Reform to the General Health Law: Modernization, digital health and health regulation

I. ORIGIN AND OBJECTIVE

On January 15, 2026, the decree amending, adding to, and repealing various provisions of the General Health Law in Mexico was published in the Official Gazette of the Federation. This reform responds to the need to strengthen service delivery, regulation, infrastructure, and innovation in public health and medical care, incorporating new concepts and obligations for the institutions of the National Health System.

II. MAIN CHANGES INTRODUCED

II.I. Infrastructure and Strategic Planning

Systematic planning for the creation, replacement, and expansion of medical infrastructure, as well as the acquisition of high-technology medical equipment, is established through the National Master Plan for Health Infrastructure and High-Tech Medical Equipment. All infrastructure projects must be registered in this Plan, allowing for their monitoring and justification, regardless of the funding source.

II.II. Digital Health

The reform introduces digital health as a matter of public interest, defining it as the application of information and communication technologies in health services (telehealth, telemedicine, mobile health, electronic health records, wearable devices). Specific objectives are established, such as expanding coverage, optimizing resources, facilitating remote care, digitizing medical information, and analyzing data to improve diagnoses and hospital management.

The Ministry of Health will be responsible for issuing provisions for the implementation, supervision and continuous improvement of digital health services, considering technological advice, continuous training, development of safety guidelines and protocols, protection of personal data and impact assessment mechanisms.

II.III. Health Regulation and Drug Control

The powers of the Federal Commission for Protection against Sanitary Risks and state authorities are strengthened in matters of regulation, control, surveillance, and health promotion. Procedures for the sanitary registration of medicines and medical devices are updated, establishing pharmacovigilance and technovigilance as obligations following the granting of registration.

The list of controlled narcotics and psychotropic substances is expanded and updated, including new substances and establishing deadlines for their entry into force. Verification by authorized third parties in the sanitary registration process is prohibited, reserving this authority to the Ministry of Health.

II.IV. Organization and Coordination of the National Health System

Universal access to healthcare is promoted through the exchange of services between public institutions, ensuring continuity and quality of care. Mechanisms are established for the reimbursement of expenses between institutions and the integration of healthcare networks.

The Federal Health System is created, made up of the Federal Commission for Protection against Health Risks and state authorities, for coordination in health regulation and control.

II.V. Alternative Dispute Resolution Mechanisms

The National Medical Arbitration Commission is strengthened as an autonomous body responsible for resolving conflicts between users and healthcare providers through alternative mechanisms such as immediate management, conciliation, mediation, and arbitration. The Commission's jurisdiction and decisions are recognized throughout the National Health System.

II.VI. Prohibition of Electronic Cigarettes and Vapes

The sale, production, import, export, distribution, and advertising of electronic cigarettes, vapes, and similar devices are prohibited throughout the national territory, permitting only their consumption and possession for non-commercial purposes. Criminal and administrative penalties are established for those who violate this provision.

II.VII. Donation, Disposal and Traceability of Blood, Blood Products and Stem Cells

The donation and disposal of blood, blood products, blood derivatives, and stem cells are regulated under the principles of altruism, non-profit status, and confidentiality. Internal coordination committees, hemovigilance and biovigilance systems are established, and the National Blood and Stem Cell Registry is created. The industrialization of residual plasma to obtain blood derivatives for the benefit of the population is envisaged.

III. OBLIGATIONS AND PROCEDURES

• Public institutions must register their infrastructure and equipment projects in the National Master Plan.
• Continuous training of staff in digital health and the integration of telehealth systems is required.
• Healthcare facilities must establish bioethics, ethics and research, and biosafety committees, in accordance with the criteria of the National Bioethics Commission.
• The obligation to report and document medical care is reinforced, especially in digital services and blood and stem cell donation.
• Procedures are established for the health verification, registration and extension of medicines and medical devices.

IV. SANCTIONS AND TRANSITIONAL PROVISIONS

• Criminal and administrative penalties are foreseen for the marketing of electronic cigarettes and vapes.
• Contrary provisions are repealed and the Regulations of the General Health Law on Social Protection in Health are abrogated.
• Deadlines are established for the integration of the National Master Plan and the issuance of guidelines by the Ministry of Health.
• Previous health authorizations related to electronic cigarettes and vapes are no longer valid.

V. CONCLUSION

The reform to the General Health Law represents a significant step forward in modernizing the Mexican health system, incorporating digital health, strengthening health regulations, promoting inter-institutional coordination, and establishing new prohibitions and obligations in public health matters. Institutions within the National Health System must adapt their procedures and structures to comply with the new provisions and guidelines established in this decree.