Telemedicine’s New Horizons in Brazil & More News Here

While new paths have emerged for telemedicine in Brazil, solely medical doctors and firms duly registered in the nation could avail themselves of this rising market. On May 5, 2022, the Brazilian Federal Council of Medicine (“CFM”) issued Resolution 2,314/22 (“Rule”) updating telemedicine laws in Brazil. Prior to the Rule’s passage, telemedicine was allowed in the nation primarily based on extraordinary guidelines partially formulated through the COVID-19 disaster.

The Rule authorizes seven sorts of telemedicine: (i) tele-orientation; (ii) telediagnosis; (iii) tele-monitoring; (iv) tele-inter session; (v) tele-surgery; (vi) tele-screening; and (vii) tele-visits. In accordance with the Rule and associated CFM laws, overseas medical medical doctors and firms could solely have interaction in tele-inter consultations and tele-visits. All different sorts of telemedicine require CFM-certified medical medical doctors and firms. Foreign medical doctors obtain certification by means of a prolonged and sophisticated course of aimed toward recognizing their college diploma’s equivalency. Similarly, overseas corporations should be on file on the corresponding Brazilian State medical registry.

The Rule requires compliance with the Brazilian General Data Protection Law (“LGPD”). Specifically, affected person information (consisting of data and pictures) should meet CFM and LGPD guidelines on dealing with and storage, integrity, veracity, confidentiality, privateness and irrefutability, in addition to skilled secrecy. The LGPD additionally ensures sufferers’ rights to know using their information, whereas requiring their consent. To that finish, medical doctors and firms should disclose how affected person information could also be shared, and sufferers could reject the sharing of information and pictures, besides in medical emergencies.

Telemedicine providers are primarily based upon consent obtained from sufferers or their consultant(s) after a CFM-certified physician explains the corresponding professionals, cons, and dangers to the affected person. Patients or their representatives who, regardless of telemedicine’s reputation, nonetheless favor in-person consultations could withdraw such consent.

The Rule additionally governs remotely issued prescriptions, for which an expert’s digital signature is required below Brazilian Public Key Infrastructure (ICP-Brasil) requirements. The prescription contains the usual telemedicine disclaimer, in addition to the affected person’s required data.

According to the CFM, the Rule requires overseas medical medical doctors and firms’ adherence to strict moral, technical and authorized parameters. This method is per the CFM’s conventional resistance to foreigners’ apply of medication in Brazil. Experts stay divided on whether or not the Rule and its protectionist provisions will promote or retard telemedicine’s development all through Brazil. 

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