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.

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.

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

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

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 contemporaneous24^-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:

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;

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:

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.

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.

Procedures for the remote monitoring of vital signs should be previously consented by the patient, with proper guidance and training regarding its use.

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.

Respect for the patients’ autonomy of will and protection of privacy regarding health data are the basis of telemedicine applied to cardiology.

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.

In a country with continental proportions like Brazil, telemedicine represents a perspective to ensure the implementation of public policies conceived when the SUS was established, which have not been entirely fulfilled due to existing unassisted or remote areas lacking health care professionals, among other reasons. Thus, infrastructure conditions must be established to deliver available resources using health-related ICTs to these areas. To understand the applicability of telemedicine in Brazil, it is important to discuss concepts related to remote areas and to know the country’s medical demography.

Artificial intelligence (AI) is a complex framework of sophisticated mathematical-computational models that allows the construction of algorithms to emulate various human tasks. AI encompasses an increasing number of subareas translating into different combined or complementary methodologies and approaches. Some examples include artificial neural networks (particularly deep learning models and convolutional networks), support vector machines, evolutionary algorithms, and natural language processing. The elaboration of analytical algorithms derived from large databases allows for interactive interpretation and apprehension, recognition of hidden patterns of combined information not obtained with traditional statistical methods, and assistance in more accurate decision making.

The availability of this huge amount of data and new analytical techniques - big data analytics - opens up new scientific possibilities and AI applications, such as machine learning and data mining, which are already widely applied in telecardiology to diagnose combinations of multiple modalities of images, biobanks, electronic cohorts, on-site and distance clinical monitoring sensors, electronic health records, genomes and other molecular techniques, among others.52^-54

The implementation of these applications in clinical cardiology has grown exponentially55 and has prognostic features, like the use of an algorithm derived from magnetic resonance based on three-dimensional patterns of right ventricular systolic function to assess with high accuracy the outcomes in pulmonary arterial hypertension,56 identification of phenotypic patterns in heart failure with preserved ejection fraction and unfavorable prognosis confirmed by heterogeneous patterns of ventricular repolarization on electrocardiogram,57 prediction of cardiovascular risk in large cohorts,58 and prediction of urgent revascularization in emergency patients with chest pain,59 among others. However, AI studies are generally based on observational data from administrative databases or clinical records, which potentially have different types of biases and confounding factors.54

AI applications in telemedicine are promising but still very limited.60 In the area of telediagnosis, efforts for automated classification and diagnosis in electrocardiography and cardiovascular imaging61 are promising but still incipient. As for cardiovascular interventions, a recent review62 found 8 studies incorporating machine learning in a real-life research setting, of which only three were evaluated in a randomized controlled trial. Of the 8 interventions, 6 (75%) showed statistical significance (at a p level of 0.05) in health outcomes. Some of these interventions are directly related to telecardiology and assessed interventions for weight loss, stress control, smoking cessation, and personalized nutrition based on glycemic response. Most studies had small sample sizes and short duration, reflecting a need for investments and further studies exploring the potentialities in the area.

In a recent review, Topol63 highlighted the presuppositions that will guide the future of AI in medicine: the patient must be considered the center for the implementation of any new technology, the incorporation of these new technologies for diagnosis and treatment should occur after robust validation of their clinical effectiveness, the use of digital tools and decision algorithms by patients should be an option for those who feel empowered to do so, and interdisciplinary training must involve health care professionals, engineers, computer scientists, and bioinformaticians. These minimum conditions presuppose the steps to incorporate AI into clinical practice and minimize implementation challenges.

However, many aspects of health care practice will continue to depend on other dimensions, such as political, economic, and cultural ones, and on the ability of the health care professionals to interact with patients and community so that AI can truly benefit the patients, given that the issue of unequal access to health care is still critical in Brazil and will require large investments and reorganization of the health care system.54

Thus, potential strategies for incorporation and planning of implementation and adoption must be aligned with the possibility and challenges of offering cardiology care centered on the patient and the final value aggregated to the line of cardiology care. There is a need to identify the best technology to incorporate and define in which part of the medical work process such technology can add value to both the process and the patient’s health. Additionally, it is necessary to plan the incorporation and design the journey of digital transformation in cardiology to ensure a high technological level.

The incorporation of these technologies into clinical practice must, at first, involve rigorous evaluation of their performance and their ultimate value for the patient. This evaluation should respect and follow the current evaluation process of incorporation of new health technologies by the Ministry of Health, considering all aspects, norms, and regulations. The incorporation should also be based on scientific evidence on the generation of ultimate value to the patient’s health from the perspective of an individual exposed to technology.

It should be made clear that AI, once incorporated, works by increasing the professionals’ capabilities and never by replacing them, and that all civil and criminal responsibilities, as well as all responsibilities related to the patient and his or her health problem, remain with the attending physician.64

Training should be multiprofessional, interdisciplinary, and focused on building services dedicated to generating the ultimate value for the patient. The medical curriculum in the cardiology area should include contents related to technical knowledge, competence development, and use of AI techniques, while cardiology services should structure a continuous program for professional qualification and human resources training in managing incorporation, training, and adoption of new digital health technologies.

At present, there is no specific regulation on the use of AI in health care, although countries like Canada, United Kingdom, and the United States have begun the first phases of planning and implementing AI regulation in this area. Also, the European Union has published a document on the ethical aspects of AI in health care.63 The fast-paced digital transformation has led to reflections on how to balance the adoption of technology and emerging digital systems with ethical, moral, emotional, and social values, particularly values related to patients’ safety.

With the development of the Information Society in the late 20^th century as a result of globalization and widespread use of ICT, the emergence of organizational, social, political, and economic innovations of the society became pressing issues, requiring new ways to learn, teach, and work. The world began to worry about the principles of equal opportunity, participation, and integration so that everyone could access and benefit from the applications of the Information Society. In health care, telemedicine has made substantial progress worldwide, as it is classically viewed as a set of actions with great potential to improve access to health care services and to care quality and effectiveness at a lower cost.65

As a mark of the new millennium, we highlight the aging of the population, the increase in chronic noncommunicable diseases, and the consequent need to provide health care services for a longer time, which increases health-related costs. Therefore, it is essential to incorporate innovative, efficient, and effective solutions like telemedicine and biotechnology to promote universality and comprehensiveness in health care.

Several actions in telemedicine are currently present in all continents and must be planned according to local needs in order to be successful. According to Bashshur et al.,66 the success of these actions depends on three pillars: access, quality, and cost.66 In developed countries, telemedicine is an alternative to traditional methods and is already present as an option to supplementary health or to address gaps in the health care system, but always aiming at integral care. In developing countries, access is the main pillar, since telemedicine can be the only option in regions where traditional specialized care is not available.

In Brazil, the systematic development of telemedicine and telehealth in the public health system started in 2006, with investments from the Ministry of Health, State Health Secretariats, and Municipal Health Secretariats. The main objective was to support primary care, particularly the Family Health Strategy in remote municipalities, through teleconsulting, telediagnosis, and tele-education. If applied on a large scale, these strategies could decrease the referral of patients to large centers and consequently improve the population’s access to specialized care and reduce health care costs.67 Therefore, telemedicine in the Brazilian public system has been anchored from the outset in the basic principles of universality, equity, and integrality of the SUS. Based on the universality principle, health is everyone’s right, and it is up to the state to ensure it. Equity targets the reduction of inequalities or increased investment in areas where it’s most needed. Integrality considers the individual as a whole to meet all his or her needs.68

Telecardiology, one of the most developed domains in telemedicine, has multiple actions in promoting health, disease prevention, diagnosis, treatment, and rehabilitation with an impact on the quality of life. It can be considered an important ally of the public, supplementary, or private health care system in promoting comprehensive and high-quality health care.

Primary Health Care (PHC) involves integrated and multidisciplinary care and is the foundation to achieve universal health, according to the PAHO, which also advocates for other health determinants like education, food, housing, financial protection, clean water, and safe environments.69 To achieve universal health, health care systems must be transformed, especially by making PHC efficient, integrated, and organized, placing the patient at the center of the system. The PAHO also estimates that about one third of the population in the Americas has no access to health care and that 800,000 additional health care professionals would be necessary to meet the needs in the region.

Telemedicine plays an important role in the qualification of the PHC, with clinical, human, organizational, educational, administrative, technical, and social benefits.70 The application of telemedicine to support PHC brings benefits to the population served, including (i) improved access to specialized services, (ii) increased solvability to the basic level, (iii) decreased number of patients referred to other municipalities for specialized care, (iv) more qualified referrals and faster hospitalization decisions, (v) better training of local health care professionals, with consequently better qualified clinical care, (vi) reduced time to diagnosis, with decreased risk of complications, (vii) diagnosis of diseases at earlier stages, (viii) cost and time savings for the patient, (ix) improved quality of life, (x) fewer hospitalizations and visits to emergency units, (xi) improved clinical care continuum, (xii) reduced risk factors and complications from chronic diseases, and (xiii) savings for the health care system.70^-74

Despite the apparent similarity between teleimaging and local diagnostic services, divergences between both occur in one fifth of the cases. Specifically, divergences with clinical impact occur in up to 1 to 3% of the cases. We can hypothesize that the reasons for these divergences may be inadequate imaging quality, unavailability of patients’ clinical data (like current and past history and physical examination), limited access to patients’ laboratory tests and other imaging evaluations, fatigue, and simple interobserver variation.

The workflow of imaging diagnosis in local hospitals and in telediagnosis may be difficult to distinguish. Generated images are stored in imaging systems (picture archiving and communication system - PACS, for example) and then analyzed by the radiology department (and other specialties working with imaging tests, like cardiology and obstetrics). In teleimaging, the image is transmitted to an external center and analyzed the same way that it would be done locally. Further studies are needed to compare the diagnostic performance of teleimaging versus local imaging. Both may even be assumed to have the same performance, but evidence is critical to confirm our assumptions and can determine not only whether teleimaging can be performed, but also the optimal conditions to be carried out safely and cost-effectively without harm to the patient.

The concept of telesurgery was introduced in the early 1970s by NASA.193 The objective of the original project was to provide medical care to astronauts during remote missions.

Robotic telesurgery devices are applications in which the surgeon controls remotely a robot that executes the surgical procedure. The da Vinci® system (da Vinci® surgical system; Intuitive Surgical, Sunnyvale, CA, USA), the most widely used robotics platform today, follows this approach. The surgeon works on a console separated from the surgical field, and the movement of his or her hands is perceived and transmitted to the instruments close to the patient. This technique yields great ergonomic benefit to the surgeon, incorporates functions like hand tremor cancellation, and broadens (in three dimensions) the view of the field that the surgeon is interested in. However, these platforms lack much automation and require continuous involvement of a human operator (surgeon) for regulatory reasons.

ARTEMIS was the first surgical robot used for cardiac procedures.194Designed as a telesurgery and telepresence system for cardiac procedures, it was used for training and planning and to perform minimally invasive procedures.

Currently, robotic cardiac surgery has been used primarily for mitral valve repair and myocardial revascularization, following approval by the Food and Drug Administration (FDA) in 2002 and 2000, respectively. Newer techniques assist in cardiac manipulation procedures by compensating heart movements. However, large-scale implementation of this technique is hampered by its high cost195 and the absence of randomized studies demonstrating its superiority over traditional minimally invasive techniques, with or without hybrid procedures.196

The first robotic mitral valve heart surgery was performed in 1998 by Carpentier, in France, and Mohr, in Germany. That same year, Carpentier conducted the first coronary artery bypass surgery in Paris, while Reichenspurner performed revascularization surgery with the voice-controlled ZEUS Robotic Surgical System (Computer Motion, Goleta, CA) in Munich.196,197 Since then, this technique has become popular as it is associated with less surgical aggression, reduced cardiopulmonary bypass and aortic clamping duration, and shorter hospital stay compared with the conventional open technique.197

The da Vinci® robotic system has allowed improved visualization of the surgical field with three-dimensional capture and ten-fold magnification, resulting in greater precision in the surgical procedure and smaller incisions following a learning curve.198^,199 It has also reduced the rates of all complications (particularly infection), blood transfusion, and time to return to work activities, with an impact on the total costs of the procedure. This has been observed especially among patients at high risk (like elderly individuals) and those with ejection fraction lower than 20%, diabetes of difficult control, and severe chronic obstructive pulmonary disease.200 This robotics system has also benefited hybrid surgeries, angioplasty, and minimally invasive procedures in patients with multilateral obstructive coronary artery disease.201

Both computer-integrated surgery and telemedicine are becoming popular in the developed world. Advancements in robotic technology and information technology, like the Internet of Things, allow robotic arms to be controlled remotely, enabling robotic telesurgery. With telesurgery, surgeons can perform surgical procedures in remote locations, away from the patients, improving the access to medical treatment and, potentially, the quality of the treatment.

As with other telemedicine applications, telesurgery can broaden the access to interventions in remote areas or centers where specialists in particular types of surgery are not present, for example. The importance of telemedicine, telesurgery, and remote surgery is not restricted to their ability to perform medical procedures in areas where these procedures are not available and can be extended to telementoring, which involves the training of medical professionals to perform these procedures.202 In this area, telesurgery could also benefit patients requiring infrequent, highly complex interventions, in which the medical-surgical expertise is not widely available. The acquisition of new technology expertise by specialists has been accompanied by mentoring programs (proctors). In robotic surgery, telemedicine can provide training with remotely connected proctors (telementoring), expanding the access to innovative technologies.203^,204

Outcomes of robotic surgeries still lack long-term analyses of hard outcomes like all-cause mortality, cardiovascular death, fatal AMI, stroke, need for repeat revascularization, and vascular graft patency. As in traditional surgeries, patient selection is essential, and the goal should be complete revascularization, bearing in mind that CO₂ insufflation decreases venous return by increasing intrathoracic pressure and may compromise hemodynamic parameters in patients with left ventricular dysfunction and in those with chronic obstructive disease, who would benefit more from minimally invasive surgery. Case series have been reported totaling about 110 patients and showing 90% of surgical success within 30 days without open surgery and a maximum follow-up of 5 years.205^-207

The largest experience in this area has been published by Cavallaro et al.,208 who reported rates of morbidity and mortality with robotic myocardial revascularization surgery in 2,582 patients between 2008 and 2010. The authors reported lower rates of postoperative complications in selected patients but concluded that these benefits decreased in patients requiring multiple bypass grafts.208

Approximately 1,700 robotic heart surgeries are performed annually in the US, including 35.5% for mitral valve repairs.209 In 2011, the FDA introduced a post-marketing surveillance plan known as the Medical Device Epidemiology Network initiative, leveraging AI to real-world data analysis, including international registries and electronic medical record data, to bridge the gap in evidence gathering concurrent with the implementation of technological innovation without compromising patient safety.210

In Brazil, none of the robotic surgical techniques have been included in the public policy list or in the List of Procedures and Events in Health of the National Health Agency.210 In this sense, the CFM, through Resolution 2.227/2018, which was later repealed, had regulated robotic telesurgery, precisely anticipating the expansion of the benefits of the technique and facilitating the follow-up of the learning curve by proctors in remote locations. Thus, robotic surgery in Brazil can be remotely assisted by a specialist at a large center in another country. Although the CFM allowed the use of robotic telesurgery in Brazil, it restricted the method to professionals qualified to practice medicine in the country.39 Of note, mentoring/proctoring programs in Brazil have not been widely regulated, except in the State of Paraíba, where the CRM, through Resolution CRM-PB 182/2018, defined rules that regulate and legally secure the practice to the medical act.39

In addition to the information presented above, synchronization between the vast potential of these technologies and the existing ethical and legal apparatus is also lacking. Unlike a comprehensive national policy, there is a general scenario of fragmentation characterized by different norms and standards issued by different agencies and with a different focus.7 Even if a single instrument could hardly achieve these objectives, fragmentation would be yet another obstacle to overcome to reach the potential that telemedicine and telesurgery have in our country.

Among other barriers to their practical use are the scarcity of resources and technical knowledge, as well as infrastructure issues. Brazil is a country of unequal regional distribution in terms of broadband availability.7 This means that the infrastructure of the broadband data network is one of the most limiting factors for the expansion of telemedicine in general and telesurgery in particular, especially in rural areas of the country.

PCI can be considered a highly predictable, safe, and minimally invasive therapy. However, this manual and operator-dependent procedure must be executed in person, demanding physical action by the physician. Full proficiency can only be achieved in high-volume environments with scenarios involving highly complex and technological interventions. Coronary angioplasty also exposes both professional and patient to ionizing radiation. As a result, the potential risks are high for occupational health damage arising not only from the radiation but also from the need of individual protection211^-213e.g., a 7-kg lead apron).

Robot-assisted coronary interventions have recently been developed as an alternative to reduce the reliance on manual operation,214^-224 potentially reducing damage from radiation exposure.225 Clinical studies have demonstrated the safety and efficacy of the robotic system, which has already been approved for routine application in the US and the European Union. Even though the current set of scientific evidence is encouraging, it is also recent and limited to the number of patients treated, hindering further consideration of possible risks and benefits of the technique, especially when it comes to particularities of its application in subgroups of clinical interest.

Over 60% of all health care facilities and between 40-50% of all US hospitals are currently estimated to use some form of digital data transmission.226 In 2016, a US health care facility reported that communication of digital health data (e-mail, phone, and video) exceeded the number of in-person consultations.227

However, it is important to note that despite new modes and means of communication transmission between physicians and patients, ethical and legal responsibilities remain the same as those governing the traditional physician-patient relationship.228 Cardiologists must inform their patients about telemedicine services and their limitations, the possibility of late follow-up, by encouraging regular reporting to their attending physicians, and how they can receive electronic health-promoting information.

Reimbursement is a key determinant of the success of clinical interventions. The movement toward value-based reimbursement rather than payment for service, which provides incentives for care in lower-cost settings, along with the identification and interaction with high-risk individuals before disease onset, and the efficient use of integrated care teams, provide incentives for telemedicine expansion. Understanding the effect of reimbursement within the context of alternative payment models is a priority.

While the path of value-based reimbursement is uncertain, the efficiency of care will inevitably be a priority in any scenario. Ensuring that these technologies are used for patients who meet the appropriate clinical requirements is also an important related topic. In the US, reimbursement for medical services by telemedicine has gradually expanded from coverage of services provided in rural settings to a broader program (Medicare Access and CHIP Reauthorization Act).229 Training and development projects have been created in Brazil, along with a continuing medical education with special attention to the SAMU/UPA care model, developed by the Ministry of Health and private hospitals.230

Regarding the payment for telemedicine and telehealth services in Brazil, as already mentioned, it should be considered that the main source of funds has been the public sector:231^-233

public communications from national (such as the National Council for Scientific and Technological Development - CNPq - and the Financier of Studies and Projects - FINEP) and regional research and innovation funding agencies (state research supporting foundations);

Many of these investments occurred at an early stage of technological development in the country, and only some of the fostered nuclei became active, sustainable services.232 There is a clear need for inclusion of telehealth procedures in the list of procedures paid by the SUS in order to regulate and encourage their routine use in the health system.

Supplementary health, in turn, lacks formal mechanisms of payment and reimbursement for telehealth activities, so telemedicine actions in this sector have been focused on optimizing care and reducing costs, and are often associated with specific conditions like stroke.231

Of note, the Ministry of Health Secretariat of Science, Technology, and Strategic Inputs, through Ordinance 26, of August 2, 2017, made public the decision to incorporate remote monitoring technology for the evaluation of patients with cardiac implantable electronic devices (CIEDs) within the scope of the SUS. This is an unprecedented incorporation of remote monitoring technology as a result of industry demand. The requester assessed the budgetary impact of the technology over 5 years, considering only direct expenses with the purchase of the remote monitoring device and the provision of conventional monitoring in a base case. A second scenario analyzed a model of dynamic transition state to account for opportunity costs of both technologies, exploring the advantages and disadvantages of each strategy. With the decision, the technology should have been included in the SUS within 180 days from the publication of the incorporation order by the Secretary of Science, Technology, and Strategic Inputs, but to date, the Clinical Protocol and Therapeutic Guidelines making this technology available in the SUS have still not been published.234

Unfortunately, there are still several gaps in the process of recognizing medical services in telemedicine for the purpose of reimbursement. The example above is the only one deliberated for public health. The process of coding hierarchical classifications or other payment modalities for the various telemedicine services has not yet been properly structured.

A more complete and structured set of codes would also provide more accurate data to address the scarcity of systematic economic evaluation of the benefits of telemedicine in both pay-per-service and value-based models.235 Bridging this gap is essential to guiding public and private health care providers and technology buyers and investors on decisions about investment returns in this field.

In 1988, Brazil opted for the establishment of a universal health care system free and fully accessible, pursuant to art. 196 of the Federal Constitution. However, health care is available to private initiative, as established in the Magna Carta (Paragraph 1 of Art. 199) pertaining to the scope of participation of the private initiative: “Private institutions may participate in a complementary way in the SUS, according to its guidelines, by means of a contract of public law or agreement, with preference given to philanthropic and nonprofit entities.”236

Supplementary health assists over 47 million beneficiaries in Brazil and is governed by its own legislation, regulated by the National Health Agency. This is a health care system with its own characteristics and regulatory framework guided by specific legislation (Law No. 9.656/1998). The benefits gained from the remarkable development of ICT also apply to supplementary health. However, it should be noted that, due to particularities of laws governing the sector, health care plan operators are required to offer a myriad of procedures included in the List of Procedures and Events in Health of the National Health Agency.237

Also worthy of note is the fact that when one buys a health care plan, priority is given to access to physicians and therapies that supplement the list of policies offered by the SUS. Most of the supplementary health beneficiaries live in large centers, with over 35 million beneficiaries in the Southeast (28,650,281) and South (6,912,748) regions and more than 18 million in capital cities. An analysis of the intersection of demographic data of supplementary health beneficiaries and Brazilian physicians, including cardiologists, shows that the proportion of physicians per inhabitant (beneficiaries of supplementary health) in these regions is different from the one observed in public health, where truly remote areas receive no coverage. It is imperative to consider that the in-person relationship between physician and patient is the rule in supplementary health, which does not hinder the possibility of making telemedicine resources available.238

Accordingly, the various services provided by telemedicine are fully applicable to supplementary health. However, the provision of face-to-face consultations with experts rather than their “tele” versions is a legal demand. ICT resources should not be offered to replace face-to-face interaction but should be an option to improve care also in the context of supplementary health.

Increased efficiency in health care requires quality improvements and costs savings.239 The integration of telemedicine into outpatient clinics and hospitals, including supplementary health, can help achieve both goals.240

Medical care is, without question, one of the most (if not the most) complex sectors in the economy. Considerable financial investment and years of persistence are required to build an effective telemedicine system. The widespread adoption of this type of practice also requires behavioral adaptations by many physicians, organizations, and patients.241 The industry in this area still requires better regulation.

Telemedicine can be an affordable alternative to meet the health needs of vulnerable populations with multiple comorbidities requiring frequent care.242 Improving patient engagement, telemedicine can provide an effective platform for patients to engage in their own decisions.243 For example, the US Veterans Health Administration introduced a national telemedicine program named Care Coordination/Home Telehealth. This model allows patients to manage their own conditions,244 and some important studies have reported that the shared-decision model has reduced hospitalization rates.245

Unequal access to health, even in supplementary health, is persistent in Brazil and requires major investments to improve the organization of health care systems. Even when health care services and evidence-based guidelines are available for common and relevant conditions like hypertension and diabetes, the implementation gap is vast, and best practices are not absorbed by health care professionals, or recommended measures are not followed by patients and their relatives. The science of implementation has proved to be as important as data analysis in recent decades for the recognition of bottlenecks preventing full use of preventive and therapeutic measures to ensure benefits for patients who can live longer and better by taking advantage of all available knowledge,246 reducing costs and increasing the efficiency of private health care systems.

Direct physician-patient teleconsultation, not yet regulated in Brazil, is the most frequently used model. A US report showed that telecardiology was useful for evaluating both new and recent postoperative referrals, with the potential benefit of knowledge transfer to local primary care. In Canada, teleconsultation has been useful for the evaluation of new patients with syncope and supraventricular tachycardia.247 In the United Kingdom, a wide range of inpatient and outpatient telecardiology services is available at district hospitals using various technologies.248 This approach has improved access, was cost neutral, and increased patient satisfaction. The authors emphasized that it complemented but did not replace regular consultations.

The demand for home care using web-based applications directed to consumers, including tablet and smartphone applications, is growing exponentially.249 Many health care providers worldwide are adopting this technology as a way to provide low-cost care for common problems that could result in a visit to the emergency department.250 Most of these applications rely solely on video and audio connections with additional software for scheduling, billing, sharing of still images, and documentation. Also, some peripherals, such as smartphone-compatible heart rate sensing devices,251 are available for purchase at decreasing prices.

Limited financial availability for the acquisition and maintenance of telemedicine equipment and infrastructure remains a barrier to the widespread deployment of telemedicine.252 This is particularly true for many health care providers or small systems that may lack the required resources and often have conflicting demands for available funds. Other costs associated with telemedicine programs include salary, administrative support and supplies, software and application development and upgrade costs, training programs, and initiatives to promote the program to patients.253 With increased mobile connectivity, smartphones, and video compression, the costs to implement simple telemedicine interactions have decreased.

Currently, none of the procedures used in telemedicine are included in the Supplementary Health List of Procedures and Events in Health, i.e., a regulatory vacuum current places telemedicine in a field of conjecture and frustrated expectations dissociated from the interest of the regulated sector. There is also no concrete scientific evidence available to support the formal use of this technology.38

Telemedicine is a disruptive innovation with the potential to change health, and its influence is likely to increase rapidly. Guided by what is best for patients, telemedicine, if properly applied, will help usher in a new age for health care that will be built by patients and physicians, identifying new ways of care, increasing quality and rationalizing costs also in supplementary care.240

The implementation of telemedicine services seeks to provide accessible and quality health care at a low cost.254 Since the 1990s, as technological communication capabilities advanced, telemedicine services became more prevalent.255

The emergence of new telemedicine-related capabilities and their integration into care systems offers opportunities to enhance value-based clinical care, promote health, and prevent diseases.256

The values associated with the adoption of telemedicine services include the collaboration with the agile accessibility of patients to highly complex centers,257 along with a reduction in mortality258 and frequency of hospitalizations.259

In cardiology, recent publications portray telemedicine and teleconsultation services as effective in the management of patients with chronic heart failure,260^,261 preparation of ECG reports, guidance of patients through mobile applications,262 and cardiac rehabilitation,263 among others.

From reported experiences, telemedicine is universally seen as offering interesting benefits for improving accessibility and quality of health.264 However, scientific and financial investments required to introduce these technologies into the health care system are high,265 which potentiates the importance of accurate studies on economic analysis to guide decisions upon implementation of telemedicine services.265^,266

Economic analysis is one of the pillars of health care assessment that aims to support and guide decision making. For a new technology to be applied to a process, it must replace existing alternatives with equal or better results. That is, it must be effective. In addition, the results thus obtained should be less expensive than the alternatives or present reasonable values related to benefits, i.e., it must be cost effective.

However, the economic evaluation of telemedicine strategies has some specificities: constant change of technology, lack of an adequate study design to manage undersized samples, inadequacy of conventional economic assessment techniques, and health outcome assessment problems not directly related to health.267 As a consequence, different types of cost analysis have gained an important role in the evaluation of telemedicine services.

Different approaches have been used to assess the economic impact of telemedicine services with varying levels of acceptability. Basically, five methods are available for calculation of cost effectiveness between conventional and telemedicine interventions: cost-minimization analysis, cost-benefit analysis, cost-effectiveness analysis, and cost-utility analysis. Additionally, return on investment has been used in telemedicine projects.268

Cost-minimization analyses assume that both alternatives (conventional and telemedicine) are equally effective in health outcomes but differ in cost. A cost-minimization analysis considers changes but keeps health outcomes unaltered. For example, telecardiology for ECG reports assumes the same result but with different costs. Consequently, managers have to consider only differences in costs when deciding which alternative is less expensive.269

Cost-benefit analysis recognizes that different projects are equally effective, but results and costs change. Changes in health costs and outcomes are considered simultaneously and attribute a monetary or numerical value not only to costs but also to health outcomes in order to express the nondimensional cost/benefit ratio. However, the idea of attributing monetary values to health outcomes, such as years of life, is not always acceptable to health decision makers.

Cost-effectiveness analysis appears as a solution when costs and results are considered simultaneously, without attributing monetary values to results. Each outcome is defined according to its specific unit so that the final indices demonstrate a relationship between economic and health outcomes. Therefore, the final decision depends on the relationship that the decision maker considers best. This ratio (incremental cost-effectiveness ratio, ICER) represents the cost for each additional result unit.252

Cost-utility analyses consider individuals’ quality of life and the time of life that they will obtain as a result of an intervention. This is a particular case of cost effectiveness in which results are measured in terms of full-life lived years, usually expressed in quality-adjusted life-years (QALYs) or disability-adjusted life-years (DALY). The WHO recommends a value for DALY equivalent to three times the gross domestic product per capita.

Return on investment is a nondimensional relationship between the monetary value invested and the monetary gain resulting from these investments, and measures the efficiency of the investment.270

A systematic literature review of cost-benefit review studies on the adoption of telemedicine services was conducted by the Federal University of Minas Gerais (UFMG) in 2016, gathering publications from 2000 to 2016.105 Considering the keywords employed in the study, a search was performed on the PubMed database with the inclusion criterion being only studies related to cardiology. Other reviews manually searched in databases and/or journals of the area were also added. Thus, the search included literature review articles on the assessment of the incorporation of telemedicine in cardiology from 2000 to April 2019.

Variables related to the economic analysis method, purpose of telemedicine in cardiology, clinical effectiveness, and cost reduction were extracted from the studies. For effectiveness, the impact on the reduction of mortality and hospitalizations, improvement of medication management, and anticipation of diagnosis were evaluated.

From the search and application of exclusion criteria, 35 articles were fully analyzed by two researchers (A.E. and B.Z.) for the collection of variables. Figure 5.1 presents the flowchart of the selection of the articles.

Figure 5.1

The number of studies focusing on telemedicine, especially the monitoring of chronic diseases, has increased over the last decade. Of the 35 studies identified, 19 were published after 2015. Table 5.1 summarizes the characteristics of the articles.

Among the studies, 26 evaluated the telemedicine telemonitoring service mHealth as primary intervention versus usual face-to-face treatment. According to the authors, the ease of use of mobile phones, through the use of applications for remote monitoring and quick communication with patients, was the most common.271

The most common outcomes in the evaluated studies were a reduction in mortality rate (54% of the reviews) and in the number of hospital readmissions (57% of the reviews), with at least one of these outcomes appearing in 26 studies. Other expected results were reduced hospitalization, early diagnosis, and better medication adherence.

On the other hand, economic evaluations were less frequent. Only 16 reviews found conclusive results with cost analyses, of which 13 concluded that telemedicine provided savings to the paying source by reducing costs. Eight reviews included the economic evaluation of incorporating telemedicine in cardiology, with cost effectiveness being the most frequent evaluation (seven studies), while cost minimization was included in a single study. One study suggested that the few existing economic assessments have low methodological rigor, not allowing an assertive conclusion about the economic viability of the implementation.264^,271

Briefly, studies on heart failure telemonitoring have shown that support strategies (video conferencing or telephone) are cost effective, meaning, they have a potential for financial return. Studies evaluating monitoring by cardiac devices showed an incremental cost-effective ratio of US$ 13,979 per QALYs. In a meta-analysis, device telemonitoring was related to a 44% reduction in hospital visits, with no effect on mortality, but a 15-50% reduction in direct health costs.272 The economic results of noninvasive telemonitoring are even more heterogeneous. Some clinical trials have shown neutral results, while one showed a significant reduction in heart failure readmissions and a direct total cost reduction of € 3,546 per patient for 6 months of follow-up.273 In a Dutch clinical trial, the TEHAF trial, the likelihood of cost-effectiveness for remote monitoring was 48% (€ 50,000/QALY threshold), probably due to differences between institutions. One of the most detailed studies was developed for the UK health system perspective using a Markov model comparing usual treatment, telephone support, or remote telemonitoring for patients with heart failure after hospital discharge. Assuming monthly costs of £ 27 for standard care, £ 179 for telephone support, and £ 175 for telemonitoring during business hours, the most cost-effective strategy was telemonitoring, with values below £ 20,000 per QALY. The telephone support strategy was very unfavorable, with an ICER of £ 228,035/QALY compared with telemonitoring.274

Variables evaluating effectiveness repeat across the studies, notably the reduction in mortality and in hospitalization frequency. However, accurate cost collection methods, definition of which cost variables should be collected, and the application of economic models still lack standard recommendations in the literature. More than 70% of the studies did not consider at least one category: health care costs, patient and family expenses, or lost productivity. Many failed to include salaries and benefits, training time, amortized capital investments, data and follow-up operations, and overhead costs. Moreover, an important constraint in these economic analyses has been the great heterogeneity of technology (intervention) and even the control group (alternatives). Technologies supporting telemedicine services advance at an impressive pace and range from complex structures and large investments less than 10 years ago to cost-effective solutions based on cell phones and mobile devices.256^,263 These are distinct services requiring a high initial investment, but most data point to a return on investment over time due to the volume of patients who then do not require the use of the traditional health care system.260^,269 Economic assessment methods must, therefore, track the service over time, including the outcomes of patients receiving care or monitored by the telemedicine services. Given the diversity of the benefits gained, the applied cost methodology - dedicated data reflecting conditions of the local health care system - must be evaluated for a proper understanding of the cost effectiveness of these technologies.

These new technologies are being gradually introduced in the routine of hospitals, clinics, and offices in the private and public sectors in Brazil. The first of these technologies to be applied was the transmission of ECG data for remotely reporting. In 1994, the company Telecardio started using this technology, transmitting the tests by telephone, and in 1995, the Instituto do Coração (InCor) created a service called ECG-FAX. Later, in 2005, a telecardiology system or Minas Telecardio project was implemented at UFMG’s Clinics Hospital.275 In 2007, the Ministry of Health, aiming to develop actions to support primary care teams through permanent education and virtual technologies, created the Telessaúde Brasil program, later renamed Telessaúde Brasil Redes. Nine Brazilian Telehealth Centers (Núcleos de Telessaúde no Brasil) were initially established, offering teleconsulting (consultation between professionals) and telediagnosis (ECG) in the public sector. Currently, several companies offer remote reporting of ambulatory BP monitoring (ABPM), Holter, and remote echocardiography and imaging analysis. AI is currently used in teleconsulting and is at an advanced stage in the preparation of diagnostic test reports. Telemonitoring of patients with heart failure is also ongoing in Brazil.

The routine use of these technologies in Brazil is an indirect indication of their effectiveness, and the continuing operation of companies in this sector is an indirect measure of cost-effectiveness, although there are few formal studies on this subject in Brazil.

At least two initiatives for the application of new technologies in cardiology in Brazil focused on these cost-effectiveness studies: 1) the telemedicine service and remote patient monitoring of InCor at the University of São Paulo Medical School and 2) the telediagnosis and teleconsultation system of the Minas Gerais Teleasssistance Network (RTMG) of the Clinics Hospital at UFMG.

In addition to the results from telecardiology services, an analysis of savings estimates for the state of Rio Grande do Sul through the TelessaúdeRS project, which offers 20 clinical specialty teleconsultation services, was conducted and are presented in this chapter as a third approach to an economic evaluation of telemedicine in Brazil.

Stevens et al. evaluated the economic burden and impact on patients’ disability of four main heart conditions - heart failure, AMI, AFib, and hypertension - in 2015 in Brazil.276 Specifically for hypertension, the authors assessed the cost effectiveness of conventional care versus telemedicine and structured telephone support over a 30-year time horizon after 2015. A summary of the results found in the study is shown in Table 5.2.

Both technologies were considered cost effective by the authors, assuming the standard defined by the WHO of an intervention being considered cost effective when having a cost per life-year between one and three times the gross domestic product per capita per QALY. However, the Brazilian health authorities have not yet defined the country’s ICER. Thus, safe inferences cannot be made on whether the procedures applied in telemedicine within the SUS would be cost effective or not within these scenarios. According to Brazilian law, products, medications, or procedures included in SUS’ protocols must be evaluated for safety, efficacy, effectiveness, and cost effectiveness. Therefore, an effective reference is still needed to validate the economic assessment in question.277

The Telehealth Center (Centro de Telessaúde, CTS HC/UFMG) coordinates the RTMG, a collaborative network established in 2005 by seven public universities in Minas Gerais: UFMG, Federal University of Uberlândia (UFU), Federal University of Triângulo Mineiro (UFTM), Federal University of Juiz de Fora (UFJF), Federal University of São João Del Rei (UFSJ), State University of Montes Claros (Unimontes), and Federal University of Jequitinhonha and Mucuri Valleys (UFVJM).

Telecare activities include teleconsultation and telediagnosis. Teleconsultations are mostly asynchronous through regulatory calls in medicine, nursing, dentistry, physiotherapy, pharmacy, psychology, nutrition, and speech therapy. Telediagnosis consists of the analysis and reports of ECGs, ABPM, Holter, and retinography, along with synchronous cardiology teleconsultations to support critical clinical cases. The service is registered in the CRM of the State of Minas Gerais.

The RTMG activity was initiated with the research project Minas Telecardio in 2006, implementing a telecardiology service with ECG reports and teleconsultation in 82 municipalities in Minas Gerais. The RTMG activities expanded over time and currently connects 814 municipalities with more than 1,000 telehealth units in Minas Gerais. Within the ONTD project of the Ministry of Health, it began to offer nationwide telecardiology services on September 2017, and currently serves 90 municipalities in the states of Acre, Bahia, Ceará, Mato Grosso and Roraima. This expansion was partly the result of studies proving the cost effectiveness of the system for the main RTMG funders (Ministry of Health and Minas Gerais State Department of Health).

Using the results of the Minas Telecardio Project, Andrade et al.278 compared the cost-benefit ratio of remote ECG reporting, considering the hypothesis of economic benefit in performing ECGs in the telecardiology project compared with the referral of the patient to perform ECG examination at another location.278 The study was conducted between June 2006 and November 2008 in 82 municipalities in rural areas of the state of Minas Gerais. Each municipality received a microcomputer with a digital electrocardiograph machine and had the possibility of forwarding the ECG recordings and establishing communication with the cardiology department at university hospitals of the RTMG. The costs of the project were divided into two categories: related to the implementation and related to the maintenance of the telecardiology system. The cost of moving patients was assessed, including the cost of transportation (using city-provided resources), the cost of food during their absence from home, and the cost of a missed working day (both paid by the patient). The cost-benefit without inclusion (perspective of the public health service) and with inclusion (perspective of the society) of the patients’ costs were evaluated. For the face-to-face scenario, the cost of ECG and cost of the consultation were added (R$ 5.15 and R$ 10.00, respectively, based on the SUS’ reference table). The sources of data for the analysis were mainly the National Household Sample Survey (Pesquisa Nacional de Amostra de Domicílios, PNAD), SIA-SUS Ambulatory Information System, and CNES.

Considering the cost of implementation and maintenance of the project of R$ 1,818,282.87 and the number of examinations performed in the 30-month period (62,865 examinations from August 2006 to December 2008), the unit cost of each remote report was R$ 28.92. A summary of the results is shown in Table 5.3.

A sensitivity analysis showed that the results are sensitive to patient travel costs, particularly related to the driver’s salary and number of patients per vehicle. Given the small difference between scenarios 1 and 2, it can be concluded that, in some situations, telecardiology may not be more economical from the point of view of public health service.

At that time, the system had a relatively low output and, since the activities have a high fixed cost, resulted in a high cost for the remote report. With the expansion of the system to other municipalities, the cost of the activities reduced, increasing the cost effectiveness of the system.

In 2007, the Ministry of Health, with resources from PAHO, engaged the CTS HC/UFMG in the project “Analysis of the Financial Management of Telehealth Services Applied to Primary Care.” In the project, the analysis of the economic sustainability of the application of telehealth in primary care was based on a comparison of costs between two scenarios:

Face-to-face care: when the patient is treated in primary care and requires to be subsequently referred to secondary level care;

The results refer to 20 municipalities participating in the National Telehealth Project with reliable data, located in the North/Northeast regions and Jequitinhonha Valley in Minas Gerais, considered one of the poorest regions of the state. The main results of the project are shown in table 5.4.279^,280

This project presented more realistic results compared with the previous one, as it collected information about the cost of patient referral directly in the municipalities. However, it maintained the sample of the participating municipalities concentrated in the same region of the state, the Jequitinhonha Valley, which has a low human development index (HDI). In 2009, the Minas Telecardio Expansion project expanded the service to higher HDI regions for a final sample of 66 other municipalities. The results were similar to those of the previous project and are shown in table 5.5.281^-283

Recently, a study (pending publication) was conducted to assess the cost effectiveness of the ONTD. The ONTD is a project of the Ministry of Health to offer telecardiology services (ECG reports and teleconsultations) to all Brazilian states, for which the CTS HC/UFMG was chosen as Specialist Center, that is, the service provider. State Telehealth Centers receive funding from the Ministry of Health to train and implement care in municipalities of their state, previously agreed with the State Health Departments, which may forward 24/7 their test requests and teleconsultations to the Expert Center. The requests may be elective or urgent. The report is available on a platform, and, when necessary, local physicians can ask questions as part of teleconsultation. An alert system informs physicians and nurses about critically emergent situations. The effectiveness of the system has been proven by performance indicators (time to submit tests, waiting time for analysis of urgent/elective reports, time to the first analysis of the report, number of tests requested by the municipality, etc.), and user satisfaction. The results proved the effectiveness of the system by replacing alternatives previously available to obtain the test/report (referral of the patient, periodic visits of the cardiologist to the municipality, and outsourcing of tests to private companies/clinics). In terms of these alternatives, the cost of the test by the ONTD is about five times lower, demonstrating cost effectiveness.

An economic analysis of the TelessaúdeRS service was performed to evaluate the financial results of the service generated to the state. Teleconsultations are offered for various specialties, in addition to the contribution to the regulation of waiting lists for the state of Rio Grande do Sul. Teleconsultations in endocrinology, gastroenterology, proctology, rheumatology, and urology were selected as samples.

The cost per teleconsultation (R$ 110.29) was evaluated considering data from 8 months of service and included costs of the physical structure of the service (rent, energy, depreciation, server capacity, among others) and payment of professionals. As a premise, all teleconsultations and regulations that resulted in the cancellation of the face-to-face consultation would represent, for the state, savings in patient transportation to Porto Alegre (which is variable according to the municipality of origin) and payment of face-to-face consultation to the municipality (R$ 100.00). Estimated savings were calculated as the difference between the cost of performing canceled teleconsultations and the cost of face-to-face care.

The analysis identified that over 21 months (October 2016 to June 2018), the state saved R$ 2,287,121.78, of which 47% were related to consultations and 53% to transportation services. For teleconsultation, the service was found to be attractive up to the amount of payment per consultation of R$ 38.95, considering the average cost of transportation. The municipalities with the greatest distances from Porto Alegre had higher savings, except for four municipalities neighboring Porto Alegre, which had a higher number of avoided teleconsultations than the others’ average.

Of note, a comparison of these results with those of other states and services should consider that the services of Telessaúde are provided by scholars and “CLT” professionals (employees following the Brazilian Labor Laws); therefore, Telessaúde can operate at a lower cost per teleconsultation. The operation of a similar service including only “CLT” employees would increase the cost per each teleconsultation and require additional economic analysis.

The WHO considers cost effective those interventions with ICER between 1 and 3 times the gross domestic product per capita per life-year, unless adjusted for QALY.