Categories

Archives

The Trump Administration’s 2025 AI Action Plan – Winning the Race: America’s AI Action Plan – and Related Executive Orders

On July 23, 2025, the Trump administration released its much-anticipated AI Action Plan, outlining 90 federal policy positions across three key pillars: Accelerating Innovation, Building American AI Infrastructure, and Leading in International Diplomacy and Security. These pillars are designed to guide near-term action and are underpinned by three cross-cutting priorities: protecting and promoting American workers, ensuring that artificial intelligence (AI) systems are trustworthy and free from ideological bias, and safeguarding AI from misuse, theft, or other risks posed by malicious actors. The scope of the AI Action Plan demonstrates the far-reaching impact of AI, with policy positions affecting not only technology but also trade, national security, cybersecurity, energy, labor, education, environmental regulation, antitrust, science, and financial markets.

(more…)

California Privacy Protection Agency Advances Substantial Rulemaking – Cyber Audits, Risk Assessments, New Automated Decisionmaking Technologies Rights, and More

The California Privacy Protection Agency (Agency) on Thursday, July 24, 2025, approved a comprehensive set of new California Consumer Privacy Act (CCPA) regulations that the Agency has been developing for over four years. Before taking effect, the proposed regulations must still be approved by California’s Office of Administrative Law (OAL). It is possible some of these provisions may change with the OAL’s review, which must be completed within 30 business days after the Agency submits to the OAL its final rulemaking package. However, many expect that most of the proposed regulations will pass OAL review. If approved, several of the proposed regulations would be effective as of January 1, 2026. (more…)

FDA Release of Complete Response Letters Raises Confidentiality, Disclosure Questions But Offers Insights for Development

On July 10, 2025 — in a move it characterized as “radical transparency” — the U.S. Food and Drug Administration (FDA or Agency) published over 200 Complete Response Letters (CRLs), which are issued when the Agency determines that it will not approve a New Drug Application (NDA) or Biologics License Application (BLA). We analyze the implications of this development for life sciences companies and their investors.

(more…)

Texas Age Verification Law Upheld: U.S. Supreme Court Balances Free Speech and Child Protection in the Digital Age

On June 27, 2025, the U.S. Supreme Court issued its opinion in Free Speech Coalition, Inc. v. Paxton, a groundbreaking decision with significant implications for online content regulation. The Court upheld a Texas statute — House Bill 1181 (HB 1181) — requiring commercial websites that host a substantial amount of sexually explicit material to verify users’ ages before granting access. In doing so, the Court applied intermediate scrutiny and upheld the statute as a constitutionally permissible measure to protect minors from harmful content.

(more…)

Artificial Intelligence in Pharmacovigilance: Eight Action Items for Life Sciences Companies

The Council for International Organizations of Medical Sciences Working Group XIV (CIOMS) Draft Report offers comprehensive principles and best practices, translating global artificial intelligence (AI) requirements — such as those in the EU Artificial Intelligence Act (EU AI Act) — into practical guidance for pharmacovigilance (PV). In the U.S., where no overarching AI legislation exists, the report can guide lawmakers, regulators, and other stakeholders as they develop approaches to using AI in PV. The consultation period for the draft report is currently open, and interested parties are encouraged to take advantage of this opportunity by providing comments on the draft report by June 6, 2025.

(more…)

Generative AI Meets Copyright Scrutiny: Highlights from the Copyright Office’s Part III Report

On May 9, 2025, the U.S. Copyright Office released a “pre-publication” version of Part III of its highly anticipated Report on Copyright and Artificial Intelligence (AI) (Report). The Report provides a technical overview of how generative AI models are developed, trained, and deployed and how U.S. copyright law, particularly the fair use doctrine, should apply in the context of training generative AI models. The prepublication report states that it was released “in response to congressional inquiries and expressions of interest from stakeholders” and that “[a] final version will be published in the near future, without any substantive changes expected in the analysis or conclusions.”

(more…)

Medicare Reimbursement Pathway for AI-Enabled Medical Devices Considered in Senate’s Health Tech Investment Act

On April 9, 2025, U.S. Sens. Mike Rounds, Republican of South Dakota, and Martin Heinrich, Democrat of New Mexico, introduced a bill titled the Health Tech Investment Act (S 1399). The proposed bill would amend Title XVIII of the Social Security Act to create a Medicare payment system for algorithm-based healthcare services (AHBS), defined in the proposed legislation as services delivered through FDA-cleared or -approved devices that use artificial intelligence (AI), machine learning, or similar software to yield clinical outcomes for use by healthcare professionals to diagnose and treat diseases.

(more…)

Regulatory Update: National Association of Insurance Commissioners Spring 2025 National Meeting

The National Association of Insurance Commissioners (NAIC) held its Spring 2025 National Meeting (Spring Meeting) March 23–26, 2026. This Sidley Update summarizes the highlights from this meeting in addition to interim meetings held in lieu of taking place during the Spring Meeting. Highlights include continued development of guidance on asset adequacy testing for reinsurance transactions, efforts to develop revisions to the Long-Term Care Insurance Multistate Rate Review Framework, and consideration of amendments to the NAIC’s Purposes and Procedures Manual regarding private letter rating rationale reports.

(more…)

Upcoming Events

Resources

 

SUBSCRIBE

To receive email alerts when we post a blog entry, please provide your name and email address.