The progress in telemedicine regulation and the emergence of the advanced practice of medicine in Brazil after the Covid-19 pandemic
Maira Materagia Imperatriz
Lefosse Advogados, São Paulo
Lucas Barreto
Lefosse Advogados, São Paulo
The advancement of digital technologies in the health sector, driven mainly by the Covid-19 pandemic, has brought about the unprecedented transformation of healthcare delivery models and the very concept of medical care. In the context of social distancing and mobility restrictions, telehealth, especially telemedicine, emerged as a strategic tool to ensure the continuity of care, expand access, reduce inequalities and modernise professional healthcare practices in Brazil.
Before the Covid-19 pandemic, the regulatory framework for telemedicine in Brazil was limited, fragmented and restrictive. The professional practice of telemedicine was governed by regulations issued by the Federal Council of Medicine (Conselho Federal de Medicina or FCM), especially the Code of Medical Ethics (FCM Resolution No. 2,217/2018) and FCM Resolution No. 1,643/2002, which is very brief and focuses mainly on the responsibilities of physicians and healthcare companies providing telemedicine services. An attempt to update this framework through the adoption of FCM Resolution No. 2,227/2018 met with resistance from part of the medical community, leading to the new regulation’s revocation before it took effect.
The onset of the pandemic highlighted the urgent need for a more robust regulatory framework for telehealth in Brazil. In response, Law No. 13,979/2020 and Ministry of Health (Ministério da Saúde or MoH) Ordinance No. 467/2020 were enacted to establish temporary and exceptional rules for the use of telemedicine during the Covid-19 pandemic. The provisions enabled the nationwide expansion of remote medical services and ensured the continuity of care during the public health emergency. This regulatory leap not only legitimised the practice of telemedicine in Brazil, but also catalysed broader discussions on the subject.
With the end of the pandemic, the Brazilian authorities were faced with the decision of whether to roll back these regulatory advancements or to maintain and improve them. Starting in 2022, a clear trend towards regulatory consolidation of the telehealth regulations emerged, paving the way for the emergence of the provision advanced health practices that are now redefining the boundaries of healthcare delivery in Brazil. The following discussion explores this transformation in greater depth.
The legal framework for telehealth in Brazil
Telehealth regulation in Brazil took on a more structured and permanent form with the passage of Law No. 14,510/2022. Born out of a regulatory maturation process accelerated by the Covid-19 pandemic, this legislation permanently authorised and regulated the provision of telehealth services throughout the country.
The law defines telehealth as ‘the modality of delivering health services remotely through the use of information and communication technologies, including the secure transmission of health data and information via text, sound, images, or other suitable formats.’ It, therefore, encompasses remote healthcare delivery across all health professions.
Although Law No. 14,510/2022 is relatively lean, consisting of just six articles, its impact is far-reaching. Key provisions include: the formal recognition of telehealth, including for first consultations and procedures; the requirement for informed consent from patients, reinforcing the importance of autonomy and transparency in regard to the doctor–patient relationship; and general rules on data protection within the context of telehealth.
The law also delegates the regulation of telehealth in regard to ethics to the competent professional councils, allowing for greater flexibility and the ability to tailor guidelines to the specific characteristics of each health profession.
Complementing this legal framework, MoH Ordinance No. 3,691/2024 established the ‘Digital SUS Strategy Action – Telehealth’. This regulation aims to strengthen healthcare networks and the indigenous health subsystem by outlining guidelines and providing services that ensure comprehensive and continuous care across all levels of the Brazilian Unified Health System (Sistema Único de Saúde or SUS). Among its provisions, the ordinance defines the modalities of telehealth services to be provided and the general rules to be followed by healthcare managers, providers and users within the SUS network.
The expected effects of these measures on the Brazilian healthcare system are significant. In the public sector, telehealth is a powerful tool for addressing gaps in healthcare access, particularly in remote or underserved areas. In the private sector, the regulations provide greater legal certainty for the expansion and diversification of care models, driving innovation in healthcare delivery and encouraging investment in the area.
The role of professional regulation
The passage of Law No. 14,510/2022 brought increased visibility to the need for specific professional regulations on telehealth. In this context, the FCM issued Resolution No. 2,314/2022, which revoked FCM Resolution No. 1,643/2002, and set forth ethical and professional rules for the practice of telemedicine in Brazil.
This resolution defines telemedicine as the practice of medicine mediated by digital information and communication technologies (DICTs), for the purposes of healthcare, education, research, disease and injury prevention, health management and promotion.
Key provisions include: definitions of various modalities of telemedicine, such as teleconsultation, telesurgery and telemonitoring; the obligation to document telemedicine assistance in the patient’s medical record and ensure data protection; and the establishment of rights, duties and responsibilities in regard to the practice of telemedicine.
The resolution also emphasises the physician’s autonomy in deciding whether or not to use telemedicine, guided by the principles of beneficence and non-maleficence towards the patient. It reaffirms that face-to-face medical consultations remain the gold standard for patient care. At the same time, the resolution imposes some challenges, such as the requirement for adequate technological infrastructure and the discussion regarding accountability in regard to services shared or mediated by digital platforms.
Other professional councils have also moved forward with specific telehealth regulations, such as the Federal Council of Nursing (Conselho Federal de Enfermagem or COFEN),[1] Psychology (Conselho Federal de Psicologia or CFP),[2] Nutritionists (Conselho Federal de Nutricionistas or CFN),[3] Pharmacy (Conselho Federal de Farmácia or CFF)[4] and Physical Therapy and Occupational Therapy (Conselho Federal de Fisioterapia e Terapia Ocupacional or COFFITO).[5] These advances reflect a trend towards regulatory specialisation, tailored to the needs of each health profession and ensuring the quality and safety of the services provided.
The advanced practice of medicine
The progress of telehealth regulation in Brazil, especially after the end of the Covid-19 pandemic, has created a favourable environment for the emergence and expansion of advanced medical practices. Personalised medicine, robotic surgery, artificial intelligence (AI) in healthcare and gene therapy have been gaining traction both in medical research and in direct patient care.
These innovations present a range of technical, ethical, professional and legal challenges that demand coordinated action among regulatory agencies, professional councils, public policymakers and society. Issues such as health data security, professional accountability and the need for regulatory frameworks to keep pace with the rapid technological advancements are just a few of the challenges that need to be addressed.
Although many of these innovations are initially tied to the medical field, advanced practices are also emerging in other health professions. For instance, COFEN issued Technical Note No. 001/2023, which addresses advanced nursing practices (ANPs) and highlights the expanded scope of nurses’ roles, particularly in the provision of primary healthcare (PHC).[6]
In this scenario, the progress in regard to telehealth regulation should not be viewed as an endpoint, but rather as the foundation for a new cycle of debate and regulation aimed at fostering innovation through digital health.
Future paths for telehealth and advanced health practices
The consolidation of telehealth in Brazil, propelled by the Covid-19 pandemic and formalised through the enactment of Law No. 14,510/2022, marks a pivotal shift in the delivery of healthcare services in the country. More than a temporary response to a public health emergency, telehealth has become a structural component of the Brazilian health system and a vital part of how healthcare is conceived, regulated and operationalised in the country.
This more stable and comprehensive regulatory landscape has not only enabled the continued provision of remote care, but has also paved the way for the emergence of advanced medical practices. Technologies such as AI are increasingly being integrated into the healthcare system, expanding diagnostic and therapeutic possibilities, while simultaneously demanding ongoing discussions and revisions of existing regulatory frameworks.
Although many of these innovations are strongly associated with the medical field, it is important to note that telehealth and advanced practices are also being adopted across other health professions. This reflects a cross-cutting trend toward the modernisation of healthcare delivery, with direct impacts on service organisation, professional training and patient safety.
Therefore, the progress in telemedicine regulation should be understood as a starting point for a new cycle of debate and regulation aimed at healthcare innovation. Building an effective legal framework for this next phase will require broad social dialogue, coordination among the various stakeholders in the system and a continuously evolving legal and regulatory architecture, so that the benefits of these transformations can be realised ethically, safely and equitably.
Notes
[1] Resolution No. 696/2022.
[2] Resolution No. 9/2024.
[3] Resolution No. 760/2023.
[4] Resolution No. 727/2022.
[5] Resolution No. 516/2020.
[6] COFEN www.cofen.gov.br/cofen-publica-nota-tecnica-sobre-praticas-avancadas-de-enfermagem/ last accessed on 6 May 2025.