Life Sciences
Brazilian National Congress overrides vetoes of the Telemedicine Law
updated on Sep 22 at 10:25 am
On August 12, 2020, the Brazilian National Congress rejected two vetoes of the President of the Republic to Law No. 13,989/2020 (Telemedicine Law).
With the overriding of vetoes, the regulation of telemedicine after the pandemic is once again the responsibility of the Federal Council of Medicine (CFM).
In note published on the CFM website (link), the Council stated that a Special Commission is already reviewing the telemedicine practice in the country, and a draft of resolution to be discussed at the CFM Plenary should be presented in the coming months.
Another veto overridden by the Congress concerns the validity of digitally presented medical prescriptions, provided they have an electronic or digital signature of the prescriber, being dismissed the presentation of the prescription form.
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ANS TECHNICAL DIVISIONS SUGGEST THE BOARD OF DIRECTORS STANDS FAVOURABLE TO COVERAGE OF ANY MEDICAL TELECONSULTATION
updated on Jul 13 at 11:35 am
By means of Technical Note No. 7/2020/GGRAS/DIRAD-DIPRO/DIPRO, signed by National Supplementary Health Agency (ANS) technical divisions Coordinators, Directors and Managers, it was recommended that the entity’s Board of Directors stands favourable to the coverage of any medical teleconsultation, regardless of any update to the list of coverages mandatory to health insurance operators, established by RN No. 428/2017, “in a way that medical services rendered via telehealth means should be considered as already mandatory”.
The responsible parties behind the Assistance Regulation, Products Norms and Qualification and Management in Healthcare Technologies defend this point considering that RN No. 428/2017 already sets in the mandatory coverage category unlimited medical consultations, in basic and specialized clinics, comprising all medical specialties. Moreover, they emphasize that many procedures defined as mandatory can be subject to being practiced via telehealth means, used by psychologists even before the COVID-19 pandemic.
They further state that the services rendered by technological means which allow remote communication are not identified as new procedures, nor as homecare (in which the healthcare professional goes to the patient’s house), “but only has a non-face-to-face manner of practice, with the intention to comply with the mandatory coverages”.
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THE BRAZILIAN MINISTRY OF HEALTH REGULATES THE PRACTICE OF TELEMEDICINE DURING THE COVID-19 PANDEMIC
updated on Apr 01 at 02:06 pm
On March 23, 2020, MoH Ordinance No. 467/2020 was published, providing actions in telemedicine that shall be exceptionally and temporarily allowed as a measure against the public health emergency due to COVID-19.
Thus, for as long as the Public Health Emergency of National Concern (ESPIN) – as declared by GM/MoH Ordinance No. 188/2020 – the public, supplementary and private healthcare sectors shall be able to practice pre-clinical, health care, consultation, monitoring and diagnosis services from a distance, by means of technological resources that allow doctor-patient direct communication.
The regulation does not expressly state that the practices above would only be restricted to COVID19 confirmed or non-confirmed cases. On the contrary, it favors the interpretation that telemedicine may be broadly exercised until the end of ESPIN in order to prevent the dissemination of COVID-19 even more efficiently.
The MoH Ordinance also provides that (i) patient’s medical records must be updated after each e-consultation, and (ii) medical doctor may issue sick leave certificates and medical prescriptions, as long as they are electronically signed with the appropriate certifications and electronic keys issued by the Brazilian Public Key Infrastructure (ICP-Brasil).
In this sense, after approval by the Lower and Higher houses of the Brazilian Congress, on March 25, 2020 and March 31, 2020 respectively, Bill No. 696/2020 is pending presidential sanction. It is a federal bill to allow, also, the use of telemedicine in an emergency manner during the crisis caused by the novel coronavirus (SARS-CoV-2/COVID-19), as well as the remote prescription of drugs.
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BRAZILIAN FEDERAL COUNCIL OF MEDICINE TAKES A STAND ON THE EXCEPTIONAL USE OF TELEMEDICINE TO FIGHT CORONAVIRUS
updated on Mar 23 at 02:00 pm
Through the Official Letter No. 1,756/2020, of March 19, 2020 and sent to the Minister of Health, the Brazilian Federal Council of Medicine (CFM) took a position on the use of telemedicine to fight coronavirus pandemic (COVID-19).
According to the letter addressed to the Ministry of Health, telemedicine may be used, in exceptional circumstances and for the duration of the fight against the pandemic, for the following practices:
(a) Teleorientation, so that medical professionals can provide remote orientation and guidance to isolated patients;
(b) Telemonitoring, an act performed under medical orientation and supervision to monitor or attest health and/or disease parameters remotely; and
(c) Teleinterconsultation, exclusively for the exchange of information and opinions between physicians, for diagnostic or therapeutic assistance.
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DOES THE DECLARATION OF A PUBLIC HEALTH EMERGENCY DUE TO COVID-19 AUTHORIZE THE USE OF TELEMEDICINE IN BRAZIL? [Short version]
updated on Mar 19 at 02:11 pm
Given the state of pandemic declared by the World Health Organization (WHO), the Brazilian Government and the Ministry of Health (MoH) have taken urgent measures to provide proper assistance to cases involving coronavirus (COVID-19).
Even without a broader and more complete telemedicine regulation in Brazil, private entities that act in the health sector have already begun to make use of technological resources in order to provide primary and secondary assistance to patients all over Brazil and, at this moment, new questions arise regarding the legality of remote doctor-patient consultations.
The excerpt from the CFM Resolution No. 1,643/2002 comprehended as a limitation to the exercise of telemedicine is extracted from article 3, providing that “in case of emergency, or when required by the responsible doctor, the doctor shall issue the medical certificate remotely and shall be able to duly provide diagnosis and therapeutic support”.
However, that is the same extract that, analysing from a current emergency situation point of view, leads to the conclusion that, even in a temporary manner, the use of telemedicine in Brazil is authorized.
Given the current emergency situation, as declared by the MoH on February 3rd, 2020, by means of Ordinance No. 188, and the prevention and control measures that need to be adopted during the assistance to suspect or confirmed cases of infection due the new COVID-19, pursuant to Law No. 13,979 from February 6th, 2020, it is up to all healthcare services and professionals not only to comply with the provisions in the legislation and acts issued by the Brazilian Federal Government and the MoH, including the National Plan for Human Infection Contingencies, as well as to assure that all internal policies and practices minimize exposition to respiratory pathogenic agents, and also to implement the measures before the patient attends public healthcare service, until the ceasing of measures to tackle COVID-19.
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DOES THE DECLARATION OF A PUBLIC HEALTH EMERGENCY DUE TO COVID-19 AUTHORIZE THE USE OF TELEMEDICINE IN BRAZIL? [Extended version]
updated on Mar 19 at 02:11 pm
Given the state of pandemic declared by the World Health Organization (WHO), the Brazilian Government and the Ministry of Health (MoH) have taken urgent measures to provide proper assistance to cases involving coronavirus (COVID-19).
Even without a broader and more complete telemedicine regulation in Brazil, private entities that act in the health sector have already begun to make use of technological resources in order to provide primary and secondary assistance to patients all over Brazil and, at this moment, new questions arise regarding the legality of remote doctor-patient consultations.
Law No. 3,268/1957 sets out that the Federal Medicine Council (CFM) is the entity responsible for supervising professional ethics and, at the same time, for judging and regulating the medical class. Exercising such competence, CFM determined, when issuing the current Medical Code of Ethics that “remote medical assistance, in the manner of telemedicine or other method, shall be carried out under regulation of the Federal Medicine Council”.
Thus, current rules in force regulating the performance of medical acts by means of telemedicine are provided by CFM Resolution No. 1,643/2002, which defines such practice as “the exercise of Medicine by means of using audio-visual and data communication methodologies, aiming at assisting, educating and researching in healthcare”.
The excerpt from the CFM Resolution No. 1,643/2002 comprehended as a limitation to the exercise of telemedicine is extracted from article 3, providing that “in case of emergency, or when required by the responsible doctor, the doctor shall issue the medical certificate remotely and shall be able to duly provide diagnosis and therapeutic support”.
However, that is the same extract that, analysing from a current emergency situation point of view, leads to the conclusion that, even in a temporary manner, the use of telemedicine in Brazil is authorized.
Undoubtedly, telemedicine represents a measure that assures access to health, as acknowledged by WHO itself, that identifies telemedicine as a form of inclusion and increase the scope of medicine being widely recognized and used by non-governmental organizations and consolidated international movements that focus on protecting the life and health of the human being on an international level, such as the International Red Cross and Red Crescent Movement and the Médecins Sans Frontières organization.
On one hand, despite of CFM’s interpretation on the CFM Resolution No. 1,643/2002, in the direction that telemedicine could only exist as a doctor to doctor relation, one on each end of the communication channel, or in case of an emergency, it is possible to confirm the legality of telemedicine in Brazil, based on provisions in the Brazilian Federal Constitution, the Medical Act Law, among others and mainly on the absence of a prohibiting law.
On the other hand, concern in connection with the practice of telemedicine when not complying with CFM’s regulation is justified considering it could lead to liability implications/penalty imposition to the doctor who provide such service.
Nevertheless, given the current emergency situation, as declared by the MoH on February 3rd, 2020, by means of the Ordinance No. 188, and the prevention and control measures that need to be adopted during the assistance to suspect or confirmed cases of infection due the new COVID-19, pursuant to the Law No. 13,979 from February 6th, 2020, it is up to all healthcare services and professionals not only to comply with the provisions in the legislation and acts issued by the Brazilian Federal Government and the MoH, including the National Plan for Human Infection Contingencies, as well as to assure that all internal policies and practices minimize exposition to respiratory pathogenic agents, and also to implement the measures before the patient attends public healthcare service, pursuant to GVIMS/GGTES/ANVISA Technical Note No. 04/2020.
The ceasing of measures to tackle COVID-19 depend on the termination of the public emergency of national concern, which shall happen when the Healthcare Surveillance Secretariat in the MoH performs a new risk evaluation and declare the end of the emergency in public health situation MoH Ordinance No. 356/2020.
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