Reed Smith has announced the dates and topics for it’s 11th annual health care conference from March 17-21, 2024. The conference will be conducted entirely virtually this year with CLE webinars offered throughout the week on important and timely topics for the health care industry.
The schedule of the sessions is below, all of the
On 3 February 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) launched a consultation asking for stakeholders’ views on draft guideline in relation to the regulation of individualised mRNA cancer immunotherapies (Draft Guideline).
The aim of the proposed guideline is to establish a clear and streamlined regulatory pathway to authorisation so that
Traduction par Stephanie Faber de l’article The ReAIlity of What an AI System Is – Unpacking the Commission’s New Guidelines écrit par par Charles Helleputte, Andrea Otaola & Claire Murphy
La Commission européenne a récemment publié ses lignes directrices sur la définition d’un système d’intelligence artificielle (qui à la date de l’article ne sont
On February 13, 2025, a federal court issued a highly anticipated ruling in Estate of Gene B. Lokken v. UnitedHealth Group (CASE 0:23-cv-03514-JRT-SGE)—denying UnitedHealthcare’s attempt to dismiss certain state law claims and allowing breach of contract and good faith claims to move forward. It’s a major development in a case I first discussed
Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during January and early February 2025 from the United States, United Kingdom, and European Union.
In this issue, we discuss some useful international guidance documents from the International
Johnstone and National Disability Insurance Agency (NDIS) [2025] ARTA 106 (Link to AUSTLII).
Serious injury compensation claims have for some years included provision for technology supports. This NDIS decision is novel in that the participant sought a paid subscription to “Chat GPT” at a cost of $300 per month. In support of the claim,
The United States Court of Appeals for the First Circuit issued a pivotal ruling earlier this week, finding that in order to establish falsity in a False Claims Act (“FCA”) case premised on Anti-Kickback Statute (“AKS”) liability, the kickback must have been the “but-for” cause of the submission of the claim. The court’s decision hinged
Introduction
On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and biological products. The draft guidance – the first of its kind from the agency – aims to enhance the efficacy and accuracy of the drug approval process, ensuring that applications incorporating AI meet rigorous
The California Attorney General’s Office (AG) unsurprisingly takes an expansive view of how the development, sale, and use of artificial intelligence technology (AI) in healthcare could lead to potential violations of existing California laws. In a recent legal advisory the AG highlights specific areas healthcare organizations should focus on as they develop, train, improve, and
The recent U.S. election has had profound implications for the healthcare industry, prompting industry leaders to reexamine their strategies and day-to-day operations. At the Miami Herbert Business School’s annual “The Business of Health Care” conference on January 24, 2025, a pivotal forum brought together stakeholders across key sectors—home care, hospital systems, payors, and others—to assess