Compliance into the Weeds: The Dark Side of AI in Employee Training
AI Today in 5: August 13, 2025. The Beware the EU AI Act Episode
AI Today in 5: August 7, 2025. The US v. China Episode
AI Today in 5: August 6, 2025, The Rethinking Compliance Episode
AI Today in 5: August 5, 2025, The AI at the SEC Episode
FCPA Compliance Report: Navigating Corporate Scandals: Insights on Governance, Compliance, and Recovery with Steve Vincze
Podcast - Regulating AI in Healthcare: The Road Ahead
Life With GDPR: Episode 114: Navigating GDPR in Global Outsourcing with Inge Zwick
Daily Compliance News: June 27, 2025, The ABB Gets Out of DPA Edition
Regulatory Ramblings: Episode 72 - Cultural Roots, Belonging, and the Fear of Change: What’s Next for Inclusion?
(Podcast) The Briefing: The Ninth Circuit Puts the Brakes on Eleanor’s Copyright Claim
Compliance Tip of the Day: AI, Behavioral Analytics and Cyber Security
Performance Reviews: Lessons from Severance — Hiring to Firing Podcast
FCPA Compliance Report: Recent DOJ Policy Announcements
Culture Crafters: Navigating Business Volatility Through Corporate Culture
Upping Your Game: Harnessing AI to Revolutionize Third-Party Risk Management
Compliance and AI: Using AI for Data Loss Prevention Systems with Vinay Goel
The JustPod: Prosecutor-Initiated Resentencing: A Discussion with Hillary Blout
CareYaya: A Revolutionary Approach to Elder Care
Independent Contractor Rule, EEO-1 Reporting, and New York Labor Law Amendment - #WorkforceWednesday® - Employment Law This Week®
The U.S. Department of Health and Human Services (HHS) and the Department of Justice (DOJ) have jointly announced the launch of a reinvigorated DOJ-HHS False Claims Act Working Group aimed at enhancing interagency...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
Are you responsible for privacy compliance at your company? Sharpen your pencils and grab your highlighters for this three-part series on critical privacy laws, DPOs and privacy officers (and when you should appoint one), and...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
The U.S. Food and Drug Administration (FDA) has finalized its guidance on “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” which advises medical device manufacturers on...more
In response to a growing number of cyberattacks in the healthcare and life sciences industries, on Sept. 27, 2023, the U.S. Food and Drug Administration (FDA) released updated guidance regarding cybersecurity safety...more
The use of artificial intelligence (AI) in healthcare has been growing rapidly in recent years, and AI-enabled medical devices are playing a larger role in patient care. Such devices may use machine learning algorithms to...more
As artificial intelligence technology evolves on a seemingly minute-by-minute basis, the U.S. FDA’s regulatory approach continues to evolve in an effort to keep pace. “The promise of artificial intelligence in medicine is...more
In recent years, the digitalization of the healthcare industry has been accelerated to meet demands for smarter devices and robotics, wearable technology, AI-based data analysis, and enhanced platforms and simulations, among...more
Cyberattacks affecting internet-connected medical devices like insulin pumps, intracardiac defibrillators, mobile cardiac telemetry, pacemakers and intrathecal pain pumps have increased in recent years. And such attacks show...more
Medical device manufacturers form part of the first line of defense that health delivery organizations (HDOs) rely upon to manage and combat a cybersecurity attack....more
California’s lab and biotech industries provide 435,693 jobs that generate $376 billion in total economic output, according to a new report from Biocom California, an association representing life sciences companies and...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
On Friday 21st October 2022, the Medicines and Healthcare Products Regulatory Agency (MHRA) wrote to the medical device industry to explain its intention: - To extend the current standstill period by twelve months from...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
Hogan Lovells partners Kelliann H. Payne and John J. Smith, M.D., J.D. recently joined Richard Frank, MD, PhD, Chief Medical Officer, Siemens Healthineers, and other industry leaders in person and virtually at the Health Care...more
Part 1 of this article discussed the background and purpose of the EU In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), the definition of in vitro diagnostic medical devices (IVDs), the risk-based classification system,...more
On October 14, 2021, the Food and Drug Administration (FDA) held a virtual public workshop on transparency surrounding Artificial Intelligence/Machine Learning (AI/ML) enabled medical devices. The workshop focused on the...more
Since the start of the COVID-19 pandemic, more people than ever have downloaded and used mobile applications, or apps, to communicate with their doctors, manage prescriptions, and streamline much of the healthcare activity...more
U.S. Food and Drug Administration (FDA) has acknowledged the prevalence of Artificial Intelligence/Machine Learning (AI/ML)-Based Software as Medical Devices (SaMDs) and has been taking steps towards advancing its regulatory...more
The U.S. Food and Drug Administration (FDA) named University of Michigan Associate Professor Kevin Fu Acting Director of Medical Device Security in its Center for Devices and Radiological Health. This is a newly created...more
Q: The FDA’s stance on a regulatory framework for artificial intelligence and machine learning (AI/ML) software as a medical device is continuously evolving. Could you explain the history? A: Artificial intelligence (AI) is...more
On October 29, 2020, the U.S. Department of Justice (“DOJ”) announced a unique False Claims Act (“FCA”) settlement with medical device manufacturer Medtronic USA Inc. (“Medtronic”) for $9.2 million to resolve allegations...more