Diagnosis, triage or clinical support in Ecuador: related rules
AI that helps diagnose, prioritize patients, recommend treatments, read medical images or draft clinical notes. Errors affect health, so clinical validation, medical oversight, patient transparency and, if it is a medical device, sanitary registration are required.
Sensitive health data: impact assessment required at scale; ARCSA registration if it is a device.
Obligations related to this use case
Run an impact assessment before high-risk processing
LOPDPLOPDP, art. 42; Reglamento LOPDP, arts. 29 a 32In force
Already applicable
When it relates
Mandatory before profiling people with legal effects, processing sensitive data at large scale or monitoring public areas at large scale (for example, AI video surveillance).
What the rule provides
Assess the impact before processing starts, with a description of the operations, justification of necessity and proportionality, risks and measures.
File the assessment with the Superintendency when it is mandatory; if unsure, you can ask the authority.
Verified in the official source on November 4, 2026Checked against the Official Register copies published by the SPDP: LOPDP, art. 42 (mandatory cases, before processing) and Regulation (Third Supplement 435), arts. 29-32 (query when in doubt, art. 31; filing with the Authority, art. 32).
AI impact assessment when the risk calls for it
SPDP AI ruleRes. SPDP-SPD-2026-0009-R, arts. 6 y 7.2, reformados por la SPDP-SPD-2026-0037-R; LOPDP, art. 42In force
Applies from March 10, 2026
When it relates
AI systems that profile people with significant effects or process sensitive, biometric or children's data.
What the rule provides
Carry out the impact assessment when the risk level requires it, before processing.
Verified in the official source on November 4, 2026Checked against the text of Res. SPDP-SPD-2026-0009-R published by the SPDP, art. 7.2 (impact assessment "where applicable") and art. 6 as worded by 0037-R ("where appropriate, the impact assessment"), with LOPDP art. 42. Res. 0037-R confirms its publication in Official Register No. 240 of Mar 10, 2026.