Law that regulates telehealth sector sanctioned by the President of Brazil

On December 28, 2022, Brazilian President Jair Bolsonaro approved Law No. 14,510, which:

• amends the Organic Health Law, in order to authorize and regulate tlehealth services throughout Brazilian territory; and
• revokes Law No. 13,989, of April 15, 2020.

Telehealth was a widely used resource during the COVID-19 pandemic. Although telehealth has since become a well-established practice in Brazil, the matter was still pending effective regulation at the federal level. As of today, the matter was temporarily regulated by Law No. 13,989/2020, which was revoked by Law nº 14,510.

As a result, in order to ensure greater legal certainty for health professionals and companies in the telehealth sector to carry out their respective activities, the new Law introduced the following main provisions:

• Guiding principles: the telehealth sector must comply with the principles of the health professional’s autonomy, the patient’s free and informed consent, data privacy, safe and high-quality patient care, among others.
• Professional autonomy and consent: health professionals will be entitled to decide whether to use telehealth, provided that the patient’s free and informed consent is respected.
• Registration of companies: intermediary companies of health services and respective technical officers must be registered with the Local Medicine Council of the states where they are based. In the case of professionals who carry out telehealth services in another jurisdiction, secondary or complementary registration will not be mandatory.
• Standardization: Federal Councils will be responsible for publishing ethical standards, while the Ministry of Health will be in charge of drafting rules regarding the carrying out of telehealth services, taking into consideration the competences of other regulatory bodies.
• Applicable legislation: the new Law must be in line with the respective existing regulations, such as the Brazilian Civil Rights Framework for the Internet, the Medical Act Law, the Brazilian General Data Protection Law (LGPD), the Consumer Protection Code and, when applicable, the Electronic Health Record Law.

In addition to the new regulation, the telehealth practice had already been addressed by CFM Resolution No. 2,314/2022, of the Federal Medicine Council, and by GM/MS Resolution No. 2,314/2022, which regulates telehealth services as a whole. 

Following the enactment of the new Law, the telehealth sector is expected to continue growing in Brazil, now supported by a landscape of increased  ethical and legal certainty.

Demarest’s Life Sciences team is monitoring the updates of the industry and is available to provide any further clarifications that may be necessary.