2025 AI Compliance Trends to Watch

From EU AI Act implementation to new FDA guidance, here are the regulatory trends that will shape AI adoption in 2025.

1. EU AI Act Implementation

The EU AI Act, passed in 2024, will see its first enforcement deadlines in 2025. Key provisions include:

• Prohibited practices become enforceable (e.g., social scoring, certain biometric systems)
• High-risk AI requirements take effect (transparency, human oversight, accuracy)
• General-purpose AI obligations begin for foundation model providers

Organizations using AI in the EU or serving EU citizens should prepare for compliance requirements.

2. Expanded FDA AI/ML Guidance

The FDA continues to refine its approach to AI in healthcare:

• New guidance on continuous learning systems
• Updates to predetermined change control plans
• Increased focus on real-world performance monitoring
• Enhanced requirements for algorithmic bias detection

Healthcare AI vendors should expect more detailed premarket submission requirements.

3. State Privacy Laws Proliferation

With CCPA/CPRA as a model, more states are enacting comprehensive privacy laws:

• Several states have laws taking effect in 2025
• Many include specific provisions for automated decision-making
• Opt-out rights for profiling and targeted advertising

Organizations need a national privacy strategy, not just state-by-state compliance.

4. Financial Services AI Regulation

Banking regulators are increasing scrutiny of AI use:

• Updated model risk management guidance (SR 11-7)
• New fair lending requirements for AI underwriting
• Enhanced third-party risk management for AI vendors
• Consumer protection focus on AI-driven decisions

Financial institutions should review their AI governance frameworks.

5. Healthcare AI Transparency

Beyond FDA requirements, healthcare is seeing new transparency demands:

• CMS reimbursement considerations for AI
• Health equity audits for clinical AI
• Physician disclosure requirements
• Patient consent and transparency

Healthcare organizations should prepare for increased documentation requirements.

Preparing for 2025

To get ahead of these trends:

1. Audit your AI inventory: Know what AI systems you use and their risk profiles
2. Review vendor contracts: Ensure vendors can support compliance requirements
3. Build governance frameworks: Document decision-making processes and accountability
4. Invest in transparency: Create explainability capabilities for high-risk AI
5. Monitor developments: Stay current on regulatory guidance and enforcement

The organizations that prepare now will have a competitive advantage as regulations tighten.