Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 233: Prioritizing Women’s Health Through Innovation with Lindsey Calcutt of Incora Health
Hospice Insights Podcast - But Wait: Things to Consider Before Adopting AI Tools In Your Hospice
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 213: AI Transformations in Life Sciences and Beyond with Igor Jablokov of Pyron
Advancements of Artificial Intelligence in Health Care – One Year After White House Executive Order – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 212: Fujifilm’s Investment in North Carolina with Christine Vannais and Laurie Braxton of Fujifilm
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 208: Extended Reality Technology and the ThinkReality Headset with Mattney Beck of Lenovo
AI in the Operating Room: Liability Issues for Device Makers — The Good Bot Podcast
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
Introduction to The Good Bot: Decoding AI and Its Integration Into Health Care — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 178: Life Sciences Industry Impact with Bob Coughlin, JLL Director and Former MassBio CEO
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 175: Healthcare Inequity with Kim Smith, Healthcare Advocate and Founder of Health Evolve Technologies
Health + Tech - Leveraging AI to Drive Growth
Podcast - Artificial Intelligence in Healthcare and How to Comply with HIPAA & State Privacy Laws
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 157: Sarah Glover, Maynard Nexsen Cybersecurity Attorney
Podcast - Insights on the FTC's Approach to Digital Health Companies
Health + Tech - How Digital Health Tools Help Create Greater Consumer Focus in Healthcare
Podcast - SEC's Oversight on Cybersecurity Requirements
Podcast - Digital Health Market Assessment
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 118: Matthew Roberts and Darra Coleman, Health Care Attorneys, Nexsen Pruet
Video: Leaders Moving Business Forward Featuring Clear Eye Test
On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products...more
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
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
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
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
Wilson Sonsini’s 30th Annual Medical Device Digital Health Conference will address topics of critical importance to medical device and digital health companies today, including key healthcare regulatory considerations, the...more
On Wednesday, May 10, 2023, the Food and Drug Administration (FDA) announced the publication of a new discussion paper titled “Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological...more
On April 18, 2023, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) published a far-reaching proposed rule, Health Data, Technology, and...more
On April 3, 2023, the US Food and Drug Administration (FDA) published its draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning...more
Multiple policy documents relating to software and digital health have been issued by the U.S. Food and Drug Administration (FDA). The documents offer: a framework for the use of digital health tools in the context of drug...more
The U.S. Food and Drug Administration (FDA) – in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) – recently hosted a one-day virtual public workshop entitled,...more
2022 was a big year for the pharmaceutical and biotechnology sectors. Novel technologies emerged at a rapid clip. The Food and Drug Administration (“FDA” or the “Agency”) approved over forty novel drugs and biologics and...more
The U.S. Food and Drug Administration (FDA) will schedule a public meeting of the Medical Devices Advisory Committee later this year to discuss study results, real-world data, and other evidence concerning the accuracy and...more
The Food and Drug Administration recently sought comments on the role of transparency for artificial intelligence and machine learning-enabled medical devices. The FDA invited comments in follow up to a recent workshop on the...more
FDLI hosted a virtual conference November 9-10, 2021, titled Digital Health Technology and Regulation During COVID-19 and Beyond. One of the keynote events was the panel on “FDA’s Digital Health Center of Excellence: Working...more
On October 14, 2021, the U.S. Food and Drug Administration (“FDA” or the “Agency”) held a virtual workshop entitled, Transparency of Artificial Intelligence (“AI”)/Machine Learning (“ML”)-enabled Medical Devices. The workshop...more
In the weeks leading up to FDA’s October 14, 2021 Transparency of AI/ML Enabled Medical Devices Workshop (Workshop), we took a brief look at the history of FDA’s regulation of medical device software and the agency’s more...more