U.S. FDA and CMS Actions on Generative AI-Enabled Mental Health Devices Yield Insights Across AI Product Development
Industry is increasingly exploring the use of AI chatbots to potentially diagnose and treat various medical conditions, including in the area of mental health. FDA is just beginning to develop its regulatory framework for approved, cleared, or authorized devices in the mental health space based on generative AI technology. The medtech industry, healthcare providers, and the public are closely watching FDA developments and guidance regarding the use of generative AI across the medical device space.
The UK’s First Copyright vs. AI Decision: Key Takeaways on a Win for the AI Industry
The UK’s first “Copyright vs. AI” decision (Getty Images (US) Inc & ors vs. Stability AI Limited [2025] EWHC 2863 (Ch)) marks a clear win for the artificial intelligence industry. The English High Court raised the rhetorical question on the industry’s lips, “whether this judgment will, in reality, have anything to say on the balance to be struck between the two warring factions…”. The Judge’s answer is clear: the case does not answer whether training and development of AI models in the UK is an indefensible infringement of copyright. As to deployment of that trained model, the High Court concluded that an AI model itself cannot constitute an infringing copy. On Stability AI’s reproduction of the Getty trademarks, the High Court found that there was a historic and limited infringement.
Women in Privacy – Global Privacy Leadership Lunch
Join us in Brussels for our next Women in Privacy – Global Privacy Leadership Lunch.
Regulatory Update: National Association of Insurance Commissioners Summer 2025 National Meeting
The National Association of Insurance Commissioners (NAIC) held its Summer 2025 National Meeting (Summer Meeting) August 10–13, 2025. This blog summarizes the highlights from this meeting in addition to interim meetings held in lieu of taking place during the Summer Meeting. Highlights include adoption of guidance on asset adequacy testing for reinsurance transactions, renewed focus on the risks of offshore reinsurance transactions, evaluation of insurers’ use of funding-agreement-backed note (FABN) and funding-agreement-backed securities (FABS) programs, and consideration of additional regulatory frameworks to address insurers’ use of artificial intelligence (AI).
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A Mid-Year Privacy Check-In – Important Developments and New Compliance Obligations for Privacy Laws
During the first half of 2025, state legislators and regulators have been working overtime to enact new data privacy laws and expand existing laws, all of which are likely to have an impact on businesses in the remainder of the year and into 2026. These efforts reflect key themes such as increased regulation of teen data and social media platforms, enhanced restrictions on the collection and sale of geolocation and biometric data, simplified opt-out mechanisms for tracking technologies, and broader obligations concerning consumer health data and data minimization. In parallel, significant regulatory activity surrounding AI has emerged, including a new federal AI Action Plan and proposed amendments to the CCPA addressing automated decision-making technologies, alongside a wave of new state AI laws.
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.
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…)
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.
