After extensive debate, CFM regulates the practice of Telemedicine in Brazil |

The Federal Council of Medicine (CFM) released this Thursday (4) Resolution No.ACCESS HERE), which defines and regulates telemedicine in Brazil, as a form of medical services mediated by technologies and communication. The rule, the result of a broad debate reopened in 2018 with medical entities and specialists, now regulates the practice in place of CFM Resolution No.

“Based on strict ethical, technical and legal parameters, the standard opens the door to comprehensiveness for millions of Brazilians who depend exclusively on the Unified Health System (SUS) and, at the same time, provides security, privacy, confidentiality and integrity of data from patients”, highlighted the president of CFM, José Hiran Gallo.

For him, it is a method that, especially during the pandemic, has demonstrated its great ability to bring assistance to the interior cities and also benefit the large centers, reducing the bottleneck caused by demand and the migration of patients in search of treatment.

The rule guarantees the doctor duly registered with the Regional Councils of Medicine the autonomy to decide whether to use or refuse telemedicine, indicating face-to-face care whenever deemed necessary. This autonomy is limited to the principles of beneficence and non-maleficence of the patient and in line with ethical and legal precepts.

“The face-to-face medical consultation remains the gold standard, that is, a reference in patient care. But the pandemic has shown that telemedicine can be an important complementary act to medical care, allowing access to thousands of patients”, highlighted the rapporteur of the standard, Donizetti Giamberardino. The starting point for the elaboration of the recently approved Resolution, according to him, was also to put Brazilian medical assistance in line with innovation and advances in technology.

For the CFM, when exercised with the use of safe technological and digital means, medicine must aim at the benefit and the best results for the patient, the doctor must assess whether telemedicine is the most appropriate method for the patient’s needs, in that situation. “The doctor who uses telemedicine, aware of his legal responsibility, must assess whether the information received is qualified, within strict digital security protocols and sufficient for the proposed purpose”, points out the standard.

broad debate – Donizetti Giamberardino believes that, by legal force, the health crisis caused a significant increase in the use of Telemedicine, providing even more relevance to the CFM to issue the update of its regulations, which had already been discussed since 2018. Since then, he explains , a Special Commission evaluated almost two thousand proposals on the subject, which were sent by doctors working in public and private services.

In addition, the CFM opened the topic for medical entities across the country to present their contributions, in writing or at specific meetings. Among the participating entities are the Brazilian Medical Association (AMB), the National Federation of Physicians (Fenam), the Brazilian Medical Federation (FMB), Regional Councils of Medicine (CRMs), specialty societies, medical associations and medical unions.

“With this initiative, CFM reinforces its commitment to the category of expanding discussions on changes in these rules, seeking to involve different segments of representation”, said Giamberardino. From now on, CFM Resolution No. 2,314/2022 defines and regulates telemedicine as a form of medical services mediated by technologies and communication.

security and privacy – To ensure respect for medical confidentiality, for example, a fundamental ethical principle in the relationship with patients, in the services provided by telemedicine “the data and images of the patients, contained in the record of the medical record, must be preserved, obeying the legal norms and the CFM pertinent to the custody, handling, integrity, veracity, confidentiality, privacy, irrefutability and guarantee of professional secrecy of information”.

According to the new resolution, telemedicine care must be recorded in physical medical records or in the use of information systems, in the patient’s Electronic Health Record System (SRES), meeting standards of representation, terminology and interoperability.

The anamnesis and propaedeutic data and the results of complementary exams, and the medical conduct adopted, related to the care provided by telemedicine must also be preserved, under the custody of the doctor responsible for the care in his own office or of the technical director, in case of intervention of company or institution.

patient agreement – The resolution establishes that the patient or his legal representative must authorize the telemedicine service and the transmission of his images and data through (term of agreement and authorization) free and informed consent, sent by electronic means or by recording the reading of the text and concordance, and must be part of the patient’s SRES.

It also establishes that, in the case of remote issuance of a report, it must contain the doctor’s identification, including name, CRM record number and doctor’s professional address, patient identification and data, in addition to the date, time and signature of the doctor with digital certification of the physician in the ICP-Brasil standard or another legally accepted standard. In addition, personal and clinical data from medical telecare must follow the definitions of the LGPD and other legal provisions regarding the primary purposes of the data.

“There is no doubt that this technological innovation makes a major contribution to patient care, but as with any healthcare act, the patient needs to be assured that there is a credible governance structure in place. The quality and safety of care should be a priority at these points of care”, points out the rapporteur.

Check out some of the highlights of the new Telemedicine Resolution:

Face-to-face consultation: the doctor has the autonomy to decide whether or not the first consultation can be in person. It is reiterated that the gold standard of reference for medical consultations is the meeting in person, with telemedicine being a complementary act. Remote medical services can never replace the constitutional commitment to guarantee face-to-face care according to the SUS principles of integrality, equity, universality to all patients.

Clinical follow-up: In the care of chronic diseases or diseases that require long-term care, a face-to-face consultation with the patient’s attending physician must be carried out at intervals not exceeding 180 days.

security and secrecy: the data and images of the patients, contained in the medical record, must be preserved, complying with the legal and CFM rules pertaining to safekeeping, handling, integrity, veracity, confidentiality, privacy, irrefutability and guarantee of secrecy information professional.

consent form: the patient or his legal representative must expressly authorize telemedicine care and the transmission of his images and data.

medical fees: the provision of telemedicine services, as a medical assistance method, in any modality, must follow the usual normative and ethical standards of face-to-face care, including in relation to financial consideration for the service provided.

territoriality: companies providing telemedicine services, communication platforms and data archiving must have their headquarters established in Brazilian territory and be registered in the CRM of the state where they are based, with the respective technical responsibility of a doctor regularly registered in the same Council.

Oversight: CRMs will maintain surveillance, inspection and evaluation of telemedicine activities, in their territories, with regard to the quality of care, doctor-patient relationship and preservation of professional secrecy.

Six modalities distinguish the practice of Telemedicine

The resolution establishes that telemedicine is “the exercise of medicine mediated by Digital, Information and Communication Technologies (DICTs), for the purposes of assistance, education, research, disease and injury prevention, health management and promotion”, and can be carried out real-time online (synchronous), or offline (asynchronous).

According to the new Resolution, remote service can be carried out through seven different modalities. See details below.

TELECONSULTATION: characterized as a non-face-to-face medical consultation, mediated by DICTs, with doctor and patient located in different spaces.

TELEINTERCONSULTATION: Occurs when there is an exchange of information and opinions between physicians, with or without the patient’s presence, for diagnostic or therapeutic, clinical or surgical assistance. It is very common, for example, when a family and community doctor needs to hear the opinion of another specialist about a patient’s problem.

TELEDIAGNOSIS: The issuance of a report or opinion of exams, through graphics, images and data sent over the internet is also allowed and is defined as telediagnosis. In these cases, the procedure must be performed by a physician with a Specialist Qualification Record (RQE) in the related area.

TELE SURGERY: It is when the procedure is done by a robot, manipulated by a doctor who is in another location. This modality was recently regulated by CFM Resolution No. 2,311/2022, which regulated robotic surgery in Brazil.

TELEVIGILANCE: Also known as telemonitoring, it consists of the act performed under the coordination, indication, guidance and supervision of health or disease parameters, through clinical evaluation or direct acquisition of images, signals and data from equipment or devices added or implanted in patients.

TELETRIAGE: performed by a doctor to evaluate the patient’s symptoms, remotely, for outpatient or hospital regulation, with definition and directing the patient to the appropriate type of assistance he needs or to a specialist.

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She's our PC girl, so anything is up to her. She is also responsible for the videos of Play Crazy Game, as well as giving a leg in the news.

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