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The Next FCRA Frontier: Identity Theft and CFPB Updates — FCRA Focus Podcast
Episode 366 -- DOJ Issues Data Security Program Requirements
The Privacy Insider Podcast Episode 13: Preserving Privacy and Social Connection with Christine Rosen of the American Enterprise Institute
AI in Employment: Navigating the Legal Landscape with Lessons from I, Robot — The Good Bot Podcast
FCPA Compliance Report: AI, Data Compliance, and Ownership - A Conversation with Andrew Hopkins
Innovations in Compliance: Data Collection & Cybersecurity with ModeOne’s Matt Rasmussen and Ryan Frye
Fintech Focus Podcast | Responding to a Cyber Attack – Key Considerations for GCs and CISOs
A Blueprint for Efficient SRRs: Mastering Your Subject Rights Workflow
What is the CCF?
AI in Employment: Navigating the Legal Landscape with Lessons from I, Robot — Hiring to Firing Podcast
A Less is More Strategy for Data Risk Mitigation
Auditing Your Hotline and Case Management System
Compliance and AI: Ali Khan on Implementing AI Risk Management Systems
Weathering the 2025 Whirlwind: How to Keep Calm & Carry On
No Password Required Podcast: Chief Product Officer at ThreatLocker and Advocate of Buc-ee’s, Mascots, and Buc-ee Mascots
Compliance Tip of the Day: AI for Whistleblower Anonymity
The Evolving Role of AI/ML in Healthcare - The use of artificial intelligence/machine learning (AI/ML) in healthcare is evolving rapidly and introducing new challenges. Not only are medical devices using AI for diagnostics,...more
Welcome to our second issue of 2025 of Decoded - our technology law insights e-newsletter. For those of you with an interest in the Corporate Transparency Act, Brienne Marco and Joe Unger report that the recent injunction...more
The Department of Justice’s (DOJ) final rule implements President Biden’s Executive Order 14117 of February 28, 2024, on “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data...more
Last week, the U.S. Cybersecurity and Infrastructure Security Agency (“CISA”) and the U.S. Food and Drug Administration (“FDA”) released warnings about an embedded function they found in the firmware of the Contec CMS8000,...more
With daily media reports citing to the explosion of interest in Artificial Intelligence (“AI”), AI start-ups have attracted a huge capital influx. During the last fiscal quarter of 2024 ending on December 31st, investors...more
In 2024, as in years past, healthcare fraud enforcement by the U.S. Department of Justice (DOJ) was substantial. Federal actions under the False Claims Act (FCA) alone resulted in $1.67 billion in settlements and judgments...more
Key Points - - It remains to be seen what priorities Robert F. Kennedy Jr. and Marty Makary might set if confirmed as HHS secretary and FDA commissioner, respectively. - The Trump administration will likely focus on drug...more
The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025....more
News Briefs - Number of Official Physician Union Drives Soared Over Two Years - While fewer than 10 percent of U.S. physicians are unionized, the number of official union drives among private-sector doctors have skyrocketed...more
On October 30, 2023, President Biden signed Executive Order 14110, laying the groundwork for the ethical and secure deployment of AI across industries, including healthcare. This comprehensive directive outlines policy goals...more
The Learned Concierge - Welcome to your monthly legal insights on the trends impacting the Retail, Hospitality, and Food & Beverage Industries....more
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
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
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
(May 30, 2023) Going forward, medical device approval will require the device maker to provide cybersecurity information to the FDA. Congress made this change by adding Section 524B to the Federal Food, Drug, and Cosmetic...more
Medtech companies are evolving rapidly as more and more of them develop products that collect and leverage substantial patient and provider data. Companies that once only developed hardware-based solutions for...more
In this month’s Privacy & Cybersecurity Update, we look at Washington state’s passage of the first-ever state-level health data privacy law and the finalized California Consumer Privacy Act regulations. We also examine a...more
On December 29, 2022, President Biden signed a new statute that will significantly impact medical device cybersecurity regulation. Section 3305 of the Consolidated Appropriations Act of 2023 (“Section 3305”) authorizes the...more
Join Gardner Law and colleagues live from Lord Fletcher's on Lake Minnetonka, Minnesota for a complimentary CLE event. Hear from a panel of experts on compliance, data breaches, FDA regulations, privacy, and more....more
On March 15, the U.S. Food and Drug Administration (FDA) issued revised draft guidance summarizing how it intends regulate the use of electronic systems, records, and signatures in clinical investigations to account for...more
The last year has seen a multijurisdictional regulatory push for increased cybersecurity standards for medical devices. The new approaches, issued by regulatory authorities in the United States (U.S.), the United Kingdom (UK)...more
Here are key points made by the all general counsel panel on various topics. Key Points: Physician remunerative relationships, OIG Special Fraud Alert on Speaker Programs, & Virtual Interactions...more
CHIPS and Science Act Will Lower Costs, Create Jobs, Strengthen Supply Chains, and Counter China "Spurred by the passage of the CHIPS and Science Act of 2022, companies have announced nearly $50 billion in additional...more
Data Privacy, Abortion Limits Set to Collide Post-Roe "Even before the June 24 ruling in Dobbs v. Jackson Women’s Health Organization, privacy advocates, concerned that data on women seeking abortions could be used to target...more
Is the U.S. Finally Getting a Comprehensive Cybersecurity and Data Protection Law? What You Need to Know About the Proposed American Data Privacy and Protection Act - In the beginning of the 2000s, as a result of the...more