Business Better Podcast Episode: Bridging Campuses: Legal Insights on Education Industry Consolidation – Privacy and Data Security
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
Why Privacy Matters to Your Business and What's in Store for 2025
CFPB's Inquiry Into Payments Privacy — Payments Pros – The Payments Law Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 223: Cybersecurity and Privacy Risks with Healthcare Vendors with Brandon Robinson of Maynard Nexsen
For early-stage life sciences and health tech companies, raising capital is about more than demonstrating scientific promise. Investors are increasingly focused on regulatory preparedness, reimbursement strategy, and risk...more
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
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
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
Pharma: Launch of Shortages Monitoring Platform, several Changes re Clinical Trial Management in EU Countries; Devices: Resolution on the need to revise the MDR and IVDR published; Compliance: CSRD still not implemented in...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
This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more
The Court of Justice of the European Union (CJEU), the EU’s highest court, recently announced its significant Lindenapotheke decision, permitting companies to use the General Data Protection Regulation in business-to-business...more
Welcome to our eighth 2024 issue of Decoded - our technology law insights e-newsletter. Thank you for reading. EU AI Act Tightens Grip on High-Risk AI Systems: Five Critical Questions for U.S. Companies - Why this is...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
Hosted by the American Conference Institute, the 19th Annual FCPA & Anti-Corruption Conference for the Life Sciences Industry returns for another exciting year with carefully researched programming based on critical findings...more
On Jan. 17, 2024, McGuireWoods partners Kimberly Kannensohn and Sam Bernstein conducted a webinar regarding how the Health Insurance Portability and Accountability Act (HIPAA) applies to medical device companies and certain...more
On December 6, 2023, HHS released a concept paper that outlines the Department’s cybersecurity strategy for the healthcare sector titled, “Healthcare Sector Cybersecurity Strategy.” HHS reports that cyber incidents in...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
This regular alert covers key regulatory developments related to EU emergency responses, including in particular, to COVID-19, Russia’s war of aggression on against Ukraine, and cyber threats. ...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
This regular alert covers key regulatory EU developments related to the COVID-19 situation. It does not purport to provide an exhaustive overview of developments and contains no analysis or opinion. This COVID-19 Update...more