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Brazil to provide new framework on telehealth

by | Aug 22, 2022 | Blog, data protection, Intellectual Property, Life Sciences, Technology

According to a recent study, the global telehealth market grew to USD 144,38 billion in 2020, which represents growth of 135.2% on the 2019 average. In Brazil, revenue in the digital health market (including different technologies such as health apps, wearable devices, and telemedicine) is projected to reach US$2.12bn in 2022.

The Brazilian Congress is currently discussing new legislation to definitively regulate telemedicine in the country, a move that could ultimately have a profound effect on both the Brazilian public and private health sectors. The term ‘Telemedicine’ refers to the remote treatment of patients by means of telecommunications technology.

The bill, which seeks to regulate so called “telehealth” services across Brazil has already been discussed by the Chamber of Deputies and is currently under review in the Senate.

In June 2022, the Brazilian Ministry of Health had already introduced new regulations on Telemedicine, encompassing the broader concept of telehealth, which could also apply to other fields, such as psychology or physical therapy, for example.  It also recently announced the investment of BR$ 14.8 million to develop Digital Basic Health Units across the country.

It is clear that the Brazilian Ministry of Health has incorporated telemedicine into its long-term public health strategy, as a measure to reduce costs, and also provide access to health across the national territory.

Some brief background

Under the old laws, telemedicine practices were effectively outlawed in Brazil, a position that became increasingly untenable in view of the new technologies emerging on the market, increasing the efficiency of such services (e.g., 5G internet, AI, the internet of things, etc.).

While telemedicine and telehealth initiatives where already on the government agenda prior to the Covid 19 outbreak, the pressures of the pandemic led to the urgent need for patients to consult with doctors without putting themselves at risk to contamination by the virus. As a result, the Brazilian Ministry of Health was forced to act in 2020 by regulating online healthcare access to patients on a temporary basis.

With the official ending of the state of emergency due to Covid-19, the Brazilian Ministry of Health took further regulatory steps in 2022, to deal with some important details regarding the regulation of the practice (e.g., the relationship to laws regulating the medical profession, confidentiality, privacy and data protection).

The new framework on telehealth

In 2020, the field of telehealth was regulated as an exceptional measure to deal with the Covid 19 pandemic, but this temporary status left many questions unanswered, particularly regarding the regulation of the medical profession and questions related to confidentiality and data protection.

In response to this challenge, the new regulations now make express reference to different laws that apply to the area, including Brazil’s Internet Law and the Brazilian General Data Protection Law.

Importantly, amongst further requirements, the new regulation on telehealth (1348/22) states that:

  • Such services should be carried out directly between health professionals and patients, through information and communication technology that guarantees the integrity, privacy, security and confidentiality of information;
  • Telehealth actions and services must be carried out in mobile and fixed health units with the proper registration at CNES (the Brazilian national registry of health facilities);

Furthermore, Telehealth acts and services must:

  • be practiced by health professionals duly registered with regular status in the respective professional supervisory boards;
  • be made available by digital platforms whose technical manager is registered in the respective professional council;
  • comply with the ethical precepts of good faith, non-maleficence, confidentiality of information, autonomy and other ethical standards in force;
  • observe the patient’s free decision and informed consent;
  • observe the norms and guidelines of the Ministry of Health on compulsory notification of diseases and other health problems;
  • ensure privacy, confidentiality, data protection and information security, and comply with the provisions of Law No. 12,965, of July 10, 2013 (“Marco Civil da Internet”), in Law No. 2018 (“LGPD”), in Law No. 12,527, of November 18, 2011 (“Access to Information Law”), and in the Professional Codes of Ethics;
  • follow the ethical precepts of each profession in the exercise of health activities mediated at a distance, observing the same standard of care quality as that adopted for face-to-face care; and
  • provide their updated data to the official databases of the Ministry of Health.

In addition, the regulation clarifies that patient care through information technology within the scope of the SUS must be recorded in the clinical record, in compliance with the rules and standards of interoperability and health information established by the Ministry of Health.

Looking forward, Bill 1,998/2020 is set to definitively authorise and regulate telehealth practices in Brazil.

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