The complexity of medical AI in LatAm
AI in Latin American healthcare operates at the intersection of medical device regulation, personal and sensitive data legislation, and emerging AI frameworks. This complexity varies by country but shows common patterns: health data is sensitive data with reinforced protections, diagnostic software is a medical device subject to sanitary approval, and the use of AI in clinical decisions creates obligations of transparency and medical supervision.
Sanitary registration of medical software with AI
In Mexico, medical diagnostic software with AI must obtain authorisation from COFEPRIS (the Federal Commission for Protection against Sanitary Risks). In Colombia, INVIMA (the National Institute for the Surveillance of Medicines and Food) has jurisdiction over medical devices, including diagnostic software. In Argentina, ANMAT (the National Administration of Medicines, Food and Medical Technology) regulates this area. The registration process is long, typically 12 to 24 months, and must be anticipated in product planning.
Health data: the highest standard
In all Latin American data protection frameworks, data relating to health is considered sensitive data or special category data, with a higher standard of protection. This means that the legal basis for processing it is more restrictive (generally explicit consent or specific public health purposes), the technical and organisational security measures must be more robust, and in several countries prior notification to the data protection authority is required before processing begins.
