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  <front>
    <journal-meta>
      <journal-id journal-id-type="nlm-ta">Arq Bras Cardiol</journal-id>
      <journal-id journal-id-type="publisher-id">abc</journal-id>
      <journal-title-group>
        <journal-title>Arquivos Brasileiros de Cardiologia</journal-title>
        <abbrev-journal-title abbrev-type="publisher">Arq. Bras. Cardiol.</abbrev-journal-title>
      </journal-title-group>
      <issn pub-type="ppub">0066-782X</issn>
      <issn pub-type="epub">1678-4170</issn>
      <publisher>
        <publisher-name>Sociedade Brasileira de Cardiologia - SBC</publisher-name>
      </publisher>
    </journal-meta>
    <article-meta>
      <article-id pub-id-type="publisher-id" specific-use="scielo-v3">fyW5SgPYP9RhfT7BLdWVKhR</article-id>
      <article-id pub-id-type="publisher-id" specific-use="scielo-v2">S0066-782X2019000900429</article-id>
      <article-id pub-id-type="publisher-id" specific-use="previous-pid">S0066-782X2019005015106</article-id>
      <article-id pub-id-type="doi">10.5935/abc.20190161</article-id>
      <article-categories>
        <subj-group subj-group-type="heading">
          <subject>Viewpoint</subject>
        </subj-group>
      </article-categories>
      <title-group>
        <article-title>Digital Health, Universal Right, Duty of the State?</article-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="author">
          <contrib-id contrib-id-type="orcid">0000-0003-1253-1514</contrib-id>
          <name>
            <surname>Lopes</surname>
            <given-names>Marcelo Ant&#244;nio Cartaxo Queiroga</given-names>
          </name>
          <xref ref-type="aff" rid="aff1">1</xref>
          <xref ref-type="corresp" rid="c1"/>
        </contrib>
        <contrib contrib-type="author">
          <contrib-id contrib-id-type="orcid">0000-0002-0737-6188</contrib-id>
          <name>
            <surname>Oliveira</surname>
            <given-names>Gl&#225;ucia Maria Moraes de</given-names>
          </name>
          <xref ref-type="aff" rid="aff2">2</xref>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Maia</surname>
            <given-names>Luciano Mariz</given-names>
          </name>
          <xref ref-type="aff" rid="aff3">3</xref>
        </contrib>
      </contrib-group>
      <aff id="aff1">
        <label>1</label>
        <institution content-type="orgname">Hospital Alberto Urquiza Wanderley</institution>
        <addr-line>
          <city>Jo&#227;o Pessoa</city>
          <state>PB</state>
        </addr-line>
        <country country="BR">Brazil</country>
        <institution content-type="original">Hospital Alberto Urquiza Wanderley, Jo&#227;o Pessoa, PB - Brazil</institution>
      </aff>
      <aff id="aff2">
        <label>2</label>
        <institution content-type="orgname">Universidade Federal do Rio de Janeiro</institution>
        <addr-line>
          <city>Rio de Janeiro</city>
          <state>RJ</state>
        </addr-line>
        <country country="BR">Brazil</country>
        <institution content-type="original">Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ - Brazil</institution>
      </aff>
      <aff id="aff3">
        <label>3</label>
        <institution content-type="orgname">Universidade Federal da Para&#237;ba</institution>
        <institution content-type="orgdiv1">Centro de Ci&#234;ncias Jur&#237;dicas</institution>
        <addr-line>
          <city>Jo&#227;o Pessoa</city>
          <state>PB</state>
        </addr-line>
        <country country="BR">Brazil</country>
        <institution content-type="original">Centro de Ci&#234;ncias Jur&#237;dicas da Universidade Federal da Para&#237;ba, Jo&#227;o Pessoa, PB - Brazil</institution>
      </aff>
      <author-notes>
        <corresp id="c1"><bold>Mailing Address: Marcelo Ant&#244;nio Cartaxo Queiroga Lopes,</bold> Cardiocenter - Av. Ministro Jos&#233; Am&#233;rico de Almeida, 1450, Torre, Hospital - Alberto Urquiza Wanderley. Postal Code 58.040-300, Jo&#227;o Pessoa, PB - Brazil. E-mail: <email>mqueiroga@cardiol.br</email>, <email>marcelocartaxoqueiroga@gmail.com</email>
				</corresp>
        <fn fn-type="con">
          <p>Author contributions</p>
          <p>Conception and design of the research, Acquisition of data, Analysis and interpretation of the data, Writing of the manuscript and Critical revision of the manuscript for intellectual content: Lopes MACQ, Oliveira GMM, Maia LM.</p>
        </fn>
        <fn fn-type="conflict">
          <p>Potential Conflict of Interest</p>
          <p>No potential conflict of interest relevant to this article was reported.</p>
        </fn>
      </author-notes>
      <pub-date date-type="pub" publication-format="electronic">
        <day>29</day>
        <month>08</month>
        <year>2019</year>
      </pub-date>
      <pub-date date-type="collection" publication-format="electronic">
        <month>09</month>
        <year>2019</year>
      </pub-date>
      <volume>113</volume>
      <issue>3</issue>
      <fpage>429</fpage>
      <lpage>434</lpage>
      <history>
        <date date-type="received">
          <day>24</day>
          <month>06</month>
          <year>2019</year>
        </date>
        <date date-type="rev-recd">
          <day>26</day>
          <month>06</month>
          <year>2019</year>
        </date>
        <date date-type="accepted">
          <day>26</day>
          <month>06</month>
          <year>2019</year>
        </date>
      </history>
      <permissions>
        <license license-type="open-access" xlink:href="https://creativecommons.org/licenses/by/4.0/" xml:lang="en">
          <license-p>This is an Open Access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited</license-p>
        </license>
      </permissions>
      <kwd-group xml:lang="en">
        <title>Keywords:</title>
        <kwd>Comprehensive Health Care/legislation &amp; jurisprudence</kwd>
        <kwd>Personal Health Services/trends</kwd>
        <kwd>Telemedicine</kwd>
        <kwd>Unified Health System</kwd>
        <kwd>Health Public Administration</kwd>
      </kwd-group>
    </article-meta>
  </front>
  <body>
    <sec sec-type="intro">
      <title>Introduction</title>
      <p>The Brazilian Constitution establishes, in its art. 196,<xref ref-type="bibr" rid="B1">1</xref> that &#8220;health is a universal right and duty of the State, guaranteed by social and economic policies aimed at reducing the risk of diseases and other ailments, and universal and equal access to actions and services for their promotion and recovery&#8221;.</p>
      <p>In addition, article 198,<xref ref-type="bibr" rid="B1">1</xref> states that &#8220;public health actions and services are part of a regionalized and hierarchical network and constitute a single system, organized with the following guidelines: I - decentralization, with a single direction in each sphere of government; II - integral care, with priority for preventive actions, without loss to the care services; III - community participation&#8221;.</p>
      <p>From a systematic reading of these two constitutional provisions, it is possible to list the basic elements of the implementation of the right to health by the public authorities: universal and equal access, as well as integral care. Integral health care determines that &#8220;the duty of the State cannot be limited, mitigated or divided, since health as an individual, collective and development asset presupposes a complete approach to care&#8221; and providing integral care &#8220;means nothing more than privileging life to the detriment of the administration's budgetary interests - the so-called secondary public interest&#8221;.<xref ref-type="bibr" rid="B2">2</xref>
			</p>
      <p>Within this context, the Unified Health System (SUS) was designed to be the mechanism by which universal and equal access, as well as integral care, should be implemented. SUS must act according to these guidelines, not being able to impose any restrictions specifically directed to a particular group or class, nor can it privilege the administration&#8217;s budgetary interests to the detriment of the right to life.</p>
      <p>As observed by Resende<sup>,(</sup><xref ref-type="bibr" rid="B3">3</xref> &#8220;the concept of health as a fundamental right in the international normative framework has been extended over the years to include, in addition to the negative idea of absence of disease, positive content related to the improvement in quality of life and wellbeing&#8221;. According to the Bangkok Charter<xref ref-type="bibr" rid="B4">4</xref> for Health Promotion in a Globalized World, drafted at the VI Global Conference on Health Promotion in 2005, &#8220;The United Nations recognizes that the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without discrimination. Health promotion is based on this critical human right and offers a positive and inclusive concept of health as a determinant of the quality of life and encompassing mental and spiritual well-being&#8221;.</p>
      <p>Access to health is a social right, guaranteed in Article 6 of the Constitution,<xref ref-type="bibr" rid="B1">1</xref> in accordance with the dignity of the human person, which is the basis of the democratic rule of law. The Constitution, said to be citizen-oriented, inaugurated a new legal order in the country that promotes the inclusion of millions of Brazilians who were excluded from any kind of healthcare.</p>
      <p>Putting it into perspective, at the beginning of the 20<sup>th</sup>century, only those who integrated welfare funds had access to the health system. Even with the unification of the Institutes of Social Security Assistance, the so-called IAPs, and the creation of the National Institute of Social Security (INPS), there was still the exclusion of non-participants - non-taxpayers, a true legion of indigents.</p>
      <p>SUS, observing the federative organization of the Brazilian State, was conceptually conceived as a solution, but after three decades, chronic problems of financing and management persist, jamming the gears of the world's largest system of universal access to healthcare, hampering the achievement of its original objectives. The gigantism of Brazil and the heterogeneity of the different regions impose the need for efficient management that can be capable of promoting, within the priorities of the State, the convenient allocative justice. Only with the adoption of consequent public policies and its capillarity in the whole country will it be possible to change the panorama of public health in Brazil.</p>
      <p>In recent decades, as a consequence of the success of public policies, life expectancy has increased, and we are currently experiencing a real demographic transition. The growth in the number of elderly people is exponential, and it is estimated that this social segment will represent 25% of the Brazilian population in 20 years. The impact on social security is a challenge for the State, and requires increased attention, with the adoption of sustainable public policies, especially in the area of health.<xref ref-type="bibr" rid="B4">4</xref>
			</p>
      <p>Non-communicable chronic degenerative diseases (NCDs) are responsible for more than 30% of global mortality and this context will be aggravated by the aging and sickness of the current population. As a matter of fact, there is no way to ignore that offering the resources needed for the expansion of health care, especially for the growing prevalence of NCDs, mainly in remote areas of a country such as Brazil, is a complex task. It will be a challenge, to be overcome, to bring health professionals - notably specialists - to the most distant corners of the country.<xref ref-type="bibr" rid="B4">4</xref>
			</p>
      <p>On the other hand, there is a constant tension between the medical class and health authorities about the possible alternatives for the supply of doctors to society. This theme took on an epic battle line on the occasion of the sanction of Law 12.871, dated October 22, 2013,<xref ref-type="bibr" rid="B5">5</xref> which instituted the &#8220;<italic>Programa Mais M&#233;dicos</italic>&#8221; (More Doctors Program) in Brazil. The offer of doctors in the country, since the institution of this Program, has increased, mainly due to the increase in the number of medical schools opened in the country. However, the proportion of doctors per 100,000 inhabitants is still below the average of the countries in the Organization for Economic Cooperation and Development (OECD). It should be added that the distribution of these physicians is heterogeneous, aggravating this scenario.<xref ref-type="bibr" rid="B6">6</xref> In this sense, the use of information and communication technologies, through a Telemedicine network, could contribute to the universality and integrality of the health system, in line with the constitutional decree.</p>
      <sec>
        <title>Telemedicine as a tool to expand universal access to health</title>
        <p>The remarkable advancement of information and communication technologies and their application in medicine have enabled a secure transmission of data, facilitating the interaction of health professionals, opening a door for the democratization of access to medical knowledge, and strengthening collaboration among the various levels of healthcare.</p>
        <p>Telemedicine can be conceptualized as an organized and efficient way of practicing distance medicine for the purposes of informing, diagnosing and treating individuals, alone or in groups, based on data, documents or other reliable information transmitted by means of telecommunications. Currently, the use of telemedicine has been increasing, ranging from consultations (teleconsultation), diagnosis (telediagnosis) to complex robotic surgeries (tele-surgery). All these advancements, which project the broader concept of digital health, must take place preserving the millennial postulates of medical art, always focused on the patient&#8217;s best interests.<xref ref-type="bibr" rid="B7">7</xref>
				</p>
        <p>Digital health interventions are not a substitute for the health systems already in place, as there are still significant limitations to what digital health is capable of addressing. However, the judicious use of this technology can contribute to improvements in health care, as long as it is based on the evaluation of its benefits, damages, acceptability and viability.<xref ref-type="bibr" rid="B7">7</xref>
				</p>
        <p>When approaching the intricate subject of health-guaranteeing regulations, as a fundamental right, and of the application of information and communication technologies to promote the practice of distance medicine, the basis of Telemedicine, there is the need to defend the preservation of the patients' privacy. The inviolability of private life, such as the right to health, is also an inseparable part of the concept of the dignity of the human person.<xref ref-type="bibr" rid="B1">1</xref> Therefore, security in data transmission is imperative for the implementation of any Telemedicine program. The millennial principle of medical secrecy, valid since Hippocrates, is also a constitutional imposition.</p>
        <p>The legal framework applicable to Telemedicine in Brazil is comprehensive, involving from the sanitary legislation to the recent internet regulatory framework to ensure its regular practice. Currently, international protocols ensure the secure transmission of data: the Health Insurance Portability and Accountability Act (HIPPA)<xref ref-type="bibr" rid="B7">7</xref> contains a set of standards that ensure the security of the data transported and of those responsible for its transmission.</p>
      </sec>
      <sec>
        <title>Regulation of Telemedicine by the Brazilian Federal Council of Medicine</title>
        <p>The Brazilian Federal Council of Medicine (CFM), an autarchic body established by Law 3.268, dated September 30, 1957,<xref ref-type="bibr" rid="B8">8</xref> is responsible for supervising professional ethics throughout the Republic and, at the same time, judging and disciplining the medical profession through supervisory and regulatory action. With a focus on these attributions, CFM is responsible for regulating the participation of doctors in activities related to the employment of Telemedicine throughout the country&#8217;s territory.</p>
        <p>Law 12.842,<xref ref-type="bibr" rid="B9">9</xref> dated July 10, 2013, the Medical Act, which provides for the practice of medicine, ratifies that the new medical procedures and therapies for regular use in Brazil must necessarily be evaluated by the Brazilian Federal Medical Council regarding safety, efficiency, convenience, and benefits to the patient. Telemedicine, with a myriad of employment possibilities in prevention, diagnosis, treatment and rehabilitation, as well as in health promotion, undoubtedly falls within and can be validated by CFM. Because of its innovative character, it brings a bioethical conflict potential, which imposes a zetetic - investigative - analysis of its principles, due to the clash between traditional ethics, which permeates the face-to-face relationship between doctors and patients, and the new frontier opened by the progress of information and communication technology.</p>
        <p>The Brazilian Federal Medical Council, through Resolution CFM 1.643/2002,<xref ref-type="bibr" rid="B10">10</xref> provided for Telemedicine, defining it &#8220;as the exercise of Medicine through the use of interactive audiovisual and data communication methodologies, with the objective of health assistance, education and research&#8221;. This regulation requires the use of appropriate technology and observance of the CFM&#8217;s technical standards regarding data storage, handling and transmission, confidentiality, privacy and guarantee of professional secrecy. The role of doctors who participate in the professional act at a distance is restricted to emergencies, or when requested by the doctor in charge of administering in-person care.</p>
        <p>In 2014, the CFM again expressed its views on the subject, through Resolution CFM 2.107/2014,<xref ref-type="bibr" rid="B11">11</xref> to discipline the use of Teleradiology. This Resolution updated the previous standard, published in 2009. The development of technology and the democratization of access to cellular telephony pluralized the development of applications dedicated to digital health. Current possibilities of employment of Telemedicine include several services, which include: (a) Teleconsulting, Teleinterconsulting, Telediagnosis, Tele-orientation, Telemonitoring, Tele-surgery and Medical Tele-Screening. Although part of these services is not explicitly regulated by the CFM, there is an offer by specialized companies, especially in the scope of supplementary health, with the imperative need by such companies of their own administrative act.</p>
        <p>In this sense, the CFM issued Resolution CFM 2.227/2018,<xref ref-type="bibr" rid="B12">12</xref> published in the Brazilian Federal Official Gazette on February 6, 2019, to update the current discipline. The resolution aimed to guarantee security to the provision of medical services mediated by information and communication technologies in Brazil. There is no doubt of the need to update the regulatory framework that disciplines the participation of doctors in the so-called Telemedicine. This measure legitimizes the doctor-patient relationship in the field of digital health. However, there was an avalanche of questions from the medical category about the form and merit of this standard.</p>
        <p>In their article <italic>Window to the future or door to chaos?</italic>, Lopes et al.<xref ref-type="bibr" rid="B13">13</xref> discussed several aspects related to the legality and timeliness of Resolution CFM 2.227/2018, and the allowing of Teleconsultations was the most challenging question, precisely due to the flexibility of prescription without the direct examination of the patient, a conduct that is prohibited by the Brazilian Code of Medical Ethics.* For the authors, the regulation of CFM &#8220;should therefore represent a step forward, not a setback. Broadening access to public health is a common desire of all doctors. The major challenge of Resolution CFM 2.227/2018 would be having the effectiveness and applicability to move forward in the field of justice and deliberative ethics&#8221;.</p>
        <p>The avalanche of corporate questions from the medical category, among other reasons, motivated the revocation of this Resolution by CFM.<xref ref-type="bibr" rid="B11">11</xref> Thus, the use of telemedicine by doctors in Brazil must occur according to the provisions of Resolution CFM 1.643/2002.<xref ref-type="bibr" rid="B10">10</xref> It is noteworthy that there were problems in communication regarding the contents of the norm, generating an intense reaction from doctors in relation to the merit of the regulation.</p>
        <p>In addition, as discussed by Lopes et al.,<xref ref-type="bibr" rid="B13">13</xref> CFM could not delegate exclusively to specialty societies the prerogative of developing guidelines on Telediagnosis. It is important to emphasize that Law 12.401, dated April 28, 2011,<xref ref-type="bibr" rid="B9">9</xref> defines that the elaboration of clinical protocols and therapeutic guidelines within SUS is a jurisdiction of the National Commission for the Incorporation of Technologies in SUS (Conitec). Therefore, CFM could not, on the basis of a normative resolution, exclude those who have legal jurisdiction to elaborate guidelines within the Brazilian health system, delegating this attribution exclusively to private entities, even if conditioned to their approval. Hence, whether in relation to Robotic Telesurgery or Telediagnosis, the revoked Resolution could be improved.</p>
      </sec>
      <sec>
        <title>Difficulties for the implementation of digital health as a duty of the State</title>
        <p>In this sense, we could imagine Telemedicine as a useful complementary tool to allow fair access to health for all Brazilians, regardless of ethnicity, gender, socioeconomic status and location in the national territory. It could be assumed, especially if we consider the continental dimension of Brazil, that populations living in remote areas would benefit from the State&#8217;s investment in the dissemination of digital health.</p>
        <p>According to the Brazilian Institute of Geography and Statistics (IBGE),<xref ref-type="bibr" rid="B14">14</xref> about 65% of the municipalities located in remote areas are located in the North and Midwest regions of the country. On the other hand, the study Demografia M&#233;dica no Brasil (Medical Demography in Brazil, 2018)<xref ref-type="bibr" rid="B6">6</xref> reported significant inequality in the distribution of doctors, who are predominately located in the large urban agglomerations of the South and Southeast Regions, which also concentrates the largest number of specialists, with he North and Northeast Regions having a lower medical/inhabitant density. If we also look at the issue from the perspective of care, through the National Register of Health Establishments (CNES)<xref ref-type="bibr" rid="B15">15</xref> of the Brazilian Ministry of Health, we can observe a greater concentration of medical activity in the Southeast and South Regions. It is also important to mention that there is a lower concentration of networks linked by fiber optics in municipalities in the North Region, and that mobile cellular telephone coverage for the Brazilian population is between 98 and 99%, with a higher concentration in the urban centers of the Southeast and South regions.<xref ref-type="bibr" rid="B16">16</xref><sup>,</sup><xref ref-type="bibr" rid="B17">17</xref>
				</p>
        <p>It is understood that, although the demand for medical services in remote areas is an opportunity, the provision of Telemedicine services to these areas presents a great implementation challenge similar to the universal access to traditional health services. The expansion of Telemedicine would have to be preceded by improved digital technology infrastructure.</p>
        <p>On the other hand, through the International Telecommunication Union (ITU),<xref ref-type="bibr" rid="B18">18</xref> the United Nations has been working with the World Health Organization (WHO) to stimulate the reduction of the global digital divide, with the e-health strategy, focused on digital health, via Telemedicine.</p>
        <p>Investments in digital health have generated a number of WHO publications. Examples are the Digital Health Atlas,<xref ref-type="bibr" rid="B19">19</xref> a virtual global repository to support governments in monitoring and coordinating digital investments, BeHe@lthy, BeMobile (BHBM),<xref ref-type="bibr" rid="B20">20</xref> for prevention and control of NCDs, mHealth Assessment and Planning for Scale (MAPS), a manual for monitoring and evaluation of digital health,<xref ref-type="bibr" rid="B21">21</xref> aimed at strengthening the research and implementation of digital health, and the first WHO Digital Health Interventions Guideline.<xref ref-type="bibr" rid="B22">22</xref> The latter document<xref ref-type="bibr" rid="B22">22</xref> suggests that most of the available scientific evidence on the benefits of implementing global digital health is still not robust, and that there are numerous gaps for large-scale use, albeit in a complementary way to traditional methods. The WHO recommends that a planned process should take place, including: the feasibility of network coverage for access to remote locations, the construction of the legal framework for its implementation, the budget impact and the cost-effectiveness evaluation of each stage of the project's implementation, with the elaboration of indicators of the clinical continuum of applicability for the safety of users.</p>
      </sec>
      <sec>
        <title>Telemedicine to reduce inequalities in the approach to NCDs</title>
        <p>Telemedicine, if applied in its broad context, could allow access and equity, offering quality services with supposed cost-effectiveness, especially considering the increase in the prevalence and mortality of NCDs, of which cardiovascular diseases (CVD) are its main component.</p>
        <p>There were 55.9 million deaths worldwide in 2017 in an estimated world population of 7.64 billion people.<xref ref-type="bibr" rid="B23">23</xref> Of these, 70% were due to NCDs, and are expected to continue to increase in the coming decades, especially in low- and middle-income countries, even though all-cause mortality has decreased, notably due to the reduction of infant and child mortality of children under 5 years, stabilization of mortality from 5 years to 49 years and increase in life expectancy.<xref ref-type="bibr" rid="B23">23</xref> The increase in NCDs is expected with the aging of the population, with the control of communicable diseases and with the increase of premature mortality in individuals from 30 to 70 years of age.<xref ref-type="bibr" rid="B24">24</xref>
				</p>
        <p>In Brazil, NCDs were responsible for about 60% of deaths in 2017, according to the Department of Informatics of the Unified Health System (DATASUS),<xref ref-type="bibr" rid="B25">25</xref> noting that this group of diseases shares the same risk factors and social determinants. The severity of the issue is large enough to set targets for 30% reduction of premature mortality by NCDs as part of the Sustainable Development Goals (SDG) for 2030.<xref ref-type="bibr" rid="B26">26</xref><sup>,</sup><xref ref-type="bibr" rid="B27">27</xref> It is also believed that one-third of the populations of the Americas do not have access to health care, and that an additional 800,000 health workers would be needed to meet the demands of health systems in the region.<xref ref-type="bibr" rid="B28">28</xref>
				</p>
        <p>The combined approach to NCDs and their risk factors was considered a cost-effective package by WHO, requiring investment of USD 1 per capita in low-income countries, USD 1.5 in low-middle-income countries, and USD 3 in average income countries, underscoring the importance of joint study of NCDs.<xref ref-type="bibr" rid="B29">29</xref> According to the WHO Director-General, Dr. Tedros Adhanom Ghebreyesus, &#8220;leveraging the power of digital technologies will be essential to achieving the Global Sustainable Development Goals, including universal health coverage, and that such technologies are no longer a luxury, but a necessity&#8221;. He also suggests that we make sure that innovation and technology alleviate inequalities, and that countries must be guided by evidence to establish harmonized digital systems, and not be seduced by the novelties.<xref ref-type="bibr" rid="B30">30</xref>
				</p>
        <p>The World Health Assembly resolution on Digital Health, unanimously adopted by WHO Members in May 2018, demonstrated collective recognition of the value of digital technologies in contributing to the advancement of universal health coverage, with an emphasis on NCDs, and recommended that health ministries evaluate the use of digital technologies dedicated to health, prioritizing development, evaluation, implementation and increased use of these technologies, as well as guiding their standardization, including through the promotion of digital health interventions. However, it was pointed out that, in order to reduce health inequalities, a rigorous evaluation of eHealth strategies would be necessary in order to generate evidence and promote the appropriate integration of the use of these technologies.<xref ref-type="bibr" rid="B18">18</xref>
				</p>
      </sec>
      <sec>
        <title>Recommendations of the Telemedicine Directive of the Brazilian Society of Cardiology for cardiovascular health</title>
        <p>To guide the practice of Telemedicine in CVD, Lopes et al. developed the Telemedicine Directive of the Brazilian Society of Cardiology,<xref ref-type="bibr" rid="B31">31</xref> with the objective of discussing legal and ethical support, technical conditions and priority for implementation, cost-effectiveness and budget impact for the use of Telemedicine for the cardiovascular health of the Brazilian population.</p>
        <p>It was found that there is space for Telemedicine initiatives as a specialist matrix support for general practitioners and family health doctors in basic health units in remote areas of the Brazilian territory, especially with regard to diagnostic methods, avoiding unnecessary displacements with additional burden to the health system. The clinical and economic results obtained with public policies focused on digital health in Brazil suggest that technologies that allow patient monitoring (telemonitoring) and the issuance of remote reports (Telediagnosis) applied to cardiology can be cost-effective, with an acceptable impact on the public budget. However, the set of scientific evidence in Brazil is still limited, given the small number of patients involved, to infer that the application in subgroups of clinical interest should be generalized.</p>
        <p>The benefits of this technology could be equally applicable to supplemental health in Brazil, even in the face of a diverse regulatory framework, and of the appropriate coverage of face-to-face social assistance. It should be noted that the majority of the beneficiaries of supplementary health reside in larger centers, where the ratio of doctors/specialists per inhabitant is appropriate, and consultations in person are a legal imposition.</p>
        <p>Telemedicine may be an important incremental tool in supplemental health, provided there is additional regulation for its implementation. Among the possible measures to extend the scope of Telemedicine in supplementary health, as already exists in American Medicare, would be the inclusion of technologies, with scientific and legal basis, in the Health Procedures and Events List of the National Supplementary Health Agency, since coverage would be mandatory, providing equity and legal certainty.</p>
        <p>It is recommended that the bases established by the Brazilian Code of Medical Ethics be maintained in the Telemedicine and Telecardiology procedures. Telemedicine should be considered an additional tool for the face-to-face physician-patient relationship, without ever replacing it.</p>
      </sec>
    </sec>
    <sec sec-type="conclusions">
      <title>Conclusion</title>
      <p>Telemedicine as a means of increasing universal and integral access to health, backed by solid evidence, attested by the scientific community, within the budgetary capacity of the Brazilian State, expressed in legitimate public policies, integrates the existential minimum of each Brazilian citizen. It is, therefore, a universal right and duty of the State, and must be guaranteed through social and economic policies in force in the country. The remarkable advance of information and communication technologies and their application in health must be a constant focus of attention of the public authorities, being an instrument of equity and fostering the dignity of the human person. The use of technology in medicine emphasizes the duty of due care to preserve patients&#8217; privacy and the transcendent values that underlie the practice of Medicine.</p>
    </sec>
  </body>
  <back>
    <fn-group>
      <fn fn-type="financial-disclosure">
        <p>Sources of Funding</p>
        <p>There were no external funding sources for this study.</p>
      </fn>
      <fn fn-type="other">
        <p>Study Association</p>
        <p>This study is not associated with any thesis or dissertation work.</p>
      </fn>
    </fn-group>
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  </back>
  <sub-article article-type="translation" id="s1" xml:lang="pt">
    <front-stub>
      <article-categories>
        <subj-group subj-group-type="heading">
          <subject>Ponto de Vista</subject>
        </subj-group>
      </article-categories>
      <title-group>
        <article-title>Sa&#250;de digital, direito de todos, dever do Estado?</article-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="author">
          <contrib-id contrib-id-type="orcid">0000-0003-1253-1514</contrib-id>
          <name>
            <surname>Lopes</surname>
            <given-names>Marcelo Ant&#244;nio Cartaxo Queiroga</given-names>
          </name>
          <xref ref-type="aff" rid="aff4">1</xref>
          <xref ref-type="corresp" rid="c2"/>
        </contrib>
        <contrib contrib-type="author">
          <contrib-id contrib-id-type="orcid">0000-0002-0737-6188</contrib-id>
          <name>
            <surname>Oliveira</surname>
            <given-names>Gl&#225;ucia Maria Moraes de</given-names>
          </name>
          <xref ref-type="aff" rid="aff5">2</xref>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Maia</surname>
            <given-names>Luciano Mariz</given-names>
          </name>
          <xref ref-type="aff" rid="aff6">3</xref>
        </contrib>
      </contrib-group>
      <aff id="aff4">
        <label>1</label>
        <institution content-type="original">Hospital Alberto Urquiza Wanderley, Jo&#227;o Pessoa, PB - Brasil</institution>
      </aff>
      <aff id="aff5">
        <label>2</label>
        <institution content-type="original">Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ - Brasil</institution>
      </aff>
      <aff id="aff6">
        <label>3</label>
        <institution content-type="original">Centro de Ci&#234;ncias Jur&#237;dicas da Universidade Federal da Para&#237;ba, Jo&#227;o Pessoa, PB - Brasil</institution>
      </aff>
      <author-notes>
        <corresp id="c2"><bold>Correspond&#234;ncia: Marcelo Ant&#244;nio Cartaxo Queiroga Lopes,</bold> Cardiocenter - Av. Ministro Jos&#233; Am&#233;rico de Almeida, 1450, Torre, Hospital - Alberto Urquiza Wanderley. CEP 58.040-300, Jo&#227;o Pessoa, PB - Brasil. E-mail: <email>mqueiroga@cardiol.br</email>, <email>marcelocartaxoqueiroga@gmail.com</email>
				</corresp>
        <fn fn-type="con">
          <p>
            <bold>Contribui&#231;&#227;o dos autores</bold>
          </p>
          <p>Concep&#231;&#227;o e desenho da pesquisa, Obten&#231;&#227;o de dados, An&#225;lise e interpreta&#231;&#227;o dos dados, Reda&#231;&#227;o do manuscrito e Revis&#227;o cr&#237;tica do manuscrito quanto ao conte&#250;do intelectual importante: Lopes MACQ, Oliveira GMM, Maia LM.</p>
        </fn>
        <fn fn-type="conflict">
          <p>
            <bold>Potencial conflito de interesses</bold>
          </p>
          <p>Declaro n&#227;o haver conflito de interesses pertinentes.</p>
        </fn>
      </author-notes>
      <kwd-group xml:lang="pt">
        <title>Palavras-chave</title>
        <kwd>Assist&#234;ncia Integral &#224; Sa&#250;de/legisla&#231;&#227;o &amp; jurisprud&#234;ncia</kwd>
        <kwd>Assist&#234;ncia Individualizada &#224; Sa&#250;de/tend&#234;ncias</kwd>
        <kwd>Telemedicina, Sistema &#218;nico de sa&#250;de</kwd>
        <kwd>Administra&#231;&#227;o em Sa&#250;de P&#250;blica.</kwd>
      </kwd-group>
    </front-stub>
    <body>
      <sec sec-type="intro">
        <title>Introdu&#231;&#227;o</title>
        <p>A Constitui&#231;&#227;o Federal estabelece, em seu art. 196,<xref ref-type="bibr" rid="B1">1</xref> que &#8220;a sa&#250;de &#233; um direito de todos e dever do Estado, garantido mediante pol&#237;ticas sociais e econ&#244;micas que visem &#224; redu&#231;&#227;o do risco de doen&#231;as e de outros agravos, e ao acesso universal e igualit&#225;rio &#224;s a&#231;&#245;es e servi&#231;os para sua promo&#231;&#227;o e recupera&#231;&#227;o&#8221;.</p>
        <p>Considera, ademais, em seu artigo 198,<xref ref-type="bibr" rid="B1">1</xref> que &#8220;as a&#231;&#245;es e servi&#231;os p&#250;blicos de sa&#250;de integram uma rede regionalizada e hierarquizada e constituem um sistema &#250;nico, organizado com as seguintes diretrizes: I - descentraliza&#231;&#227;o, com dire&#231;&#227;o &#250;nica em cada esfera de governo; II - atendimento integral, com prioridade para as a&#231;&#245;es preventivas, sem preju&#237;zos dos servi&#231;os assistenciais; III - participa&#231;&#227;o da comunidade.&#8221;</p>
        <p>A partir de uma leitura sistem&#225;tica desses dois dispositivos constitucionais, podem ser elencados os elementos basilares da implementa&#231;&#227;o do direito &#224; sa&#250;de pelo poder p&#250;blico: o acesso universal e igualit&#225;rio, bem como o atendimento integral. A aten&#231;&#227;o integral &#224; sa&#250;de determina que o &#8220;dever do Estado n&#227;o pode ser limitado, mitigado ou dividido, pois a sa&#250;de como bem individual, coletivo e de desenvolvimento pressup&#245;e uma abordagem assistencial completa&#8221; e fornecer a aten&#231;&#227;o integral &#8220;nada mais significa do que privilegiar a vida em detrimento de interesses or&#231;ament&#225;rios da administra&#231;&#227;o - o chamado interesse p&#250;blico secund&#225;rio&#8221;.<xref ref-type="bibr" rid="B2">2</xref>
				</p>
        <p>Dentro desse contexto, o Sistema &#218;nico de Sa&#250;de (SUS) foi concebido para ser o mecanismo pelo qual o acesso universal e igualit&#225;rio, bem como a aten&#231;&#227;o integral, deve ser implementado. O SUS deve atuar conforme essas diretrizes, n&#227;o podendo impor quaisquer restri&#231;&#245;es direcionadas especificamente a um determinado grupo ou classe, nem pode privilegiar interesses or&#231;ament&#225;rios da administra&#231;&#227;o em detrimento do direito &#224; vida.</p>
        <p>Como observa Resende,<xref ref-type="bibr" rid="B3">3</xref> &#8220;o conceito de sa&#250;de, como direito fundamental, no marco normativo internacional, foi alargado ao longo dos anos para incluir, al&#233;m da ideia negativa de aus&#234;ncia de doen&#231;a, um conte&#250;do positivo relacionado &#224; melhora da qualidade de vida e bem-estar&#8221;. De acordo com a Carta de Bangkok<xref ref-type="bibr" rid="B4">4</xref> para a promo&#231;&#227;o da sa&#250;de em um mundo globalizado, elaborada por ocasi&#227;o da VI Confer&#234;ncia Internacional sobre Promo&#231;&#227;o da Sa&#250;de, de 2005, &#8220;as Na&#231;&#245;es Unidas reconhecem que a obten&#231;&#227;o do mais alto n&#237;vel de sa&#250;de &#233; um dos direitos fundamentais de qualquer ser humano, sem discrimina&#231;&#227;o de ra&#231;a, cor, sexo, ou condi&#231;&#227;o socioecon&#244;mica. A promo&#231;&#227;o da sa&#250;de se baseia neste direito humano fundamental e oferece um conceito positivo e inclusivo de sa&#250;de como um determinante de qualidade de vida, incluindo o bem-estar mental e espiritual&#8221;.</p>
        <p>O acesso &#224; sa&#250;de &#233; um direito social, assegurado no artigo 6&#186; da Constitui&#231;&#227;o,<xref ref-type="bibr" rid="B1">1</xref> em conformidade com a dignidade da pessoa humana, que constitui fundamento do Estado democr&#225;tico de direito. A Constitui&#231;&#227;o, dita cidad&#227;, inaugurou uma nova ordem jur&#237;dica no pa&#237;s que promove a inclus&#227;o de milh&#245;es de brasileiros que estavam &#224; margem de qualquer assist&#234;ncia &#224; sa&#250;de.</p>
        <p>Tomando-se como perspectiva, no in&#237;cio do s&#233;culo XX apenas tinham acesso ao sistema de sa&#250;de aqueles que integravam caixas de assist&#234;ncia previdenci&#225;ria. Mesmo com a unifica&#231;&#227;o dos Institutos de Assist&#234;ncia Previdenci&#225;ria, os chamados IAPs, e a cria&#231;&#227;o do Instituto Nacional de Previd&#234;ncia Social (INPS), persistiu a exclus&#227;o dos n&#227;o part&#237;cipes - n&#227;o contribuintes, uma verdadeira legi&#227;o de indigentes.</p>
        <p>O SUS, observando a organiza&#231;&#227;o federativa do Estado brasileiro, conceitualmente foi pensado como solu&#231;&#227;o, mas, ap&#243;s tr&#234;s d&#233;cadas, persistem problemas cr&#244;nicos de financiamento e gest&#227;o que emperram as engrenagens do maior sistema de acesso universal &#224; sa&#250;de do mundo, dificultando a consecu&#231;&#227;o dos seus objetivos originais. O gigantismo do Brasil e a heterogeneidade das diversas regi&#245;es imp&#245;em gest&#227;o eficiente e capaz de promover, dentro das prioridades do Estado, a conveniente justi&#231;a alocativa. Somente com a ado&#231;&#227;o de pol&#237;ticas p&#250;blicas consequentes e sua capilaridade em todo pa&#237;s se conseguir&#225; modificar o panorama da sa&#250;de p&#250;blica no Brasil.</p>
        <p>Nas &#250;ltimas d&#233;cadas, como consequ&#234;ncia do acerto das pol&#237;ticas p&#250;blicas, houve aumento da expectativa de vida e, atualmente, experimentamos uma verdadeira transi&#231;&#227;o demogr&#225;fica. O crescimento do n&#250;mero de idosos &#233; exponencial, estimando-se que esse segmento social represente 25% da popula&#231;&#227;o do Brasil em 20 anos. O impacto sobre a seguridade social &#233; desafio para o Estado, e requer aten&#231;&#227;o redobrada, com ado&#231;&#227;o de pol&#237;ticas p&#250;blicas sustent&#225;veis, sobretudo na &#225;rea da sa&#250;de.<xref ref-type="bibr" rid="B4">4</xref>
				</p>
        <p>As doen&#231;as cr&#244;nico-degenerativas n&#227;o transmiss&#237;veis (DCNT) s&#227;o respons&#225;veis por mais de 30% da mortalidade global e esse contexto ser&#225; agravado com o envelhecimento e o adoecimento da popula&#231;&#227;o j&#225; vigente. <italic>Ipso facto</italic>, n&#227;o h&#225; como desconhecer que os recursos para ofertar a amplia&#231;&#227;o da assist&#234;ncia &#224; sa&#250;de, especialmente para a crescente preval&#234;ncia das DCNT, sobretudo em &#225;reas remotas de um pa&#237;s como o Brasil, &#233; uma miss&#227;o complexa. Ser&#225; um desafio, a ser superado, levar profissionais de sa&#250;de aos mais long&#237;nquos rinc&#245;es, notadamente os especialistas.<xref ref-type="bibr" rid="B4">4</xref>
				</p>
        <p>Por outro lado, h&#225; uma constante tens&#227;o entre a classe m&#233;dica e as autoridades sanit&#225;rias acerca das alternativas poss&#237;veis para a oferta de m&#233;dicos &#224; sociedade. Esse tema adquiriu contornos de batalha &#233;pica por ocasi&#227;o da san&#231;&#227;o da Lei 12.871, de 22 de outubro de 2013,<xref ref-type="bibr" rid="B5">5</xref> que instituiu o &#8220;Programa Mais M&#233;dicos&#8221; no Brasil. A oferta de m&#233;dicos no pa&#237;s, desde a institui&#231;&#227;o do Programa Mais M&#233;dicos, tem aumentado, em virtude, principalmente, da crescente abertura de escolas m&#233;dicas. Contudo, a propor&#231;&#227;o de m&#233;dicos por 100 mil habitantes ainda &#233; inferior &#224; m&#233;dia dos pa&#237;ses da Organiza&#231;&#227;o para a Coopera&#231;&#227;o e Desenvolvimento Econ&#244;mico (OCDE). Adite-se que a distribui&#231;&#227;o desses m&#233;dicos &#233; heterog&#234;nea, agravando esse cen&#225;rio.<xref ref-type="bibr" rid="B6">6</xref> Nesse sentido, o emprego de tecnologias da informa&#231;&#227;o e comunica&#231;&#227;o, por interm&#233;dio de uma rede de Telemedicina, poderia contribuir para universalidade e integralidade do sistema de sa&#250;de, em conson&#226;ncia com o ditame constitucional.</p>
        <sec>
          <title>Telemedicina como ferramenta para ampliar o acesso universal &#224; sa&#250;de</title>
          <p>O not&#225;vel avan&#231;o das tecnologias de informa&#231;&#227;o e comunica&#231;&#227;o e sua aplica&#231;&#227;o na Medicina propiciaram a transmiss&#227;o segura de dados, facilitando a intera&#231;&#227;o de profissionais de sa&#250;de, abrindo uma porta para democratiza&#231;&#227;o do acesso ao conhecimento m&#233;dico e estreitando a colabora&#231;&#227;o entre os diversos n&#237;veis de aten&#231;&#227;o &#224; sa&#250;de.</p>
          <p>A Telemedicina pode ser conceituada como forma organizada e eficiente de exerc&#237;cio da Medicina a dist&#226;ncia para fins de informa&#231;&#227;o, diagn&#243;stico e tratamento de indiv&#237;duos, isoladamente ou em grupo, baseada em dados, documentos ou outras informa&#231;&#245;es confi&#225;veis transmitidas por interm&#233;dio de telecomunica&#231;&#245;es. Atualmente, o emprego da Telemedicina tem abrang&#234;ncia crescente, sendo poss&#237;vel realizar desde consultas (teleconsulta), diagn&#243;sticos (telediagn&#243;stico) at&#233; complexas cirurgias rob&#243;ticas (telecirurgia). Todo esse avan&#231;o, o qual projeta o conceito mais amplo de sa&#250;de digital, deve ocorrer preservando os postulados milenares da arte m&#233;dica, sempre centrada no melhor interesse do paciente.<xref ref-type="bibr" rid="B7">7</xref>
					</p>
          <p>As interven&#231;&#245;es de sa&#250;de digital n&#227;o s&#227;o um substituto para os sistemas de sa&#250;de em funcionamento, pois ainda existem limita&#231;&#245;es significativas para o que a sa&#250;de digital &#233; capaz de resolver. No entanto, o emprego criterioso dessa tecnologia pode contribuir para melhorias na aten&#231;&#227;o &#224; sa&#250;de, desde que ancorado na avalia&#231;&#227;o dos seus benef&#237;cios, danos, aceitabilidade e viabilidade.<xref ref-type="bibr" rid="B7">7</xref>
					</p>
          <p>Ao adentrar a intricada discuss&#227;o das normas garantidoras da sa&#250;de, como direito fundamental, e &#224; guisa da aplica&#231;&#227;o de tecnologias da informa&#231;&#227;o e comunica&#231;&#227;o para promover o exerc&#237;cio da Medicina a dist&#226;ncia, base da Telemedicina, h&#225; que pugnar-se pela higidez da privacidade dos pacientes. A inviolabilidade da vida privada, como o direito &#224; sa&#250;de, tamb&#233;m constitui parte indissoci&#225;vel do conceito de dignidade da pessoa humana.<xref ref-type="bibr" rid="B1">1</xref> Portanto, a seguran&#231;a da transmiss&#227;o dos dados &#233; um imperativo para a implementa&#231;&#227;o de qualquer programa de Telemedicina. O princ&#237;pio milenar do segredo m&#233;dico, vigente desde Hip&#243;crates, &#233; tamb&#233;m uma imposi&#231;&#227;o constitucional.</p>
          <p>O ordenamento jur&#237;dico aplic&#225;vel &#224; Telemedicina no Brasil &#233; abrangente e envolve desde a legisla&#231;&#227;o sanit&#225;ria ao recente marco regulat&#243;rio da internet para assegurar sua pr&#225;tica regular. Atualmente, protocolos internacionais garantem a transmiss&#227;o segura dos dados: o <italic>Health Insurance Portability and Accountability Act</italic> (HIPPA)<xref ref-type="bibr" rid="B7">7</xref> cont&#233;m um conjunto de normas que garantem a seguran&#231;a dos dados transportados e dos respons&#225;veis por sua transmiss&#227;o</p>
        </sec>
        <sec>
          <title>Regulamenta&#231;&#227;o da Telemedicina pelo Conselho Federal de Medicina</title>
          <p>O Conselho Federal de Medicina (CFM), &#243;rg&#227;o de natureza aut&#225;rquica, institu&#237;do pela Lei 3.268, de 30 de setembro de 1957,<xref ref-type="bibr" rid="B8">8</xref> tem a incumb&#234;ncia de supervisionar a &#233;tica profissional em toda a Rep&#250;blica e, ao mesmo tempo, julgar e disciplinar a classe m&#233;dica, por interm&#233;dio de a&#231;&#227;o fiscalizadora e regulat&#243;ria. Com fulcro nessas atribui&#231;&#245;es, compete ao CFM regulamentar a participa&#231;&#227;o dos m&#233;dicos em atividades vinculadas ao emprego da Telemedicina em todo o territ&#243;rio nacional.</p>
          <p>A Lei 12.842,<xref ref-type="bibr" rid="B9">9</xref> de 10 de julho de 2013, Lei do Ato M&#233;dico, que disp&#245;e sobre o exerc&#237;cio da Medicina, ratifica que os novos procedimentos e terapias m&#233;dicas para uso regular no Brasil devem ser, necessariamente, avaliados pelo Conselho Federal de Medicina quanto a sua seguran&#231;a, efici&#234;ncia, conveni&#234;ncia e benef&#237;cios aos pacientes. A Telemedicina - com a mir&#237;ade de possibilidades de emprego em preven&#231;&#227;o, diagn&#243;stico, tratamento, reabilita&#231;&#227;o, bem como na promo&#231;&#227;o da sa&#250;de - enquadra-se, indubitavelmente, e &#233; pass&#237;vel de valida&#231;&#227;o pelo CFM. Por seu car&#225;ter inovador, traz consigo um potencial de conflitos de natureza bio&#233;tica, que imp&#245;e uma an&#225;lise zet&#233;tica - investigativa - dos seus princ&#237;pios, em virtude do choque entre a &#233;tica tradicional, que permeia a rela&#231;&#227;o presencial entre o m&#233;dico e o paciente, e a nova fronteira aberta pelo progresso da tecnologia da informa&#231;&#227;o e da comunica&#231;&#227;o.</p>
          <p>O Conselho Federal de Medicina, por interm&#233;dio da Resolu&#231;&#227;o CFM 1.643/2002,<xref ref-type="bibr" rid="B10">10</xref> disp&#244;s sobre a Telemedicina, definindo-a &#8220;como o exerc&#237;cio da Medicina atrav&#233;s da utiliza&#231;&#227;o de metodologias interativas de comunica&#231;&#227;o audiovisual e de dados, com o objetivo de assist&#234;ncia, educa&#231;&#227;o e pesquisa em Sa&#250;de&#8221;. Essa regula&#231;&#227;o obriga o emprego de tecnologia apropriada e a observa&#231;&#227;o &#224;s normas t&#233;cnicas do CFM relativas a guarda, manuseio, transmiss&#227;o de dados, confidencialidade, privacidade e garantia do sigilo profissional. A atua&#231;&#227;o do m&#233;dico que assiste o ato profissional a dist&#226;ncia se restringe &#224;s emerg&#234;ncias, ou quando solicitado pelo m&#233;dico respons&#225;vel pelo atendimento presencial.</p>
          <p>Em 2014, o CFM voltou a se manifestar sobre o tema, por interm&#233;dio da Resolu&#231;&#227;o CFM 2.107/2014,<xref ref-type="bibr" rid="B11">11</xref> para disciplinar o emprego da Telerradiologia. Essa Resolu&#231;&#227;o atualizou a norma anterior, publicada em 2009. O desenvolvimento da tecnologia e a democratiza&#231;&#227;o do acesso &#224; telefonia celular pluralizaram o desenvolvimento de aplicativos dedicados &#224; sa&#250;de digital. Atualmente, as possibilidades de emprego da Telemedicina contemplam uma s&#233;rie de servi&#231;os, dentre os quais citamos: (a) Teleconsulta, Teleinterconsulta, Telediagn&#243;stico, Teleorienta&#231;&#227;o, Telemonitoramento, Telecirurgia e Teletriagem M&#233;dica. Embora parte desses servi&#231;os n&#227;o esteja explicitamente regulamentada pelo CFM, h&#225; a oferta por empresas especializadas, sobretudo no &#226;mbito da sa&#250;de suplementar, sendo imperiosa a disciplina destes em ato administrativo pr&#243;prio.</p>
          <p>Nesse sentido, o CFM editou a Resolu&#231;&#227;o CFM 2.227/2018,<xref ref-type="bibr" rid="B12">12</xref> publicada no <italic>Di&#225;rio Oficial da Uni&#227;o</italic> em 6 de fevereiro de 2019, para atualizar a disciplina vigente. A resolu&#231;&#227;o visava garantir seguran&#231;a &#224; presta&#231;&#227;o de servi&#231;os m&#233;dicos mediados por tecnologias de informa&#231;&#227;o e comunica&#231;&#227;o no Brasil. N&#227;o h&#225; d&#250;vida da necessidade de atualizar o marco regulat&#243;rio que disciplina a participa&#231;&#227;o de m&#233;dicos na chamada Telemedicina. Tal medida legitima a rela&#231;&#227;o me&#769;dico-paciente no &#226;mbito da sa&#250;de digital. No entanto, houve uma avalanche de questionamentos da categoria m&#233;dica sobre a forma e o m&#233;rito desta norma.</p>
          <p>Em <italic>Janela para o futuro ou porta para o caos?</italic>, Lopes et al.,<xref ref-type="bibr" rid="B13">13</xref> discutiram diversos aspectos vinculados a legalidade e oportunidade da Resolu&#231;&#227;o CFM 2.227/2018, sendo a libera&#231;&#227;o da Teleconsulta o que mais suscitou questionamentos, justamente por flexibilizar a prescri&#231;&#227;o sem o exame direto do paciente, conduta vedada pelo C&#243;digo de &#201;tica M&#233;dica.* Para os autores, a regulamenta&#231;&#227;o do CFM &#8220;deve, portanto, representar um avan&#231;o, n&#227;o um retrocesso. Ampliar o acesso na sa&#250;de p&#250;blica &#233; desejo comum a todos os m&#233;dicos. O grande desafio da Resolu&#231;&#227;o CFM 2.227/2018 seria ter efic&#225;cia e aplicabilidade para avan&#231;armos no campo da justi&#231;a e da &#233;tica deliberativa.&#8221;</p>
          <p>A avalanche de questionamentos corporativos da categoria, entre outras raz&#245;es, motivou a revoga&#231;&#227;o desta Resolu&#231;&#227;o pelo CFM.<xref ref-type="bibr" rid="B11">11</xref> Assim, o emprego da Telemedicina pelos m&#233;dicos no Brasil deve ocorrer segundo os ditames da Resolu&#231;&#227;o CFM 1.643/2002.<xref ref-type="bibr" rid="B10">10</xref> &#201; preciso referir que houve problemas de comunica&#231;&#227;o sobre o conte&#250;do da norma, suscitando intensa rea&#231;&#227;o dos m&#233;dicos em rela&#231;&#227;o ao m&#233;rito da regula&#231;&#227;o.</p>
          <p>Discorrendo, ainda, sobre o tema, vale dizer, como alertam Lopes et al.,<xref ref-type="bibr" rid="B13">13</xref> o CFM n&#227;o poderia delegar, exclusivamente, &#224;s sociedades de especialidade a prerrogativa de elaborarem diretrizes sobre telediagn&#243;stico. &#201; importante destacar que a Lei 12.401, de 28 de abril de 2011,<xref ref-type="bibr" rid="B9">9</xref> define que a compet&#234;ncia de elabora&#231;&#227;o de protocolos cl&#237;nicos e diretrizes terap&#234;uticas no &#226;mbito do SUS &#233; da Comiss&#227;o Nacional de Incorpora&#231;&#227;o de Tecnologias no SUS (Conitec). Com efeito, n&#227;o poderia o CFM, com base em resolu&#231;&#227;o normativa, excluir quem tem compet&#234;ncia legal para elaborar diretrizes no &#226;mbito do sistema de sa&#250;de do Brasil, delegando, exclusivamente, essa atribui&#231;&#227;o a ente privado, mesmo que condicionada a sua aprova&#231;&#227;o. Portanto, seja em rela&#231;&#227;o &#224; Telecirurgia rob&#243;tica ou ao Telediagn&#243;stico, a Resolu&#231;&#227;o revogada poderia ser aprimorada.</p>
        </sec>
        <sec>
          <title>Dificuldades para implementa&#231;&#227;o da sa&#250;de digital como dever do Estado</title>
          <p>Desse modo, poder&#237;amos imaginar a Telemedicina como uma ferramenta complementar &#250;til para permitir equidade de acesso a sa&#250;de integral para todos os brasileiros, independente de etnia, sexo, <italic>status</italic> socioecon&#244;mico e localiza&#231;&#227;o no territ&#243;rio nacional. Especialmente se considerarmos a dimens&#227;o continental do Brasil, poder&#237;amos supor que as popula&#231;&#245;es que vivem em &#225;reas remotas seriam beneficiadas pelo investimento do Estado na dissemina&#231;&#227;o da sa&#250;de digital.</p>
          <p>Segundo o IBGE,<xref ref-type="bibr" rid="B14">14</xref> cerca de 65% dos munic&#237;pios situados em &#225;reas remotas se localizam nas Regi&#245;es Norte e Centro-Oeste do pa&#237;s. Por outro lado, o estudo Demografia M&#233;dica no Brasil (2018)<xref ref-type="bibr" rid="B6">6</xref> relatou significativa desigualdade na distribui&#231;&#227;o dos m&#233;dicos, que predominam nos grandes aglomerados urbanos das Regi&#245;es Sul e Sudeste, onde se encontra tamb&#233;m o maior n&#250;mero de especialistas, com menor densidade m&#233;dico/habitante nas Regi&#245;es Norte e Nordeste. Se olharmos ainda pela &#243;tica da assist&#234;ncia, por interm&#233;dio do Cadastro Nacional de Estabelecimentos de Sa&#250;de (CNES)<xref ref-type="bibr" rid="B15">15</xref> do Minist&#233;rio da Sa&#250;de, observamos maior concentra&#231;&#227;o da atividade m&#233;dica nas Regi&#245;es Sudeste e Sul. &#201; importante mencionar, ainda, que h&#225; menor concentra&#231;&#227;o de redes ligadas por fibras &#243;pticas em munic&#237;pios da Regi&#227;o Norte, e que a cobertura de telefonia celular m&#243;vel para a popula&#231;&#227;o brasileira situa-se entre 98 e 99%, com maior concentra&#231;&#227;o nos centros urbanos do Sudeste e Sul.<xref ref-type="bibr" rid="B16">16</xref><sup>,</sup><xref ref-type="bibr" rid="B17">17</xref>
					</p>
          <p>Depreende-se que, embora a demanda por servi&#231;os m&#233;dicos nas &#225;reas remotas seja uma oportunidade, a disponibiliza&#231;&#227;o de servi&#231;os por meio de Telemedicina para essas regi&#245;es encontra um grande desafio de implementa&#231;&#227;o semelhante &#224; universaliza&#231;&#227;o do acesso aos servi&#231;os de sa&#250;de tradicional. A expans&#227;o da Telemedicina teria que ser precedida pela melhoria da infraestrutura de tecnologia digital.</p>
          <p>Por outro lado, a Organiza&#231;&#245;es das Na&#231;&#245;es Unidas (ONU), por interm&#233;dio da Uni&#227;o Internacional das Telecomunica&#231;&#245;es (UIT),<xref ref-type="bibr" rid="B18">18</xref> vem trabalhando em conjunto com a Organiza&#231;&#227;o Mundial da Sa&#250;de (OMS) para estimular a redu&#231;&#227;o do <italic>gap</italic> digital global, com a estrat&#233;gia e-sa&#250;de, com foco na sa&#250;de digital, via Telemedicina.</p>
          <p>O investimento em sa&#250;de digital gerou v&#225;rias publica&#231;&#245;es da OMS. S&#227;o exemplos o <italic>Digital Health Atlas</italic>,<xref ref-type="bibr" rid="B9">9</xref>um reposit&#243;rio global virtual para apoiar os governos no monitoramento e na coordena&#231;&#227;o de investimentos digitais, o BeHe@lthy, BeMobile (BHBM),<xref ref-type="bibr" rid="B20">20</xref> para preven&#231;&#227;o e controle de DCNT, o mHealth Assessment and Planning for Scale (MAPS), manual para monitoramento e avalia&#231;&#227;o da sa&#250;de digital,<xref ref-type="bibr" rid="B21">21</xref> com o objetivo de fortalecer a pesquisa e a implementa&#231;&#227;o da sa&#250;de digital, e a primeira Diretriz sobre Interven&#231;&#245;es de Sa&#250;de Digital da OMS.<xref ref-type="bibr" rid="B22">22</xref> Este &#250;ltimo documento<xref ref-type="bibr" rid="B22">22</xref> sugere que as evid&#234;ncias cient&#237;ficas dispon&#237;veis sobre os benef&#237;cios da implementa&#231;&#227;o da sa&#250;de digital global ainda n&#227;o s&#227;o, em sua maioria, robustas, e que existem in&#250;meras brechas para utiliza&#231;&#227;o em larga escala, ainda que de forma complementar aos m&#233;todos tradicionais. A OMS recomenda que ocorra um processo planejado que preveja: a viabilidade da cobertura da rede para acesso a lugares remotos, a constru&#231;&#227;o do arcabou&#231;o legal e jur&#237;dico para sua efetiva&#231;&#227;o, o impacto or&#231;ament&#225;rio e a avalia&#231;&#227;o de custo-efetividade de execu&#231;&#227;o de cada etapa do projeto, com a elabora&#231;&#227;o de indicadores do <italic>continuum</italic> cl&#237;nico da aplicabilidade para seguran&#231;a dos usu&#225;rios.</p>
        </sec>
        <sec>
          <title>Telemedicina para reduzir as desigualdades na abordagem das DCNT</title>
          <p>A Telemedicina, se aplicada em seu contexto amplo, poderia permitir o acesso e a equidade, ofertando servi&#231;os de qualidade com suposta custo-efetividade, especialmente considerando-se o aumento da preval&#234;ncia e da mortalidade das DCNT, das quais as doen&#231;as cardiovasculares (DCV) s&#227;o seu principal componente.</p>
          <p>Foram registrados 55,9 milh&#245;es de mortes no mundo em 2017 em uma popula&#231;&#227;o mundial estimada em 7,64 bilh&#245;es de pessoas.<xref ref-type="bibr" rid="B23">23</xref> Destes, 70% foram decorrentes de DCNT, e estima-se que continuem a aumentar nas pr&#243;ximas d&#233;cadas, especialmente nos pa&#237;ses de baixa e m&#233;dia renda, ainda que a mortalidade por todas as causas tenha diminu&#237;do, notadamente por conta de diminui&#231;&#227;o da mortalidade infantil e dos menores de 5 anos, estabiliza&#231;&#227;o da mortalidade dos 5 anos aos 49 anos e aumento da expectativa de vida.<xref ref-type="bibr" rid="B23">23</xref> Espera-se o aumento das DCNT com o envelhecimento da popula&#231;&#227;o, com o controle das doen&#231;as comunic&#225;veis e com o aumento da mortalidade prematura em indiv&#237;duos de 30 a 70 anos de idade.<xref ref-type="bibr" rid="B24">24</xref>
					</p>
          <p>No Brasil, as DCNT foram respons&#225;veis por cerca de 60% dos &#243;bitos em 2017, de acordo com o Departamento de Inform&#225;tica do Sistema &#218;nico de Sa&#250;de (DATASUS),<xref ref-type="bibr" rid="B25">25</xref> observando-se que esse grupo de doen&#231;as partilha dos mesmos fatores de risco e determinantes sociais. A gravidade do tema &#233; grande o suficiente para que fossem estabelecidas metas de redu&#231;&#227;o de 30% da mortalidade prematura por DCNT como parte das Metas de Desenvolvimento Sustent&#225;vel Global (<italic>Sustainable Development Goals</italic> - SDG) para 2030.<xref ref-type="bibr" rid="B26">26</xref><sup>,</sup><xref ref-type="bibr" rid="B27">27</xref> Acredita-se, ainda, que um ter&#231;o das popula&#231;&#245;es das Am&#233;ricas n&#227;o tenha acesso a cuidados de sa&#250;de, e que seriam necess&#225;rios 800.000 profissionais de sa&#250;de adicionais para atender &#224;s demandas dos sistemas de sa&#250;de na regi&#227;o.<xref ref-type="bibr" rid="B28">28</xref>
					</p>
          <p>A abordagem combinada das DCNT e de seus fatores de risco foi considerada um pacote custo-efetivo pela OMS, requerendo investimento de 1 d&#243;lar <italic>per capita</italic> nos pa&#237;ses de baixa renda, 1,5 nos de baixa-m&#233;dia renda, e 3 d&#243;lares nos de m&#233;dia-alta renda, ressaltando a import&#226;ncia do estudo em conjunto das DCNT.<xref ref-type="bibr" rid="B29">29</xref> Para o diretor-geral da OMS, Dr. Tedros Adhanom Ghebreyesus, &#8220;aproveitar o poder das tecnologias digitais ser&#225; essencial para alcan&#231;ar as Metas de Desenvolvimento Sustent&#225;vel Global, incluindo a cobertura universal da sa&#250;de, e que tais tecnologias n&#227;o s&#227;o mais um luxo, mas uma necessidade&#8221;. Sugere tamb&#233;m que nos certifiquemos de que a inova&#231;&#227;o e a tecnologia atenuem as desigualdades, devendo os pa&#237;ses ser guiados por evid&#234;ncias para estabelecer sistemas digitais harmonizados, e n&#227;o se deixem seduzir pelas novidades.<xref ref-type="bibr" rid="B30">30</xref>
					</p>
          <p>A resolu&#231;&#227;o da Assembleia Mundial da Sa&#250;de sobre Sa&#250;de Digital, aprovada por unanimidade pelos Membros da OMS, em maio de 2018, demonstrou um reconhecimento coletivo do valor das tecnologias digitais em contribuir para o avan&#231;o da cobertura universal de sa&#250;de, com &#234;nfase nas DCNT, e recomendou que os minist&#233;rios da sa&#250;de avaliem o uso de tecnologias digitais dedicadas &#224; sa&#250;de, priorizando desenvolvimento, avalia&#231;&#227;o, implementa&#231;&#227;o e aumento do uso dessas tecnologias, bem como orientando a sua normatiza&#231;&#227;o, inclusive por meio da promo&#231;&#227;o de interven&#231;&#245;es em sa&#250;de digital. No entanto, ressalvou-se que, para reduzir as desigualdades na sa&#250;de, seria necess&#225;ria uma avalia&#231;&#227;o rigorosa das estrat&#233;gias do <italic>eSa&#250;de</italic> com a finalidade de gerar evid&#234;ncias e promover a integra&#231;&#227;o apropriada do uso dessas tecnologias.<xref ref-type="bibr" rid="B18">18</xref>
					</p>
        </sec>
        <sec>
          <title>Recomenda&#231;&#245;es da Diretriz de Telemedicina da Sociedade Brasileira de Cardiologia para a sa&#250;de cardiovascular</title>
          <p>Para nortear a pr&#225;tica da Telemedicina nas DCV, Lopes et al. elaboraram a Diretriz de Telemedicina da Sociedade Brasileira de Cardiologia,<xref ref-type="bibr" rid="B31">31</xref> com o objetivo de discutir o suporte legal e &#233;tico, as condi&#231;&#245;es t&#233;cnicas e a prioridade para a implementa&#231;&#227;o, a custo-efetividade e o impacto or&#231;ament&#225;rio para o emprego da Telemedicina para a sa&#250;de cardiovascular dos brasileiros.</p>
          <p>Constatou-se que existe espa&#231;o para iniciativas de Telemedicina como apoio matricial de especialista para m&#233;dicos generalistas e de sa&#250;de da fam&#237;lia em unidades b&#225;sicas de sa&#250;de em &#225;reas remotas do territ&#243;rio brasileiro, especialmente no que tange aos m&#233;todos diagn&#243;sticos, evitando deslocamentos desnecess&#225;rios com &#244;nus adicional ao sistema de sa&#250;de. Os resultados cl&#237;nicos e econ&#244;micos obtidos com pol&#237;ticas p&#250;blicas, com foco na sa&#250;de digital, vigentes no Brasil sugerem que as tecnologias que permitem o acompanhamento do paciente (telemonitoramento) e a emiss&#227;o de laudos a dist&#226;ncia (telediagn&#243;stico) aplicadas &#224; cardiologia podem ser custo-efetivas, com impacto aceit&#225;vel no or&#231;amento p&#250;blico. Por&#233;m, o conjunto de evid&#234;ncias cient&#237;ficas no Brasil ainda &#233; limitado, em face do reduzido n&#250;mero de pacientes envolvidos, para inferir-se que a aplica&#231;&#227;o em subgrupos de interesse cl&#237;nico deva ser generalizada.</p>
          <p>Os benef&#237;cios dessa tecnologia poderiam ser, igualmente, aplic&#225;veis &#224; sa&#250;de suplementar brasileira, mesmo diante de marco regulat&#243;rio diverso, e da cobertura assistencial presencial adequada. Cabe ressaltar que a maior parte dos benefici&#225;rios da sa&#250;de suplementar residem em centros maiores, onde a rela&#231;&#227;o m&#233;dicos/especialistas por habitante &#233; apropriada, e as consultas presenciais, uma imposi&#231;&#227;o legal.</p>
          <p>A Telemedicina pode ser ferramenta incremental importante na sa&#250;de suplementar, desde que haja uma regulamenta&#231;&#227;o adicional para sua implementa&#231;&#227;o. Dentre as provid&#234;ncias cab&#237;veis para ampliar a abrang&#234;ncia da Telemedicina na sa&#250;de suplementar, como j&#225; existe no Medicare americano, estaria a inclus&#227;o das tecnologias, com base cient&#237;fica e legal, no Rol de Procedimentos e Eventos em Sa&#250;de da Ag&#234;ncia Nacional de Sa&#250;de Suplementar, pois a cobertura seria obrigat&#243;ria, provendo equidade e seguran&#231;a jur&#237;dica.</p>
          <p>Recomenda-se que sejam mantidas, nos procedimentos de Telemedicina e Telecardiologia, as bases estabelecidas pelo C&#243;digo de &#201;tica M&#233;dica. A Telemedicina deve ser considerada uma ferramenta adicional para a rela&#231;&#227;o m&#233;dico-paciente presencial, sem jamais substitu&#237;-la.</p>
        </sec>
      </sec>
      <sec sec-type="conclusions">
        <title>Conclus&#227;o</title>
        <p>A Telemedicina como meio de ampliar o acesso universal e integral &#224; sa&#250;de, respaldada por evid&#234;ncia s&#243;lida, atestada pela comunidade cient&#237;fica, dentro da capacidade or&#231;ament&#225;ria do Estado brasileiro, expressa em pol&#237;ticas p&#250;blicas legitimadas, integra o m&#237;nimo existencial de cada cidad&#227;o brasileiro. &#201;, portanto, um direito de todos e dever do estado, e deve ser garantida mediante pol&#237;ticas sociais e econ&#244;micas vigentes no pa&#237;s. O not&#225;vel avan&#231;o das tecnologias da informa&#231;&#227;o e comunica&#231;&#227;o, e sua aplica&#231;&#227;o na sa&#250;de, deve ser foco constante da aten&#231;&#227;o do poder p&#250;blico, sendo um instrumento de equidade e fomento &#224; dignidade da pessoa humana. O uso da tecnologia na Medicina acentua o dever de devida cautela para se preservar a privacidade dos pacientes e os valores transcendentes, que fundamentam o exerc&#237;cio da Medicina.</p>
      </sec>
    </body>
    <back>
      <fn-group>
        <fn fn-type="financial-disclosure">
          <p>
            <bold>Fontes de financiamento</bold>
          </p>
          <p>O presente estudo n&#227;o teve fontes de financiamento externas.</p>
        </fn>
        <fn fn-type="other">
          <p>
            <bold>Vincula&#231;&#227;o acad&#234;mica</bold>
          </p>
          <p>N&#227;o h&#225; vincula&#231;&#227;o deste estudo a programas de p&#243;s-gradua&#231;&#227;o.</p>
        </fn>
      </fn-group>
    </back>
  </sub-article>
</article>
