Lines of Thought / Organisation
FDA: every development we track
6 developments and 3 rules, in date order. Built automatically from every development involving this organisation.
- Rule · In forceUSOMB M-25-21
- FDA rolls out 'Elsa', a generative AI assistant for all agency staff
The regulator that clears medical AI is now using generative AI inside its own review work, raising questions about validation and accountability for regulatory decisions.
- FDA gives all employees agentic AI tools after 70% take-up of Elsa
Agentic tools inside premarket review and inspections could speed approvals but make it harder for outsiders to see how regulatory judgements are reached.
- HHS publishes department-wide AI strategy built on a 'OneHHS' platform
It sets the procurement and governance direction for the largest US health payer and regulator, and signals heavier AI use in Medicare, Medicaid and public-health operations.
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- FDA loosens oversight of AI decision-support software and health wearables
More AI tools used by clinicians and consumers can reach market without FDA clearance, shifting safety assurance to developers and health systems.
- FDA and EMA issue ten joint principles for AI in drug development
Sponsors using AI in trials, manufacturing or safety monitoring get a single transatlantic baseline, reducing divergent expectations between the two largest drug regulators.
- FDA proposes a risk framework for generative AI medical devices
It is the first concrete sign of how FDA might clear LLM-based clinical tools, and comments will shape whether chatbots and scribes need premarket review.