On Nov. 12, 2025 EU Commissioner Henna Virkkunen said the European Commission will present a digital simplification package on Nov. 19, 2025 proposing AI Act amendments to ease compliance—potentially including a one‐year grace period delaying enforcement of transparency fines until August 2027—after the AI Act entered into force in August 2024 and with high‐risk rules due August 2026; the goal is legal certainty for firms juggling overlapping rules like the DSA/DMA. In the U.S., the FDA’s Digital Health Advisory Committee met Nov. 5–7, 2025 to consider how generative AI therapy tools should be regulated amid state bans/limits (e.g., Illinois, Utah, Nevada) with civil penalties up to $10,000. Separately, ten foundations pledged $500 million over five years via Humanity AI, with grants starting early 2026. Immediate actions to watch: the Nov. 19 EU package and evolving U.S. federal/state rules on AI mental‐health tools.