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Advances in Telemedicine Regulation in Brazil

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Up until now, telemedicine in Brazil had been regulated by Law 13,989 of April 15, 2020, which provided for the use of telemedicine during the crisis caused by the coronavirus (SARS-COV-2). That is, apparently there was only regulation approved in Congress, after the country faced a national emergency, because of the pandemic that was expanding and causing deaths and sequelae wherever it arrived, forcing social isolation. In fact, social isolation was the driving force for services, such as those resulting from the use of telemedicine.

However, according to statistical data, the pandemic situation has already changed dramatically, becoming endemic in some places, no longer characterizing the previously verified pandemic scenario.

1.3. REGULATION BY THE CHAMBER OF REPRESENTATIVES

On April 24, 2022, an encouragement came to health professionals who serving under this modality and to patients who found an alternate access to medical services, without needing to physically travel to offices, clinics and hospitals. The Chamber of Representatives finally approved the bill (PL 1998/2020) that authorizes and conceptualizes the practice of telehealth throughout the national territory, and the process must now be processed in the Federal Senate, and if approved, proceed to presidential sanction.

According to the bill, telehealth will be understood as the modality of providing health services at a distance using information and communication technologies, through the secure transmission of data and health information through texts, sounds, images, and other forms considered appropriate, and the acts performed by health professionals are considered valid throughout the national territory.

The issue of jurisdiction of the healthcare provider is an important point, since they professional will not need another secondary or complementary registration to that of the board of their state to provide healthcare through telehealth. However, registration will be mandatory to the respective state medical boards  (CRMs) where the intermediary companies of medical services, which hire healthcare providers directly or indirectly, are headquartered. In fact, even the medical technical director of such companies must also be registered in the CRM of the state where the company intends to provide services.

Another provision introduced provides that, at the discretion of the healthcare professional, face-to-face care can be requested from the patient at any time, however deemed necessary.

Telehealth care must always be performed with the free and informed consent of the patient or his/her legal representative.

The bill approved in the Chamber of Representatives revokes Law 13.989/2020 mentioned above, but it is important to note that its approval still depends on a voting round in the Federal Senate, by a simple majority (50% + 1 of those present in the session) and sanction of the President of the Republic.

1.1. REGULATION BY THE FEDERAL MEDICAL BOARD

Following the regulation in progress in the National Congress, the Federal Medical board (CFM) approved on April 20, 2022 and published on May 5, 2022, in the Official Gazette of the Federal Government, Rule CFM 2314, which defines and regulates telemedicine, as a form of medical services mediated by communication technologies.

The rule begins by defining telemedicine as the exercise of medicine mediated by Digital, Information and Communication Technologies (DICTs), for the purposes of assistance, education, research, disease and injury prevention, management and health promotion, allowing both telemedicine in real time online (synchronous), as well as offline (asynchronous), throughout the national territory, given that the data and images of patients, contained in the medical record, must be preserved, complying with legal and CFM standards relevant to the safekeeping, handling, integrity, veracity, confidentiality, privacy, irrefutability and guarantee of professional secrecy of information.

Telemedicine care must be recorded in a physical medical record or in the use of information systems, in the patient's Electronic Health Record System (SRES), meeting standards of representation, terminology and interoperability; This system must enable the capture, storage, presentation, transmission and printing of digital and identified health information and fully meet the requirements of Security Assurance Level 2 (NGS2), in the Brazilian Public Key infrastructure standard (ICP-Brasil) or another legally accepted standard. The responsibility for storing such information lies with the medical professional and if outsourced, the responsibility is shared with the third party providing the service. It should be noted that electronic signature tools are currently only recognized by the authorities of the Judiciary in Brazil if such tools are registered and follow the standard of the Brazilian Public Key Infrastructure (ICP-Brasil).

CFM reaffirms the content of its Code of Professional Ethics in that it is the right of the patient or their legal representative to request and receive a copy in digital and/or printed media of the data of their record, that is, access to their medical record, and must respect the limits imposed by the General Data Protection Law (LGPD).

The autonomy to choose telemedicine care should always belong to the physician, with the option for face-to-face care whenever deemed necessary.

Telemedicine is regulated by CFM for use in the following types of medical teleservices:

MODALITY

DEFINITION

1. Teleconsultation

It is a non-face-to-face medical consultation, mediated by DICTs, with doctor and patient located in different locations, and the patient must be informed of the limitations inherent to teleconsultation, due to the impossibility of performing a complete physical examination. When caring for chronic diseases or diseases that require a long-term follow-up, a face-to-face consultation with the patient's attending physician must be carried out at intervals not exceeding 180 days. Both the doctor and the patient can interrupt the distance care and opt for the face-to-face consultation.

2. Teleinterconsultation

It is the exchange of information and opinions between physicians, with the help of DICTs, with or without the presence of the patient, for diagnostic or therapeutic, clinical or surgical assistance. The responsible physician must be the physician accompanying the patient.

3. Telediagnosis

It is the geographical and/or temporal medical act carried out at a distance, with the transmission of graphics, images and data for the issuance of a report or opinion by a doctor with a specialist qualification record (RQE) in the area related to the procedure, in compliance with the request of the assistant physician. There must be a responsible medical technician.

4. Telesurgery

It is the performance of a surgical procedure at a distance, using robotic equipment and mediated by safe interactive technologies.

5. Telemonitoring or telesurveillance

It is the act performed under the coordination, indication, guidance and supervision by a doctor for remote monitoring or surveillance of health and/or disease parameters, through clinical evaluation and/or direct acquisition of images, signals and data from equipment and/or aggregated or implantable devices in patients at home, in a medical clinic specialized in chemical dependency, in a long-stay institution for the elderly, in a clinical or home stay or in the transfer of the patient until their arrival at the health establishment. Telemonitoring includes the collection of clinical data, its transmission, processing and management, without the patient having to go to a healthcare unit, and must be carried out by indication and justification of the patient's doctor, and all acts must be recorded in the patient's medical record.

6. Teletriage

It is the act performed by a doctor, with evaluation of the patient's symptoms, at a distance, for outpatient or hospital regulation, for defining and directing the patient to the appropriate type of assistance needed or to a specialist, and the healthcare provider must highlight and record that it is only a diagnostic and severity evaluation.

7. Teleconsulting

It is an act of consulting mediated by TDICs between doctors, managers and other professionals, with the purpose of providing clarification on administrative procedures and health actions.

In the case of remote issuance of a report, certificate or medical prescription, the following must be included in the medical record:

1. Physician identification, including name, CRM, professional address;

2. Patient identification and data (address and informed location of the service);

3. Timestamp;

4. Signature with the doctor's digital certification within the ICP-Brasil standard or another legally accepted standard;

5. That it was issued in telemedicine mode.

As in the bill approved by the Chamber of Representatives, the patient or their legal representative must authorize telemedicine care and the transmission of their images and data through free and informed consent (term of agreement and authorization), sent by electronic or recording means of reading the text with the agreement, and must be part of the patient's SRES.

The resolution also addresses 2 important aspects:

Medical teleconferencing by synchronous video transmission, of medical procedure, can be carried out for the purpose of assistance, education, research and training, with the authorization of the patient or their legal guardian, provided that the image, data and audio recipient group is composed exclusively of physicians and/or medical students, all duly identified and accompanied by their tutors.

Legal entities that provide telemedicine services, communication platforms and data storage must have their headquarters established in Brazilian territory and be registered with the Medical Board of the State where they are based, with the respective technical responsibility of a doctor regularly registered with the same Board. If the provider is an individual, they must be a doctor duly registered with the State Medical Board of their jurisdiction and inform the entity on their option to use telemedicine.

As can be seen above, the text of the CFM resolution is perfectly in line with the Bill approved in the Chamber of Representatives.

Undoubtedly, such regulation brings greater legal certainty and ethical limits to the doctor-patient relationship.

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