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Article

10 de May de 2022

The Brazilian new standards on telehealth

With the drop in COVID-19 contamination level and hospitalization rates in Brazil and the end of the Public Health Emergency of National Concern (“Espin”) declared by the Brazilian government, Brazilian legislative and regulatory bodies have a big challenge ahead to give permanent status to some practices and innovations, that were only allowed during the health emergency, but turned out to be great public policies for the society.

One of these practices is the perform of remote appointments by healthcare professionals, called telehealth, which had been authorized during the pandemic in areas such as medicine, physical therapy and nutrition. Therefore, in order to assure the continuation and expansion of telehealth, the Brazilian House of Representatives approved on April 27, 2022 the Bill of Law No. 1.998/2020, which could authorize telemedicine on a permanent basis and the performance of online appointments in all healthcare areas, including pharmaceuticals, psychologists, physiotherapists, nutritionists and nurses, and shall now be voted by the Senate. If approved, it will be sent to the chief of the Executive branch for sanctioning or veto.

The bill of law intends to assure the freedom of choice between online or face-to-face appointments. It has established the obligation of obtaining the patient informed consent and prioritized personal data protection and confidentiality.

Furthermore, the document expressly allows any healthcare professional that is duly enrolled with the competent local professional board to act nationwide, without the need of having a secondary enrollment to act in other jurisdictions. Currently, some local professional boards require a secondary enrollment for telehealth care, for performing appointments with patients living in a jurisdiction other than the one in which the physician is enrolled.

By the way, in line with such standard, the Federal Board of Doctors (“CFM”) edited Resolution CFM No. 2.314/2022, on on May 5th, 2022 (“Resolution”), which regulates telemedicine in Brazil and replaces Resolution CFM No. 1643/2022.

The Resolution emphasizes the importance of in-person appointments, but sets forth a great shift by allowing remote appointments without a pre-existing patient-physician relation. In order to encourage face-to-face care, Resolution provides that the financial consideration for telemedicine appointments shall not be different from that one paid for in-person appointments.

Moreover, the Resolution enhances the protection and confidentiality of medical records, providing that any system for electronic registration of health data (so called SERS) shall comply with legal standards of data security, such as ICP-Brasil. For this reason, physicians that use telemedicine shall necessarily have a qualified electronic signature that complies with ICP-Brasil standards. Additionally, any document issued during online appointments shall be included in medical records and meet all legal standards on data protection and medical records safekeeping.

The Resolution clarifies that telemedicine is not restricted to online appointments, but includes several other types of remote communication, from preparing medical reports and diagnoses remotely to conducting medical screening. In this latter case, the physician assesses the patient’s symptoms through online tools (so called “teletriage”), in order to refer the patient to outpatient or hospital regulation. The teletriage establishment shall offer and assure the regulation system for referring patients.

Lastly, regarding medical companies, both the bill of law and the Resolution establish that companies which intermediate physician services or file medical data and communication platforms shall be registered and have a physician technical responsible enrolled in the Local Board of Doctors, where their head offices are located. According to the Bill of Law, intermediate companies are legal entities that contract, directly or indirectly, physicians to perform telemedicine.

As the Resolution is effective immediate, the market has certainty of continuity of telehealth for medical services post covid pandemic. We will keep monitoring the approval of Bill of Law No. 1.998/2020 and the issuance of similar resolutions for other telehealth services, by the respective professional boards.