The Informed Board Podcast | Board Oversight at a Time of Political and Geopolitical Uncertainty
We get Privacy for work — Episode 8: The Surge in Data Breach Lawsuits: Trends and Tactics
The Privacy Insider Podcast Episode 17: Security, Cyber-Intel, and a Sense of Humor with Nir Rothenberg of Rapyd
Daily Compliance News: August 20, 2025, The Boss is Back Edition
12 O’Clock High, A Podcast on Business Leadership – Leadership in Cybersecurity and Privacy with Robert Meyers
The Road to Regulation: Vehicle Service Contracts Explained — Moving the Metal: The Auto Finance Podcast
AI Today in 5: August 12, 2025, The Creating Billionaires Episode
AI Today in 5: August 11, 2025, The ACHILLES Project Episode
Under the Radar: DOJ's Data Security Rules and Their Impact on Payments Companies — Payments Pros – The Payments Law Podcast
Podcast - Regulating AI in Healthcare: The Road Ahead
Innovation in Compliance: The Future of Compliance Training: AI, Adaptive, Learning, and Cultural
No Password Required: Former Lead Attorney at U.S. Cyber Command, Cyber Law Strategist, and Appreciator of ‘Mad Men’ Hats
Lawyers Beware: There Could Be Serious Ethics Issues With The New AI Browsers
We get Privacy for work – Episode 6: The Potential Privacy Risks Inherent to Mergers and Acquisitions
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 243: HIPAA Compliance and Potential Changes with Shannon Lipham of Maynard Nexsen
Compliance Tip of the Day: Rethinking Corporate AI Governance Through Design Intelligence
The Privacy Insider Podcast Episode 16: Protecting Privacy at Every Walk of Life with France Bélanger and Donna Wertalik of Virginia Tech
10 For 10: Top Compliance Stories For the Week Ending July 19, 2025
SkadBytes Podcast | Tech’s Shifting Landscape: Five Trends Shaping the Conversation
Hospice Insights Podcast - AI in Action: Exploring How AI Is Helping Hospices Do Things in New Ways
Gardner Law is excited to announce Navigating What's Next: AI, Compliance, and Regulation in Life Sciences, being held live at the Shashi Hotel in the heart of Silicon Valley on November 6, starting at 9:00 a.m. Pacific Time....more
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
Artificial Intelligence (AI) continues to revolutionize industries and is poised to bring transformative change in healthcare delivery, drug discovery, diagnostics, and data analysis and communication. This technology is...more
On June 24, 2025, in a hearing before the U.S. House of Representatives Committee on Energy and Commerce, the Secretary of Health and Human Services (HHS), Robert F. Kennedy Jr. revealed that his department plans to soon...more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more
If the initiative proceeds as planned, it will mark a pivotal shift in the regulatory landscape, introducing both efficiencies and novel questions related to the reliability and validity of the AI reviews, as well as...more
Innovation in life sciences isn’t just about scientific breakthroughs—it’s about making the right business decisions. Whether a company is developing AI-driven diagnostics, biotech therapies, connected medical devices, or...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
Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...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
In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on the use of artificial intelligence (AI) in the context of drugs, biologics,...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
As the New Year begins, questions surrounding how recent election results will impact technology regulation across industries loom large. It’s hardly a bold prediction that artificial intelligence (“AI”) and the regulation...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
Gain firsthand insights from leading in-house experts on the transformative power of AI in the life sciences at ACI's 2nd Annual Life Sciences AI Summit. Discover strategies to navigate the complex legal and regulatory...more
Welcome to Venable’s BiologicsHQ Monthly Injection - December 2024....more
U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, M.D., and other senior FDA officials recently published a “Special Communication” in JAMA describing FDA’s concerns with the use of AI in medical product...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 January 7, 2025, FDA published “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff”...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
Wilson Sonsini’s 31st Annual Medical Device & Digital Health Conference will address topics of critical importance to medical device and digital health companies, including early and late-stage venture financing, partnering...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
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