MEXICO Law and Practice Contributed by: Bernardo Martínez-Negrete, Lisandro Herrera Aguilar and Martha Contreras Secchi, Galicia Abogados, SC
while telehealth is practised, there is no dedicat- ed legal framework outlining the requirements and standards for telehealth services. 2.6 Sufficiency of Legislative Framework The current laws and regulations in Mexico do not adequately regulate digital healthcare. While there have been some isolated modifications to the legal framework, these changes do not seem to be part of a cohesive, long-term nation- al policy on digital health. As a result, there are significant gaps in the legislation that leave sev- eral aspects of digital healthcare insufficiently regulated. These gaps include the regulation of telehealth, AI in healthcare, cybersecurity, and the use of self-care and wellness technologies like wearables. Without comprehensive and inte- grated legislation, Mexico’s digital healthcare system faces challenges in ensuring consistent standards, data protection, and the safe integra- tion of new technologies. 3. Regulatory Oversight 3.1 Oversight of Digital Healthcare In Mexico, the oversight of digital healthcare is primarily handled by two key bodies: The Federal Commission for Protection Against Sanitary Risks (Cofepris) The Federal Commission for Protection Against Sanitary Risks ( Comisión Federal para la Pro- tección contra Riesgos Sanitarios , or Cofepris) is the main regulatory and enforcement agency for the digital health industry. Its remit includes verifying the quality, efficacy and efficiency of health-related products and services, including medicines, medical devices, and software used as medical devices. Cofepris is responsible for granting marketing authorisations for SaMD and
ensuring that these technologies meet the nec- essary standards for safety and effectiveness. The Federal Consumer Protection Bureau (PROFECO) The Federal Consumer Protection Bureau ( Pro- curaduría Federal del Consumidor , or PRO- FECO) is responsible for safeguarding and pro- moting consumer rights, particularly in relation to commercial and promotional activities. While PROFECO’s focus is not directly on digital health technologies, it oversees the consumer protec- tion aspects of digital health products and ser- vices, ensuring that businesses comply with consumer rights laws, especially in advertising and sales. However, there is currently no specific body tasked with the oversight of digital health tech- nologies, such as self-care devices or wellness products, as they are not directly regulated under the existing Mexican legal framework. Addition- ally, healthcare institutions do not have a legal obligation to self-assess or report issues related to digital medicine or digital health technologies. As such, the regulatory environment for digital health in Mexico remains fragmented and lacks comprehensive oversight. 3.2 Non-Healthcare Regulatory Bodies Certain aspects of digital healthcare in Mexico fall under the remit of non-healthcare regulatory bodies. The following are two key examples. PROFECO PROFECO oversees commercial practices and advertising in the marketplace, including for digi- tal health products and services. This includes ensuring that consumers are not misled by pro- motional claims made about digital health tools such as mobile health apps, wearable devices or telehealth platforms. PROFECO’s involvement
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