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
Drug and device manufacturers are increasingly targeted by cyber threats that can compromise patient safety, intellectual property, and other critical data and systems, while also facing new regulatory demands. As regulators...more
In this episode, Monica Chmielewski, vice chair of Foley’s Health Care Practice Group and Shannon Sumner, Chief Compliance Officer and Nashville’s Office Managing Principal of PYA explore how supply chain compliance is...more
The U.S. Food and Drug Administration (FDA) recently finalized its March 2024 select updates to its guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (“Premarket...more
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
The EU Cyber Resilience Act (CRA), adopted by the European Parliament in 2024, marks a major milestone in European cybersecurity legislation. As the first EU-wide law focused on the cybersecurity of digital products, it...more
On April 1, 2025, the subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce held a hearing on cybersecurity vulnerabilities in legacy medical devices. The hearing was largely a...more
As global trade policy evolves faster than ever, now is the time to connect with your peers, discover new strategies, and most importantly, hear from the regulatory agencies on the front lines of policy change. ACI’s 15th...more
The European Union has significantly overhauled its product liability regime with a new directive concerning liability for defective products (Product Liability Directive). EU member states have until December 9, 2026, to...more
The 2025 Consumer Electronics Show (CES) — one of the world’s most influential tech events — once again showcased groundbreaking innovations that are shaping the future of technology. I was among the over 141,000 attendees of...more
This year’s Data Privacy Week theme is “take control of your data.” That can be really challenging to do. Data is collected from everywhere—whether online or offline—and can be stored and used indefinitely (even if the...more
Our Privacy, Cyber & Data Strategy Team discusses the new Cyber Resilience Act (CRA) that affects manufacturers and distributors of connected devices that are in use anywhere in the European Union....more
In this edition of Three Questions, health care & life sciences partner Nate Brown spoke with Jeremy Schutz, director of business development, recall & remediation at Sedgwick, to explore key strategies that pharmaceutical...more
On 20 November 2024, the EU Cyber Resilience Act (CRA) was published in the Official Journal of the EU, kicking off the phased implementation of the CRA obligations....more
As the manufacturing sector continues to embrace the hyper-connected era of Smart Manufacturing, known as Industry 4.0, more and more organizations are integrating advanced automation, artificial intelligence (AI), the...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
The EU AI Act, which was passed by the European Parliament on 13 March and is set to become law later this year, will probably be the world’s first legislation to introduce a general regulatory framework for artificial...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
Lately, I have been asked a lot about security in Business Central and how good it is… Permissions, Roles, Field Level Permission with an APP, and so on. How do you know if anything has been compromised, or if you have a...more
For the second year in a row, the manufacturing industry has fallen victim to more cyberattacks than any other major business sector. Indeed, according to IBM Security’s X-Force Threat Intelligence Index, nearly 25 percent...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
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’s 5th National Forum on FOCI is back IN PERSON this September! Don’t miss the only comprehensive, practical FOCI event of its kind. The Defense Counterintelligence Security Agency (DCSA) is heightening its scrutiny and...more
Cybellum released a medical device survey report on April 20, 2022 entitled “Medical Device Cybersecurity: Trends and Predictions.” The company’s website states that their “mission is to enable manufacturers and their...more
2021 was a game-changing year in cybersecurity. There were many high profile vulnerabilities and data breaches, and responses from the government and private sector. A few examples include Accellion, SolarWinds, Microsoft...more