On December 28th, the Brazilian Food & Drug Agency (called “Anvisa” in the Portuguese acronym) published a call for comments (#1,137 of 2022) on its proposal to amend its Board of Director’s Rule #47 of 2009, whereby an exemption will be made, allowing generics and branded generics (called also “similar”) to omit patented uses in their labels.
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.
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.
On December 23, 2022, the National Data Protection Authority (“ANPD”) released new instructions for data breach reporting. The new guidelines update a previous guide that had been released on February 22, 2021, which provides orientations on (i) the measures that shall be taken when a data breach is identified, (ii) the information that must be reported to the ANPD, (iii) the situations in which data subjects must be notified of a data breach, and (iv) the deadline and the means to report a data breach to the ANPD.
