MEXICO Law and Practice Contributed by: Bernardo Martínez-Negrete, Lisandro Herrera Aguilar and Martha Contreras Secchi, Galicia Abogados, SC
tal medicine. Instead, regulations are interpreted based on broader laws and guidelines applica- ble to health services and medical devices. The reliance on international definitions is not explicitly mentioned, but as digital healthcare continues to grow globally, international stand- ards and definitions often influence national policies and understanding of a term. However, ongoing work to formalise or update definitions within national regulations is likely to continue, as the landscape of digital health evolves. 2.2 Laws and Regulations The key laws and regulations that apply to digital healthcare are the following: • the General Health Law; • the General Law for the Protection of Per- sonal Data in the Possession of Obligated Parties; • the Federal Law on Protection of Personal Data Held by Private Parties; • the Federal Consumer Protection Law; • the Health Inputs Regulations; • the Regulation of Sanitary Control of Products and Services; • NOM-004-SSA3-2012, for clinical records; • NOM-024-SSA3-2012, for electronic health record information systems and health infor- mation exchange; and • NOM-241-SSA1-2021, for good manufactur- ing practices for medical devices. 2.3 Role of Policymakers In Mexico, policymakers and lawmakers are working to stay up to date with technological developments, especially in the healthcare sec- tor, through a series of legislative actions and regulations. For instance, in December 2021, a new regulation was introduced to govern soft- ware as a medical device, reflecting a response
to the growing role of technology in healthcare. More recently, in May 2023, a new General Law on Humanities, Sciences, Technologies, and Innovation was enacted, which will influence research and development in the healthcare technology sector. However, this law also raises concerns, as it centralises control over public research funding and requires that projects be aligned with a special programme developed by the federal government, potentially introducing biases in the allocation of resources. While there are several initiatives under discus- sion, Mexico does not yet have comprehensive, state-of-the-art legislation specifically governing digital healthcare and digital medicine. Various draft regulations are currently being debated in Congress, including those related to artificial intelligence, cybersecurity, digital health eco- systems, electronic clinical records and digital prescriptions. However, these regulations are still pending approval. Additionally, specific amendments to the Gen- eral Health Law are being considered. These ongoing efforts show that while regulatory devel- opment is happening, Mexico still lacks fully comprehensive and up-to-date laws to govern the dynamic field of digital health. 2.4 Technical Standards In Mexico, technical standards play a growing but still limited role. The most notable example is the Mexican Official Standard NOM-241- SSA1-2021, which regulates software as a medical device. It sets requirements for manu- facturing practices, quality control and product classification, ensuring that such software meets safety and performance standards before reach- ing the market.
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