On September 25, 2026, the U.S. Food and Drug Administration (FDA) released draft guidance that sets out the agency’s recommendations on nonclinical testing, clinical data, and labeling for premarket submissions involving certain robotically assisted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
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Information Sharing Between the SEC and the FDA on Regulated Products
By Ty Kayam, Eva Yin & Nawa Lodin
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…
What the FTC’s Health App Policy Withdrawal Actually Changes
By Ty Kayam, Jodi Daniel & Brandon Ge
The Federal Trade Commission (FTC) has rescinded its 2021 Statement of the Commission on Breaches by Health Apps and Other Connected Devices.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…
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.…
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…
FDA Introduces a Potential Review Architecture for Generative AI-Enabled Medical Devices
By Ty Kayam & Jodi Daniel
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…
CMS Proposes Changes to Incentivize FHIR-Enabled Electronic Prior Authorization Use
By Jodi Daniel & Ty Kayam
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…
DOJ Issues First Healthcare Declination Under Revised Corporate Enforcement Policy: Key Takeaways for Healthcare Companies and MSOs
The Department of Justice (DOJ) has issued its first healthcare-related corporate declination under its revised Corporate Enforcement and Voluntary Self-Disclosure Policy, declining to prosecute a management services organization (MSO) while simultaneously indicting the former CEO and founder of the underlying…
New Oregon HCMO Rules Bring Higher Fees, New Penalties, and Deal Timing Requirements
Oregon’s Health Care Market Oversight (HCMO) program regulations underwent significant amendments that took effect on July 1, 2026, expanding which entities may qualify as “out-of-state” for HCMO purposes, narrowing the internal reorganization exclusion, and substantially increasing review fees. Preliminary review…
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…