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: