Healthcare
Regulations related to healthcare policy, drug safety, public health, and medical devices.
5 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.
Lead and Copper Rule Improvements; Strengthening Protections for Communities With Lead Service Lines
This final rule strengthens drinking water protections by requiring water systems to replace lead service lines within ten years. It lowers the lead action level from 15 parts per billion to 10 parts per billion and mandates improved tap water sampling methods to better identify communities at risk of lead exposure.
Heat Injury and Illness Prevention in Outdoor and Indoor Work Settings
This proposed rule would establish the first federal standard to protect approximately 36 million indoor and outdoor workers from heat-related injuries, illnesses, and deaths. Employers would be required to develop heat illness prevention plans, provide water and shade, allow rest breaks, and implement acclimatization protocols when the heat index reaches specified thresholds.
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.
HIPAA Privacy Rule To Support Reproductive Health Care Privacy; Final Rule
This final rule amends the HIPAA Privacy Rule to prohibit the use or disclosure of protected health information for the purpose of investigating or imposing liability on individuals, health care providers, or others who seek, obtain, provide, or facilitate reproductive health care that is lawful under the circumstances in which it is provided. Regulated entities must update their notices of privacy practices and obtain signed attestations before disclosing reproductive health information.