ASGE Provides FDA Recommendations on Regulation of Generative AI-Enabled Medical Devices
On October 19, ASGE submitted comments to the Food and Drug Administration (FDA) regarding the agency’s discussion paper, Considerations for the Regulation of Generative AI-Enabled Medical Devices. The FDA is seeking stakeholder input on a regulatory framework addressing risk assessment, clinical evaluation, ongoing monitoring, and oversight of generative artificial intelligence (GenAI) technologies used in medical […]
HHS Rolls Back AI Transparency Requirements for Healthcare Technology
The Trump administration has finalized a rule eliminating certain federal transparency requirements for artificial intelligence (AI) tools integrated into certified electronic health record (EHR) systems. The change, included in the October 2026 Health Data, Technology, and Interoperability (HTI-5) final rule, removes requirements for developers to provide standardized information about how certain clinical decision-support algorithms are developed, tested, […]