While new paths have emerged for telemedicine in Brazil, only doctors and companies duly registered in the country may avail themselves of this emerging market. On May 5, 2022, the Brazilian Federal Council of Medicine (“CFM”) issued Resolution 2,314/22 (“Rule”) updating telemedicine regulations in Brazil. Prior to the Rule’s passage, telemedicine was allowed in the country based on extraordinary rules partially formulated during the COVID-19 crisis.

The Rule authorizes seven types of telemedicine: (i) tele-orientation; (ii) telediagnosis; (iii) tele-monitoring; (iv) tele-inter consultation; (v) tele-surgery; (vi) tele-screening; and (vii) tele-visits. In accordance with the Rule and related CFM regulations, foreign medical doctors and companies may only engage in tele-inter consultations and tele-visits. All other types of telemedicine require CFM-certified medical doctors and companies. Foreign doctors receive certification through a lengthy and complex process aimed at recognizing their university degree’s equivalency. Similarly, foreign companies must be on file at the corresponding Brazilian State medical registry.

The Rule requires compliance with the Brazilian General Data Protection Law (“LGPD”). Specifically, patient data (consisting of information and images) must meet CFM and LGPD rules on handling and storage, integrity, veracity, confidentiality, privacy and irrefutability, as well as professional secrecy. The LGPD also guarantees patients’ rights to know the use of their data, while requiring their consent. To that end, doctors and companies must disclose how patient data may be shared, and patients may reject the sharing of data and images, except in medical emergencies.

Telemedicine services are based upon consent received from patients or their representative(s) after a CFM-certified doctor explains the corresponding pros, cons, and risks to the patient. Patients or their representatives who, despite telemedicine’s popularity, still prefer in-person consultations may withdraw such consent.

The Rule also governs remotely issued prescriptions, for which a professional’s electronic signature is required under Brazilian Public Key Infrastructure (ICP-Brasil) standards. The prescription includes the standard telemedicine disclaimer, as well as the patient’s required information.

According to the CFM, the Rule requires foreign medical doctors and companies’ adherence to strict ethical, technical and legal parameters. This approach is consistent with the CFM’s traditional resistance to foreigners’ practice of medicine in Brazil. Experts remain divided on whether the Rule and its protectionist provisions will promote or retard telemedicine’s growth throughout Brazil.