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Telemedicine in Brazil: regulatory developments in the wake of Covid-19

Friday 21 October 2022

Camila Martino Parise
Pinheiro Neto Advogados, São Paulo
cparise@pn.com.br

The Brazilian healthcare industry has undergone sweeping changes prompted by the public health emergency of national concern (ESPIN) declared in response to the Covid-19 pandemic. The Federal Government, the Ministry of Health and the National Public Health Agency (ANVISA) rolled out several exceptional and temporary rules to fight the Covid-19 spread and to facilitate the access to essential services while social and physical distancing measures were in place.

Healthcare activities that had no legal backing until then – such as making the first medical appointment online, issuing medical prescriptions in electronic format or dispensing controlled drugs remotely – were then greenlighted, with a positive impact on patients.

As the ESPIN ended in Brazil on 22 May 2022,[1] the temporary rules issued during the pandemic expired and the pre-pandemic set of regulatory standards returned. In view of the positive impact for patients, however, some provisional advancements in the regulation became definitive.

This article addresses the changes to Brazilian telemedicine regulation during the pandemic and the regulatory developments after the end of the ESPIN.

Telemedicine has always been a bone of contention in Brazil. Until the Covid-19 outbreak, there was no law in Brazil regulating telemedicine. The activity was ruled by the Code of Medical Ethics and by Resolution No. 1,643 of 2002 (Resolution 1,643) issued by the Federal Council of Medicine (FCM) and was only enforceable on physicians and legal entities engaged in medical practice.

Resolution No. 1,643, which defined telemedicine as the exercise of medicine through interactive audiovisual and data communication methods aimed at the promotion of health care, education and research, contained no express authorisation or prohibition with regard to remote medical appointments. The FCM, however, fiercely stood against virtual appointments until at least a first in-person appointment had taken place between doctor and patient. As the FCM put it, a first virtual appointment breached the Code of Medical Ethics, according to which no treatment and other procedures could be prescribed without the patient’s direct examination, extending such prohibition to appointments, diagnoses or prescriptions by any mass media.

With the ESPIN declaration, the FCM relaxed its approach to telemedicine as per Official Letter No. 1,756 of 2020 sent to the Ministry of Health, which, in turn, through Ordinance No. 467 of 2020, authorised telemedicine in the country on an emergency and extraordinary basis. Shortly after, the Congress passed Law No. 13,989 of 2020, expressly authorising telemedicine in Brazil during the ‘Covid-19 crisis’, overruling Resolution No. 1,643.

Right after the end of ESPIN, the FCM, recognising the benefits of telemedicine to patients’ care, enacted Resolution No. 2,314 of 2022 (Resolution 2,314) setting new standards of ethics in telemedicine applicable to physicians and healthcare service providers, and revoking Resolution No. 1,643. Among the several innovations brought about by Resolution No. 2,314, the following are worthy of note: (i) the definition of telemedicine was widened to encompass illness and injury prevention, as well as healthcare management and promotion activities; (ii) the first medical (telehealth) appointment between doctors and patients in different locations was allowed, although face-to-face care remains the ‘gold standard’ and is required mainly for chronic diseases or for those in need of long-term care at maximum intervals of 180 days, as a way of preserving and developing the doctor-patient relationship; and (iii) telemedicine was permissible throughout Brazil.

Further, Resolution No. 2,314 has imposed a duty of medical secrecy and warranty to privacy of patient data, also requiring a patient’s explicit informed consent to transmission of their images and data (which consent can be denied by the patient, save in medical emergencies).  

Legal entities providing telemedicine services, as well as data archiving and communication platforms, as per Resolution No. 2,314, must be registered with the Regional Council of Medicine (RCM) with jurisdiction over the state where they are established, and they must designate a physician registered with that same RCM as the responsible technician. As this provision applies not only to healthcare institutions providing telemedicine services, but also to data archiving and communication platforms, doubts have arisen over the FCM’s authority to make such requirement with regard to the latter.

In the same vein of the FCM, upon the end of ESPIN, several professional councils (such as the Federal Council of Nursing,[2] the Federal Council of Pharmacy[3] and the Federal Council of Psychology[4]) acknowledged and issued ethical rules to govern the provision of healthcare services through the use of information and communication technologies.

Within the context of the public health system, the Ministry of Health with the end of ESPIN published Ordinance No. 1,348 of 2022 to regulate the provision of remote care, education, research, prevention of illnesses and injuries, healthcare management and promotion activities using information and communication technologies, namely telehealth, in public health matters.

The Ministry of Health’s ordinance is arguably more far-reaching than the resolution issued by the professional councils in that it does not refer solely to activities performed individually by physicians, nurses or pharmacists, but rather encompasses any and all activities carried out by healthcare professionals.

In the legislative sphere, it is uncertain whether the end of ESPIN has automatically triggered revocation of Law No. 13,989 of 2020 or if the latter remains in force since its validity is conditioned to the end of the ‘Covid-19 crisis’, an undefined event. In view of that, in order to prevent statutory or ethical rules from limiting telehealth and telemedicine in Brazil, Bill of Law No. 1,998 of 2020 and Bill of Law No. 4,223 of 2021 (the Bills) are currently under discussion in Brazilian Congress.

Both regulate the provision of telehealth services, are very similar and mostly repeat the provisions of those statutory rules, such as the national validity of telehealth actions, the freedom and autonomy of professionals to decide on making a first appointment online, the need to apply the same standards of ethical conduct and rules as those effective for face-to-face care and the need to obtain a patient’s informed consent.

Nevertheless, they innovate in other aspects. Bill of Law No. 1,998 expressly provides that potential restrictions on telehealth must be grounded on the need to preserve a patient’s health and repeals Law No. 13,989 of 2020, bringing discussions over its continuing effectiveness to an end, while Bill of Law No. 4,223 establishes that private healthcare plan operators may offer telehealth and are entitled to charge fees in the same way as they do for face-to-face care.

As to compulsory registration of telehealth service providers, Bill of Law No. 1,998 requires registration of companies intermediating medical services (ie, those directly or indirectly hiring healthcare professionals to provide telemedicine services) and the medical officer of these companies with the RCM that has jurisdiction over the states in which such companies are established. For its part, Bill of Law No. 4,223 calls for the registration of all companies that provide telehealth services before the competent local professional council.

As described above, the Covid-19 pandemic boosted the efforts to harmonise the Brazilian regulatory environment in relation to telemedicine and telehealth services, which are expected to continue growing. In Brazil, digital health revenues are estimated at $2.12bn in 2022, according to a report by Statista, a German company specialising in market and consumer data.[5]

Despite the regulatory advances in telemedicine and telehealth regulation after the end of ESPIN, some important measures are still necessary so that telemedicine and telehealth activities can continue to benefit Brazilian patients, such as: the use of reliable and security-certified platforms; the need to train healthcare professionals on providing remote care and suggesting face-to-face appointments when necessary; the need to educate patients on the importance of sharing complete information with doctors (because, in the absence of physical examination, doctors will be guided by the information received remotely); and the duty to obtain and retain a patient’s informed consent.

Notes

 

[1] Ordinance No. 913/2022

[2] Resolution No. 696/2022

[3] Resolution No. 727/2022

[4] Resolution No. 17/2022

[5] www.statista.com/outlook/dmo/digital-health/brazil#revenue