Technology
Regulations related to telecommunications, AI, cybersecurity, and digital infrastructure.
4 regulationsClinical Decision Support Software Utilizing Artificial Intelligence and Machine Learning; Updated Regulatory Framework
This proposed rule establishes an updated regulatory framework for clinical decision support software that uses artificial intelligence and machine learning. It creates a tiered classification system based on the clinical risk level of the AI's intended use and introduces a predetermined change control plan pathway that allows manufacturers to update algorithms without requiring new premarket submissions for each modification.
Federal Motor Vehicle Safety Standards; Framework for Automated Driving System Safety
This proposed rule would establish the first comprehensive federal motor vehicle safety standards specifically designed for vehicles equipped with automated driving systems operating at SAE Levels 3 through 5. The proposed framework addresses occupant protection in vehicles without traditional manual controls, minimum performance requirements for ADS perception and decision-making systems, and cybersecurity standards for connected autonomous vehicles.
Preventing Digital Discrimination of Access; Rules To Facilitate Equal Access to Broadband Internet Service
This final rule implements provisions of the Infrastructure Investment and Jobs Act by establishing rules to prevent digital discrimination in broadband deployment and access. Internet service providers are prohibited from policies or practices that differentially impact consumers' access to broadband based on income level, race, ethnicity, color, religion, or national origin.
Medical Devices; Laboratory Developed Tests; Phased Oversight Framework
This final rule phases out the FDA's longstanding enforcement discretion for laboratory developed tests (LDTs) and brings them under the same regulatory framework as other in vitro diagnostics. The rule implements a four-year phaseout period, beginning with adverse event reporting requirements and culminating in full premarket review for high-risk tests.