Introduction
AI regulatory landscape changes dramatically. Staying compliant with ever-evolving changes in AI industry is crucial. At Pacific AI, we continuously track regulatory changes and update our policies at least on a quarterly basis. We ensure that our services align with the latest requirements, keeping you fully compliant with current and upcoming legislation.
Here is a summary of new rules and regulations that came about in Q1 2025.
In the USA
At the federal level the President Trump signed the Removing Barriers to American Leadership in Artificial Intelligence executive order. The order mandates the development of a new AI action plan within 180 days. Among the previous administration directives revoked is the Executive Order of October 30, 2023 (Safe, Secure, and Trustworthy Development and Use of AI) introduced by the President Biden.
Within the same period, the FDA issued the following guidelines:
Considerations for the Use of AI to Support Regulatory Decision-Making for Drug and Biological Products: The FDA released this draft guidance in January 2025 and has opened the draft for comments for 90 days. It details about what should be documented when implementing an AI risk management process for AI models used to produce information or data intended to support regulatory decision regarding safety, effectiveness, or quality for drugs. Specifically, this guidance provides a risk-based credibility assessment framework that may be used for establishing and evaluating the credibility of an AI model for a particular context of use (COU).
Comprehensive Draft Guidance for Developers of AI-Enabled Medical Devices was released by the FDA and includes recommendations to support development and marketing of safe and effective AI-enabled devices throughout the device’s Total Product Life Cycle. The guidance, if finalized, would be the first guidance to provide comprehensive recommendations for AI-enabled devices throughout the total product lifecycle, providing developers an accessible set of considerations that tie together design, development, maintenance and documentation recommendations to help ensure safety and effectiveness of AI-enabled devices. This guidance complements the recently issued final guidance on predetermined change control plans for AI-enabled devices, which provides recommendations on how to proactively plan for device updates once the product is on the market.
At state level
California SB-1120 Health care coverage: utilization review went into effect on January 1st, 2025 and prohibits using AI as the sole basis for denying health insurance claims. It means that “AI” (generally, algorithms, including automated rules) can be used in such systems, but if the system recommends denying a claim, it needs to go to a human expert reviewer first before a denial is sent to the patient/clinician.
California AB-2013 – Generative Artificial Intelligence: Training Data Transparency requires developers of GenAI systems that are available to Californians and released on or after January 1, 2022 to publicly disclose detailed information about the datasets used in their development on their website.
Effective as of the previous year, the Utah AI Policy Act establishes liability for using generative AI that violates consumer protection laws if not properly disclosed.
The Illinois HB-3773: Limit Predictive Analytics Use (effective January 1, 2026) prohibits the use of AI that results in illegal discrimination within employment recruitment, hiring, promotion, selection for training, or discipline decisions. It also requires notification to employees when using AI during employment decisions. Additional regulations on this amendment are to be issued.
The Minnesota HF 4757: Minnesota Consumer Data Privacy Act (Effective July 31, 2025) provides that individuals may opt out of automated decision-making, question the profiling and the outcome of an automated profiling decision, and to be informed of actions they can take to secure a different decision in the future and the right to review the data used in the profiling.
Pacific AI monitors other states, including California, Connecticut, Hawaii, Georgia, Maryland, New York, Nevada, Texas, and Virginia, where new changes are to be soon released.
In the EU
Under the Article 4 of the EU AI Act, AI literacy becomes a compliance requirement when working with AI powered medical devices. It prohibits practices and obligations for General-Purpose AI (GPAI) models.
In the UK
The UK introduced the AI Opportunities Action Plan on January 13, 2025 confirming its commitment to shaping the future of AI and including enabling safe and trusted AI development adoption through regulation, safety, and assurance.
Adopting the New AI Policy Suite
At Pacific AI, we have meticulously analyzed the recent legislative, regulatory, and standard developments detailed above and have proactively updated our AI policy suite to reflect these changes. By adopting our comprehensive suite of policies, your organization can ensure compliance with the latest regulations and legislation, including those highlighted in this post.
To delve deeper into these updates and understand their implications, we invite you to join our upcoming webinar AI Governance Simplified: Unifying 70+ laws, regulations, and standards Into a Policy Suite on March 19, 2022 at 2:00 PM ET, where David Talby, CEO at Pacific AI and John Snow Labs, and Maria Baranchikova, AI Governance Lead at Pacific AI will provide in-depth insights and answer your questions.
