business decisions. Whether a company is developing AI-driven diagnostics, biotech therapies, connected medical devices, or...more
In recent weeks, the FDA has faced significant cuts, including the layoffs of probationary employees. These employees, many of whom had been hired to fill roles left by retirees or to bolster the agency’s staffing during the...more
On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and biological products. The draft guidance – the first of its kind from the agency – aims to...more
With daily media reports citing to the explosion of interest in Artificial Intelligence (“AI”), AI start-ups have attracted a huge capital influx. During the last fiscal quarter of 2024 ending on December 31st, investors...more
Welcome to the November-December edition of Akin Intelligence. As the end of 2024 approached, the European Union (EU) sustained progress on guidance and supporting materials for its AI Act and international AI Safety...more
Artificial intelligence already is positively affecting health, according to Mark Gardner, MBA, Esq., Founder and Managing Partner, Gardner Law, which represents clients subject to Food and Drug Administration regulations....more
On January 7, 2025, the Food and Drug Administration (FDA) made available a draft guidance for industry (GFI) titled “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and...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
On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products...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
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
Artificial intelligence already is positively affecting health, according to Mark Gardner, MBA, Esq., Founder and Managing Partner, Gardner Law, which represents clients subject to Food and Drug Administration regulations. ...more
The House Task Force on Artificial Intelligence (AI) released a comprehensive 253-page report providing a roadmap for Congress as it develops policies to regulate and optimize the use of this rapidly advancing technology. The...more
The Department of Justice's Criminal Division recently released an updated version of its Evaluation of Corporate Compliance Programs document (the "Guidance" or “ECCP”). This Guidance is designed to be a resource for...more
The expansion of artificial intelligence (“AI”) applications in healthcare (“Healthcare AI”) has made recent headlines, from the transformation of clinical diagnostics with increased accuracy, to use of personalized medicine...more
As the first state law to regulate the results of Artificial Intelligence System (AI System) use, Colorado’s SB24-205, “Concerning Consumer Protections in Interactions with Artificial Intelligence Systems” (the Act), has...more
For music aficionados, many would agree that the rock band, Pink Floyd, was ahead of its time. “Welcome to the Machine,” from the 1975 album Wish You Were Here, was one of those transformative songs for one of this Bulletin’s...more
The goal of value-based care (VBC) is to promote better care for individual patients and improved health outcomes for communities at reduced costs. This is an important and admirable purpose as many VBC stakeholders attempt...more
As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more
FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...more
Artificial intelligence (AI) is rapidly transforming the life sciences industry, with significant advancements in various areas. These innovations bring new legal challenges related to intellectual property, data protection,...more
Medtech companies are evolving rapidly as more and more of them develop products that collect and leverage substantial patient and provider data. Companies that once only developed hardware-based solutions for...more
As the global economy faces the third year of the pandemic, manufacturers are no longer focused on figuring out when things will return to “normal.” Instead, they are applying lessons learned from the past few years to become...more
On March 1, 2021, the Consumer Product Safety Commission (CPSC) signaled its intent to increase enforcement of its product safety regimen by seeking to more than double its current $135 million budget via a public letter from...more