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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.

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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.

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Women in Privacy – Global Privacy Leadership Lunch

Join us in Brussels for our next Women in Privacy – Global Privacy Leadership Lunch.

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U.S. SEC Regulation S-P and Checklist: Compliance Deadline, December 3, 2025, Approaching for Large Entities

On May 16, 2024, the U.S. Securities and Exchange Commission (SEC or Commission) issued amendments to Regulation S-P: Privacy of Consumer Financial Information and Safeguarding Customer Information, which became effective on August 2, 2024 (the Final Amendments). The deadline for larger entities to comply with the Final Amendments is December 3, 2025, and for smaller entities, June 3, 2026.

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New York Department of Financial Services (NYDFS) Clarifies Expectations for Third-Party Cybersecurity Risks Under its Cybersecurity Regulation, and Additional Amendments Go into Effect on November 1, 2025

On October 21, 2025, NYDFS, the New York State agency responsible for regulating financial services and products, issued an Industry Letter clarifying how “Covered Entities”[1] should manage cybersecurity risks arising from Third‑Party Service Providers (TPSPs) under the NYDFS Cybersecurity Regulation (23 NYCRR Part 500).

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EU Court of Justice Issues Landmark Judgment on Concept of “Personal Data”

On 4 September 2025, the EU Court of Justice (the “CJEU”) issued a landmark ruling in SRB v. EDPS confirming that pseudonymous data is not automatically personal data in all cases (the “SRB Case”). Instead, the key question is whether the controller can realistically re-identify the individual. This judgment is expected to have a significant impact on instances where effective technical and/or organisational measures prevent re-identification by the controller. Importantly, although the ruling arose under EU Regulation 2019/1725 – i.e., the EU data protection law applicable to EU Institutions (such as the Commission) – the CJEU confirmed that the same interpretation applies under the General Data Protection Regulation (the “GDPR”).

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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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Texting in Texas: The State Expands Telemarketing Registration Requirements to Include Text Marketers

Texas has amended its telephone solicitation and telemarketing law (the Texas “mini-TCPA” — after the federal Telephone Consumer Protection Act) to require certain businesses that engage in text marketing to register with the Texas Secretary of State and make detailed disclosures, pay registration fees, and post a $10,000 security deposit. The amendments, which were enacted by Senate Bill 140 and went into effect on September 1, 2025, also make certain violations of the Texas mini-TCPA de facto violations of the state’s deceptive trade practices law, which includes a private right of action and can carry significant penalties. While the law includes several provisions that will likely exempt established businesses that obtain one-to-one opt-in consent for text marketing messages and other types of calls, in light of the substantial fines and private right of action, businesses will want to carefully review the application of these new amendments to their marketing programs.

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