Tag
Compliance
5 posts
Law 21.719 in clinical software: consent and real ARCO-P
How I turned privacy into architecture for Examya: consent ledger, ARCO-P, reporting and self-service before December 2026.
Human-in-the-loop is not enough: designing real oversight for medical AI
Medical AI oversight is not a doctor watching a screen. It requires authority, traceability, escalation, drift monitoring, and auditable evidence.
Fhirex by Examya: FHIR pilots without touching production
Why we launched fhirex.examya.cl: FHIR/Core-CL pilots with synthetic data, technical evidence, and IT review before production.
Compliance is not a feature: it's evidence
In digital health, a working feature is not enough. Without auditable traceability, it does not exist for the regulator.
100% Compliant: How we closed all 36 MINSAL verifiers in record time
Closing MINSAL accreditation (Law 21.541) isn't just about coding. Here's how we jumped from 33% to 100% compliance in a single weekend.