MEXICO Law and Practice Contributed by: Bernardo Martínez-Negrete, Lisandro Herrera Aguilar and Martha Contreras Secchi, Galicia Abogados, SC
Liability (Contractual, Statutory and Otherwise)
recognise the need for clearer rules to keep pace with the rapid growth of digital healthcare tech- nologies. 4. Liability 4.1 Legal Risks of Digital Healthcare Digital healthcare in Mexico presents certain legal risks due to the current lack of compre- hensive regulation. These manifest most clearly in the following areas. Non-Compliance With Regulations One of the main challenges is that many aspects of digital healthcare are not yet specifically reg- ulated. This regulatory gap increases the risk of non-compliance – not necessarily because entities are intentionally violating the law, but because there is uncertainty about what is required or permitted. Without clear rules, it is difficult for healthcare providers, tech develop- ers, and manufacturers to ensure they are oper- ating within legal boundaries, especially regard- ing areas like SaMD, AI and telehealth. Enforcement by Regulatory Authorities Although Cofepris has sufficient authority to enforce regulations concerning health-related technologies, the lack of clear and targeted digi- tal health regulations limits its ability to act deci- sively. Enforcement actions are typically reactive and based on general health regulations, which may not fully address the nuances of digital healthcare. As a result, regulatory enforcement can be inconsistent or delayed, leaving gaps in oversight that can compromise patient safety and data protection.
The absence of specific legal standards also complicates liability issues. In cases of harm caused by digital health tools – such as faulty software, data breaches or misdiagnoses dur- ing teleconsultations – it is not always clear who is legally responsible. Questions of contractual liability (eg, between providers and patients), statutory liability (eg, under health or consumer protection laws) or civil liability (eg, negligence or malpractice) may arise, but the resolution of these difficulties often depends on interpreting outdated or non-specific laws. This legal uncer- tainty increases the exposure of both healthcare providers and technology developers to poten- tial disputes and legal claims. In summary, the key risks in digital healthcare stem from regulatory ambiguity, inconsistent enforcement, and unclear liability frameworks – all of which highlight the urgent need for more tailored, up-to-date legislation in Mexico. 4.2 Liability Frameworks In Mexico, the legal exposures related to digital healthcare – such as non-compliance, regula- tory breaches, or liability – are not specifically addressed under a dedicated digital health stat- ute, but they may be handled through general legal and administrative frameworks. Formal mechanisms for redress exist, but they are often indirect and fragmented, due to the lack of a comprehensive legal regime for digital health- care. These exposures are typically addressed as fol- lows. Statutory Frameworks • Health Law: General provisions in the General Health Law may apply to healthcare services,
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