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Advances on Telemedicine regulation in Brazil

Life Sciences and Healthcare

​Considering the development of new technologies in the Life Sciences and Healthcare industries, it seems unlikely that traditional healthcare models of assistance and payment will continue to be the only choice available for patients and medical care providers. 

In fact, on February 6, 2019, the Brazilian Federal Council of Medicine ("CFM") issued Resolution No. 2,227/2018, establishing rules for the use of technologies in the provision of medical services. 

With respect to health assistance, education, research, promotion and prevention activities, Resolution No. 2,227/2018 creates a number of business opportunities by authorizing the use of telemedicine as a facilitating tool for accessing medical care. Its purpose is to permit the safe exchange of information, lower territorial barriers and improve the doctor-patient relationship. In this regard, telemedicine may be applied to a wide array of services in different settings and specialties.

The new rule establishes the following main categories of telemedicine services (real-time synchronous or asynchronous) each with specific assumptions and requirements for its exercise: 

  • Teleconsultation: remote medical consultation facilitated by technology, having doctor and patient located in different geographic locations. It may also entail Tele-interconsultation, which is the exchange of information and opinions among doctors with or without the patient's presence for diagnostic, therapeutic, clinical or surgical assistance matters.

  • Tele-diagnosis: geographic and/or time remote medical action carried out by means of transmission of graphics, images and data for issuance of a technical opinion by a physician.

  • Tele-surgery: remote surgical procedure carried out by a physician through the use of safe interactive technologies and robotic equipment from a different location.

  • Medical tele-triage: action remotely carried out by a physician for assessment of symptoms in order to establish the preliminary appropriate conduct for medical assistance.

  • Tele-monitoring: action remotely carried out under medical supervision and guidance to monitor health and disease parameters by means of the analysis of images, signals and data from equipment and devices attached to inpatients or outpatients.

  • Tele-orientation: remote declaration of a health condition for the purpose of joining a private health care plan.

  • Teleconsulting: technology-mediated consulting action carried out between doctors and health managers, professionals and workers, with the purpose of clarifying questions regarding procedures, health actions and other issues. 

Below, we highlight certain points introduced by Resolution No. 2,227/2018:

(i) Obligation to obtain the patient's informed consent (or consent from the patient's legal representative) when applicable for transmission of images or data; 

(ii) Obligation to ensure preservation and secure digital recording of all data (images, text and/or audio) collected during telemedicine services, in compliance with the patient-doctor confidentiality duty;

(iii) Possibility of remote diagnosis (without personal contact with the patient), subject to complementary guidelines to be proposed by the relevant medical specialty association acting with the CFM;

(iv) Possibility of issuance of remote medical prescription to a patient; and

(v) Requirement that the entity or individual responsible for the telemedicine services be headquartered or domiciled, as the case may be, in Brazil and be enrolled with in the Regional Medical Council of the applicable jurisdiction.

These new arrangements do not replace traditional medical care services. In addition, Resolution No. 2,227/2018 should not be interpreted separately from other regulations concerning medical activity, patients' rights and health data protection.

CFM established a ninety day period for the effectiveness of Resolution No. 2,227/2018, which is considered fundamental for the analysis of all issues to implement it and clarify any gaps. CFM has also recently issued a public consultation, allowing companies in the health industry, associations, health professionals as well as any public or private stakeholder to comment and suggest improvements to the new resolution by April 7, 2019.

Please don't hesitate to contact us should you need further information.

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