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Wilson Sonsini’s Healthcare and FDA Regulatory practice launched this blog because innovation in healthcare and life sciences doesn’t wait for regulatory certainty. New technologies, new uses of data, and new business models often emerge before existing legal frameworks provide clear answers. The result is a steady stream of new questions…
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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The Federal Trade Commission (FTC) has rescinded its 2021 Statement of the Commission on Breaches by Health Apps and Other Connected Devices.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…
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…
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…
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…
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…
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 optometry practice on healthcare fraud…