Brazil’s House of Representatives approves bill regulating telehealth

On December 13, 2022, Brazil’s House of Representatives approved Bill No. 1,998/2020, authorizing and regulating telehealth services in Brazil. The bill amends Law No. 8,080/1990, which provides guidelines for remote health services, and also revokes Law No. 13,989/2020, which authorized telemedicine services specifically during the Covid-19 pandemic. Given its approval in the House, the bill now awaits presidential assent.

Background

Brazilian law contained provisions for regulating telehealth services even before the Covid-19 pandemic. Decree No. 9,795/2019 (amended by Decree No. 11,098/2022) established that the Ministry of Health (MoH) was responsible for preparing, coordinating, and monitoring activities and strategies related to the National Health System’s (SUS) National Digital Health and Telehealth Policy.

Telehealth services are also included within the scope of Brazil’s Health Data Network (RNDS) – an important technological tool for the health sector established by GM/MS Ordinance No. 1,434/2020.

Covid-19

With the emergence of Covid-19 and the resulting Public Health Emergency of International Concern (PHEIC), Law No. 13,989/2020 authorized telemedicine services in Brazil during the pandemic.

As the impacts of the pandemic gradually subsided, Brazil’s Federal Council of Medicine (CFM) updated the requirements for telemedicine services regarding education, research, disease and injury prevention, health management and healthcare through CFM Resolution No. 2,314/2022. Furthermore, the Ministry of Health also published Ordinance GM/MS No. 1,348/2022 to regulate the use of information and communication technology for activities in the fields mentioned above.

New aspects of Bill No. 1,998/2020

Considering the provisional nature of Law No. 13,989/2020, the need to regulate other professions within the field of healthcare and the proven efficiency of the telehealth model, Bill No. 1,998/2020 seeks to set guidelines for remote healthcare services provided by doctors, nurses, psychologists, physical and occupational therapists, and speech therapists.

Telehealth services regard remote healthcare services that use information and communication technology, securely transmitting health data via text, sound, images, or other relevant means.

The main aspects of the bill include the following:

• Telehealth services must be conducted by healthcare professionals in accordance with the law, ensuring the dignity of healthcare professionals, quality assistance and patient safety, and must promote the population’s universal access to healthcare services;
• Any future regulation that restricts telehealth services must be able to demonstrate it is necessary for preventing harm to patient health;
• Remote healthcare services require each patient’s informed consent. The patient also has the right to refuse telehealth services and request in-person assistance;
• Services provided remotely are valid throughout all of Brazil. Healthcare professionals operating outside the jurisdiction where they are registered do not require secondary or supplementary registration to provide telehealth services;
• The new law should be construed in line with the existing ethical regulations for each medical profession, including but not limited to doctor-patient confidentiality. Laws No. 12,965/2014 (Civil Rights Framework for the Internet), No. 12,842/2013 (Medical Act Law), No. 13,709/2018 (General Data Protection Law), No. 8,078/1990 (Consumer Protection Code) and, where applicable, Law No. 13,787/2018 (Digital Medical Record Law) must also be observed.

Impacts of the bill

Bill No. 1,998/2020 would ensure that healthcare professionals have total freedom and independence in determining whether to provide patients with telehealth services or in-person care – including first-time consultations – as deemed necessary, in line with existing regulations.

Companies acting as intermediaries (those that directly or indirectly contract healthcare professionals to provide telemedicine services) must register with the Regional Medical Councils in the Brazilian states where they are headquartered and must appoint a technical manager.

In approving the bill, the House of Representatives maintained only one change from when it passed through the Senate. This amendment regards including Brazil’s Disability Act (Law No. 13,146/2015) within the scope of the SUS, making it responsible for developing strategies for preventing avoidable disabilities by promoting campaigns and services that would prevent brain damage and neurological sequelae in newborns.

For further information on telehealth, please contact Mattos Filho’s Life Sciences & Healthcare practice area.

* With the collaboration of Henryk Trelinski Alvarenga.