Brazilian Telehealth act Comes Into Force

On December 28, 2022, Law No. 14,510/2022 (Telehealth Act), which authorizes the practice of Telehealth throughout the Brazilian territory, came into force. After lengthy discussion and approval by Congress, the President sanctioned the final wording of the Bill of Law 1,998/2020 without vetoes.

According to the Act, Telehealth is:

The modality of providing health services at a distance through information and communication technologies, which involves, among others, the secure transmission of data and health information through texts, sounds, images, or other suitable forms.

The concept reaches all healthcare professionals governed by Professional Councils established and controlled by law, and their respective services, not limited to telemedicine. This expansion occurred during the debate on the Bill of Law, initially intended to regulate only telemedicine.

The acts performed by healthcare professionals within Telehealth will be valid throughout the country.

According to the legal framework, Telehealth must comply with the following principles: (i) the autonomy of the healthcare professional in deciding whether or not to use telehealth services; (ii) the patient’s informed consent; (iii) the patient’s right to refuse Telehealth, with the guarantee of in-person care whenever requested; (iv) dignity and appreciation of the healthcare professional; (v) safe and quality patient care; (vi) data confidentiality; (vii) promotion of universal access for Brazilians to health actions and services; (viii) strict observance of the legal activities of each profession; and (ix) digital responsibility.

The Telehealth Act promoted changes to the National Health System Statute (Law No. 8,080/1990), including ‘Title III-A – On Telehealth’, and revoked Law No. 13,989/2020 – that authorized telemedicine, under emergency, during the health crisis generated by Covid-19.

Federal Professional Councils will be responsible for regulating and enforcing the ethical rules related to the provision of Telehealth within the exercise of health professions such as the Federal Council of Medicine, Nursing, and Dentistry, among others.

The Telehealth Act must comply with correlated statutes, such as (i) the Internet Bill of Rights; (ii) the Medical Act; (iii) the Brazilian Data Protection Act; (iv) the Consumer Defense Code; and (v) the Electronic Health Records Act.  

To practice Telehealth, the professional must register before the local Regional Professional Council. However, secondary registration is waived for healthcare professionals who practice their profession in another jurisdiction exclusively through Telehealth.

Companies hiring healthcare professionals to practice telemedicine, directly or indirectly, will be considered intermediary companies. Those companies must seek registration with the State Council of Medicine, where they are established, along with the registration of a medical technical director.

With the Telehealth Law into force, it will be essential to monitor the developments in regulations at the ethical level and how their adoption will occur in public and private health systems so the Brazilian society can benefit from the progress provided by this Statute.

Our Life Sciences & Healthcare team is available if you need further assistance. Please reach our team via email: lifesciences@soutocorrea.com.br.