Moving Beyond the Usual Helpline Data
Compliance Tip of the Day: Why Engage in Pre-acquisition Due Diligence
Innovation in Compliance: Operationalizing Trust at Scale: A Conversation with Amanda Carty on Compliance and AI
AI Today in 5: August 7, 2025. The US v. China Episode
Hill Country Authors – Exploring the Challenges of a Green Transition with Tom Ortiz
Taxing Intelligence: AI's Role in Modern Tax Administration
LathamTECH in Focus: Move Fast, Stay Compliant
AI Today in 5: August 6, 2025, The Rethinking Compliance Episode
Daily Compliance News: August 6, 2025, The Spanking Banks Edition
AI Today in 5: August 5, 2025, The AI at the SEC Episode
Compliance Tip of the Day: M&A – International Issues
From Forest to Fortune: Navigating Workplace Ethics With Robin Hood — Hiring to Firing Podcast
Under the Radar: DOJ's Data Security Rules and Their Impact on Payments Companies — Payments Pros – The Payments Law Podcast
Adventures in Compliance: The Novels - The Valley of Fear, Introduction and Compliance Lessons Learned
Episode 381 -- NAVEX's 2025 Annual Hotline Report
12 O’Clock High, a podcast on business leadership: Building Trust and Relationships: The Power of Compliance and Ethics with Jacqui Pruet
Data Driven Compliance: Understanding the ECCTA and Its Impact on Fraud Prevention with Vince Walden
Daily Compliance News: August 1, 2025, The All AI Edition
AI and the False Claims Act
Compliance Tip of the Day: AI, Continuous Monitoring and Compliance
The FDA has finalized its guidance on cybersecurity for medical device premarket submissions, providing additional insight into the agency’s expectations for how manufacturers integrate cybersecurity risk management into...more
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
Increases in Counterfeit Beauty and Personal Care Products - The rise of e-commerce has led to increasing sales of counterfeit or noncompliant beauty and personal care products, including many that are knockoffs of...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
TSCA/FIFRA/TRI - EPA Issues Final Risk Management Rules For TCE, PCE, And CTC: The U.S. Environmental Protection Agency (EPA) released final risk management rules under the Toxic Substances Control Act (TSCA) for...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
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
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 November 1, 2024, CMS issued a rule finalizing changes to Medicare payments under the Physician Fee Schedule (PFS) and other Medicare Part B policies effective on or after January 1, 2025 (the Final Rule). Section 1848 of...more
On September 24th and 25th, the National Institute of Standards and Technology (NIST) convened a symposium to generate new insights about the next steps needed to unleash AI innovations that will enable trust in this...more
Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on HHS' recent final rule on the confidentiality of substance use disorder patient...more
Healthy food and beverage (“F&B”) companies frequently use social media to advertise. When used appropriately, social media campaigns can be incredibly effective tools to help emerging F&B companies reach target consumers,...more
The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...more
On September 27, 2023, FDA finalized its guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (the “2023 Final Guidance”). The Final Guidance replaces...more
This first part of a two-part series on U.S. regulation of artificial intelligence systems provides an overview and modern context for the existing regulatory, legal and risk management landscape for AI systems in the U.S.,...more
Medical device cybersecurity continues to create buzz, as the FBI issues a Private Industry Notification to health care providers outlining cybersecurity risks for medical devices. This follows FDA’s released Draft Guidance...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
The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...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
Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....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 Patient Engagement Advisory Committee to the Food and Drug Association (FDA) met recently to discuss cybersecurity in medical devices. Medical devices are increasingly connected to the internet, hospital networks, and...more
While cyberattacks continue to increase in number, health care organizations face some of the greatest risks. According to the Health Sector Coordinating Council (HSCC) — a coalition of industry associations that operates in...more
The Food & Drug Administration has recently released for comment a draft expansion of guidance regarding Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Although the FDA issued existing...more