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10 For 10: Top Compliance Stories For the Week Ending May 17, 2025
Podcast - Innovations and Insights in the Palliative Care Space
Regulatory Ramblings: Episode 69 - Human Intelligence vs. Machine Judgment with Nigel Morris-Cotterill and Patrick Dransfield
CareYaya: A Revolutionary Approach to Elder Care
Innovation in Compliance: Innovative Approaches to Compliance and Training with Catherine Choe
Daily Compliance News: May 15, 2025, The Downfall in Davos Edition
Work This Way: A Labor & Employment Law Podcast | Episode 46: The 2025 Greenville SHRM Conference with Tyler Clark and Brittany Goforth of GSHRM
Early Returns Podcast - Oliver Roberts: AI and the Law, and an Education
Daily Compliance News: May 14, 2025, The Widened Whistleblower Program Edition
No Password Required: CEO of HACKERverse.ai, Disruptor of Cybersecurity Sales and Most Other Things
Navigating the Maze: eDiscovery Essentials for Employers — Hiring to Firing Podcast
Daily Compliance News: May 13, 2025, The Leaving on a Jet Plane Edition
FCPA Compliance Report: Upping Your Game in Compliance
Episode 368 — LRN Issues New Report Highlighting Growing Gap in Compliance Program Performance
Creativity and Compliance: From Compliance Enforcers to Trusted Advisors: The Path Forward
Join medical device and digital health entrepreneurs, CEOs of venture-backed companies, and business development executives from large Medtech and digital health companies, as well as angels, venture capitalists, and...more
News Briefs - Hospitals, Medical Device Makers Concerned Over Tariff Impact - A week after declaring "Liberation Day" and levying hefty tariffs on most of the country’s trading partners, President Donald Trump reversed...more
Our 2025 Life Sciences and Health Care Horizons edition is now live! Explore the latest global insights from the U.S., Asia-Pacific, Europe, Latin America, and the Middle East on the key issues and emerging trends shaping the...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
Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration (FDA) and its regulatory oversight for medical device and digital health...more
In the waning days of the Biden administration, the FDA released a flood of new guidance documents and other agency actions, including several important items related to digital health. On January 7, FDA published two new...more
Every year, 12,000 leaders in the healthcare industry meet at HLTH. This year's conference covered all aspects of the healthcare ecosystem, and here are the nine that we should watch as we enter the new year....more
This report compiles several important developments that shaped the healthcare and life sciences industries in 2024 and spotlights key areas to watch in 2025. Each section addresses either an industry sector within healthcare...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
On January 6 and 7, 2025, the FDA announced, by our count, 31 draft or final guidances, on a wide range of topics. Historically, an incoming administration will impose a temporary freeze on the issuance of guidances and...more
While generative artificial intelligence ("GenAI") has the potential to fundamentally change health care, it presents unique risks and complexities that challenge the U.S. Food and Drug Administration's ("FDA" or "Agency")...more
Amid continued rapid development of novel software products that present new opportunities in the health care space, FDA has yet to grant marketing authorization to a medical device incorporating artificial intelligence (AI)...more
On December 4, 2024, the U.S. Food and Drug Administration (“FDA”) released its final guidance for industry on predetermined change control plans (“PCCPs”) for devices that utilize artificial intelligence-enabled software...more
The U.S. Food and Drug Administration will focus on “Total Product Lifecycle Considerations for Generative AI-Enabled Devices” during its upcoming Digital Health Advisory Committee meeting on November 20–21. This meeting will...more
The U.S. Food and Drug Administration's ("FDA") new advisory committee on digital health is set to examine its approach for evaluating and regulating the safety and effectiveness of medical devices utilizing generative...more
On September 26, 2024, FDA published a compilation of commonly used terms in the digital health, artificial intelligence (AI), and machine learning space and their definitions, available here. FDA intends the glossary to be...more
Join Troutman Pepper Partner Brett Mason for a podcast series analyzing the intersection of artificial intelligence (AI), health care, and the law. In this installment, Brett Mason is joined by Partner Eric Rumanek and...more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more
Join Troutman Pepper Partner Brett Mason for a podcast series analyzing the intersection of artificial intelligence (AI), health care, and the law. In this installment, Brett is joined by Partner Judy O'Grady and Associate...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
The American Conference Institute hosted its inaugural Life Sciences AI Summit in New York on February 21 and 22. The two-day conference brought together key stakeholders, including regulatory players such as FDA and the...more
BCLP’s Healthcare & Life Sciences Practice Group recently partnered with EMIG Digital Health Group to co-host an in-person breakfast seminar and networking event focused on FemTech. Specialists from across the FemTech and...more
Today, a tale of two markets are seen in healthcare mergers and acquisition (M&A): the present (as reflected in the data about declining dealmaking) and the future (reflected in the increasingly positive outlook by...more
FDA announced on October 11, 2023 that it is creating a new Digital Health Advisory Committee to provide guidance to FDA on issues relating to digital health technologies ("DHTs"), including artificial intelligence,...more
In this article, we share our key takeaways from our recent webinar titled "AI, Digital Health & European Health Data Space", which was part of our "AI, Big Data and Law, Digital Deep Dive" webinar series. The webinar delved...more