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Top Healthcare Compliance Priorities for 2025
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CMO Series Podcast RE-RELEASE: Tracey Whyte on Getting The Most Out of AI in a Lean Marketing and BD team
AI Legislation: The Statewide Spotlight - Regulatory Oversight Podcast
Compliance Tip of the Day: Standing at the Turning Point
Compliance Tip of the Day – Role of Chatbots in Compliance
AI Legislation: The Statewide Spotlight — The Consumer Finance Podcast
Compliance Tip of the Day – AI and Behavioral Analytics
Key Discovery Points: Don’t Rush in as an AI Fool!
100 Days In: What Employers Need to Know - Employment Law This Week® - #WorkforceWednesday®
5 Key Takeaways | AI and Your Patent Management, Strategy & Portfolio
Upping Your Game: Episode 1 – Meeting Hui Chen’s Challenge
Compliance Tip of the Day: AI and Compliance Education
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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
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
On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and biological products. The draft guidance – the first of its kind from the agency – aims to...more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
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On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products...more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
We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, we present a timely discussion about increasing litigation and...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
FDA’s primary challenge in regulating AI-enabled device software functions (“AI-DSF”) has been that the self-modifying nature of these functions simply does not fit within the Agency’s long-standing framework for medical...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
Walking away from Digital Health Counsel 2024 AI Summit, the stunning impact that AI and data-powered innovation are making on healthcare is undeniable. Organized by Ogden Murphy Wallace and sponsored by Fenwick, the summit...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
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
These are exciting times for the advancement of healthcare, whether you’re a hospital, health system, or healthcare technology company or a consumer that benefits from the proliferation of products and services provided. In...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
At the start of 2022, we reflected on what the Food and Drug Administration (FDA) had accomplished during the preceding 12 months and the challenges that could be ahead for the agency during the impending year, especially...more
We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, our lawyers describe the increasingly common regulation of...more
The FDA has announced the formation of the Digital Health Advisory Committee, a group dedicated to navigating the complexities of emerging DHTs like AI/ML, augmented reality and more. This development evidences the FDA’s...more