Rubens Granja Vieira
Kestener, Granja & Vieira Advogados, São Paulo
rubens.granja@kgvlaw.com.br

Julia Kesselring
Kestener, Granja & Vieira Advogados, São Paulo
​​​​​​​julia.kesselring@kgvlaw.com.br

The World Health Organization (WHO) defines telemedicine as:

‘[T]he delivery of health care services, where distance is a critical factor, by all health care professionals using information and communication technologies for the exchange of valid information for diagnosis, treatment and prevention of disease and injuries, research and evaluation, and for the continuing education of health care providers, all in the interests of advancing the health of individuals and their communities.’^[1]

Although there are limited historical records of its use – such as in combating the Black Death and in caring for wounded soldiers during the First and Second World Wars – the fact is that the regulation of telemedicine is quite recent and is based on the Tel Aviv Declaration on Responsibilities and Ethical Standards in the Use of Telemedicine (adopted by the 51st General Assembly of the World Medical Association, Tel Aviv/Israel, October 1999).

The first Brazilian norms on the use of telemedicine

In Brazil, telemedicine was first regulated by the Federal Council of Medicine (FCM) on 26 August 2002, through FCM Resolution No 1,643/2002. According to that standard – which remains in force to this day – the use of telemedicine would be limited to the care of patients in remote locations (far from health institutions or in areas with a shortage of medical professionals) and, even then, only under the following requirements:

• through the use of appropriate technological infrastructure, capable of guaranteeing the quality of the consultation, the preservation of the doctor-patient relationship, professional secrecy, confidentiality and the preservation of patient data;
• the attending physician has professional responsibility for any harm caused to the patient; and
• registration with the FCM (in the case of companies providing telemedicine services).

In addition, following the publication of this general and vague rule, the FCM also edited several sparse Resolutions, which aimed to regulate specific aspects of telemedicine, such as:

• FCM Resolution No 1,671/2003, which deals with remote pre-hospital care, with the objective of assisting the victim in the first minutes of care;
• FCM Resolution No 2,107/2014, which provides for the requirements for the exercise of teleradiology; and
• FCM Resolution No. 2,264/2019, which provides for the requirements for the exercise of telepathology.

In the context of public health, the use of telemedicine was officially embraced by the Ministry of Health (MoH) in 2007, through the institution of the National Telehealth Program,^[2] which aimed to expand access to health and improve the quality of care in the Unified Health System (UHS). Reformulated and expanded in 2010^[3] and 2011,^[4] the National Program for Telehealth Brazil Networks started to provide teleconsulting services, telediagnosis, formative second opinion and tele-education, all with the purpose of facilitating the exchange of information and knowledge among professionals, workers and managers in the health area.

The failed attempt to revise FCM Resolution No 1,643/2002

FCM Resolution No 1643/2002, however, was never enough to fully allow the practice of telemedicine, especially given the restrictive conditions historically imposed by the Code of Medical Ethics and the various norms and opinions of the FCM. This is the case, for example, of the prohibition of medical prescription without a physical examination of the patient^[5] and the need to register the professional with the Regional Council of Medicine of all states where the doctor provides services.^[6]

In order to resolve these obstacles and recognise telemedicine as a broader instrument that enhances the quality and efficiency of medical services, on 6 February 2019, FCM published FCM Resolution No 2,227/2019, revoking FCM Resolution No 1,643/2002 and establishing clearer and more permissive rules for the exercise of telemedicine in Brazil.

As a way of bringing the exercise of telemedicine in line with technological advances in medicine and electronic communications, FCM Resolution No 2,227/2019 encompassed issues such as information privacy, professional secrecy and physician responsibilities – defining, delimiting and regulating the services subject to be provided by telemedicine (consultation, diagnosis and surgery, among others). In addition, the new resolution established mandatory requirements for the correct collection, storage and communication of patient data, with express reference to the Brazil’s Internet Bill of Rights^[7] and the General Data Protection Law.^[8]

While it was celebrated by the Brazilian health market as enabling the expansion of telemedicine-related businesses, FCM Resolution No 2,227/2019 was widely rejected by medical unions and Regional Councils of Medicine. Although the final text of the Resolution trod carefully regarding the preservation of the doctor-patient relationship (emphasising that distance care could happen only after a face-to-face consultation and in-care coverage in geographically remote areas), a significant faction of the medical community argued that the new rules would leave doctors and patients vulnerable and would cause an undesirable distance between doctor and patients.

In view of the broad rejection of the new Resolution, the FCM decided to revoke it days after its publication (on 22 February 2019), with the promise of reopening the topic for discussion by the medical profession. For the time being, however, the validity of FCM Resolution No 1,643/2002 has been re-established.

The normative revolution forced by Covid-19

The regulation of telemedicine remained untouched until the beginning of 2020, when the Covid-19 pandemic compelled its use on a large scale. Faced with overcrowded hospitals, doctors on the front lines in the fight against the virus and the need for social isolation to prevent the spread of the disease, public authorities were quickly forced to regulate telemedicine, allowing remote medical care with no personal contact.

Thus, on 19 March 2020, the FCM sent an official letter to the MoH, recognising the possibility of the ethical use of telemedicine in cases of teleorientation (for guidance and referral of patients in isolation), telemonitoring (for remote monitoring of health parameters) and teleinterconsultation (for the exchange of information and opinions among physicians, as a way of assisting in the diagnosis or therapeutic approach).

In response to the FCM, on 23 March 2020, the MoH published Ordinance No 467/2020,^[9] which, exceptionally and temporarily, authorised the exercise of telemedicine for pre-clinical care, assistance support, consultation, monitoring and diagnosis (in public or private health systems); and  the electronic issuance of medical certificates and prescriptions.

In a further step to ensure greater legal certainty for the exercise of telemedicine, on 16 April 2020, the National Congress published Law No 13,989/2020, authorising the exercise of telemedicine on an emergency basis while the public health crisis caused by Covid-19 persists.

Short and objective (composed of only six articles), Law No 13,989/2020 broadly authorises the use of telemedicine (which it defines as ‘the exercise of medicine mediated by technologies for the purposes of assistance, research, prevention of diseases and injuries and promotion of health’), provided that the usual ethical and normative standards of face-to-face care are followed. In addition, the Law expressly recognises the possibility of exercising telemedicine even without any possibility of physical examination in person (something absolutely unthinkable in the pre-pandemic scenario).

Finally, on 10 June 2020, the Presidency of the Republic published Provisional Measure No 983/2020, allowing and regulating the electronic signature in public communications and in documents related to health (notably for documents signed by health professionals and medical prescriptions).^[10]

Expectations for the future of telemedicine in Brazil

History proves that times of crisis tend to stimulate important technological and social advances. This was the case during the sanitary crises of the late 19th and early 20th centuries, during the 20th century’s two World Wars and during the Cold War period. It is not surprising, therefore, that the pandemic forced advances in the regulation of telemedicine.

Now, telemedicine is a reality in the Brazilian territory. On the one hand it is widely used by health plans, hospitals and doctors; on the other, it is evaluated extremely favourably by patients in all corners of the country. However, as much as it has been incorporated into medical practice, telemedicine continues to be regulated on a provisional basis, and its exercise is authorised only by exceptional and temporary measures, which will remain in force only until the end of the resulting public health emergency of the pandemic.^[11] In theory, once the pandemic is over, we will return to the previous scenario, with vague and restrictive regulations.

For this reason, authorities, the medical community and the various stakeholders of the health market (in particular, health plans and hospitals) are already intensely deliberating the regulation of telemedicine in a post-pandemic world. Debates have been deadlocked both in the scope of the FCM (which is weighing a new Resolution on telemedicine) and in the National Congress (where bills on the subject are being processed).

While telemedicine was very well-received during the pandemic, there is no consensus on critical points for future regulation. Among the most controversial points are whether to require a first face-to-face consultation (for a physical examination of the patient); the need for physicians to register with the Regional Councils of Medicine of all states to which they provide remote services; and the unrestricted or limited possibility of using telemedicine in different medical areas (due to the greater or lesser degree of physical interaction with the patient).

Regardless of the solution reached regarding each of these controversial points, it is both necessary and urgent to regulate telemedicine as soon as possible, to provide legal certainty for its exercise after the end of the pandemic. Once the Covid-19 pandemic has been overcome, it is essential that Brazilian authorities recognise telemedicine as a concrete, current and effective instrument for expanding access to healthcare.