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.
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.”
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.
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.
EU Commission Publishes AI Continent Action Plan and Seeks Input
On April 9, 2025 the European Commission adopted a communication on the so-called AI Continent Action Plan – its strategy to shape the next phase of AI development in Europe, with consultation to follow. The Commission’s declared objective is to transform the EU into a global leader in AI by fostering innovation, ensuring trustworthy AI, and enhancing competitiveness while safeguarding democratic values and cultural diversity. Keep monitoring Data Matters for more on the Commission’s consultation, when available. (more…)
New UK Consumer Rules Herald Stricter Enforcement and Significant Fines
Consumer protection is rising to the top of the regulatory agenda worldwide. The UK consumer protection regime is undergoing a major shift: The Competition and Markets Authority (CMA) now has powerful new tools under the Digital Markets, Competition, and Consumers Act (DMCCA) (see our Sidley Update here), including the ability to directly enforce consumer law and fine companies up to 10% of global annual turnover for serious infringements. (more…)
Meeting EU Data, Cybersecurity, and Artificial Intelligence Law Obligations: A Checklist for Swiss Life Sciences Companies
For Swiss companies, the next six months are critical for preparing to meet new Digital Data Law obligations. In this briefing, we outline the key timelines, compliance requirements, and practical steps to align with EU requirements. (more…)
New Pathway of Regulating Artificial Intelligence in Switzerland: Competitive Edge or Challenge?
On February 12, 2025, the Swiss Federal Council unveiled its long-awaited approach to artificial intelligence (AI) regulation. Instead of adopting a comprehensive AI Act like the European Union, Switzerland has opted for a sector-specific framework, integrating AI considerations into existing laws rather than creating a standalone regulatory regime. (more…)
U.S. HHS Office of General Counsel Statement of Organization Suggests Potential Consolidation, Expansion of Authority
On March 14, 2025, the U.S. Department of Health and Human Services (HHS) issued a revised Statement of Organization for the Office of the General Counsel (HHS-OGC).1 Changes include a return to an organizational structure more like the early days of the first Trump administration for the lawyers advising the Food and Drug Administration (FDA), as well as the closing of certain regional HHS-OGC offices. Additional changes could potentially signal an effort to consolidate and expand HHS-OGC’s authority, especially with respect to matters currently opined upon by lawyers advising the HHS Office of Inspector General (HHS-OIG). Stakeholders should consider opportunities to engage with HHS in light of the changes announced in the March 2025 Statement of Organization.
Impact of U.S. Outbound Investment Rules on Loan Transactions in China and Practical Considerations
The final rule on the new U.S. outbound investment security program (Outbound Investment Rules), implemented by the U.S. Department of the Treasury (Treasury) and effective on January 2, 2025, represents a significant regulatory framework aimed at prohibiting, or requiring notification to Treasury of, investments directed by, or undertaken by subsidiaries of U.S. persons in Chinese-affiliated companies that design, develop, or manufacture certain sensitive technologies deemed important to U.S. national security. Understanding the implications of the Outbound Investment Rules will be essential for both borrowers and lenders operating within these jurisdictions.
