In this issue, you will find the following:
U.S. News
- Health Care Fraud and Abuse Updates
- Corporate Transactions Updates
- FDA Updates
- Privacy and AI Updates
- Policy Updates
U.S. Featured Content
The Make America Healthy Again Commission released its "Make Our Children Healthy Again" report on September 9, 2025, outlining over 120 initiatives aimed at addressing childhood chronic diseases. The report highlights four key contributors to the epidemic — poor diet, environmental chemicals, lack of physical activity and chronic stress, and overmedicalization — and estimates that over 40% of U.S. children have at least one chronic condition. It also recommends increased oversight of direct-to-consumer drug marketing and encourages the U.S. Department of Health and Human Services to adopt artificial intelligence platforms for future health initiatives, including improving childhood cancer outcomes.
EU and UK News
EU/UK Featured Content
It has been relatively quiet in August. However, the European Commission and industry bodies continue to gather evidence and call for change to help streamline the overlapping regulatory framework that applies to digital health products. The European Commission has published a Call for Evidence on revision of the EU rules for medical devices and in vitro diagnostics, and MedTech Europe has set out its vision for a digital policy framework that supports innovation while remaining aligned with existing sectoral legislation. It is clear that authorities and industry alike are seeking ways to streamline and simplify the legislative framework. However, as yet, there are no concrete proposals for reforms.
U.S. News
Health Care Fraud and Abuse Updates
Alabama Doctor Pleads Guilty to $6 Million Telemedicine Fraud Scheme. On August 18, 2025, Tommie Robinson, an Alabama doctor, was charged and pleaded guilty for his role in a $6 million telemedicine fraud scheme. According to the charging documents, Robinson allegedly worked with telemedicine companies to sign orders for medically unnecessary durable medical equipment (DME) and genetic testing. Robinson allegedly signed pre-populated orders for Medicare beneficiaries with whom he had no prior contact or medical relationship. As a result of these orders, DME suppliers and laboratories submitted over $6 million in false claims to Medicare.
Corporate Transactions Updates
Wellth Secures $36 Million To Boost Care Plan Adherence. On August 21, 2025, Wellth, a digital health company based in Los Angeles, California that leverages behavioral economics to help individuals adhere to care plans, closed its $36 million Series C funding round. Wellth's platform, accessible via mobile application and powered by generative artificial intelligence (GAI), encourages patients to take actions that drive measurable health outcomes, medication adherence, and monitoring blood pressure and glucose levels. The round was led by Mercato Partners, with participation from FCA Venture Partners, Comcast Ventures, and existing investors, including SignalFire and NY Life.
Wellth has logged over 50 million daily check-ins, tracking an average 90% care plan adherence, a 51% reduction in inpatient admissions, and a 16% improvement in medication adherence. The funds will be used to expand access to Wellth's platform for high-need populations, including Medicare Advantage and Medicaid users.
Twin Health Secures $53 Million To Scale Digital Twin Technology. On August 21, 2025, Twin Health, a digital health company based in Mountain View, California that builds a "Digital Twin," or real-time model, of an individual's metabolism to help its members lower A1C, lose weight, and reduce reliance on medications, raised $53 million in its Series E funding round. The Series E funding round was led by Maj Invest of Denmark, with participation from existing investors, including ICONIQ and Temasek.
Twin Health's Whole Body Digital Twin" platform creates a model of each member using data from wearable devices and lab results. In a recent study, the Whole Body Digital Twin helped 71% of participants lower their A1C. The new funding round, which brings Twin Health's valuation to approximately $950 million, will be used to expand partnerships with health plans and Fortune 500 employers.
FDA Updates
The U.S. Food and Drug Administration (FDA) recently announced that its Digital Health Advisory Committee will convene a public virtual meeting on November 6, 2025 to discuss the regulation of mental health devices powered by GAI. The meeting will focus on evaluating the potential benefits, health risks, and mitigation strategies associated with these emerging technologies, including both premarket evidence and post-market regulatory considerations. To inform the discussion, the FDA has established a public docket for comments, which will remain open until December 8, 2025. Comments submitted by October 17, 2025 will be shared directly with the Digital Health Advisory Committee, while those submitted afterwards will remain under consideration by the agency. This meeting comes amid growing bipartisan scrutiny and ongoing investigations by the U.S. Federal Trade Commission (FTC) following reports of AI-powered chatbots providing harmful suggestions to vulnerable users.
Privacy and AI Updates
HHS Proposes Survey of Digital Health Companies. In a notice published in the Federal Register on August 25, 2025, the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT (ASTP/ONC) announced a proposed survey of digital health companies to assess ASTP/ONC's implementation of information blocking and application programming interfaces (APIs) "without special effort" policies under the 21st Century Cures Act (Cures Act). As stated in the notice, one of the goals behind the Cures Act was to foster patient access to electronic health information through standardized APIs. In 2022, ASTP/ONC and the University of California, San Francisco conducted a survey of digital health companies to assess their implementation of and experiences with health care APIs, and "ASTP/ONC finds it essential to continue efforts to survey digital health companies to assess ASTP/ONC's implementation of [the Cures Act mandates]." ASTP/ONC believes information gathered from the proposed survey will provide ASTP/ONC with a more educated basis for promoting an ecosystem of innovation and transparency in health care. ASTP/ONC is accepting comments on the proposed survey until September 25, 2025.
HHS Announces Crackdown on Blocking Health Data Access. On September 3, 2025, HHS announced increased resources dedicated to preventing health care entities from blocking patients' access to electronic health information. In the announcement, the agency said that the crackdown will promote health IT innovation and improve the health ecosystem by giving patients full access to their health information to monitor their conditions, find errors in their health records, adhere to treatment plans, and track their progress in wellness and disease prevention programs. The announcement quotes HHS Deputy Secretary Jim O'Neill as stating: "Unblocking the flow of health information is critical to unleashing health IT innovation and transforming our healthcare ecosystem." It warns developers of certified health IT, health information networks, and health information exchanges that violations of the prohibitions on information blocking could result in civil monetary penalties of up to $1 million per violation.
Policy Updates
FTC Launches Investigation Into AI Chatbots. On September 11, 2025, the FTC voted 3-0 to launch an investigation into seven large technology companies regarding each of their GAI product lines, especially as it relates to GAI chatbots that act as "companions" to users. FTC plans to evaluate if each company is in compliance with the agency's Children's Online Privacy Protection Act regulations and better understand GAI's impact on children's mental health, evaluate GAI chatbots' safety protocols, and alert parents of potential risks associated with such products. In response, House Energy & Commerce Committee Chair Brett Guthrie (R-KY) and Ranking Member Frank Pallone (D-NJ) released a joint statement in support of FTC's decision, arguing that "additional investigation is needed to ensure children and teens are not in danger when using these [AI chatbot] services" and stating that Congress plans to develop bipartisan legislation on this issue.
MAHA Commission Publishes "Make Our Children Healthy Again" Report. On September 9, 2025, the Make America Healthy Again (MAHA) Commission published the "Make Our Children Healthy Again" report with over 120 initiatives intended to "realign incentives, increase public awareness, and strengthen private-sector collaboration" to combat childhood chronic diseases. The report estimated that over 40% of children in the U.S. have at least one chronic condition and outlines four major factors contributing to the U.S. chronic disease epidemic: (1) poor diet; (2) aggregation of environmental chemicals; (3) lack of physical activity and chronic stress; and (4) overmedicalization. In addition to additional oversight on direct-to-consumer marketing for prescription drugs, the report directs the HHS to prioritize the uptake of AI platforms for several future initiatives, including improvements to childhood cancer rates.
Congressman Bera Pushes for House AI Select Subcommittee. On September 9, 2025, Rep. Ami Bera (D-CA) attended a Washington Post event titled, "How AI could transform the future of medicine." Rep. Bera said that he is working closely with Rep. Ro Khanna (D-CA) and House Minority Leader Hakeem Jeffries (D-NY) to urge House Republican leadership to create an AI Select Subcommittee. Some lawmakers expressed concerns that an AI Select Subcommittee may unfairly diminish the power of other Congressional committees with jurisdiction over AI issues.
House Energy and Commerce Committee Holds Hearing on Examining AI in U.S. Health Care. On September 3, 2025, the House Energy & Commerce Health Subcommittee held a hearing titled, "Examining Opportunities to Advance American Health Care Through the Use of Artificial Intelligence Technologies." During the hearing, lawmakers broadly supported the responsible integration of AI in health care to enhance clinician decision-making, improve patient outcomes, and reduce administrative burdens. However, members shared bipartisan concern about ethical risks, data privacy, mental health impacts, and the need to modernize regulatory frameworks to ensure safe and effective implementation of AI in the health care system.
NIH Director Orders Review of Research Activities. Dr. Jay Bhattacharya, Director of the National Institutes of Health (NIH), reportedly ordered a review of all NIH research activities to determine whether projects align with agency priorities. In a statement released on August 15, 2025, Director Bhattacharya outlined a new "unified strategy" for NIH, including agency priorities such as establishing a real-world data platform and use of AI. The strategy incorporates directives of President Trump's Executive Order on "Restoring Gold Standard Science," as well as elements of the MAHA Commission's initial report. Earlier, on August 5, 2025, the NIH published guidance regarding the use of AI in research applications, which outlined that beginning in September 2025, NIH will limit the number of applications the agency will consider per principal investigator per year.
House L-HHS AI Appropriations Provisions. On September 9, 2025, the House Appropriations Committee voted to advance its Fiscal Year 2026 Labor, Health and Human Services, Education, and Related Agencies (L-HHS) appropriations bill by a vote of 35-28. The accompanying report includes several provisions related to AI, including:
- Autonomous Artificial Intelligence and Diabetic Retinopathy. The committee encourages the Health Resources and Services Administration to establish, expand, or maintain efforts at Federally Qualified Health Centers (FQHC) to use "FDA-cleared" AI technology to aid in the diagnosis of diabetic retinopathy and to increase educational efforts on successful patient referral pathways from FQHCs to specialty care.
- Artificial Intelligence Innovation. The committee recognizes the Bipartisan Artificial Intelligence Task Force's creation of its 2024 report and highlights the report's stated benefits of using AI in medical research, including at the NIH.
- Artificial Intelligence in Prior Authorization. The committee acknowledges that AI is being used in the prior authorization process for federal health programs, including Medicare, Medicaid, Tricare, and the Federal Employees Health Benefits Program, and directs the GAO to provide a briefing with a report on how AI is being used in this process.
EU and UK News
Regulatory Updates
Call for Evidence on Revision of EU Rules on Medical Devices and In Vitro Diagnostics. On September 8, 2025, the European Commission (EC) published a call for evidence on "the targeted revision of the EU rules for medical devices and in vitro diagnostics." This is part of the EC's ongoing "targeted evaluation" of the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR), with the aim of identifying methods to tackle critical issues experienced throughout the industry as a result of the regulations. The current call for evidence follows a number of previous consultations, and is aimed at gathering input from stakeholders to address the problems identified during the consultations in a "targeted way." Feedback will be taken into account as the EC "further develops and fine-tunes this initiative." Read our September 2025 Blog post for more details.
EU AI Act Obligations for General-Purpose AI (GPAI) Providers Now Apply. Since August 2, 2025, the obligations under the EU AI Act apply to providers of GPAI models placed on the EU market (i.e., original developers and those who substantially modify or adapt a GPAI model), whether or not they are established in the EU. The obligations for GPAI providers include (1) maintaining technical documentation on the model's training, testing, and evaluation; (2) providing sufficient information for downstream providers on model capabilities, limitations, and integration requirements; (3) implementing policies to ensure compliance with EU copyright laws; and (4) publishing a summary of data used to train the GPAI model. Additional requirements apply to GPAI models posing systemic risk, while exemptions apply to open-source GPAI and AI systems used only in research and development phases. See our August 2025 Advisory on the obligations.
In addition, to assist GPAI providers, the European Commission has issued guidelines clarifying key definitions, a voluntary Code of Practice (see our August 2025 Blog post on the guidelines and code), and a template for the summary of training data. The EC will begin enforcing these obligations on August 2, 2026.
Commission Publishes Study on Deployment of AI in EU Health Care Systems. The EC has published a study examining barriers to AI deployment in EU health care systems. The report identifies various challenges faced by health care systems, including rising demand due to an aging population, increasing prevalence of chronic and complex conditions, rising costs, and shortages in the health care workforce. The report recommends leveraging the large amount of health data available and using innovative AI solutions to improve the overall efficiency, quality, and access to health care, alongside technical, organizational, and social barriers.
MedTech Europe Makes Proposal To Ensure Coherent Implementation of EU Digital Legislation. MedTech Europe has outlined its vision for a digital policy framework that supports innovation while remaining aligned with existing sectoral legislation, such as the IVDR, the MDR, and the European Health Data Space Regulation. MedTech Europe states that a mind-shift toward regulation simplification is urgently needed.
Privacy Updates
UK Information Commissioner's Office (ICO) Launches Consultations To Assist Interpretation of the Data (Use and Access) Act (DUAA) 2025. Following the entry into force of the majority of the provisions in the UK DUAA last month, the ICO has initiated public consultations that will inform its final draft guidance on the act's interpretation. Such guidance is intended to assist organizations in applying the amendments to the act, which include "recognized legitimate interest" as a new lawful basis for using personal information, and a novel obligation for all companies to have a procedure for handling "data protection complaints" by June 2026. The consultation closes on October 30, 2025. You can read more about the DUAA in ourJuly 2025 Advisory.
*The following individuals contributed to this Newsletter:
Eugenia Pierson is employed as a senior health policy advisor at Arnold & Porter's Washington, D.C. office. Eugenia is not admitted to the practice of law.
Sonja Nesbit is employed as a senior policy advisor at Arnold & Porter's Washington, D.C. office. Sonja is not admitted to the practice of law.
Mickayla Stogsdill is employed as a senior policy specialist at Arnold & Porter's Washington, D.C. office. Mickayla is not admitted to the practice of law.
Caroline Oliver is employed as a policy specialist at Arnold & Porter's Washington, D.C. office. Caroline is not admitted to the practice of law.
Eleanor Brittain is employed as a trainee solicitor at Arnold & Porter's London office. Eleanor is not admitted to the practice of law.
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