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
Episode 325 -- AI and Emerging Compliance Frameworks
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
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 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
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
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
On October 1, 2018, the Food and Drug Administration (FDA) issued its “Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook” to address continued threats to medical devices that could affect...more
Earlier this week, the FDA launched a new webpage to simplify the process of reporting violations of the law by medical device manufacturers and individuals marketing medical devices. Unlike the MedWatch system for reporting...more
The rise of social media has introduced new opportunities and new legal challenges for companies in the health care industry. Attorneys Seth Northrop and Sharon Roberg-Perez discuss the legal issues faced by care providers,...more
Are medical devices, subject to pre- and post-market regulatory controls, under increasing cybersecurity scrutiny? The FDA recently published recommendations for consideration of cybersecurity management in a product’s design...more