Publicado em 22/04/2020

Covid-19 | Law 13.989/2020 authorizes the practice of telemedicine

Law 13.989/2020 was published on April 15, 2020, authorizing the use of telemedicine throughout the country while the health crisis caused by the SARS-CoV-2 Coronavirus continues. The measure aims to make medical care safer and reduce the rate of contagion, also allowing for services not related to the new Coronavirus to take a normal course even during the period of social isolation.

Modalities of Telemedicine

Telemedicine’ consists of the provision of certain types of health services at a distance. Although this idea is generally associated with medical care for patients by modern technological means such as video conferencing or remote-controlled robotic surgeries, telemedicine includes several possible applications of communication and information technologies for the development of activities related to health services.

Considering the wide interpretation of telemedicine definitions, the possible modalities of telemedicine present immense potential for the health sector. Law 13,989, in its article 3, presents a broad definition that includes “the exercise of medicine mediated by technologies for the purpose of assistance, research, prevention of diseases and injuries, and health promotion,” among others.

Thus, the term may include from consultations made by videoconference to the exchange of medical information between institutions. Taking as a basis the currently revoked Resolution CFM no. 2,227/2018, the modalities already named include teleconsultation, teleinterconsultation, telediagnosis, telesurgery, medical teletriaging, telemonitoring, teleconsulting, and remote medical prescription. This list, however, does not rule out the possibility of other types of care, whether in real time or not, given the open nature of the list in Law No. 13,989/2020.

The regulation of Telemedicine in Brazil

The provision of health services at a distance by digital means has been foreseen since 2002 in a Resolution of the Federal Council of Medicine, but until recently it had not been regulated. In 2018, the CFM published Resolution no. 2,227, which regulated the practice, addressing several aspects of this new form of health service provision, such as minimum safety requirements, records to be kept of the services provided and even modalities of remote surgery.

The Resolution, however, generated great debate among health professional associations and was the object of criticism. The Resolution, however, generated great debate among health professional associations and was the object of much criticism. Among them, the main ones touched the obligation of recording the consultation, which would bring a great risk to the doctor-patient confidentiality, and lack of clarity regarding the responsibility of the doctor who performs the services remotely. In light of this scenario, the CFM revoked Resolution nº 2,227/2018 in February 2019.

In this scenario, the CFM Resolution of 2002 remained in force, of reduced practical application due to the absence of subsequent regulation. With the beginning of the public health crisis caused by the Covid-19 outbreak, a contagious disease with high risk of transmission by proximity, interest in telemedicine was rekindled in several sectors. The argument to press for authorization to practice telemedicine concerns the safety of health professionals themselves and their patients, preventing them from being exposed to the possibility of contagion during medical care. This caused the Federal Medical Council to send a letter to the Ministry of Health defending and recognizing the need and possibility of authorizing the practice of telemedicine, at least during the crisis.

In response to this letter, the Ministry of Health issued Ordinance No. 467/2020, which partially authorized and regulated the practice of telemedicine and electronic prescriptions, but there were still doubts about the legal security of this type of service based on a mere Ordinance and Resolution of the CFM. With the new Law, the authorization for the use of telemedicine gains the status of a federal law, giving greater security to players in the health market to start operations in this field.

Law 13,989 of 2020

With the growth of discussions about telemedicine and the perception of its benefits in times of crisis, a large part of the market is currently betting on an advance that will hardly be abandoned after the end of the crisis, with the prediction that telemedicine and the use of remote health care technologies are here to stay. This movement follows other areas of health services that have been experimenting with remote care for some time, such as psychotherapy, in which online care is authorized since 2012 and is now regulated by Resolution nº 11/2018 of the Federal Council of Psychology.

Law 13.989/2020 is quite synthetic in material terms. Article 4 of the rule establishes an obligation for the physician to inform the patient about the limitations of this method of care, especially in view of the impossibility of physical examinations during the consultation, an obligation that can be deduced from the very rules of medical ethics but whose explanation seems to indicate concern with the patient as a consumer of services. In the same line, article 5 establishes that the service must follow all other legal, ethical and administrative rules applicable to face-to-face care, further clarifying that financial compensation for the service will be due, in the same manner as traditional care.

Without other provisions, the correct interpretation of the rules generally applied to health services in a context of technological innovation becomes highly necessary, in order to seek minimum safety and transparency standards and to search for reasonable standards based on the rules in force, a delicate work due to the absence of clear indications and which must be based on a risk approach, considering both the doctor and the patient.

Precautions in the implementation of Telemedicine

In view of the scenario described above, some precautions are needed in the deployment of telemedicine services. Among the main concerns that should guide such a project, one can highlight:

1. The importance of maintaining the secrecy, integrity and availability of medical information related to the care, considering minimum information security measures and reasonably safe systems;

2. Appropriate controls on the collection and processing of personal health data, considering the imminent entry into force of the General Data Protection Law (Law nº 13,709/2018);

3. The minimum transparency necessary regarding the service provided, considering both the information to be provided to the patient and the records that must be kept by the health professional;

4. The registration of the informed consent of the patient, in a compatible and safe format, so as to enable remote care;

5. The adoption of an appropriate format or system for issuing electronic documents, such as reports, certificates, and electronic prescriptions, necessary in the course of treatment;

6. The awareness and, to the extent possible, limitation of medical liability in relation to the services and technological means employed;

7. The practical and ethical limitations to remotely conducted care.

The transition from a traditional model of care to health services intermediated by technology should be made cautiously, in order to avoid embarrassment to the patient and minimize risks to all involved.

We continue to follow the development of this matter, reporting on any relevant news.