May 4, 2020
Covid-19 pandemic has accelerated the regulatory process of telemedicine in Brazil. On Monday, March 31st, Brazilian National Congress approved Bill #696/2020 that allows the use of telemedicine during the coronavirus’ public health emergency declaration and sent it to presidential sanction. President Jair Bolsonaro sanctioned the Telemedicine Act (Law #13,989/2020) with two vetos.
Previously, the Ministry of Health had already addressed the issue through Ordinance #467/2020, approving telemedicine during Covid-19 pandemic. The approved law reinforces the authorization and confers to it more legal certainty.
Brazil does not have a general regulation of telemedicine in force, beyond the temporary Act approved for the pandemic period. Brazilian Federal Council of Medicine (“CFM”) the federal entity in charge of doctors’ professional regulation practices as well as medical licensing has attribution to regulate the matter. As a federal entity, its acts are equivalent to those issued by Federal Regulatory Agencies. The Code of Medical Ethics (CFM Resolution #1,931/2009) authorizes the use of telemedicine conditioned to the issue of a proper regulation, issued by CFM. There is an ongoing regulatory process, conducted by CFM, that has received over 1,444 proposals from the regulated sector.
The scope of application of the Law #13,989/2020 is narrow and well definied by the Act: the authorization for Telemedicine in Brazil is valid until the public health emergency declaration is in force. After this period, the regulation of the practice must follow its regular path, either by the Legislative or the Executive Branch, through the Health Ministry and the Federal Council of Medicine (CFM).
Law #13,989/2020 is also synthetic, with seven general articles, serving as national guidelines. The grounds established by the Act are the following:
(i) Define “telemedicine” as the exercise of medicine mediated by technologies for the purposes of assistance, research, disease and injury prevention and health promotion. The Law is only directed to doctors and not to other health professionals, such as psychologists.
(ii) There must be mutual consent between doctor and patient regarding the viability of the remote appointment. The doctor must inform the patient of all limitations inherent to the use of telemedicine;
(iii) The provision of telemedicine services will follow the usual normative and ethical standards for face-to-face appointments, including medical charges for the appointment;
(iv) Public Administration will not fund or pay for such activities when it is not exclusively a service provided to Brazil’s Unified Public Health System (SUS).
It leaves the specific aspects of the practice’s regulation in Brazil to the Health Ministry, CFM, Brazilian Health Regulatory Agency (ANVISA) and National Agency of Supplementary Health (ANS). Each of those entities are responsible for different aspects of the telemedicine. Health Ministry is responsible for setting the general rules and guidelines; CFM for defining parameters for doctors’ practice, including charges, restrictions for the use of remote appointments, among others related to the profession; ANVISA for prescriptions and ANS for health insurance coverages.
Regulation issued by those entities must be complied with in order to guarantee the regular practice of the activity.
There were two presidential vetos in Telemedicine Act sanction.
The first regards CFM’s attribution to issue a general regulation on the issue in Brazil. The Article was removed from the text as the President considers that it is a matter for Legislative discussion. Despite the relevance of the competence issue, CFM, since 2018, has already adopted measures to regulate telemedicine, as highlighted in the introduction. The definition of the regulatory competence for the matter will be one of the points to be discussed after the pandemic.
The second comprises electronic prescriptions. In the original text, it authorized the use of digital prescriptions that did not have an electronic certified signature. To prevent frauds, the President chose to follow ANVISA’s actual regulation for the matter. In Brazil, digital prescriptions must meet the ANVISA’s requirements provided in Ordinances SVS/MS #344/1998 and #6/1999. The doctors’ electronic signature in the prescription must be in accordance with ICP-Brasil (Brazil’s Public Key Infrastructure) standards.
The Electronic Prescription project is a result of joint actions from the Brazilian Federal Council of Medicine (CFM), Brazilian Federal Pharmacy Council (CFF) and the National Institute of Information Technology (ITI) that enable the processing of secure digital documents, such as prescriptions and medical certificates through a digital platform.
The platform gives support to telemedicine’s practice in the country. Doctors will be able to file the necessary documents for the appointments and patients will have online access. CFM made available standard forms for several documents, such as prescriptions, certificates, and reports. Those templates are filed by the doctor, who submits the document in the platform and includes the digital signature, using an ICP Brasil certificate. CFM also established a technical cooperation agreement with the Certification Authorities to offer the digital certificate with different conditions to doctors.
The document forms available are:
Our regulatory team is closely monitoring the developments regarding telehealth in Brazil. For more information on this matter, e-mail us at email@example.com.
The english version of Brazilian Covid-19 Telemedicine Act is available here.