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      Guideline of the Brazilian Society of Cardiology on Telemedicine in Cardiology - 2019

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      Arquivos Brasileiros de Cardiologia
      Sociedade Brasileira de Cardiologia - SBC

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          Abstract

          Grades of recommendation and levels of evidence in this update were applied according to the following standards: Classes (grades) of recommendation Grade I Conditions for which there is conclusive evidence or, in the absence of conclusive evidence, a general consensus that the procedure is safe and useful/effective. Grade IIa Conditions for which there is conflicting evidence and/or divergent opinions regarding the procedure's safety and usefulness/effectiveness. Weight or evidence/opinion in favor of the procedure. Received approval by most studies/experts. Grade IIb Conditions for which there is conflicting evidence and/or divergent opinions regarding the procedure's safety and usefulness/effectiveness. Safety and usefulness/effectiveness are less well established, with no prevailing opinions in favor. Grade III Conditions for which there is evidence and/or consensus that the procedure is not useful/effective and in some cases may be potentially harmful. Levels of evidence Level A Data obtained from multiple, concordant, large randomized trials, and/or robust meta-analysis of randomized clinical trials. Level B Data obtained from less robust meta-analysis, from a single randomized trial, or from nonrandomized (observational) trials. Level C Data obtained through a consensus of expert opinions. Declaration of potential conflict of interests of authors/collaborators of theGuideline of the Brazilian Society of Cardiology on Telemedicine in Cardiology - 2019If, within the last 3 years, the author/collaborator of the guideline: Names of guideline collaborators Participated in clinical and/or experimental studies sponsored by pharmaceutical or equipment companies related to this guideline Spoke at events or activities sponsored by industry related to this guideline Was (is) a member of a board of advisors or a board of directors of a pharmaceutical or equipment industry Participated in normative committees of scientific research sponsored by industry Received personal or institutional funding from industry Wrote scientific papers in journals sponsored by industry Owns stocks in industry Alexandre Fonseca Santos No No No No No No No Alexandre Siciliano Colafranceschi No No No No No No No Ana Paula Beck da Silva Etges No No No No No No No Andréa Araújo Brandão No No No No No No No Antonio Luiz Pinho Ribeiro No No No No No No No Bárbara Campos Abreu Marino No No No No No No No Bruna Stella Zanotto No No No No No No No Bruno Ramos Nascimento No No No No No No No Carisi Anne Polanczyk No No No No No No No Carlos Eduardo Rochitte No No No No No No No Cesar Rocha Medeiros No No No No No No No Cidio Halperin Apple No No No No No No Daniel Vitor de Vasconcelos Santos No No No No No No No Daniela Matos Arrowsmith Cook No No No No No No No Edson Correia Araújo No No No No No No No Eduardo Antoniolli No No No No No No No Erito Marques de Souza Filho No No No No No No No Evandro Tinoco Mesquita No No No No No No No Fábio Fernandes No No No No No No No Fabio Gandour No No No No No No No Fausto J. Pinto No No No No No No No Fernando Bacal No No No No No No No Francisco Fernandez No No No No No No No Germano Emilio Conceição Souza No No No No No No No Gláucia Maria Moraes de Oliveira No No No No No No No Guilherme de Souza Weigert No No Conexa Saúde No Conexa Saúde No Conexa Saúde Helena Cramer Veiga Rey No No No No No No No Iran Castro No No No No No No No Jamil Ribeiro Cade No No No No No No No José Airton de Arruda No No No No No No No José Albuquerque de Figueiredo Neto No No No No No No No Juliano Lara Fernandes No No No No No No Hypera Pharma, Grupo Biotoscana Leandro Ioschpe Zimerman No No No Pfizer Bayer, Pfizer, Biotronik No No Ludhmila Abrahão Hajjar No No No No No No No Luis Eduardo Paim Rohde No No No No No No No Marcelo Antônio Cartaxo Queiroga Lopes No No No No No No No Marcelo Souza Hadlich No No No No No No No Marco Antonio Praça Oliveira No No No No No No No Maria Beatriz Alkmim No No No No No No No Maria Cristina da Paixão No No No No No No No Maurício Lopes Prudente No No No No No No No Max Grinberg No No No No No No No Miguel A. S. Aguiar Netto No No No No No No No Miguel Antonio Moretti No No No No No No No Milena Soriano Marcolino No No No No No No No Monica Amorim de Oliveira No No No No No No No Osvaldo Simonelli No No No No No No No Paulo Ricardo Avancini Caramori No No Medtronic SciTech, Biotronik No No No Pedro A. Lemos Neto No No No No No No No Priscila Raupp da Rosa No Aruba/Kapersky No No No No No Renato Minelli Figueira No No No No No No No Roberto Caldeira Cury No No No No No No No Roberto Vieira Botelho No No No No No No No Rodrigo Coelho de Almeida No No No No No No No Sandra Regina Franco Lima No No No No No No No Silvio Henrique Barberato No No No No No No No Thiago Inocêncio Constancio No No No No No No No Wladimir Fernandes de Rezende No No No No No No No Presentation In due time, the Brazilian Society of Cardiology decided to create a guideline on telemedicine applied to cardiology, also known as telecardiology. According to the Pan American Health Organization (PAHO) and the World Health Organization (WHO), telemedicine is “The delivery of health care services, where distance is a critical factor, by all health care professionals using information and communication technologies for the exchange of valid information for diagnosis, treatment, and prevention of disease and injuries, research and evaluation, and for the continuing education of health care providers, all in the interests of advancing the health of individuals and their communities.” Such a seemingly simple and altruistic definition carries a wide range of potential implications at various levels, from an ethical point of view to a potential impact on clinical practice and outcomes. Hence, the importance of guidelines, organized by the medical community through scientific societies, in offering to all of those involved in the process a reference based, as much as possible, on expert opinion, current scientific evidence, and on respect for medical ethical and deontological values. Considering that cardiovascular diseases are the main cause of morbidity and mortality in the 21st century in Brazil and worldwide, the opportunity to use instruments to allow more effective actions in the prevention, diagnosis, treatment, and follow-up of these diseases paves the way to very relevant perspectives of better care for the populations and communities that we serve. At the same time, bioethical aspects and consequences should never be neglected, as they can (and should) undermine programs that, disguised as “medical,” fail to meet these ethical requirements. Therefore, regulated operating models based on guidelines organized by medical-scientific authorities are fundamental in striking a balance. The introduction and implementation of new digital technologies are favoring the emergence of new methodologies (many still experimental) aimed at improving the capacity of intervention on individual patients and allowing for more customized care. We are experiencing what Eric Topol 1 in his latest book, “Deep Medicine: How Artificial Intelligence Can Make Healthcare Human Again,” called the “Fourth Industrial Age” comprising artificial intelligence, robotics, and big data that will have a great impact on the way we live and see ourselves as human beings. If this is very positive at first sight, it is also true that it is not devoid of risk, particularly in the way that we approach or will approach the patient. Therefore, one must not forget the Hippocratic principle: “It is far more important to know what person the disease has than what disease the person has.” In fact, when we are sick, we all want to have our doctor - and not a computer - taking care of us and offering us a word of comfort and confidence. Therefore, we must think smartly about how to apply to human benefit this impressive array of elements that have opened up frontiers that were unfathomable just a few years ago. Telemedicine - or telecardiology - can indeed play a very important role, particularly when this may be the only available resource. However, its use must be properly delineated to prevent abuse and misuse. The present document and guideline was prepared for this purpose. This complete document offers a detailed review of the regulation of telemedicine in Brazil, defines the meaning of a geographically remote area, and describes the fundamentals of telemedicine and the secure grounds for its transmission. This document also offers up-to-date information on current evidence and applications of so-called teleconsultation, telediagnosis, and telemonitoring, and reflects on how telemedicine can provide technology-based medical services, with artificial intelligence playing a key role. The document also includes the economic assessment and budgetary impact of incorporating telemedicine in cardiology in Brazil and telemedicine in supplementary health, and - in one of the most important chapters - presents the ethical and legal aspects of telemedicine. Finally, the document includes a set of recommendations intended to be practical and adapted to the Brazilian perspective. The result is a guideline perfectly aligned with the WHO guidelines on the principle that the implementation of telemedicine must be properly planned and should predict situations like the feasibility of network coverage for technology access in remote locations, construction of a legal and judicial structure for the implementation, budgetary impact and cost-effectiveness assessment of the implementation of each stage of the project, and development of indicators of the clinical continuum of applicability for user safety. As the president-elect of the World Heart Federation, I see this as a model document in terms of how it was planned and implemented, as well as in its content, reflecting the current evidence and perspective of the main scientific players in the area. As such, I think it will become a historical document, a milestone in the responsible introduction of telemedicine-telecardiology in clinical practice, in this case, applied to Brazil, but which can serve as an example for others globally, contributing to decrease the burden of cardiovascular diseases worldwide. Lisbon, June 2019. Prof. Fausto J. Pinto, FESC, FACC President-elect, World Heart Federation (WHF) Past President, European Society of Cardiology (ESC) University of Lisbon, Portugal Introduction For more than 26 years now, starting after the publication of the Consensus on Severe Heart Disease in 1993, 2 the Brazilian Society of Cardiology (SBC) has been regularly issuing guidelines on most diverse topics, guiding the practice of cardiology in Brazil. In 1999, the Brazilian Federal Council of Medicine (CFM) 3 partnered with the Brazilian Medical Association (AMB) and, aiming to support medical decision making and optimize patient care, started a process along with specialty societies for the development of Medical Guidelines based on current scientific evidence. Thus, the commitment of SBC precedes the initiative by AMB and fulfills one of the society’s objectives, described in the society’s bylaws. Resolution 1.642/2002, 4 passed by the CFM to preserve the autonomy of the physician, defined that, in their relationship with physicians and beneficiaries, health insurance and group medical companies, medical cooperatives, self-management companies, and other companies offering direct care or care mediated by medical-hospital services should only adopt medical guidelines or protocols prepared by Brazilian specialty societies along with the AMB. Within this context, 5 the CFM initiated discussions in 2018 to update the regulations of telemedicine. Telemedicine can be defined as the application of information and communication technologies to health care with the goal of offering, in a broad concept, health-related services ranging from primary care to robotic surgery and education, expanding coverage to remote areas in a country with continental dimensions. The Pan American Health Organization (PAHO) and the WHO define telemedicine as “The delivery of health care services, where distance is a critical factor, by all health care professionals using information and communication technologies for the exchange of valid information for diagnosis, treatment, and prevention of disease and injuries, research and evaluation, and for the continuing education of health care providers, all in the interests of advancing the health of individuals and their communities.” The PAHO estimates that one third of the population in the Americas has no access to health care and that 800,000 additional health care professionals would be needed to meet the needs in the region. 6 If applied in its broad context, telemedicine could allow access and reduce inequality for this population by providing supposedly cost-effective quality services, especially considering the increased prevalence and mortality from chronic noncommunicable diseases (NCDs) in low- and middle-income countries like Brazil. Added to this context is the aging and increasing disease rate of the Brazilian population, which makes telemedicine an ideal tool to face the contemporary challenges of universal health care systems. 7 Beyond the vast possibilities and applications of telemedicine, rigorous evaluations of telemedicine projects must be undertaken, not only because all health care systems face financial sustainability challenges beyond investments in health care interventions, but also because of the limited clinical evidence available, especially in the current order of value-based medicine. This topic of utmost importance has been the subject of several publications by the WHO. Examples of that include the Digital Health Atlas, 8 a global virtual platform to support governments in monitoring and coordinating digital health activities; “BeHe@lthy, BeMobile” (BHBM), 9 for the prevention and control of NCDs; and mHealth Assessment and Planning for Scale (MAPS), a manual for digital health monitoring and evaluation 10 to enhance digital health research and implementation; among others. These documents culminated in the publication by the WHO of the first guideline on digital health interventions on April 17, 2019. 11 In addition to updating the guideline on telemedicine applicable to cardiology published in 2015, the main objective of the present guideline is to answer the following questions: Is there legal and ethical support for the application of telemedicine in Brazil? Are there technical conditions for the application of telemedicine in the country? What is the priority of incorporating telemedicine into the health care system? For which modalities is there good quality scientific evidence to support this practice? For modalities supported by solid evidence, does cost effectiveness justify this application? What would be the budgetary impact? Is the Brazilian health care system prepared to provide comprehensive care? This guideline, which is in line with the WHO guidelines, 11 advocates that the implementation of telemedicine should be a planned process that provides feasibility of the network coverage in remote locations, elaboration of the legal and judicial bases for its implementation, budgetary impact and cost-effectiveness assessment of each stage of the project, and development of clinical continuum indicators of the applicability for the safety of the beneficiaries. Telemedicine can be a potential tool in improving health care services but is not exempt from risks and challenges related to its implementation and from the evaluation of the real impact of its benefits. In the final chapter, the authors present a summary of recommendations based on current evidence, in an attempt to guide the discussions that will certainly permeate the democratization of comprehensive health care services, especially the actions involving telemedicine as a tool to expand the universality and integrality of the Brazilian Unified Health System (SUS), recommendations that also extend to supplementary health care. Brazil, June 2019. Dr. Marcelo Antônio Cartaxo Queiroga, FESC, TEC-SBC President-elect of the Brazilian Society of Cardiology (Sociedade Brasileira de Cardiologia - SBC) Director of the Department of Interventional Cardiology, Alberto Urquiza Wanderley Hospital, João Pessoa, PB, Brazil Member of the Paraíba State Academy of Medicine Dr. Gláucia Maria Moraes de Oliveira, FACC, FESC, TEC-SBC Associate Professor of Cardiology at the Federal University of Rio de Janeiro (Universidade Federal do Rio de Janeiro - UFRJ) Coordinator of the Postgraduate Cardiology Program at UFRJ, Rio de Janeiro, RJ, Brazil President of the Federation of the Cardiology Societies of the Portuguese-Speaking Countries (2015-2016) 1. Fundamentals of Telemedicine: Concepts, Bioethical Aspects, Legislation and Regulation, Applicability in Brazil, and Artificial Intelligence 1.1. Fundamentals of Telemedicine In May 2005, Ministers of Health from 192 countries members of the World Health Organization (WHO) approved the Resolution on eHealth, 12 which recognized for the first time the importance of information and communication technologies (ICTs) applied to health - digital health or eHealth - “reinforcing the fundamental human rights by increasing and improving equity, solidarity, quality of life, and quality of care.” The Brazilian Ministry of Health defines the following areas of telehealth application: 13 Innovation in digital health and telehealth Innovation in digital health is transversal to telehealth initiatives and seeks to explore via ICT new ideas to solve chronic problems with difficult solutions by usual methods. It must start with the population’s health care needs. Teleconsulting Registered consultation between health care workers, professionals, and managers using two-way telecommunication instruments in order to answer questions about clinical procedures, health care actions, and suggestions related to the work process in health care. Teleconsulting can occur in real time or by offline messaging. Telediagnosis Autonomous service using ICT to deliver diagnostic support services (e.g., remote evaluation of diagnostic tests) to facilitate access to specialized services. The use of telediagnosis seeks to reduce the time to diagnosis by enabling treatment for predictable complications through early diagnosis. Telemonitoring Remote monitoring of patients’ health and/or disease parameters through ICT. Monitoring may include clinical data collection, transmission, processing, and management by a health care professional using an electronic system. Teleregulation Set of actions in regulatory systems for evaluation of adequate responses to existing demands, promoting equity and access to services, and enabling health care access. Teleregulation also includes the evaluation and planning of actions to provide regulatory operational intelligence to management teams. The objective of teleregulation is to potentiate primary health care services, thus enabling the qualification and reduction of wait for specialized care. Tele-education Availability of interactive educational materials on health-related topics delivered remotely through ICT and focused on professional education across activity areas. 1.2. Types of Intervention in Telehealth Synchronous video conference: modality of remote interaction via live conference between primary care and medical specialty services. Asynchronous video conference (“store and forward”): use of a storage system to forward diagnostic images, vital signs, and/or video clips along with patients’ data for later review by a specialist. Provides diagnostic and treatment support for the primary care system. Remote monitoring: use of equipment to remotely collect and forward patients’ data to a hospital or monitoring center for interpretation. These (wearable) devices monitor remotely a variety of indicators ranging from specific vital signs (heart rate, blood pressure [BP], and blood glucose) to other indicators. Mobile health (mHealth): defined as a medical and public health care practice supported by mobile devices like cell phones, monitoring devices, personal digital assistants (PDAs), and other wireless devices. 14 The goals of telemedicine include: Remote assistance: teleconsultation, telediagnosis or diagnostic telemonitoring, remote patient monitoring and/or treatment; Administrative management of patient care: request of diagnostic tests, medical prescriptions, and actions related to service reimbursement; Remote qualification of human resources to facilitate continuing education programs; Network collaborative clinical research: use of ICT to share and disseminate best practices and generate knowledge. 1.3. Safe Bases for Data Transmission Information safety is fundamental for data transmission, and two immediate effects must be considered: a) understanding of the critical value of data storage and use, and b) possible implications for individuals and organizations of violating safety and compliance standards. The European General Data Protection Regulation (GDPR) and the Brazilian General Data Protection Act (Lei Geral de Proteção de Dados, LGPD) impose heavy fines and sanctions for improper access to information under their custody. The following sections list the main requirements for establishing appropriate safety policies. 15 1.4. Data Protection and Confidentiality For proper information protection, the safety of the systems must be ensured, reducing vulnerabilities and preventing improper access and breach of confidentiality. Authorizations and hierarchical levels for access to information must be clearly determined. 16 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: