Life Sciences Horizons Brochure 2025 - Flipbook - Page 18
17
2025 Horizons Life Sciences and Health Care
LATAM patchwork of AI regulations raise compliance and liability risks
Despite fascinating innovations, implementing
AI in health care presents critical challenges for AI
developers and health care providers, including the
increasing prevalence of cybersecurity attacks. In
addition, regional AI regulatory frameworks in Latin
America often lack common legal standards, leading
to different criteria and enforcement by regulators in
several countries that require complex analyses
before a company can safely launch an AI tool while
simultaneously ensuring legal compliance.
In Mexico, for example, there is currently no regulatory
framework for AI aside from data protection and general
guidelines. Nonetheless, existing regulations for Software as a
Medical Device could serve as a foundation for future policies.
Meanwhile, countries such as Brazil are already taking steps to
implement regulations that include technical and ethical
standards for AI´s development in health care, setting an
important precedent for the LATAM region, which we are
already seeing Mexico, Colombia, and Chile beginning to follow.
In other national developments, countries including Mexico,
Brazil, Colombia, and Argentina have enacted regulatory
frameworks for “sensitive” data. In addition, novel cybersecurity
regulations are emerging in countries like Chile and Colombia,
in the aftermath of high-profile cyber-attacks. Sponsors of health
care AI products must therefore make country-by-country
decisions on how to ensure compliance with national standards,
and carefully explore technical solutions when applying for
approvals in the LATAM region, as needed.
For medical devices, functionalities of many AI-powered health
apps can fall under the concept of “medical consultation” or
“health service,” which have different interpretations in each
LATAM country. This results in additional aspects that are worth
considering, including scope of liability of developers and health
professionals, compliance with requirements for the rendering of
such type of health services, and even requiring the registration
of these apps before the competent national health authorities.
Forward-looking AI solutions require the expertise of legal experts
who understand the regulatory frameworks for health care, as well
as the technical aspects of AI, cybersecurity, and privacy, to ensure
responsible AI use in the Latin American region.
Guillermo Larrea
Partner
Mexico City
Ernesto Algaba Reyes
Partner
Mexico City
