Federal Council of Medicine regulates telemedicine services in Brazil
Pre-existing telemedicine guidelines replaced by new resolution, in effect as of May 5, 2022
On May 5, 2022, the Brazilian Federal Council of Medicine (CFM) published CFM Resolution No. 2,314/2022, sanctioning and regulating telemedicine in Brazil. Effective immediately, the new resolution revokes a previous resolution regulating telemedicine before the pandemic and other regulations that were put in place because of it.
According to the CFM, the pandemic and subsequent health crisis have contributed to a significant increase in telemedicine, and as such, updating regulations was urgently required.
The new resolution establishes rules for remote medical care, covering specific forms while still recognizing that in-person care should remain a priority in healthcare, with telemedicine taking on a complementary nature.
General regulatory aspects
CFM Resolution No. 2,314/2022 defines telemedicine as “the practice of medicine using digital, information and communication technology (TDICs) for assisting patients, education, research, disease and injury prevention, and healthcare management and promotion”. Remote assistance still requires the patient’s authorization, which must be formalized through a term of consent.
When attending to patients remotely, physicians must follow the same ethical and legal standards as with in-person care, including in regard to the financial value of the service provided. Medical professionals have autonomy when making decisions on the use of telemedicine, and are able to refer patients for in-person care whenever necessary. However, the resolution clarifies that medical professionals remain liable for any possible problems stemming from the decision to opt for telemedicine over in-person care.
Telemedicine services may only be provided by Brazil-based legal entities registered with the Regional Council of Medicine (CRM) in the state where they conduct their activities. They also must hold a respective technical responsibility certificate. Similarly, if an individual physician provides the service, they must be a member of the CRM and must inform the council when they opt for telemedicine assistance.
Similarly, legal entities that provide communication and archiving services for the telemedicine data must also be headquartered in Brazil and registered with the CRM in the corresponding state.
Documents and data protection
Remote medical services must follow the Brazilian General Data Protection Law’s (LGPD) provisions when processing personal data linked to medical care.
According to the new resolution, telemedicine assistance must also be recorded in physical medical records or other information systems, such as the patient’s Digital Medical Record (SRES). In the event a medical report, certificate, or prescription is issued, the resolution determines that the medical record must:
• Identify the physician, including name, CRM registration, and work address;
• Identify the patient, including personal details (address and place of care);
• Register the date and time of the medical consultation;
• Include the physician’s signature and digital certification following ICP-Brasil standards (or other legally accepted standards) issued for telemedicine.
Forms of telemedicine
The new resolution defines teleconsultation as a medical appointment carried out remotely (physician and patient located in different places) through communication technology, such as cell phones, computers, and other similar devices.
Both patients and physicians have the right to terminate remote medical services – respecting the pre-established term of consent – and continue the treatment in person.
For chronic diseases or those requiring long-term follow-up, in-person consultations must take place at least once every 180 days, as the resolution determines that medical care cannot be entirely provided at a distance in such cases.
According to CFM Resolution No. 2,314/2022, it is possible for doctors and patients to first establish contact via a telemedicine consultation. However, an in-person follow-up consultation is also required.
In addition to teleconsultation, the resolution regulates other forms:
• Teleinterconsultation (exchange of information and opinions between physicians);
• Telediagnosis (sharing data between doctors in order to prepare a report or expert opinion);
• Telesurgery (performing surgery at a distance, using robotic equipment);
• Telemonitoring or telesurveillance (remote patient follow-up);
• Teletriage (evaluation and definition of the patient’s symptoms, with directions for proceeding);
• Teleconsultancy (when doctors consult each other about administrative processes and health-related actions).
The new resolution also permits teleconferences (video transmission) for medical procedures regarding patient assistance, education, research, and training. Again, the patient must authorize this, and all people who receive the teleconference’s images, data, and audio must exclusively be physicians or medical students.
The post-Covid-19 scenario
With the onset of the pandemic in 2020, Law No. 13,989/2020 was enacted to authorize the use of telemedicine, specifically during the government-mandated Covid-19 health crisis in Brazil.
To provide greater security and permit telemedicine initiatives to continue in perpetuity, Bill No. 1,998/2020 was introduced to the Brazilian Congress, though it has yet to be passed into law. As well as authorizing telemedicine as a medical practice, the bill seeks to regulate telehealth (i.e., remote healthcare services using information and communication technology) in Brazil.
The House of Representatives recently approved the proposed text, which is set to be sent to the Senate for final deliberations.
The publication of the CFM’s new resolution prior to the federal law represents an advance in terms of specific telemedicine regulations. However, it is still necessary to wait for Bill No. 1,998/2020 to be passed into law to verify the resolution’s conformity.
For further information about telemedicine and other legal developments that impact the health sector, please contact Mattos Filho’s Life Sciences & Healthcare practice area.
*With the collaboration of Henryk Trelinski Alvarenga.