Podcast - Navigating the New Landscape of Private Equity in Healthcare
The fatal flaws in the 2023 CRA rule
New Executive Order Targets Disparate Impact Claims Nationwide - #WorkforceWednesday® - Employment Law This Week®
Welcoming a New Payment Pro: Jason Cover Joins the Payments Pros Podcast — Payments Pros – The Payments Law Podcast
Constangy Clips Ep. 10 - 3 Ways the GDPR Is Evolving with Today’s Tech Landscape
Medicaid Cuts: Potential Challenges and Legal Implications for Long-Term Care Facilities — Assisted Living and the Law Podcast
Rewriting the Rules: The Supreme Court's Landmark Decision on Clean Water Act Permits
Tariffs and Trade Series: What Boards of Directors Need to Know
Under the Hood: Exploring the CFPB's 2025 Focus — Moving the Metal: The Auto Finance Podcast
Evolving AI Legislation: Federal Policies, Task Forces, and Proposed Laws — The Good Bot Podcast
Episode 369 -- Stepping Into the Enforcement Spotlight -- Customs and Border Patrol and Import Enforcement
10 For 10: Top Compliance Stories For the Week Ending May 17, 2025
Tariffs and Trade Series: What Investors Need to Know
Compliance Tip of the Day: Using Supply Chain to Innovate in Compliance
State AGs Unite: New Privacy Task Force Signals Shift in Regulatory Power Dynamics — The Consumer Finance Podcast
Early Returns Podcast - Oliver Roberts: AI and the Law, and an Education
Compliance into the Weeds: Leaving on a (Qatari) Jet Plane
(Podcast) California Employment News: Back to the Basics of Employee Pay Days
Compliance Tip of the Day: Multiplying the Influence of Compliance
Innovation in Compliance: Navigating Regulatory Changes and Compliance in Trade and Data Privacy with Stephanie Font
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The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025....more
Last week, the U.S. Food and Drug Administration (FDA) issued two significant draft guidance documents concerning the use of artificial intelligence (AI) in medical devices and in drug and biological product development....more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