ONC is ending 2025 with a tight set of four (4) new Information Blocking FAQs issued on December 19, 2025 that squarely target how Actors (i.e., HIE/HINs, Developers of Certified Health IT and Health Care Providers) behave in the real world: automation, contract leverage, and the Manner and Fees exceptions. These December FAQs do not
From complexity to clarity: How the EU Commission plans to overhaul the MDR and IVDR
Introduction
The European Commission has published its proposals on the amendment of the Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostic Regulation 2017/746 (IVDR) (“the proposals”). This marks a pivotal moment for the EU healthcare and MedTech landscape, following a public consultation by the Commission in early 2025 (see our blog here) and
California SB 243: Setting New Standards for Regulating and Ensuring Integrity of AI Companion Chatbots
The rapid advancement of artificial intelligence (“AI”) has spurred remarkable innovation for the healthcare industry, while also resulting in swiftly emerging regulatory frameworks. On October 13, 2025, Governor Gavin Newsom signed into law California Senate Bill 243 (“SB 243”) – the first law in the nation to address the “human interface” of AI chatbots, especially
Battle of the Arbitration Seats: Contrasting the 2025 English Arbitration Act Reform with France’s Reform Proposal
The so-called “battle of seats” in international arbitration isn’t new, spanning over half a century. Various global capitals have developed favorable legal ecosystems—either through enacting legislation ensuring legal certainty or issuing court decisions viewed as favorable towards arbitration. This competition has helped to position arbitration as the preferred mechanism for resolving cross-border disputes.[1] The
Updated NHS IP Guidance: Unlocking Healthcare Innovation
The UK government has published its first major update to the NHS Intellectual Property (IP) guidance in over two decades. Developed by the Department of Health and Social Care (DHSC) and NHS England with support from the National Institute for Health and Care Research (NIHR), the framework aims to remove long-standing barriers to innovation and
New WISeR Model Aims to Leverage AI Technology to Reduce Costs and Inefficiencies
The Centers for Medicare and Medicaid Services (“CMS”) recently announced the first six participating states in the Wasteful and Inappropriate Service Reduction (“WISeR”) Model that will begin on January 1, 2026: Arizona, New Jersey, Ohio, Oklahoma, Texas, and Washington.[1] As its hallmark objective, the Model aims to refine prior authorization processes for traditional fee-for-service
Virtual and Digital Health Digest – November 2025
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 October and early November 2025 from the the United Kingdom, and European Union.
AI-Powered Matching: How Technology Is Solving the NP-Physician Collaboration Crisis
AI-powered healthcare matching platforms are transforming how Nurse Practitioners (NPs) and physicians collaborate by using intelligent algorithms to pair providers based on specialty, location, workload, and patient demand. These technologies reduce physician shortages, improve care continuity, and streamline staffing operations across hospitals, clinics, and telehealth networks.
Introduction
Healthcare systems across the globe are facing a
Illinois Becomes the First State to Regulate the Use of AI Mental Health Therapy Services
In early August, Illinois enacted the Wellness and Oversight for Psychological Resources Act (HB 1806, or the “Act”), making it the first state to pass a law regulating the use of AI[1] in the delivery of therapy and psychotherapy services. The Act, which took immediate effect, imposes guardrails on the use of AI to
Genesis Mission and New Guidance for AI-Assisted Inventions
The Federal government is accelerating AI‑enabled innovation by launching the Genesis Mission, a sweeping national initiative to accelerate scientific discovery using artificial intelligence. The goal of the Mission is to “build an integrated AI platform to harness Federal scientific datasets…to train scientific foundation models and create AI agents to test new hypotheses, automate research