ABC | Volume 113, Nº5, November 2019

Guidelines Guideline of the Brazilian Society of Cardiology on Telemedicine in Cardiology – 2019 Arq Bras Cardiol. 2019; 113(5):1006-1056 p. creation of a mood of confidence despite the distance; q. conceptual and event-driven alerts about non-presential limitations; r. individual assessment of the level of competence for the required care at the moment; s. assessment of the completeness of the required information; t. concern with the continuity of the care provided; u. promotion of adherence to the recommendedmanagement; v. respect for professional confidentiality; w. “passport adjustments” related to the state geographical limitation of the physician’s registration in themedical council; x. continued research for reliable evidence of advantages and disadvantages; y. interface with consumerism in health care, including due and undue expectations about the possibility of immediate care; z. valuing the contribution of bioethics to the harmonization between classic, innovative, and novelty. Therefore, in light of the existing ethical-normative bases of the current legislation and the bioethical principles that guide physician-patient relationships, we can establish the following guidelines for the use of telemedicine in cardiology: 1. Cardiologists should use caution, and prior to using telemedicine applied to cardiology (or simply telecardiology), they should maintain a fruitful relationship with their patients based on the Code of Medical Ethics. 2. The free and informed consent form is the document that obtains authorization from the patient for the use of telecardiology when the alternative of direct teleconsultation is considered. 3. Procedures for the remote monitoring of vital signs should be previously consented by the patient, with proper guidance and training regarding its use. 4. Medical companies providing telecardiology services must be registered with the Regional Medical Council ( Conselho Regional de Medicina , CRM) and have a cardiologist as a technical manager, who will be in charge of overseeing the procedures performed, especially regarding the technological tools available to professionals. 5. Respect for the patients’ autonomy of will and protection of privacy regarding health data are the basis of telemedicine applied to cardiology. 1.6. Legislation and Regulation in Brazil The Brazilian Internet Civil Framework (Federal Law No. 12.965, dated April 23, 2014) 34 and the General Data Protection Law (LGPD; Federal Law No. 13.709, dated August 14 2018) 35 are the main normative instruments with direct impact on telemedicine in Brazil, even though they are not specific for this purpose. The main authorities regulating telemedicine in Brazil are the Ministry of Health, the National Sanitary Surveillance Agency (Anvisa), the National Supplementary Health Agency (ANS), and the CFM. 1.6.1. The Brazilian Internet Civil Framework The Brazilian Internet Civil Framework (Decree 8.771, dated May 11, 2016) 34 establishes the principles, guarantees, rights, and duties of users of the World Wide Web in Brazil. The Brazilian Internet Civil Framework recognized legal relations in the virtual world and their effects on Brazilian order. In addition to establishing the neutrality of the web, it also excelled in safeguarding freedom of expression and privacy protection but failed to address important aspects related to personal data, leading to the development of the LGPD. 34 1.6.2. General Law Data Protection Law Federal Law No. 13.709, 35 dated August 14, 2018 (LGPD) deals with the processing of personal data, including digital information, by an individual or entity governed by public or private law, with the purpose of protecting the fundamental rights of freedom and privacy and the free development of the personality of the natural individual. An important contribution of the LGPD 35 is the clear definition of the concept of data: I. Personal data - information related to an identified or identifiable natural individual; II. Anonymized data - data related to a holder that cannot be identified by reasonable technical means available at the time of processing; III. Sensitive personal data - racial or ethnic origin; religious belief; political opinion; union affiliation or membership in religious, philosophical, or political organizations; health- or sex-related data; and genetic or biometric data, when linked to a natural individual. According to the legislation, access to the Internet is essential to the exercise of citizenship, and inviolability of intimacy, privacy, and communications established through the Internet must be ensured to users. Safety and confidentiality measures and procedures must be clearly informed by the service provider and should meet the standards set by regulations, respecting the right of confidentiality related to business privacy. Regarding telemedicine, the need to deal with a large amount of sensitive data (patient registration, health complaints, prior and current disease history, test requests and results, diagnostic hypotheses, therapeutic plan, clinical follow-up, and opinions, among others) makes LGPD an object of significant interest. In 2007, the Brazilian Ministry of Health established the National Telehealth Program to improve the quality of primary health care in the Unified Health System (SUS) and support the Family Health Strategy program. Ordinance 2.546, dated October 2011, expanded, redefined, and renamed the program to Brazilian National Telehealth Network Program, which governs the services of synchronous or asynchronous teleconsultation, telediagnosis, second formative opinion, and health tele-education. 36 1016