Brazilian Telehealth Act comes into force

December 29, 2022

Brazilian Telehealth Act comes into force

President Bolsonaro sanctioned on December 27, 2022  the Telehealth Act (Statute #14,510/2022), which came into force the following day, finally authorizing the practice of telehealth services in Brazil in a definitive manner. The Act was a result of Bill #1,998/2020, which has been proposed by Congresswoman Adriana Ventura. Prior to its sanction, Bill #1,998/2020 has been widely discussed by the regulated sector and various class entities, which pushed for a definitive regulation on the topic. The objective was to revoke Statute #13.989/2020, which permitted the practice of telemedicine only as an exceptional measure during the Covid-19 pandemic.

Initially, Bill #1998/2020 focused on governing telemedicine, but it was then expanded to encompass telehealth, meaning all healthcare professionals. During the debate within the Federal Senate, the proposal was further broadened to include (i) electronic prescription; (ii) telehealth coverage by health insurance; and (iii) telehealth services to prevent brain and other neurological damage in newborns. However, item “iii” was the only amendment maintained in the approved text.

In a nutshell, Statute #14,510/2022 has (i) included “Title III-A”, with eight articles, in the Public Healthcare System Act (Statute #8,080/1990), establishing principles and general rules for the practice of telehealth services throughout Brazil; (ii) set a mandatory registration of intermediary companies of medical services by telemedicine, as well as their medical technical director only in the Brazilian Federal Medical Board of the state in which they are based (article 3 of the Telehealth Act); (iii) amended article 19 of the People with Disabilities Act (Statute #13,146/2015) to enable the provision of telehealth services to prevent brain injuries and neurological scarring in newborns (article 19 of Statute 13,146/2015); and (iv) revoked the abovementioned Statute #13,989/2020.

Most importantly, the National Health System Statute (Statute #8,080/1990) now provides:

  • The principles of dignity, acknowledgement, and autonomy for the healthcare professional in deciding whether or not to use telehealth services (article 26-A, I and IV) opting for the in-person assistance, which is relevant, for instance, to avoid medical institutions' pressure for using telehealth services as a way to minimize costs and increase the number of appointments;
  • The principle of the patient's informed consent (article 26-A, II and article 26-G, I), which is relevant for the patient to agree to the use of the modality, being aware of its limitations and risks;
  • The definition of telehealth, alluding to the use of digital information and communication technologies to access health care services remotely, including the secure transmission of data and health information (article 26-B);
  • Exemption of secondary or complementary registration in the medical board when the healthcare professional practices his profession in another state exclusively through telehealth (article 26-H);
  • Mandatory justification of the indispensability of any act that intends to restrict the practice of telehealth services (article 26-F);
  • The requirement for regulating the ethical aspects of telehealth practice by professional boards (article 26-D), as well as regulating the conditions of telehealth practice by the directive body of the Public Healthcare System (article 26-E);
  • The requirement of compliance with the provisions of correlated statutes, such as the Internet Bill of Rights, the Medical Act, the Brazilian Data Protection Act, the Consumer Defense Code, and, in appropriate situations, the Electronic Health Records Act (article 26-G, II).

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