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:
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);
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:
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.