The landscape of healthcare regulation is always evolving, but few shifts have been as intriguing as the FDA’s recent pivot in its approach to artificial intelligence. For years, the agency was laser-focused on developing guidance for how the healthcare industry should use AI. But in a surprising twist, the FDA has now turned its attention inward, exploring how it can harness AI to improve its own operations.
This change became especially apparent in 2024, a year marked by the creation of the CDER AI Council and the release of several white papers and guidance documents. Early 2025 continued this momentum, with new drug and device guidance documents eagerly anticipated by industry stakeholders. However, as the first half of 2025 unfolded, the FDA’s external communications on industry AI regulation grew noticeably quieter.
Instead, the agency made headlines in May by announcing an ambitious plan to scale up its internal use of AI across various centers. The centerpiece of this initiative is Elsa, a cutting-edge AI tool designed to accelerate clinical protocol reviews, enhance scientific evaluations, and help identify high-priority inspection targets. While Elsa’s full impact remains to be seen, its introduction signals a new era for the FDA—one where AI is not just something to regulate, but a tool to drive efficiency and innovation from within.
For those working in healthcare, this shift brings both opportunities and challenges. On one hand, the FDA’s adoption of AI could lead to faster regulatory reviews and more streamlined processes, benefiting companies and patients alike. On the other hand, the agency’s pause on new industry guidance has created a regulatory gap. As federal oversight slows, state governments are stepping in with their own AI laws, adding complexity for companies that operate nationwide.
So, what does this mean for compliance, privacy, and legal teams? Staying informed is more important than ever. Teams should monitor both FDA updates and the rapidly changing landscape of state AI regulations. Proactive communication and collaboration across departments can help organizations adapt to new requirements and avoid compliance pitfalls.
Key Takeaways:
- The FDA is now prioritizing internal AI adoption, with tools like Elsa leading the way.
- Regulatory guidance for industry AI use has slowed, creating uncertainty.
- State-level AI laws are emerging to fill the gap, increasing compliance complexity.
- Healthcare organizations should stay vigilant and agile in their regulatory strategies.
- The FDA’s evolving approach may set the stage for future industry guidance as internal initiatives mature.