ABC | Volume 112, Nº4, April 2019

Viewpoint Lopes et al Window to the future or door to chaos? Arq Bras Cardiol. 2019; 112(4):461-465 a II – Clinical protocol and therapeutic guideline: document that establishes criteria for the diagnosis of the disease or health problem; the recommended treatment, with the medications and other appropriate products, when applicable; the recommended dosages; the mechanisms of clinical control; and the monitoring and verification of the therapeutic results, to be followed by administrators at the SUS. that he can give or not give consent, which should not be obtained at the outset as a carte blanche . 12 Essential questions need to be well defined: (1) level of biological safety for the patient; (2) level of ethical and legal safety for the physician; (3) impact on physician training; (4) impact on society's habits. 5 Another point worth mentioning is telesurgery, provided for in Article 8 and defined as "performing a remote surgical procedure, mediated by safe interactive technologies, with medical executor and robotic equipment in distinct physical spaces." 3 Telesurgery is only possible due to robotic surgery, whose clinical application in Brazil is still restricted, being that most parts of the techniques lack assessment by the CFM. In order to be effective, it is imperative that the medical team be composed, at least, of the robotic equipment (remote surgeon) and physician responsible for the instrumental manipulation (local surgeon), both of whommust be specialists with Specialist Qualification Registry ( Registro de Qualificação de Especialista , RQE) in the area corresponding to the main surgical act, registered with the Regional Council of Medicine (CRM) of its jurisdiction, excluding, at least in theory, the performance of telesurgery by physicians not enrolled in the CRM in other countries. 3 The legal competence to define the experimental nature or not of medical procedures is of the CFM, with a focus on Law 12.842/2013, 4 embodied in Article 7, authorizing or prohibiting its practice by doctors inBrazil. In this way, it would be appropriate to insert a device in the resolution restricting the practice of robotic telesurgery to techniques already approved by CFM and in current use in the country, since it would be unreasonable to offer somethingwith restrictedavailability frustrating the fair expectations of the medical profession and Brazilian society. It is worth mentioning that none of the techniques of robotic surgery is part of Brazil’s public policy roll, nor are they included in the ANS Health Procedures and Events Role. In other words, the expansion of the robotic surgery care network, without even being predicted coverage in the country, can inaugurate the “tele-judicialization” of health, a new way of reversing priorities in the country's health system. Finally, it is opportune to discuss Article 9, which regulates the diagnosis: "Telediagnosis must be carried out according to scientific guidelines proposed by the Association of Specialty linked to the method, recognized by the Joint Commission of Specialties, constituted according to Decree No. 8.516, of September 10, 2015.” 13 In this sense, it is important to note that Law 12.401, dated April 28, 2011, 14 defines that the competence to elaborate clinical protocols and therapeutic guidelines a within the scope of the SUS is of the National Commission for the Incorporation of Technologies in the SUS ( Comissão Nacional de Incorporação de Tecnologias , Conitec). Conitec, based on the discussed legislation, has legal attribution for the elaboration of clinical protocols and therapeutic guidelines. The CFM could not, based on a normative resolution, exclude those who have legal competence to elaborate guidelines within the Brazilian health system, delegating exclusively this attribution to private entity, even if conditioned to its approval. The improvement of the standard in this regard is becoming more pressing. Moreover, it would not be too much to say that Resolution 2.227/2018 3 does not have the power to legitimize, broadly speaking, the incorporation of telemedicine in Brazil, but only regulates the participation of physicians in its practice. The entry of any technology according to current legislation, this includes telemedicine, will necessarily consider: I. the scientific evidence on the efficacy, accuracy, effectiveness, and safety of the medication, product, or procedure that is the subject of the proceedings, which is complied with by the entity responsible for registration or authorization for use; II. the comparative economic evaluation of the benefits and costs in relation to technologies already incorporated, including with regard to home, outpatient or hospital care, when appropriate." Resolution 2.227/2018, 3 although necessary, as it is drafted, unless it is better judged, confronts the domestic legislation that regulates the other health professions, as discussed, and should be modified, at least as far as the wording of Articles 4, 8, and 9 are concerned. In our understanding, the wording below would be more appropriate for the opportunity and species. The adequation below would be reasonable as a way of making compatible the already published norm and the set of theses defended in this article: Art. 4 Teleconsultation is the remote medical consultation, mediated by technologies, with doctor and patient located in different geographic spaces. § 1 In teleconsultation, the prior establishment of a face-to-face relationship between doctor and patient is a mandatory premise. § 2 In long-term care or chronic diseases, it is recommended to consult face-to-face at intervals not exceeding 120 days. § 3 The establishment of a doctor-patient relationship in a virtual way is permitted exclusively for health care coverage in geographically remote areas, provided that there are the recommended physical and technical conditions and legally qualified health profissional. § 4 For the purposes defined in this article, it is the responsibility of the Regional Councils of Medicine within their jurisdictions to define, in their own act, which are the geographically remote areas. § 5 The teleconsultation must be duly consented by the patient or his legal representative and performed by free decision and under the professional responsibility of the physician. § 6 In case of participation and training of other health professionals, the requirements of the legislation that regulates their respective professions must be met. § 7 Teleconsultation is prohibited in the scope of supplementary health. Article 8 (...) § 10 Surgical procedures not evaluated or considered experimental by the Federal Council of Medicine should be carried out in research protocols according to the rules of the CEP/CONEP System. 464