Telehealth regulated in Brazil’s National Health System

On June 3, 2022, Brazil’s Ministry of Health published GM/MS Ordinance No. 1,348/2022, providing for telehealth-related services and initiatives within Brazil’s National Health System (SUS). The ordinance regulates the use of information and communication technology for providing remote healthcare assistance, health education, research, disease and injury prevention, as well as healthcare management and promotion.

During an event to launch the Brazil Telehealth Program (Telessaúde Brasil), the Ministry of Health announced its intention to invest BRL 14.8 million to develop Digital Basic Health Units (Digital UBSs) in 326 rural and geographically remote municipalities. These municipalities will be subject to requirements established in GM/MS Ordinance No. 1,355/2022 concerning their participation in the pilot project, which is expected to last for 18 months.

The new ordinance is already in effect. It also revokes GM/MS Ordinance No. 467/2020, which permitted telehealth services as a temporary and exceptional measure during the state-declared Covid-19 Public Health Emergency.

SUS telehealth services

According to GM/MS Ordinance No. 1,348/2022, telehealth services must:

• Be provided by health professionals registered with their respective regional professional councils;
• Be provided by digital platforms, which must managed by responsible technical professionals  registered with their respective professional councils;
• Ensure that patients give informed consent;
• Ensure the security, privacy and confidentiality of information as determined by the Brazilian General Data Protection Law (LGPD), and comply with ethical standards;
• Meet the ethical standards of each profession in relation to remote health services;
• Comply with the Ministry of Health’s standards and guidelines regarding mandatory notification of diseases and health conditions.

The new ordinance also establishes that telehealth services can be provided at fixed or mobile UBSs that are registered in the National Health Establishment Registry (CNES).

GM/MS Ordinance No. 1,348/2022 also determines that medical records must be kept for telehealth services provided within the SUS. These records must comply with the Ministry of Health’s rules and standards for interoperability and health information, and must also include:

• The professional’s registration number with their respective council;
• Any clinical data necessary for ensuring the patient receives adequate assistance during each appointment;
• The date and time of the appointment, as well as the forms of information and communication technology used.

Background of telehealth in Brazil

Even before the outbreak of the Covid-19 pandemic, telehealth services featured in Brazil’s Digital Health Strategy. Decree-Law No. 9,795/2019 determined that the Digital Health Department (DESD) is responsible for formulating, coordinating, and monitoring strategies and actions related to Brazil’s National Digital Health and Telehealth Policy. The program aims to:

• Overcome socioeconomic, cultural, and geographic barriers to ensure Brazil’s entire population has access to health information and services;
• Improve user satisfaction, provide higher quality care and lower costs for the SUS;
• Meet the basic principles of quality healthcare services, providing them in a safe, timely, effective, efficient and patient-focused manner;
• Reduce waiting times;
• Reduce the time it takes professionals to attend to patients and provide specialized diagnoses;
• Avoid unnecessary patient and health professional displacements.

The National Health Data Network (RNDS) – created in 2020 by GM/MS Ordinance No. 1,434 – should also assist in implementing telehealth services. The RNDS sets strategies for using technology and information platforms, considering governance and management, the computerization of private and public health institutions, connectivity in healthcare, innovative ecosystems, user engagement and professional training.

Other regulations

GM/MS Ordinance 1,348/2022 must be considered together with other regulations issued by the health councils for each profession – such as CFM Resolution No. 2,314/2022, which regulates telemedicine services.

Bill No. 1,998/2020, which would authorize and regulate telehealth services throughout Brazil, has already been approved by the House of Representatives and is currently in the Brazilian Senate. If the Senate does not significantly change the bill, it will then be sent to the President’s office to be signed into law.

For further information about telehealth and other legal developments that impact the health sector, please contact Mattos Filho’s Life Sciences & Healthcare practice area.

*With the collaboration of Lucas Barreto and Leandro Expedito Rodrigues