FEDERAL MEDICAL COUNCIL UPDATES TO TELEMEDICINE REGULATIONS IN BRAZIL

On February 6, 2019, the Federal Medical Council (“Conselho Federal de Medicina” in Portuguese, hereinafter “CFM”) published Resolution No. 2.227/18, which establishes new rules for Telemedicine care in the country.

Telemedicine care was previously regulated by CFM Resolution No. 1643/2002, however, according to the justification for the new resolution, a revision was necessary due to technological advances in both medicine and electronic communications.

Under the new resolution, the CFM now recognizes that Telemedicine, which was once viewed as a way to care for patients in remote areas far from healthcare facilities or in areas with a shortage of medical professionals, is a tool of greater amplitude, in favor of quality and efficiency of medical services.

Considering that this method of medical care inherently involves issues regarding information privacy and physician’s responsibilities for professional secrecy, in addition to define and enlarge the possible services that can be provided through Telemedicine (such as teleconsultation, telediagnosis, and telesurgery, among others), the new resolution also establishes mandatory requirements for proper collection, custody, and communication of patient data, with express reference to the Brazilian Civil Rights Framework for the Internet (Marco Civil da Internet, in Portuguese) and Brazil’s General Data Protection Law. The resolution will enter into force 90 days from the date of publication.

According to newspaper articles published in Valor Econômico and São Paulo State on February 5 and 6, 2019, while part of the market celebrates this novel change to medicine – which, in theory, will enable the expansion of businesses in the health areas – several medical unions and regional medical councils (CRMs) have reacted negatively to the new rules. Medical unions, CRMs, and other medical entities have objected to the fact that they were unable to participate in the discussions to revise the Telemedicine regulations and have expressed concerns that, in their opinions, the new regulations may result in a distancing between professional and patient, and could leave both parties vulnerable.

In response to the criticisms, on February 5, 2019, the CFM published a clarification note to doctors and the public on its website, repudiating the criticism and clarifying that the standard was indeed created with the participation of the medical community, and that the new rules cover technical, legal, and ethical issues such as the preservation of secrecy and confidentiality. The CFM also emphasized that remote care would be possible after a face-to-face consultation and that the doctor-patient relationship by way of virtual assistance would be allowed in geographically remote areas.

While reiterating that the new resolution will come into force 90 days from the date of publication, the CFM also published on its website on February 6, 2019 that (i) it will allow 60-days for CRMs and other medical entities to submit proposals for the improvement of the new standards, and (ii) it will publish, on its website later this week, details regarding how this public consultation will be conducted.

The first discussions about the regulation took place today, February 7, 2019, at the Telemedicine Forum at CFM’s headquarters.

The Life Sciences team at Kestener, Granja & Vieira Advogados is available to provide further information on this subject.