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ai security
FDA Pilot Gives AI Health Tools a Real-World Test Bed
The FDA launched the TEMPO pilot program, which allows four manufacturers to deploy artificial intelligence (AI)-enabled health devices for diabetes, hypertension, and mental health management before obtaining formal marketing authorization. Manufacturers collect real-world evidence that regulators can use to evaluate safety, performance, and patient outcomes.
Why it matters: Healthcare organizations and device manufacturers need to understand the regulatory pathway for AI health tools; this pilot may influence how quickly such devices reach patients and what compliance requirements apply.
- First seen by Cybersecurity Tracker