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
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Latest from Wilson Sonsini Goodrich & Rosati - Page 2
SEC Announces 37% Decrease in Registration Fee Rates Effective October 1, 2026
On August 21, 2026, the U.S. Securities and Exchange Commission (SEC) announced a decrease in the fees that public companies and other issuers will be required to pay to register their securities, from $138.10 per million dollars to $87.00 per…
CalPrivacy Authorizes Rulemaking on Opt-Out Signals, Raises Data Broker Fees, and Starts the Clock on DROP Amendment Comment Period
At its August 6–7, 2026, board meetings, the California Privacy Protection Agency (CalPrivacy) Board directed staff to prepare formal rulemaking to name Global Privacy Control (GPC) in the California Consumer Privacy Act (CCPA) regulations and tighten how opt-out preference signals…
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…
Ninth Circuit Addresses CFAA and Agentic AI Tools in Groundbreaking Decision
On August 4, 2026, the U.S. Court of Appeals for the Ninth Circuit issued a groundbreaking decision in Amazon.com Services, LLC v. Perplexity AI, addressing the legal status of so-called “agentic AI” tools, which help users expedite various online…
EU AI Act Enforcement Phase Begins
On August 2, 2026, the European Commission (EC), acting through its European AI Office (EU AI Office), became formally entitled to exercise its powers to investigate and enforce the EU AI Act obligations imposed on providers of general-purpose artificial intelligence…
Status of California Climate Laws: Deadline for SB 253 Reporting Delayed Until November; SB 261 Remains Stayed
Our recent Client Alert provides an update on the status of California’s climate disclosure laws including the California Air Resources Board’s (CARB’s) plan to defer the SB 253 deadline for reporting Scope 1 and Scope 2 greenhouse gas emissions from…