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source: 2025-xx-babic-npj-digital-medicine-maude-aiml-postmarket-surveillance-framework.md → processed

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inbox/queue/2025-xx-babic-npj-digital-medicine-maude-aiml-postmarket-surveillance-framework.md → inbox/archive/health/2025-xx-babic-npj-digital-medicine-maude-aiml-postmarket-surveillance-framework.md
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@ -7,10 +7,13 @@ date: 2025-01-01
domain: health domain: health
secondary_domains: [ai-alignment] secondary_domains: [ai-alignment]
format: journal-article format: journal-article
status: unprocessed status: processed
processed_by: vida
processed_date: 2026-04-02
priority: high priority: high
tags: [FDA, MAUDE, AI-medical-devices, post-market-surveillance, governance, belief-5, regulatory-capture, clinical-AI] tags: [FDA, MAUDE, AI-medical-devices, post-market-surveillance, governance, belief-5, regulatory-capture, clinical-AI]
flagged_for_theseus: ["MAUDE post-market surveillance gap for AI/ML devices — same failure mode as pre-deployment safety gap in EU/FDA rollback — documents surveillance vacuum from both ends"] flagged_for_theseus: ["MAUDE post-market surveillance gap for AI/ML devices — same failure mode as pre-deployment safety gap in EU/FDA rollback — documents surveillance vacuum from both ends"]
extraction_model: "anthropic/claude-sonnet-4.5"
--- ---
## Content ## Content