Every neural signal. Every stimulation decision. Every safety check. Observable, queryable, and FDA-auditable. Finally answer the question patients and regulators both ask: "Why did the implant send that signal?"
Brain-computer interfaces make thousands of decisions per second. When a patient reports discomfort or an adverse event occurs, "the AI decided" isn't an acceptable answer for the FDA — or for the patient.
Regulatory approval requires demonstrating that every decision is traceable, auditable, and explainable. Black-box neural networks won't pass review for implantable devices.
When a patient reports discomfort or unusual sensations, clinicians need to reconstruct exactly what the device did in the preceding seconds — and why.
If something goes wrong, the decision chain must be traceable. "We're investigating" doesn't work in court when a device is implanted in someone's brain.
Every neural interface decision becomes a structured, queryable event.
The same domain.entity.action:version pattern that works for software telemetry
works for medical device telemetry — with FDA-grade auditability.
Total time to generate FDA incident report with EventIDs: 12 minutes
Previous method (manual log review): 3-5 days
Demonstrate explainability from day one. Every decision is logged, queryable, and auditable — exactly what regulators need to see.
Real-time safety monitoring with queryable thresholds. Know immediately when parameters approach limits, and prove the device responded correctly.
Complete audit trail for every stimulation pulse. In litigation, show exactly what the device did, when, and why — with millisecond precision.
Query patterns across all patients to improve decoder algorithms. "Which electrode configurations produce highest confidence?" becomes a SQL query.
Trust requires transparency. Transparency requires observability.
The Event Model makes every neural interface decision visible, queryable, and accountable.
The same Event Model that makes AI code observable can make any medical device explainable. Neural interfaces. Insulin pumps. Cardiac monitors. If it makes decisions, it should emit events.