Introduction
In today’s economy, there is a silent yet critical premise: what cannot be measured, digitized, and shared risks operational irrelevance. For decades, Mexico’s National Health System (SNS) has operated under a fragmented logic based on paper or disjointed electronic files, with a fierce guardianship of clinical information. This inertia is no longer just inefficient; it’s unsustainable.
The Need for Digital Health Infrastructure
The discussion about the future of healthcare should no longer be limited to building hospitals or purchasing medications. It must focus on the invisible infrastructure that connects everything: Digital Health. For this transformation to move beyond isolated silos and become a state policy, Mexico urgently needs a specific, robust legal framework aligned with global standards.
The Role of Technology and Legislation
Technological advancement has outpaced our legislation, which remains anchored in the analog era of the General Health Law of 1984. While this law now acknowledges Digital Health, it needs to go beyond mere recognition. We stand at a crossroads where technological innovation meets a governance vacuum. It’s not about buying computers; it’s about legislating interoperability, security, and data management.
Interoperability: The Core of Digital Health Policy
Interoperability, a technical concept, has profound political and economic implications. It’s the ability for diverse systems to ‘speak’ the same language, regardless of whether a patient is treated in Tijuana or Mérida, in IMSS, ISSSTE, or a private hospital.
Without a law mandating standardization under international protocols (like HL7 FHIR or CIE-11), we’ll continue building ‘information silos.’ Today, a clinical electronic record in ISSSTE is unreadable for a doctor in a CAF, and vice versa. This disconnection generates redundant tests, treatment error risks, and fundamentally, massive resource wastage.
The Need for a Comprehensive Legal Framework
A state digital health policy must declare interoperability as a national security mandate. We cannot allow each health subsystem to purchase proprietary software that ‘captures’ patient data in closed formats. The law must ensure that data belongs to the person and their portability is as fluid as a mobile phone.
Designing this legal framework requires an unprecedented call. Historically, health policies were discussed at a table occupied solely by doctors, pharmacists, and medical device manufacturers. Today, that table would be incomplete.
Key Players in the Digital Health Ecosystem
Digital health is where two giant industries intersect: Life Sciences and Information and Communication Technologies (ICT). To legislate with future vision, the state must convene new ecosystem players:
- ICT and Hyperscalers: Cloud, cybersecurity, and data processing companies are as vital to a hospital as oxygen suppliers. Their role in mass data custody and processing (Big Data) is the foundation of resource planning and predictive medicine.
- Integrators and Developers: Medical software requires specific health regulation (Software as a Medical Device – SaMD), which COFEPRIS must modernize.
- Logistics Operators: In a digital pharmacy and telemedicine model, the last mile is health. Real-time communication standards are needed for digital traceability of medication from factory to patient’s home.
Excluding technology companies from the drafting of the norm will result in laws regulating traditional medical acts but ignoring algorithm reality, artificial intelligence, and telemetry.
The Impact of Lack of Specific Legislation
Lack of clear specific legislation is a barrier to investment. Global capital is ready to deploy AI solutions for early diagnosis, remote monitoring of chronic conditions, and smart hospitals in Mexico. However, uncertainty about algorithm civil liability, the legal validity of digital prescriptions across jurisdictions, or biometric data protection stalls these projects.
Mexico needs legislation offering a framework for developers and doctors alike, ensuring legal, regulatory, and normative certainty. We need to define: Who is responsible for each step in the health value chain? How do we audit a health algorithm? What are the minimum standards of cybersecurity/pharmacovigilance/technovigilance that must be met to avoid disconnection from the national network?
Digital Health: A Strategy for Financial Solvency
Digital health is not just an added technological component to the General Health Law; it requires a Digital Health Law acting as the system’s backbone.
We cannot continue adding analog regulations to govern a digital reality. We need a public policy that seats the health supplies, programmers, doctors, and data engineers industries at the table.
Digital health is the new source code of health. If Mexico establishes a clear, interoperable, and secure legal framework, it not only improves patient care but also triggers a new high-value service industry. Ignoring this convergence condemns the health system to operational obsolescence while the rest of the world advances towards precision medicine.
