Podcast - Regulating AI in Healthcare: The Road Ahead
Avoiding a Bored Board
Podcast - Tips for Maintaining FTC Compliance When Using AI
Daily Compliance News: July 22, 2025, The I-9 Hell Edition
FCPA Compliance Report: Ethical Challenges in AI, Data Protection, and Sports with Andre Paris
Compliance into the Weeds: Boeing’s New Safety Initiatives and Compliance Reforms
Great Women in Compliance – Compliance is the Floor, Ethics is the Ceiling with Ellen Hunt
Great Women in Compliance: Creating Space to Speak Up: The Story Behind Psst.org
Hidden Fees in the Live-Event Ticketing and Short-Term Lodging Industries
Digital Planning Podcast Episode: Estate Planning and the Corporate Transparency Act
Episode 330 – Halyna Senyk on Anti-Corruption Progress in Ukraine
ESG Masterclass — ESG and Impact Investing
FCPA Compliance Report – Jonathan Wilson on The NSBU Decision
Áine Bryn of Mercer UK on Demonstrating the Strategic Credibility of the Marketing Function - Passle's CMO Series Podcast
Podcast - The CFPB's Proposal to Create a Public Registry
Breaking Mindsets with Sharon Sorkin from Ford on Being Reliably Transparent
Auditing and Monitoring in Healthcare
Exploring The ‘S’ In ESG & What To Expect In 2023
The Line Between Gift Giving and Bribery
Recently, it was reported that the U.S. Food and Drug Administration (FDA) is launching two cross-agency artificial intelligence (AI) councils. One AI council will be tasked with addressing how the agency uses AI internally...more
On July 10, 2025, in the name of embracing “radical transparency,” the U.S. Food and Drug Administration (“FDA”) announced that it was publishing more than 200 complete response letters (“CRLs”) issued in response to drug and...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
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issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were three notable draft guidance documents pertaining to medical devices (together, the...more
The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI in medical devices and drug and biological product development.These guidance...more
The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some cases, precedent-setting enforcement actions in 2024. The government continued to...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
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
The rapid advancement of Artificial Intelligence (AI) and Machine Learning (ML) is revolutionizing the healthcare industry. However, as these innovative devices emerge, understanding the complex regulatory landscape becomes...more
On June 17, 2024, the U.S. Food and Drug Administration’s (FDA) Digital Health Center of Excellence (DHCE), published a blog article highlighting the promise of artificial intelligence (AI) in healthcare. In the article, the...more
Further to the guiding principles on the use of artificial intelligence (AI) and machine learning (ML) technologies jointly published by the U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s...more
Medical Devices Directorate Performance Annual Report - In September 2023, Health Canada published the Medical Devices Directorate Performance Annual Report for April 1, 2022, through March 31, 2023. The report provides...more
On Wednesday, May 10, 2023, the Food and Drug Administration (FDA) announced the publication of a new discussion paper titled “Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological...more
First mentioned in a 2019 discussion paper entitled “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD),” the idea of a defined set of...more
As artificial intelligence technology evolves on a seemingly minute-by-minute basis, the U.S. FDA’s regulatory approach continues to evolve in an effort to keep pace. “The promise of artificial intelligence in medicine is...more
US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more
On April 8, 2022, FDA issued new, long-awaited draft guidance “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (Draft Cybersecurity Guidance). 1 This draft guidance...more
The Food and Drug Administration recently sought comments on the role of transparency for artificial intelligence and machine learning-enabled medical devices. The FDA invited comments in follow up to a recent workshop on the...more
On October 14, 2021, the Food and Drug Administration (FDA) held a virtual public workshop on transparency surrounding Artificial Intelligence/Machine Learning (AI/ML) enabled medical devices. The workshop focused on the...more
In the weeks leading up to FDA’s October 14, 2021 Transparency of AI/ML Enabled Medical Devices Workshop (Workshop), we took a brief look at the history of FDA’s regulation of medical device software and the agency’s more...more
The US Food and Drug Administration (FDA) published an Action Plan for artificial intelligence (AI) and machine learning (ML) software on January 12, 2021 that provides near-term actions to develop a regulatory framework for...more
In an August 20, 2020, press release, the Food and Drug Administration (FDA) provided an update on the medical device reports (MDRs) received by the agency relating to breast implants, including breast implant-associated...more
Many countries around the world are being forced to watch as the only tool they have to suppress COVID-19 — social distancing — causes unprecedented damage to their economies. Because suppression measures may be required...more