Hogan Lovells – Global Life Sciences and Health Care

We're thrilled to be sponsors of both MedTech Color and the 7th Annual Networking Breakfast at The MedTech Conference powered by AdvaMed! Join us for this marquee event to connect with industry leaders and foster a strong, diverse network dedicated to thought leadership and innovation clinical advancement. Don’t miss the opportunity to collaborate with industry professionals, C-suite executives, start-up founders, students, and more!   Register today: https://lnkd.in/d2hdJxD   #MedTechColor #MTCNB2024 #ThoughtLeadership #DiversityInMedTech   Jodi Scott Beth Roberts Damon Lewis Donald DePass Suzanne Levy Friedman Stephanie Agu Daniel Garcia Xochitl Halaby Steve Bruns Breanna Reeves

Regulatory clarity in AI is critical for innovation to continue in a safe, consistent, and ethical manner. The EU AI Act has revolutionized AI regulation in the region, and we are supporting clients across industries in their compliance roadmap. When it comes to AI-based medical devices, however, regulatory ambiguity remains. In a new whitepaper, Arne Thiermann and Hannah W. address the issues concerning clinical investigations of AI-based medical devices, explain why it matters, and emphasize the importance of collaboration between regulatory bodies, industry representatives, and legal advisors. 👉 Access the full whitepaper here: https://lnkd.in/ejZTj8Z7 👉 Learn more in our press release: https://lnkd.in/e4RWSnkW #LifeSciences #EUAIAct #MDR #AI #MedicalDevice #Innovation #Compliance 

The U.S. Food and Drug Administration (FDA) finalized its revised guidance summarizing how it intends regulate the use of electronic systems, records, and signatures in clinical investigations to account for advances in digital health technologies (DHTs). The guidance applies to clinical trial sponsors, investigators, Institutional Review Boards (IRBs), and Contract Research Organizations (CROs), and it provides advice on implementing data integrity and security controls, including the protection of electronic records. In this article, we outline the critical differences between the draft and final versions of the guidance, observing how FDA seems to have taken a more flexible approach in the final. Read more here: https://lnkd.in/eVFWE-zA #FDA #DHT #IRB #CRO #DigitalHealth Authors: Robert F. Church, Blake Wilson, Alex Smith, Stephanie Agu, and Ashley Grey, JD, MSc.

Did you miss our fourth webinar in the Hogan Lovells APAC Life Sciences Series? Don’t worry! 🎥 The recording and slides on Commercialization in the U.S. (Part I – The rules of the road) are now available on-demand.                  👉 Watch here: https://lnkd.in/ehrkA5G2 👉 View slides here: https://lnkd.in/eS8yBMXb   Join us for Session No. 5 on November 21, 2024, as we explore Commercialization in the U.S. (Part II – Making it real) which will explain how best to prepare your early-stage market access strategy, including practical tips, key opportunities and risk mitigation. We look forward to seeing you there!   Dr Frederick Ch'en, Alice Valder Curran, Beth Halpern, Melissa Bianchi, Lynn Mehler, Lowell M. Zeta   #LifeSciences #WebinarSeries #APAC #Commercialization

On October 2, 2024, the Centers for Medicare & Medicaid Services (CMS) issued final guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program established by the Inflation Reduction Act (IRA) (“Final Guidance”). The Final Guidance largely represents a continuation of CMS’s IPAY 2026 approach. Perhaps most significantly, CMS also finalized the process for maximum fair price (MFP) effectuation for IPAYs 2026 and 2027, including the role of the new Medicare Transaction Facilitator (MTF). Read more here: https://lnkd.in/eGxrHXG8 #CMS #IRA #IPAY #MTP #MTF Authors: Alice Valder Curran, Ken Choe, Melissa Bianchi, Joy Sturm, Allison Pugsley, Kathleen Peterson, Samantha D. Marshall, Lindsey Thiessen Johnson, Mahmud Brifkani, Katie Kramer, Rianna Modi, and Caroline Farrington.

The emergence of digital health has led to a dramatic increase in the usage of medical health apps and fostering a culture of self-care. Pivotal trends in 2024 that will affect medical device manufacturers are digitalization via the use of software, devices that are enabled by artificial intelligence (AI) and the adoption of telehealth and digital tools for purposes such as remote patient monitoring. This article delves into the future landscape of digital health, associated risks and vulnerabilities, and the evolving legal landscape surrounding smart medical devices. Learn more here: https://lnkd.in/eS39ZPE8 #DigitalHealth #AI #MedicalDevices Author: Karishma Paroha

We’re proud to announce that our UK Life Sciences and Health Care team has retained Tier 1 ranking by Legal 500! A heartfelt thank you to our incredible clients for trusting us with impactful projects. Here’s to many more successful collaborations ahead! ✨ https://lnkd.in/e6RqPqAr #healthcare #Legal500  

U.S. President Biden signed a bill postponing the sunset date of the rare pediatric disease Priority Review Voucher (PRV) program from September 30, 2024, to December 20, 2024. The bill, the “Continuing Appropriations and Extensions Act, 2025” is a temporary measure to continue the rare pediatric disease PRV program. There are currently other ongoing legislative efforts to renew the program through 2028 and later. We have summarized these proposals here: https://lnkd.in/exn-tcha #PediatricHealth #PriorityReviewVoucher #ContinuingAppropriationsandExtensionsAct2025 Authors: Komal Karnik Nigam, Deborah Cho, and Bryan Walsh.

Hogan Lovells is a proud sponsor of Food and Drug Law Institute (FDLI)! Join us on Thursday, October 17, as Komal Karnik Nigam will moderate the session, "Sharpening Vigilance to Leverage AI Efficiently." Then, don’t miss Kristin Zielinski Duggan present at the breakout session on Friday, October 18, titled "Translating PROs and Diverse Clinical Trial Data into Credible Insights." This event brings together representatives from federal agencies, industry, patient-advocacy groups, and academics to discuss critical developments in medical product advertising and promotion. We can’t wait to see you there! 🚀 Register your interest here: https://lnkd.in/dKz7NfpE #AdvertisingandPromotion #FDLI #AI #ClinicalTrials

As AI transforms high-risk sectors like life sciences and health care, companies must stay ahead by conducting thorough risk assessments and navigating the evolving regulatory landscape. Denver-based senior associate Sophie Baum shares her guidance for organizations on managing AI risks, following a landmark settlement between the attorney general of Texas and a company accused of deceptively marketing generative Al software. In this Law.com International article, she stresses the need for transparency and responsible AI deployment in health care settings. Read the full article here: https://lnkd.in/gHDezTJd #AIRegulation #HealthcareAI #RiskManagement #Transparency