Compliance Tip of the Day: Rethinking Corporate AI Governance Through Design Intelligence
Julie Mortimer of Mills & Reeve on The Right Way to Kickstart Your CRM Strategy - Passle's CMO Series Podcast EP176
Law School Toolbox Podcast Episode 513: Grappling with AI as a Law Student and Lawyer (1L Summer Series)
(Podcast) The Briefing: Anthropic, Copyright, and the Fair Use Divide
The Briefing: Anthropic, Copyright, and the Fair Use Divide
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
How to Rank in the Age of AI Search: On Record PR
AI in eDiscovery Today: An Open Conversation
Innovation in Compliance: Allison Lagosh on Proactive Compliance Planning for Regulatory Changes
FCPA Compliance Report: Ethical Challenges in AI, Data Protection, and Sports with Andre Paris
Work This Way: An Employment Law Video Podcast | Episode 51: Smarter Recruiting Strategies with Rhiannon Poore of Forge Search
Daily Compliance News: July 9, 2025, The TACO Don Caves Again Edition
CMO Series Live Special: The AI Revolution and What it Means for CMOs
What Is Ambient AI and Why Does It Matter to Lawyers & Legal Professionals?
#Risk New York Speaker Series – Exploring Future Regulatory Trends and Compliance Strategies with Rory McGrath
The Authenticity Advantage: How Runbin Dong’s Scale Social AI Helps Small Businesses Shine
Key Discovery Points: A Judicial Approach to Handling AI-Generated Evidence
Richard Meneghello of Fisher Phillips on How Smart Content Can Set Your Firm Apart - Passle's CMO Series EP175
Feeling Disillusioned with AI? You’re Not Alone
The Center for Medicare and Medicaid Innovation (CMMI) recently announced a six-year payment model for 2026-2031 called the Wasteful and Inappropriate Service Reduction (WISeR) Model. WISeR will test the use of artificial...more
Artificial intelligence (AI) is already indispensable in the healthcare and life sciences sector. Intelligent medical devices promise nothing less than a revolution in the art of healing. With its legislative projects on AI...more
The US Food and Drug Administration (FDA) launched Elsa, a generative artificial intelligence (AI) tool designed to assist FDA employees with tasks such as reading, writing, and summarizing. The press release on the tool’s...more
Recently, it was reported that the U.S. Food and Drug Administration (FDA) is launching two cross-agency artificial intelligence (AI) councils. One AI council will be tasked with addressing how the agency uses AI internally...more
2024 was a challenging year for M&A activity in the medical technology (“MedTech”) industry. Although some sectors experienced a rebound in deal volume, MedTech dealmakers were disproportionately affected by a difficult...more
A large health system implements an Artificial Intelligence (AI)-powered clinical decision support tool that promises to ensure “complete and accurate” diagnosis documentation. Within six months, the system’s Medicare...more
As FDA medical device lawyers advising AI and digital health companies, Hogan Lovells lawyers have had a front-row seat to an increasingly common scenario: software platforms and mobile apps that launch with the best of...more
As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more
The past six months at the US Department of Health and Human Services and the US Food and Drug Administration’s Center for Devices and Radiological Health have seen a fluctuating workforce size, a slew of new executive...more
Femtech stands at an exciting inflection point. What was initially perceived as a niche category focused on period-tracking apps has evolved into a comprehensive ecosystem addressing women's health needs with individualized...more
Already highly regulated with a risk-based approach at their core, AI-powered medical devices and in vitro diagnostic medical devices face new regulatory constraints stemming from the EU AI Act, a horizontal legal instrument...more
On 19 June 2025, the Medical Device Coordination Group (“MDCG”) published new guidance on the interplay between the MDR & IVDR and the AI Act (MDCG 2025-6). The document provides a first set of answers to the most frequently...more
As we noted in our previous blog post, HealthBench, an open-source benchmark developed by OpenAI, measures model performance across realistic health care conversations, providing a comprehensive assessment of both...more
On June 10, 2025, the Commissioner of the FDA, Dr. Martin Makary, and Dr. Vinayak Prasad, the Director of the FDA’s Center for Biologics Evaluation and Research, published an article in JAMA discussing the “Priorities for a...more
Byonyks, a medical device company focused on advancing dialysis care, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Byonyks X1 APD Cycler, an automated peritoneal...more
Ariel Seeley served on the panel titled AI Trends in Medical Devices: Global Developments, FDA Policies, and Software as a Medical Device at the 2025 Food and Drug Law Institute (FDLI) Annual Conference. The panel provided an...more
Neil Young once sang of adapting to a world ruled by data and digital minds in “Computer Age.” Today, that vision feels increasingly real as the Food and Drug Administration turns to artificial intelligence (“AI”) in the face...more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more
On June 2, 2025, FDA announced the launch of Elsa, a generative AI tool designed to “help employees—from scientific reviewers to investigators—work more efficiently.” Per FDA, the tool “modernizes agency functions and...more
On April 15, 2025, Canada’s Drug Agency (CDA) released its new five-year strategic plan, Insight to Impact 2025-2030. Formerly the Canadian Agency for Drugs and Technologies in Health (CADTH), this is the CDA’s first...more
The FDA is moving quickly to bring artificial intelligence (AI) into the heart of its regulatory review process. On May 8, 2025, the agency announced the successful completion of its first AI-assisted scientific review—and...more
Evolving regulatory paradigms governing AI use in health care at the U.S. Food and Drug Administration (FDA) have set the pace for AI regulatory frameworks worldwide. Jodi Scott, partner in the Hogan Lovells medical device &...more
Hogan Lovells and the AI Health Care Coalition recently hosted their fourth annual AI Health Law & Policy Summit, where thought leaders and policymakers gathered to discuss a variety of topics including reimbursement issues...more
As AI transforms medicine, some of the most promising healthcare innovations are at risk of exclusion by Medicare’s outdated and complex reimbursement structures. The Health Tech Investment Act, or S. 1399, introduced in...more
The U.S. Food and Drug Administration (FDA) has been ahead of the curve for a number of years on emerging issues and opportunities for the agency and regulated industry arising from the advent and evolution of artificial...more