MEXICO Law and Practice Contributed by: Bernardo Martínez-Negrete, Lisandro Herrera Aguilar and Martha Contreras Secchi, Galicia Abogados, SC
5. Emerging Legal Issues and Reform 5.1 Emerging Legal Issues in Digital Healthcare There are currently several bills of laws being discussed in the Mexican Congress regarding AI, data privacy in digital healthcare, SaMD, electronic clinical records, digital prescriptions and cybersecurity. None of these initiatives have been enacted into law as yet. As this is a com- plex (and to some extent, unexplored) topic, Mexican representatives tend to be extremely cautious and risk averse when discussing and analysing such projects, which has caused a lack of appropriate regulations around AI. 5.2 Recent or Imminent Reform Between 2021 and 2024, some legislative initia- tives were introduced in Mexico to regulate AI, along with proposals to amend the constitution to grant Congress the authority to legislate on matters related to AI. These include: • the Law for the Ethical Regulation of AI and Robotics ( Ley para la Regulación Ética de la IA y la Robótica ), which emphasises human rights and proposes the creation of the Mexi- can Council of Ethics for AI; • a constitutional amendment granting Con- gress authority over AI, cybersecurity and neuro-rights; and • a bill to establish the Mexican Agency for AI Development to implement public policy in key sectors. Other initiatives seek to regulate the use of AI by prohibiting practices such as manipulation, discrimination and the creation of deepfakes, while assigning oversight to bodies such as the National Copyright Institute and the Federal Tel- ecommunications Institute. Two of the proposals
forms for patients using digital health tools helps set clear expectations and limit liability. • Contracts between healthcare providers and technology vendors should clearly define responsibilities, warranties and dispute reso- lution procedures. • Including indemnity clauses, liability limita- tions and force majeure provisions can offer further protection. Professional Liability Insurance Healthcare professionals and digital health pro- viders can reduce exposure by obtaining profes- sional indemnity or errors and omissions insur - ance, which may cover legal defence costs and damage awards related to service delivery or software use. Defensive Legal Strategies • If faced with enforcement actions by Cofepris, or legal claims, affected parties can challenge administrative sanctions through the federal courts, relying on procedural defences or lack of regulatory clarity. • In civil or contractual disputes, providers can defend themselves by showing adherence to industry best practices, demonstrating reasonable care, or invoking force majeure if applicable. In conclusion, while the legal framework for digi- tal healthcare in Mexico is still evolving, stake- holders can proactively reduce and defend against legal risks through internal governance, contractual safeguards, compliance with general laws, and strategic use of available legal rem- edies.
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