Meeting the Needs of General Counsel: Beyond the Basics of Legal Advice - On Record PR
Steps Your Nonprofit Can Take to Mitigate Fraud Risks - Part 2
A Third Party's Perspective on Third Party Risk
Why Time Matters: Partners Lindsay Gerdes and Michael J. Bronson on Swift Action in Government Investigations
Consumer Finance Monitor Podcast Episode: Why do Fintechs Want to Become Banks?
Privacy Issues from Third-Party Website Tags
What's the Tea in L&E? Employee Devices: What is #NSFW?
Episode 331- NAVEX State of Risk and Compliance Programs
What the Board Should Be Asking About the Compliance Program
Video: Artificial Intelligence Use in Political Campaigns
Episode 329 -- Bryn Sedlacek from Aravo on TPRM Holistic Risks and Unified Visibility
Compliance Lessons from Dating in Your 50s
The Justice Insiders Podcast - AI-Washing: Everything Old Is New Again
The AI Shakeup: New Tech Innovations and the Future of Corporate Law
Principled Podcast: S11E7 | Fortifying Ethical Frameworks: Navigating Emerging Risks in the Middle East
Managing Compliance Risk for Human Trafficking and Modern Slavery
Common Scenarios Triggering False Claims Act Violations, Part 3: Claims and Investigations
Navigating Bank-Fintech Partnerships: Avoiding Common Pitfalls — The Consumer Finance Podcast
Episode 326 -- Dottie Schindlinger on Diligent's Report on Board Oversight of Cybersecurity Risks and Performance
Revisiting Financial Institution Incentive Compensation Rules Under Dodd-Frank — The Consumer Finance Podcast
AI is shaving years off the drug-discovery process. But it’s not just leaving other research modalities in the dust—the law itself is struggling to keep up, especially when it comes to patenting AI-aided drug discovery....more
As technology continues to advance almost every aspect of healthcare, so the use of AI has become an increasing focus for developers and the regulators who are racing to keep pace with rapid advancements in technology. ...more
n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more
DaVita acquires portfolio of Fresenius’ South American operations for $300M - DaVita says the deal for Fresenius’ dialysis centers in Chile was finalized, while regulatory approvals for acquisitions in Brazil, Colombia...more
Amending prior requirements, medical device manufacturers and importers have two years to comply with FDA's Quality Management System Regulation final rule, a similar approach to prior good manufacturing practices but with...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
The oversight obligations of boards continue to expand. Recent enforcement actions and new laws in areas such as cybersecurity, artificial intelligence and supply chains create new challenges for boards, as we explain in this...more
As you may know, we have been submitting FOIA requests asking FDA to share data from its various programs. In October, FDA granted our April FOIA request in which we asked the agency to add back demographic data fields that...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
ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...more
Hosted by American Conference Institute, the 11th Annual Advanced Forum on False Claims and Qui Tam Enforcement returns for another exciting year for lively discussions on FCA enforcement including the ramifications of two...more
We are excited to announce Venable’s inaugural Life Sciences Webinar Series. This month-long series will explore the intricacies and latest developments that shape the life sciences industry. Join us as we hear from our...more
Are Automakers Making Sufficient Efforts to Protect Customer Data? With the ever-expanding Internet of Things, data privacy is a growing concern in today’s digital age. The automotive industry is no exception. The National...more
Of Counsel James Hastings will present a webinar titled "Managing Risks through IP Innovation Management Training" for Medmarc, the leading expert in the products liability risks facing medical technology and life sciences...more
Artificial intelligence (AI) is nothing new to the healthcare industry, as many organizations and clinicians have utilized such tools in some capacity for many years. Imaging-related AI to support radiologists is not...more
Promotional messages and activities regarding a health product are subject to the advertising provisions under the Food and Drugs Act (FDA), the Controlled Drugs and Substances Act and/or their associated regulations. For...more
Remarkable progress in DNA and RNA sequencing have democratized the generation and analysis of genomic data across diverse industry sectors, including biopharmaceutical research, healthcare, consumer ancestry, law...more
NP Strategy’s public relations experts Amanda Loveday, Chief Operating Officer, and Jesica Mackey, Vice President, join us this week to discuss the firm’s work and expertise. Our guests share their advice and best practices...more
Partners Jenny Colgate and Jennifer Maisel will present a webinar titled "Artificial Intelligence Litigation Risks for the Medical Technology Industry" for Medmarc, the leading expert in the products liability risks facing...more
ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more
Cybersecurity is a top concern for all industries, particularly for the pharmaceutical and medical device industries. These industries hold some of the most sensitive data and highly valuable technology, making them prime...more
On May 10, 2023, I attended the Association for Corporate Counsel (ACC) live CLE event "2023 Life Sciences Conference: Future-Ready Resilience: Preparing to Face Challenges in the Uncertain Future." Eric Long, executive vice...more
We’ve all heard troubling stories involving emerging tools powered by artificial intelligence (AI), in which algorithms yield unintended, biased, or erroneous results. Here are a few examples: - A monitoring tool for...more
Hosted by American Conference Institute, the 18th Annual Conference on the FCPA & Anti-Corruption for the Life Sciences Industry returns for another exciting year with curated programming that shines a global spotlight on...more
The U.S. Food and Drug Administration (FDA or the Agency) has issued guidance concerning cybersecurity requirements for certain medical device premarket submissions (the Guidance). The Guidance outlines the implementation of...more