Plan for Success: Navigating Pension De-Risking
False Claims Act Insights - Be Careful What You Wish For: HHS-OIG Advisory Opinions
Paddle's Payment Predicament: Unpacking FTC's Compliance Crackdown — Payments Pros – The Payments Law Podcast
AI Today in 5: August 22, 2025, The Angst Episode
The Privacy Insider Podcast Episode 17: Security, Cyber-Intel, and a Sense of Humor with Nir Rothenberg of Rapyd
Daily Compliance News: August 22, 2025, The WADA Returns Edition
Regulatory Ramblings: Episode 76 - The Digital Future: The US GENIUS Act and Hong Kong Stablecoins Ordinance / The Hong Kong Web3 Blueprint: Building a Web 3 International Financial Hub Report
Point-of-Sale Finance Series: Understanding the Development and Regulation of Buy Now, Pay Later Products — The Consumer Finance Podcast
Understanding BBB Ratings: Strategic Approaches to Consumer Complaints — Regulatory Oversight Podcast
Compliance Tip of the Day: Co-Thinking with AI
Joint Venture Eligibility Refresher on Requirements for Government Contractors
Compliance into the Weeds: Two Cyber Security Cases for the Compliance Professional
The Road to Regulation: Vehicle Service Contracts Explained — Moving the Metal: The Auto Finance Podcast
AI Today in 5: August 12, 2025, The Creating Billionaires Episode
Compliance Tip of the Day - The ROI of Compliance
AI Today in 5: August 11, 2025, The ACHILLES Project Episode
Taxing Intelligence: AI's Role in Modern Tax Administration
Podcast - An Overview of State Attorney General Consumer Protection Enforcement
LathamTECH in Focus: Move Fast, Stay Compliant
Work This Way: A Labor & Employment Law Podcast | Compliance Clarity for Federal Contractors with Joan Moore and Mim Munzel of Arbor Consulting Group
The EU AI Act has arrived, and the countdown to compliance is on. As of August 2, 2025, penalties, including administrative fines, are in force. ...more
Gardner Law is excited to announce Navigating What's Next: AI, Compliance, and Regulation in Life Sciences, being held live at the Shashi Hotel in the heart of Silicon Valley on November 6, starting at 9:00 a.m. Pacific Time....more
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its responses to the consultation on Medical Device Regulations: Routes to market and in vitro diagnostic devices carried out last year....more
Can human beings cure all diseases in our lifetime? For centuries, humanity has strived to cure diseases. With the advent of Artificial Intelligence (AI), the dream of a disease-free world seems more attainable than ever...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
Pharma: Reform of the EU Pharmaceutical Legislation; German Medical Research Act enacted fostering R&D also including confidentiality of drug prices; France adopts standard CTA clauses; UK easing clinical trials; Devices:...more
On July 2, 2025, the European Commission released its communication “Choose Europe for life sciences. A strategy to position the EU as the world’s most attractive place for life sciences by 2030” (the Strategy). ...more
Following approval by EU Member States in the Trade Barriers Committee, on 19 June 2025, the European Commission adopted the first measure (Implementing regulation - EU - 2025/1197 - EN - EUR-Lex) under the International...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
Last Friday, the European Commission announced its first International Procurement Instrument (IPI) measure, excluding “economic operators” from China from participation in EU public procurement procedures for medical devices...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
The Medical Device Coordination Group (“MDCG”) has issued guidance on the safe making available of medical device software (“MDSW”) apps on online platforms (MDCG 2025-4). MDCG 2025-4 outlines the regulatory roles of online...more
The European Union has “agreed overwhelmingly” to limit Chinese medical device manufacturers’ access to public procurement contracts in Europe, Bloomberg reports. On Monday June 2, 2025, European Union (EU) countries...more
This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...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 evolving regulatory...more
Overview - - The U.S. Food and Drug Administration (FDA) announced that it aims to increase the agency’s use of artificial intelligence (AI) across its centers to accelerate scientific reviews by June 30, 2025. - The...more
Regulation of artificial intelligence (AI) in Asia Pacific remains nascent, mostly governed by existing regulatory frameworks designed for other technologies and products. It’s a work in progress. AI techniques – machine...more
The boundary between medicinal products and medical devices remains a recurring issue for companies developing or marketing borderline products and courts, which has already been the subject of numerous decisions. Recently,...more
Our clients are at the forefront of many of the developments covered by the report. That said, I couldn’t help thinking that the report overlooked a law that takes effect in less than six months’ time and which will have...more
For years, medtech firms around the globe (and certainly European companies) introduced their products in Europe, which requires obtaining a CE mark certifying compliance with relevant EU health and safety standards, prior to...more
The Evolving Role of AI/ML in Healthcare - The use of artificial intelligence/machine learning (AI/ML) in healthcare is evolving rapidly and introducing new challenges. Not only are medical devices using AI for diagnostics,...more
The regulatory frameworks in the life sciences and healthcare sector keep evolving rapidly and dynamically. Several important legislative reforms have been adopted over the last years, which are set to impact players in the...more
On 14 January 2025, the European Commission ("Commission") published the findings of its first investigation under the EU's International Procurement Instrument ("IPI"). Findings of the investigation concludes that China...more
Welcome to our eighth 2024 issue of Decoded - our technology law insights e-newsletter. Thank you for reading. EU AI Act Tightens Grip on High-Risk AI Systems: Five Critical Questions for U.S. Companies - Why this is...more