Rubens Granja
Lefosse Advogados, São Paulo
rubens.granja@lefosse.com

Julia Kesselring
Lefosse Advogados, São Paulo
julia.kesselring@lefosse.com

The world is finally returning to regular activities, as they looked before the spread of Covid-19. However, it remains uncertain whether the recent achievements and discoveries made by society will continue to be effective in the future.

From a Brazilian law perspective, important topics that had been overlooked for years were suddenly brought to light and became urgent. That was the case of the regulation of remote access to health services – particularly the regulation of telemedicine.

Legal and regulatory framework before the pandemic

From the onset of the Covid-19 pandemic, it was clear that Brazil, a country of continental dimensions, would need to rely on telemedicine to assure the offering of uninterrupted access to healthcare to patients located in all parts of the country. Brazilian authorities, however, quickly realised that telemedicine was only poorly regulated by the Federal Council of Medicine (FCM): Resolution No. 1,643 of 2002 and a few sparse regulations concerning teleradiology, telepathology and remote pre-hospital care.

Although Resolution No. 1,643 of 2002 intended to regulate telemedicine in Brazil, it only allowed the use of such technological tools in very limited situations: (i) for patients located in distant places, with no access to healthcare institutions or healthcare professionals; and (ii) for patients who had a previously established relationship with their physicians.

In a frustrated attempt to create a more generic resolution, which would contemplate more updated and contemporary rules for the practice of telemedicine, the FCM published Resolution No. 2,227 on 2019. This regulation, however, was highly criticised by medical practitioners because they argued that the remote service would distance patients and their healthcare providers. After intense protests against the resolution, the FCM decided to restore Resolution FCM No 1,643 of 2002 (which is currently still in force).

The impact of the pandemic on Brazilian telemedicine

In the first weeks of the pandemic, Brazilian authorities identified the urgent need to create standards to enable and encourage the use of telemedicine. Under a temporary and exceptional basis, the Federal Government published (i) Law No. 13,989 of 2020, that broadly allowed the practice of telemedicine, and (ii) Ordinance No. 467 of 2020, to establish rules for the application of telemedicine for pre-clinical attendance, support, consultation, monitoring, diagnostic and the use of electronic signature for medical documents.

As a result of the legal certainty suddenly granted to the practice of telemedicine, the new legal framework quickly encouraged the reliance on remote medical care and increased the confidence of patients and professionals. However, new legal statutes were only temporary and dependent on the duration of the Public Health Emergency of National Importance (Emergência em Saúde Pública de Importância Nacional (ESPIN)), declared by the Brazilian Government, on 4 February 2020.

The current status of telemedicine in Brazil

With the revocation of the so-called ESPIN, in May 2022 (Ordinance No. 913/2022), the legislation authorising and regulating telemedicine abruptly lost validity, which would have led to a return to the previous (and outdated) framework of telemedicine.

However, to avoid such a scenario, the FCM moved quickly and, on 5 May 2022, published Resolution No. 2,314 of 2022, which regulated (in broad terms) the practices of teleconsultation, telediagnosis, telesurgery, telemonitoring and teleconsulting.

The FCM Resolution authorises the practice of telemedicine in Brazil and provides for rules on data protection, registration on the Regional Councils of Medicine (RCM), issuance of medical report and prescription, as well as specific standards for each modality of telemedicine. In addition, the Resolution determines that telemedicine must be preceded by patient’s informed consent and ensures the patient’s right to refuse the remote assistance at any moment.

Regardless of the clear advances brought by the new Resolution, a few points are still considered controversial, for example: (i) the Resolution does not allow for a full treatment to be conducted remotely (face to face interaction with the physician is still considered mandatory – at least one of the initial appointments must be in-person); and (ii) patients with chronic illness must be seen in-person at least every six months.

The FCM was not the only professional council involved in the regulation of telemedicine. The practice was also regulated by the Federal Councils of Nursing,^[1] Veterinary Medicine,^[2] Pharmacy^[3] and Physiotherapy and Occupational Therapy.^[4] 

Additionally, the Ministry of Health (MoH) published Ordinance No. 1,348/2022, on 3 June 2022, regulating telehealth in the Brazilian public system. According to this regulation:

• The practice can be performed in mobile and fixed units that are registered in the National Registry of Health Establishments;
• Digital telehealth platforms must have a responsible technical person registered with the professional council;
• Compulsory disease notification rules must be observed;
• Clinical records must comply with the interoperability standards and information required by the MoH; and
• Medical prescriptions must follow the rules of sanitary control and special medication control.

Expectations for the future of telemedicine

The use of telemedicine during the pandemic made clear to the authorities that there was an urgency to issue a legal standard regulating the practice. As a result, the House of Representatives proposed Bill of Law No. 1,998 of 2020 and Bill of Law No. 4,223 of 2021 before the National Congress, which aimed to grant a final legal standard to telehealth (the notion that comprises telemedicine and all other remote services performed by healthcare professionals – such nursing, nutrition and physiotherapy).

On 27 April 2022, Bill of Law No. 1,998 of 2020 was approved by the House of Representatives and submitted to the Federal Senate. If the Bill is approved by the Senate, the text shall be remitted to the President for sanction.

The Bill of Law No 1,998 of 2020, as approved by the House of Representatives, provides for general rules for telehealth, among which are the following:

• The patient and the healthcare professional are allowed to decide whether the healthcare assistance will be made remotely or physically;

• If the healthcare professional understands that the remote assistance may threaten the correct diagnosis or treatment of the patient, a physical examination shall be required;

• Telehealth is authorised except where it can be demonstrated that physical assistance is required in the best interest of the patient;

• Companies that provide, or act as intermediaries for, telemedicine services must be registered with the physicians’ council where the company is established;

• Healthcare operators are allowed to supply telehealth services to its beneficiaries if physicians are equally compensated for remote or in-person services; and

• The physician who provides remote healthcare assistance must be registered with the local professional council. It is not required to be registered in all jurisdictions where the professional provides services.

Regulatory authorities and other bodies of the Government are issuing rules to allow the effective practice of telemedicine. However, despite these regulations, the Brazilian framework on telemedicine still lacks a law generally validating the practice. It is expected that the authorities will work together to establish rules to provide a consistent framework, capable of allowing the effective use of telemedicine on routine patient consultations.