FDA Regulation of AI-Enabled Devices
A recent policy brief explains how the FDA regulates AI-enabled health applications as medical devices, balancing safety with access to lower-risk innovations. It details current pathways for authorization, the scope of regulated clinical AI tools, and ongoing debates over how to adapt regulatory frameworks to continuously learning algorithms.
About LOG Standards
LOG Standards provides an independent accreditation signal for AI models used in healthcare, helping hospitals, care networks, and AI companies bring clinical AI readiness and governance into clearer conversations.
Our AI Intelligence Briefing tracks the latest developments in AI safety, AI in medicine, mental health AI, clinical AI governance, and regulatory policy — keeping healthcare stakeholders informed about the rapidly evolving AI landscape.