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On April 22, 2022, the Ministry of Health published Ordinance GM/MS # 913/2022, declaring the end of the Public Health Emergency related to COVID, impacting the existence of an array of interim measures.
Among them, we have Federal Law # 13.989/2020, which allowed telemedicine use in Brazil during the Covid-19 pandemic. Conversely, this Law established that when the state of emergency ceases, the Federal Council of Medicine (“CFM”) would be competent to regulate the use of telemedicine.
In that sense, CFM published on May 05, 2022, Resolution # 2,314/2022, which defines and regulates telemedicine as a form of medical services mediated by communication technologies. The new Resolution is immediately into force.
According to the new Resolution, telemedicine is the “practice of medicine mediated by Digital, Information and Communication Technologies (DICTs), for the purposes of assistance, education, research, disease and injury prevention, management, and health promotion.”
The new Resolution authorizes 7 (seven) types of medical telecare: (i) teleconsultation; (ii) teleinterconsultation; (iii) telediagnosis; (iv) telesurgery; (v) telemonitoring or telesurveillance; (vi) telescreening; and (vii) teleconsultancy.
Nevertheless, the new Resolution reinforces telemedicine as an additional tool to face-to-face consultation, which is considered the gold standard.
In the case of remote prescription, the new Resolution establishes it must contain – besides the ordinary and mandatory information – the professional’s electronic signature following ICP-Brasil (Brazilian Public Key Infrastructure – PKI-Brazil) standards and disclaimer that it was prescribed after telemedicine consultation.
For further information on this new Resolution, please do not hesitate to contact our Life Sciences & Healthcare team via email: email@example.com.