Episode 374 -- Justice Department Resumes FCPA Enforcement with New, Focused Guidance
Cruising Through Change: The Auto-Finance Industry’s New Era Under Trump Unveiled — The Consumer Finance Podcast
2023 CRA Rule Repeal: Lessons to be Learned
The Classification of Gasoline & Gasoline Fumes as a Carcinogen: Considerations for Corporate Executives & Attorneys
Hot Topics in International Trade - Let's Be Serious-Supply Chain Audits
Regulatory Rollback: Inside the CFPB’s FCRA Guidance Withdrawal — The Consumer Finance Podcast
Cruising Through Change: The Auto-Finance Industry’s New Era Under Trump Unveiled — Moving the Metal: The Auto Finance Podcast
Regulatory Rollback: Inside the CFPB's FCRA Guidance Withdrawal — FCRA Focus Podcast
Innovation in Compliance: The Critical Importance of Mobile Application Security: Insights from Subho Halder
2 Gurus Talk Compliance: Episode 53 – The AI as a Whistleblower Edition
Compliance Tip of the Day: Internal Controls for Third Parties
Healthcare Enterprise Risk Management
GILTI Conscience Podcast | Navigating Brazil's New Transfer Pricing Landscape: A Shift to OECD Standards
Importance of Compliance Management in times of transition
Great Women in Compliance: From Hotline to Headline: The DOJ’s Whistleblower Awards Reboot with Mary Inman and Liz Soltan
Compliance into the Weeds: Autonomous AI Whistleblowing Misconduct
Understanding MALPB Charters: A Collaborative Approach to Banking Innovation — Payments Pros – The Payments Law Podcast
Law Firm ERGs Under Scrutiny: Navigating Compliance, Risk, and Culture - On Record PR
Compliance Tip of the Day: Risk Assessments and Internal Controls
The Medical Device Coordination Group (“MDCG”) has issued guidance on the safe making available of medical device software (“MDSW”) apps on online platforms (MDCG 2025-4). MDCG 2025-4 outlines the regulatory roles of online...more
The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter citing a failure to obtain marketing authorization via a premarket approval (PMA) or 510(k) clearance as well as Good Manufacturing Practice (GMP)...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
The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025....more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
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
On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance was long-anticipated; it...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
Happy Holidays and welcome to our year-end issue of Decoded. We hope you enjoyed reading our technology law insights e-newsletter this year. We are already planning for 2025. ...more
Telemedicine is getting more and more relevant to the healthcare industry, offering unprecedented access to medical services and enhancing patient care. However, telemedicine software providers often struggle with the...more
The capabilities and sophistication of digital health technologies are constantly expanding, especially with the integration of artificial intelligence and machine learning. Many companies, both existing and start-up, are...more
Introduction - Hardly a day goes by when we don’t see some media report of health care providers experimenting with machine learning, and more recently with generative AI, in the context of patient care. The allure is...more
When negotiating a digital health collaboration agreement between a tech company and a life sciences company, whether for the development of artificial intelligence or other software, the provision of data hosting and...more
In Part 6 of our series of consecutive articles on the reformed regulatory framework under the EU Medical Device Regulation 2017/745 (“MDR”), which will govern medical devices software (“MDSW”) in the EU, we turn to the...more
In Part 2 of our series of consecutive articles on the reformed regulatory framework under the EU Medical Device Regulation 2017/745 (“MDR”), which will soon govern medical devices software (“MDSW”) in the EU, we will shed...more
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