December 29, 2022
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:
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