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
Welcome to our seventh 2024 issue of Decoded - our technology law insights e-newsletter. We have a few events we want to pass along to those interested in technology, but also other areas of law and business. ...more
Friday, July 12, 2024, the EU published the new EU Artificial Intelligence Regulation, which is first EU AI Regulation worldwide setting requirements concerning safety and free movement of goods and services using AI...more
On May 21, 2024, the European Union finalized the adoption of the groundbreaking EU Artificial Intelligence Act, a comprehensive and sector-agnostic legislation that extends globally. This 420-page Act aims to regulate the...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
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
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
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
To quote CMS, “The Open Payments program is a national disclosure program that promotes a more transparent and accountable health care system. Open Payments houses a publicly accessible database of payments that reporting...more
Cyber incidents are on the rise with no signs of slowing down, particularly in the healthcare industry. To combat this trend, on September 27, 2023, the U.S. Food and Drug Administration (FDA) released guidance on...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
FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...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
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
Today, on Monday, March 20, 2023, Regulation (EU) 2023/607 of the European Parliament and of the Council of March 15, 2023, amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards transitional provisions for certain...more
UPDATE: The consultation period has been extended until April 26, 2023. On December 17, 2022, the proposed amendments to both regulations were published for consultation: Regulations Amending Certain Regulations Made Under...more
On Friday, January 6, 2023, the European Commission adopted a proposal to give more time to certify medical devices in hopes of mitigating the risk of shortages in the European Union (EU). The proposal introduces a longer...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
Even though they are still quoted, statements in Medtronic v. Lohr, which question whether FDA (Food & Drug Administration) medical device clearance is a judgment about a device’s safety, no longer accurately describe what...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
ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more