When HHS Secretary Robert F. Kennedy, Jr. announced on September 3, 2025, that the Department would launch an aggressive crackdown on information blocking, it signaled a turning point in federal health IT policy. For years, patients, innovators, and providers alike have complained that electronic health information (EHI) was locked behind unnecessary barriers, whether technical,
Crypto Unlocked: New Patent Eligibility Guidance on Blockchain Technology
The U.S. gave crypto one of its biggest regulatory jolts in years. With the signing of the Guiding and Establishing National Innovation for U.S. Stablecoins (“GENIUS”) Act stablecoins now have a legal framework. The GENIUS Act is part of a broader push to accelerate the development of emerging technologies in the U.S., from artificial intelligence
Virtual and Digital Health Digest – August 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 July and early August 2025 from the the United Kingdom, and European Union.
The UK government has published a number of initiatives and responses to consultations this month
So You Want to Start a Concierge Medicine Practice? Here are Five Key Legal Considerations
With increased consolidation of traditional medical practices and declining reimbursement rates, many physicians are turning to alternative models like concierge medicine to preserve their independence. Concierge medicine allows physicians to offer personalized, high-quality care to patients in exchange for a membership fee. This model is governed by private service agreements that outline the relationship between
CMS Announces Health Tech Ecosystem Initiative
The Centers for Medicare & Medicaid Services (“CMS”) has announced a Health Tech Ecosystem initiative, developed in response to a May 2025 request for information (“RFI”) to solicit suggestions from stakeholders on ways to modernize the nation’s digital health ecosystem.
The initiative focuses on two main areas: (1) promoting a CMS Interoperability Framework to easily
Flo Health Data-Sharing Case Ends in Major Jury Verdict Against Meta
Meta Inc., the parent company of Facebook, Instagram and WhatsApp, has been found liable by a California federal jury for improperly using sensitive reproductive health data to run targeted ads, in a case involving the popular Flo Health period-tracking app. Eight women brought the lawsuit on behalf of a class of up to 38 million
Proposed Medicare Payment Policies for Hospital Outpatient and Ambulatory Surgery Center Services
The Centers for Medicare & Medicaid Services recently published the calendar year (“CY”) 2026 proposed rule for Medicare payment for services provided in hospital outpatient departments under the Outpatient Prospective Payment System (“OPPS”) and services provided in ambulatory surgery centers (“ASCs”) (“the Proposed Rule”). Comments are due by September 15, 2025.
Insurer Use of AI in Medicine and Health Care Draws Expansive Scrutiny
An article published in the August 2025 issue of New Jersey Lawyer, a New Jersey State Bar Association publication, notes:
“The concept of artificial intelligence has permeated almost all aspects of society. AI is being implemented more and more each day by major technology companies to try to improve daily living and optimize the delivery
Medicare Provider Audits: When to Hire a Lawyer and the Challenge of Multiple Alleged Overpayments
Examining the threshold for legal intervention and lessons from the courts
In recent years, Medicare providers across the United States have faced a rising number of audit notices alleging overpayments—sometimes for relatively modest sums such as $25,000, $30,000, or even less. This trend presents a dilemma for providers: the cost of legal representation often exceeds
Commission guidelines for providers of general-purpose AI models
On July 18, 2025, the European Commission released its guidelines on the obligations for providers of general-purpose AI (GPAI) models under the European Union’s AI Act. This is an important development for companies, including in the Life Sciences sector, building their own GPAI models, as well as using, integrating and/or further developing third-party GPAI as