Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 245: Using AI to Improve Radiology with Angela Adams of Inflo Health
Podcast - Regulating AI in Healthcare: The Road Ahead
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 244: The Future of Independent Physician Practices with Ray Waldrup of The Leaders Rheum
Empowerment Through Hero Generation with Nicole a`Beckett and Dr. Shruti Roy
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 240: Independent Practice In Dermatology with Dr. Darragh and Dr. Shuler of Carolina Dermatology
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
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more
Recent activity among lawmakers and federal agencies signal that the government may be poised to undertake meaningful legislative and administrative efforts to harness the potential of digital health innovation and to expand...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
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
On July 8, the U.S. Food and Drug Administration (“FDA”) announced its updated guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers,” which provides recommendations and...more
On March 5, 2024, the US Food and Drug Administration (FDA) granted clearance to market the first over-the-counter (OTC) continuous glucose monitor (CGM). Dexcom’s Stelo Glucose Biosensor System (Stelo) is an integrated CGM...more
New technologies continue to emerge that improve care for patients taking prescription medications. On September 18, 2023, five years after the Food and Drug Administration sought initial public comment, the agency issued its...more
In late September 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance on “Regulatory Considerations for Prescription Drug Use-Related Software.” This guidance expands on (and was developed in response...more
On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) which adds a piece to the...more
The U.S. Food and Drug Administration (FDA) recently released draft guidance regarding clinical considerations for studies of medical devices intended to treat opioid use disorder (OUD). According to the FDA’s press release,...more
On May 2, 2023, the U.S. Food and Drug Administration (“FDA”) published draft guidance titled “Decentralized Clinical Trials for Drugs, Biological Products, and Devices” (the “Draft Guidance”). ...more
On May 2nd, the FDA published draft guidance regarding the use of DCTs to support the development of drugs, biological products and devices. In contrast to traditional site-based clinical trials, DCTs are characterized by...more
On Thursday, March 23, 2023, the Food and Drug Administration (FDA) announced the publication of the “Framework for the Use of Digital Health Technologies in Drug and Biological Product Development” (Framework) by the Center...more
The premier event for drug and medical device product liability lawyers to gain essential winning litigation strategies. ACI’s 26th Annual Flagship Conference on Drug and Medical Device Litigation is returning to New York...more
Welcome to the August 2020 issue of our Life Sciences International Review. This issue covers new developments within Asia, Europe, and the United States in intellectual property, regulatory, pricing, and international trade,...more
We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more
The US Food and Drug Administration’s (FDA’s) 2019 regulatory agenda focused on digital health, streamlined product approvals, evolving evidentiary thresholds for product approvals and strategic enforcement. The agency...more
On Monday, the FDA published the draft guidance, “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software,” which could facilitate drug manufacturers’ ability to integrate...more
As 2019 quickly approaches, we would like to take a few moments to reflect on the past year of Food and Drug Administration activities and certain big ticket items that made news in 2018. As the Magic 8-Ball would say: “signs...more
On 20 November the Food and Drug Administration (FDA) published a request for comments on a proposed framework for regulating the output of digital health applications disseminated by or on behalf of drug manufacturers with...more
Over the counter (OTC) drugs are medicines sold directly to consumers without a prescription from a healthcare professional. Traditionally, the range of OTC drugs has been limited to medical diseases and conditions for which...more