Diagnosis, triage or clinical support in Chile

Diagnosis, triage or clinical support in Chile: 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.

Risk classification

Obligations related to this use case

Data protection impact assessment

Law 21,719Ley 19.628 modificada por la Ley 21.719, art. 15 terAdopted, applies later

Applies from December 1, 2026

When it relates: If processing is likely to be high risk; always for profiling with significant effects, large-scale processing, systematic monitoring of public areas and sensitive data without consent.
What the rule provides: Carry out the assessment before processing starts.
Follow the list and minimum guidance the Agency publishes.
Typical evidence: Signed and dated assessment per system.
Related base documents: Data Protection Impact Assessment (DPIA) for AI
Supporting documents: Algorithmic Impact Assessment (AIA)
Impact Assessment Summary Register
Verification: Verified in the official source on November 2, 2026Text and date checked in BCN LeyChile (published in the Official Gazette on Dec 13, 2024; first transitional article: effective on the first day of the 24th month after publication = Dec 1, 2026). Postponement: Bill 18.623-07 (filed Sept 1, 2026, proposing Dec 1, 2027) passed the Senate on Oct 28, 2026 (33 to 6) with a new date of Oct 15, 2027 and moved to the Chamber of Deputies (press sources: Emol, Pauta, Garrigues). Until it is published as law, the legal date remains Dec 1, 2026. Recheck before that date.

Related kits

Includes 5 documents

Healthcare Kit

Technical and clinical validation, DPIA for health data, clinician oversight, in-use monitoring and a model card for clinical AI tools.

USD 139USD 215

Complete kit · available to buy