On September 25, 2026, the U.S. Food and Drug Administration (FDA) released draft guidance that sets out the agency’s recommendations on nonclinical testing, clinical data, and labeling for premarket submissions involving certain robotically assisted surgical devices (RASDs). The FDA is accepting comments through November 24, 2026. Like all draft guidance, the document is not binding
Information Sharing Between the SEC and the FDA on Regulated Products
On August 31, 2026, the Securities and Exchange Commission (SEC) and the U.S. Food and Drug Administration (FDA) signed a memorandum of understanding (MOU) governing the sharing of nonpublic information relating to FDA-regulated products and activities. The MOU is not limited to enforcement matters and expressly contemplates the SEC’s use of FDA information in carrying
What the FTC’s Health App Policy Withdrawal Actually Changes
The Federal Trade Commission (FTC) has rescinded its 2021 Statement of the Commission on Breaches by Health Apps and Other Connected Devices. In its September 9, 2026, rescission, the Commission offered several reasons for the withdrawal and described each as independently sufficient. It stated that the policy statement was contentious when issued, provided minimal benefit
Senators Warren, Wyden, and Merkley Introduce Federal CPOM Law
On September 16, 2026, Senators Elizabeth Warren (D-MA), Ron Wyden (D-OR), and Jeff Merkley (D-OR)—along with House companion sponsors Representatives Val Hoyle (D-OR), Suhas Subramanyam (D-VA), and Alexandria Ocasio-Cortez (D-NY)—introduced the Stop Corporate Takeovers of Physicians Act of 2026. Modeled after Oregon’s recent corporate practice of medicine (CPOM) law, the bill would, with
Evolving Expectations for AI in Mental Health
Artificial intelligence (AI)-enabled mental health products, including chatbots, digital companions, and coaching tools, are attracting increased attention from regulators, policymakers, and courts. Building on Wilson Sonsini’s previous alert, Legal Framework for AI in Mental Healthcare, this advisory discusses recent regulatory and litigation developments affecting these products, including new state laws on AI disclosure and
FDA Introduces a Potential Review Architecture for Generative AI-Enabled Medical Devices
The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health recently published a discussion paper, Considerations for the Regulation of Generative AI-Enabled Medical Devices: Discussion Paper and Request for Feedback, offering one of the FDA’s most detailed articulations to date of how it may approach regulation of generative AI (GenAI)-enabled medical
CMS Proposes Changes to Incentivize FHIR-Enabled Electronic Prior Authorization Use
The Centers for Medicare & Medicaid Services (CMS) has proposed changes that could reshape how healthcare providers use electronic prior authorization starting in 2027. The alert examines the agency’s proposed calendar year (CY) 2027 Physician Fee Schedule rule, which would modify incentives for such use under the Merit-based Incentive Payment System (MIPS) and the Ambulatory
Health Reimbursement Signals: CMS Proposes Significant Changes to RPM and RTM Requirements
The Centers for Medicare & Medicaid Services (CMS) has proposed significant changes to Medicare reimbursement for remote physiologic monitoring (RPM) and remote therapeutic monitoring (RTM) services under the proposed calendar year (CY) 2027 Medicare Physician Fee Schedule. The changes would limit RPM and RTM to established patients, require a qualifying face-to-face visit before monitoring begins