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- FDA modernization proposals target AI, digital tools
A new Senate report outlines legislative and regulatory reforms to modernize the FDA.
Zoom in: The Senate Health, Education, Labor, and Pensions (HELP) Committee released Patients and Families First: Building the FDA of the Future Patients.
- The report targets FDA policies on AI, clinical decision support, real-world evidence, and digital health in clinical trials.
What they’re saying: "While many parts of FDA work well, unnecessary bottlenecks slow patients and consumers getting the products they need," said Sen. Bill Cassidy, MD (R-LA), HELP Committee chair.
Here are highlights from the report:
- AI regulation: Supports a risk-based approach focused on high-risk AI uses without slowing innovation and calls for better coordination across HHS and National Institutes of Standards and Technology.
- Clinical decision support (CDS): Reaffirms that Congress excluded many CDS tools from FDA oversight and urges the FDA to stay within clear statutory boundaries.
- Real-world evidence: Emphasizes the need for more clarity and consistency in how the FDA evaluates nontraditional data sources.
- Digital health in clinical trials: Raises concerns about applying device-level standards to non-device tools, such as wearables.
Go deeper: Read the full HELP Committee report.