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 The policy related to information access and confidentiality must be reported in a document signed by the users defining the a) scope of data that can be accessed and b) legal implications and sanctions eventually applied to users in case of violation of the agreed rules. Misuse of technological installations is directly related to the safety of the environments under the responsibility of ICT teams. Strict policies must be adopted in terms of access to physical facilities, data networks, operating systems, and databases and their applications. A valuable framework to provide an understanding of the control of these environments can be found in the document “Access Control Example Policy” (Health and Social Care Information Centre, 2017). 16 The recommended standard for data transmission in Brazil follows the set of rules determined by the Health Insurance Portability and Accountability Act (HIPAA). 17 This set of norms has proven robust enough to ensure the safety of the transferred data and is recommended as the benchmark for data transfer practices. The CFM Resolution 2.227/2018, now revoked, set the standard that would meet the desirable requirements: “Use of a proprietary or an open-source electronic/digital information registration system that captures, stores, presents, transfers, or prints digitally identifiable health information and is fully compliant with the requirements of Safety Assurance Level 2 ( Nível de Garantia de Segurança 2 , NGS2) and the ICP-Brazil standard.” According to these standards, stored data (“at rest”; “in transit”) must be encrypted for transfer. One of the essential practices for data security is to maintain the tools required to encrypt and decrypt information in environments other than the original storage locations. 18-20 In addition to ensuring information security, HIPAA rules offer extensive documentation for data encryption and transfer, facilitating the work of development teams. Of note, national public data cannot be stored in cloud systems hosted outside the country. 21-22 1.5. Bioethical Aspects Initiatives to provide remote health care through telemedicine date back to the 19th century. Cardiology was a pioneer in this initiative, with the description by Einthoven in 1906 of a transtelephonic electrocardiographic transmission from the academic hospital to the physiology laboratory at Leiden University, a few miles away. 23 The big boost in the development of telemetry was by the North American Space Agency (NASA) in astronaut monitoring. 24,25 However, the incorporation of telemedicine, as currently conceived, is contemporaneous 24-29 and linked to the traditional notion that the preservation of the social value of medicine depends on content flow. Any modality of telecommunication holds both constructive and destructive potentials that trigger contradictions in terms of values and rules of moral code related to bedside medical practice. Ambivalence is welcome in medicine, which according to Osler (1849-1919), is the science of uncertainty and the art of probability. 28 Telemedicine is not immune to the pendular movements of the variety of methods addressing health needs. Bedside practice faces dilemmas inherent to the diversity of the human condition. 30 Physicians and patients face external and/or internal challenges without a single and simple solution. Any option to be considered must be judiciously expressed, clarified, and adjusted to be validated for the conceptual and individual context of the clinical circumstance. Applied technology has attributed a sense of real progress to medicine. 31 The contemporary emphasis on ICTs in health care must be critically observed by society. Bioethics has the required competence to evaluate the effects of telemedicine on the integration of health sciences, health care professionals, patients/relatives, health institutions, and health care system. The benefit of telemedicine should be considered more as a non-presential complementation of usual care rather than a replacement for face-to-face care. Telemedicine should be practiced with security and for a period relevant to the clinical circumstance (expiration dates proportional to the legitimate interests involved). 32,33 An additional ethical aspect is that certain unavoidable perspectives of abuse of a technique should not adversely affect the beneficial use of the technique. Therefore, any ethical and legal considerations regarding the still young telemedicine, especially for application in a continental, multiethnic, and multicultural country like Brazil, cannot fail to recognize that it is difficult for a health care professional to define comprehensively and in depth his or her set of responsibilities, considering that the scope of telemedicine demands an A-to-Z range of intertwining requirements, decisions, and provisions regarding: a. involvement with fundamentals of current ethics, prudence, and zeal regarding complex issues like elderly care, comfort of vulnerable individuals, decrease in hospitalizations, and prompt guidance; b. impartial judgment about covering the patient’s real needs and constraint of secondary gains and conflicts of interest, including the potential for political (mis)use and power; c. sense of beneficence; d. avoidance of maleficence; e. commitment to the biological safety of the patient; f. respect for equity; g. definition about the complementary function of the “presential” and its substitute; h. awareness about the consequences of the “non-presential” on clinical reasoning; i. clarity about the range of use variations; j. training on roles, responsibilities, and skills in equipment management with continuous improvement; k. development of a friendly connection to the patients’ records; l. respect for the patient’s right to autonomy expressed through free, informed, renewable, and revocable consent; m. imperative appreciation of human values; n. critical appreciation of cost effectiveness; o. appreciation of the value of face-to-face relationships immediately or long before the online connection; 1015