Telehealth and Telemedicine: Regulatory and Medicolegal Landscape.

ABSTRACT: Telehealth and telemedicine experienced remarkable growth during and after the recent COVID-19 pandemic. Telehealth is generally defined as nonclinical services that employ telecommunication technology. Telemedicine refers more specifically to remote clinical services including diagnosis, monitoring, and treatment. Nuclear medicine is no exception in employing telemedicine increasingly in clinical practice for image interpretation and treatment consultation and care delivery supervision. There is no doubt that soon, the use of tele-nuclear medicine will increase, comparable to the employment of telecommunication in other fields of medicine. We review the medicolegal and regulatory aspects of the evolution in the clinical practice of medicine through telehealth and telemedicine.

Increasing Telehealth Access Through Licensure Exceptions.

This Viewpoint explains how exceptions can be used to connect patients via telehealth with a physician in another state, why this is a more practical and effective strategy, and what needs to happen for this to be a feasible solution.

Expiration of State Licensure Waivers and Out-of-State Telemedicine Relationships.

This cross-sectional study compares the use of telemedicine in states where COVID-19 pandemic­related licensure waivers expired vs states where waivers continued.

Providing Responsible Health Care for Out-of-State Patients.

This Viewpoint discusses why the legality of calling patients located in another state has suddenly been called into question.

Chapitre 1. La télémédecine et ses implications sur la relation médecin/patient.

The practice of telemedicine is likely to raise ethical and legal problems that affect the doctor-patient relationship. Therefore, the respect of ethical principles is necessary, in addition to the involvement of the legislator, who must enact specific instruments capable of identifying all the problems caused by telemedicine and contributing to a certain humanization of the doctor-patient relationship.

A regulação jurídica brasileira do exercício da telemedicina no contexto da pandemia do COVID-19 / La regulació jurídica brasilera de l'exercici de la telemedicina en el context de la pandèmia de COVID-19 / La regulación jurídica brasileña del ejercicio de la telemedicina en el contexto de la pandemia de COVID-19 / The Brazilian legal regulation of the exercise of telemedicine in the context of the COVID-19 pandemic

O presente artigo tem como tema central a regulação jurídica do exercício da telemedicina, especialmente a partir do contexto criado na pandemia do COVID-19. Neste sentido, o estudo aborda os mecanismos legais e as orientações dadas pelo Conselho Federal de Medicina (CFM) para adoção da prática. Surgem, em virtude disso, diversos questionamentos referentes à situação trabalhista dos profissionais de saúde que utilizam a telemedicina como mecanismo de trabalho. O artigo, portanto, explanará a importância da adoção da telemedicina, como também as problemáticas oriundas de sua utilização.(AU)

L'article té com a tema central la regulaciójurídica de l'exercici de la telemedicina, especialment des del context creat en la pandèmia COVID-19. L'article aborda els mecanismes legals i les directrius donades pel Consell Federal de Medicina (CFM) per a l'adopció de la pràctica. Com a conseqüència, sorgeixen diverses preguntes sobre la situació laboral dels professionals sanitaris que utilitzen la telemedicina com a mecanisme de treball. L'article, per tant, explicarà la importància d'adoptar la telemedicina, així com els problemes derivats del seuús.(AU)

El artículo tiene como tema central la regulación jurídica del ejercicio de la telemedicina, especialmente desde el contexto creado en la pandemia COVID-19. El artículo aborda los mecanismos legales y las directrices dadas por el Consejo Federal de Medicina (CFM) para la adopción de la práctica. Como consecuencia, surgen varias preguntas sobre la situación laboral de los profesionales sanitarios que utilizan la telemedicina como mecanismo de trabajo. El artículo, por tanto, explicará la importancia de adoptar la telemedicina, así como los problemas derivados de su uso.(AU)

This article has as its central theme the legal regulation of the exercise of telemedicine, especially from the context created in the COVID-19 pandemic. In this sense, the study addresses the legal mechanisms and guidelines given by the Federal Council of Medicine (CFM) for the adoption of the practice. As a result, several questions arise regarding the work situation of health professionals who use telemedicine as a work mechanism. The article, therefore, will explain the importance of adopting telemedicine, as well as the problems that arise through it.(AU)

A competência normativa frente aos novos atores políticos: um estudo de caso da telemedicina / The normative competence in the face of new political actors: a case study of telemedicine

Resumo A regulação da prática de telemedicina no Brasil tem se mostrado tortuosa desde seu reconhecimento pela Resolução nº 1.643/2002, do Conselho Federal de Medicina (CFM), havendo questionamentos quanto à competência deste para inserção da prática. Em 2018, o conselho editou nova resolução, mas que foi revogada em função da repercussão negativa. A pandemia de covid-19 pressionou os serviços de saúde de tal forma que o Poder Legislativo Federal foi impelido ao conflito e editou a Lei nº 13.989/2020, permitindo a prática de telemedicina durante o período da crise sanitária. O art. 6º da lei delegou ao CFM a competência para regulação da prática pós-pandemia, acirrando ainda mais as discussões. Este trabalho constitui um estudo de caso sobre a regulação da telemedicina no Brasil, buscando identificar os conflitos jurídicos impostos pela atuação do CFM em substituição ao Poder Legislativo. Utiliza o modelo político de implementação de políticas públicas de William Clune como base da análise, empregando o método da pesquisa documental qualitativa. Conclui-se que a implementação da telemedicina deve considerar as forças políticas em atuação, compreendendo o papel do CFM no processo normativo, para que se obtenha, no texto legal, uma política pública compatível com a realidade e apta a ser implementada.

Abstract The regulation of telemedicine in Brazil has been tortuous since its recognition by the Resolution No. 1,643/2002, of the Federal Council of Medicine (CFM), with issues regarding its competence to insert this practice. In 2018, the council issued a new resolution but it was revoked due to negative repercussions. The covid-19 pandemic put pressure on health services in such a way that the National Congress was pushed into conflict and enacted the Federal Law No. 13,989/2020, which allowed the practice of telemedicine during the period of health crisis. The article 6 of the law delegated the competence to regulate the post-pandemic practice to the CFM, further intensifying the discussions. This work is a case study on the regulation of telemedicine in Brazil, seeking to identify the legal conflicts imposed by the action of CFM in substitution of the Legislative Power. It uses the political model of implementation of public policies by William Clune as the basis for the analysis, using the qualitative documentary research method. In conclusion, the implementation of telemedicine must consider the political forces involved, understanding the CFM's role in the normative process, to obtain, in the legal text, a public policy compatible with reality and capable of being implemented.

A história da telemedicina no Brasil: desafios e vantagens / The history of telemedicine in Brazil: challenges and advantages

Resumo A utilização de novas tecnologias de informação para um atendimento mais efetivo e à distância é algo que se impõe no contexto de serviços em saúde, no atual panorama sociopolítico. Entretanto, o Brasil ainda está receoso em integrar de forma permanente esses avanços. Esta pesquisa tem como objetivo revisar os marcos da história da telemedicina no Brasil, destacando as questões éticas e legislativas, bem como evidenciar os desafios para sua implantação e gerar uma proposta para superá-los. Trata-se de uma revisão integrativa da literatura acerca da história, dos desafios e da realidade da telemedicina no cenário brasileiro. A telemedicina é uma atividade recente no Brasil, defrontando-se com resistências por parte dos profissionais, em especial médicos, que diversas vezes não vislumbram claramente seus benefícios. Apesar das dificuldades previstas em aceitar este modelo, é relevante ressaltar as vantagens que esse padrão abarca, como ampliar e facilitar o acesso à assistência de saúde. Propor alternativas para superar resistências e alcançar um padrão otimizado é essencial e abrange maior abertura no campo político, legislativo e educacional.

Abstract The use of new information technologies for a more effective remote service is required in the context of health services, especially when it comes to the current socio-political panorama. Nevertheless, Brazil is still afraid to permanently integrate these advances. This research aims to review the milestones in the history of telemedicine in Brazil, highlighting the ethical and legislative issues, as well as evidencing the challenges for its implementation and generating a proposal to overcome them. It is an integrative literature review about the history, challenges, and reality of telemedicine in the Brazilian scenario. Telemedicine is a recent activity in Brazil, facing resistance from professionals, especially doctors, who often do not clearly see its benefits. Despite the anticipated difficulties in accepting this model, it is important to highlight the advantages that this standard encompasses, such as expanding and facilitating access to health care. Proposing alternatives to overcome resistance and reach an optimized standard is essential and encompasses greater openness in the political, legislative, and educational fields.

Telemedicine Rollbacks-Why Providing Care Across State Lines Is No Longer as Simple as It Was Early in the Pandemic.

This Medical News feature examines how the expiration of states' pandemic-related licensure waivers is limiting telemedicine services.

Telemedicina: aspectos juridicos

A AMHB agrade a participação dos doutores: Dr. Carlos Michaelis: Advogado Especialista em Direito Médico, consultor em telemedicina e Assessor do CREMESP. Dr.Sílvio Eduardo Valente: Médico, advogado e perito Médico. Doutor em Biodireito pela USP. Presidente da comissão de Direito Médico da OAB-SP (2014-2018).

Telemedicina: aspectos juridicos

A AMHB agrade a participação dos doutores: Dr. Carlos Michaelis: Advogado Especialista em Direito Médico, consultor em telemedicina e Assessor do CREMESP. Dr.Sílvio Eduardo Valente: Médico, advogado e perito Médico. Doutor em Biodireito pela USP. Presidente da comissão de Direito Médico da OAB-SP (2014-2018).

A statewide elder mistreatment virtual assessment program: Legal, ethical, and practical issues.

Telecommunication assisted forensic assessments of capacity and mistreatment by geriatricians with expertise in elder abuse and self-neglect are helping to meet the demand for such forensic services for Adult Protective Services (APS) clients in remote and underserved areas of Texas. The use of synchronous audiovisual assisted interviews instead of in-person interviews with clients to provide capacity assessments has become more important with the arrival of the COVID-19 pandemic. There is growing interest in establishing similar programs in other states using geriatrician faculty from medical schools to serve the clients of their state Adult Protective Services agencies. The arrangement between APS and the geriatricians at McGovern Medical School in Houston, Texas is novel. The structure of the arrangement is important for the success of the program. Legal, ethical, and practical considerations are discussed in this article, including approaches to the Health Insurance Portability and Accountability Act, physician liability, state law, and resource limitations. It is hoped that sharing how one such collaboration has addressed these important issues will suggest approaches for the structuring of similar programs.

Pediatric Telehealth in the COVID-19 Pandemic Era and Beyond.

The coronavirus disease 2019 (COVID-19) pandemic led to an unprecedented demand for health care at a distance, and telehealth (the delivery of patient care using telecommunications technology) became more widespread. Since our 2018 state-of-the-art review assessing the pediatric telehealth landscape, there have been many changes in technology, policy, payment, and physician and patient acceptance of this care model. Clinical best practices in telehealth, on the other hand, have remained unchanged during this time, with the primary difference being the need to implement them at scale.Because of the pandemic, underlying health system weaknesses that have previously challenged telehealth adoption (including inequitable access to care, unsustainable costs in a fee-for-service system, and a lack of quality metrics for novel care delivery modalities) were simultaneously exacerbated. Higher volume use has provided a new appreciation of how patients from underrepresented backgrounds can benefit from or be disadvantaged by the shift toward virtual care. Moving forward, it will be critical to assess which COVID-19 telehealth changes should remain in place or be developed further to ensure children have equitable access to high-quality care.With this review, we aim to (1) depict today's pediatric telehealth practice in an era of digital disruption; (2) describe the people, training, processes, and tools needed for its successful implementation and sustainability; (3) examine health equity implications; and (4) critically review current telehealth policy as well as future policy needs. The American Academy of Pediatrics (AAP) is continuing to develop policy, specific practice tips, training modules, checklists, and other detailed resources, which will be available later in 2021.

The case for the use of telehealth for abortion in India.

India has the world's fastest growing outbreak of COVID-19. With limited mobility, increased reports of intimate partner violence, changes in living patterns of migrants, delays in accessing contraception and safe abortion care, and potential changes to decisions about parenting, there may be an increased need for abortion services in India due to the pandemic. The use of technology for providing abortion information and services has been well documented in global literature. The safety of abortion provision using telehealth has been established in several contexts including the United States and Australia. The importance of hotlines and other support systems that use technology to provide information and support to clients through their abortion is also highlighted in the literature. Several countries, such as the United Kingdom, France, New Zealand, and Pakistan are now allowing the use of technology for abortion/post-abortion care in light of the pandemic; however, India's telemedicine guidelines do not include abortion. In a country where the majority of abortions take place outside the health system, allowing the use of telemedicine for abortion can help bring legality to users, and expand access to those facing additional barriers in accessing the care they deserve. We outline models for telemedicine provision of abortion in India and discuss the regulatory changes required to make telehealth for abortion a reality in India.

Consentimiento informado en la reciente regulación de la telemedicina en Uruguay / Informed consent in the recent regulation of telemedicine in Uruguay / Consentimento informado no recente regulamento da telemedicina no Uruguai

En el presente artículo se analizarán algunos de los aspectos medulares de la Ley N°19.869 (a un año de su entrada en vigencia), que a texto expreso reguló en nuestro país los servicios provistos mediante Telemedicina; y principalmente en lo atinente a la formación del consentimiento informado a través de dicha práctica (AU)

This paper will analyze some of the core aspects of Law No. 19,869 (one year after its entry into force), which expressly regulated in our country the services provided through Telemedicine; and mainly with regard to the formation of informed consent through such practice (AU)

Este artigo analisará alguns dos aspectos centrais da Lei Nº 19.869 (um ano após da sua entrada em vigor), que por meio de texto expresso regulamentou em nosso país os serviços prestados por meio da Telemedicina; e principalmente no que diz respeito à formação do consentimento informado por meio dessa prática (AU)

Telemedicine, ethics, and law in times of COVID-19. A look towards the future.

The health emergency in Spain caused by COVID-19 was of such a magnitude that on March 14, 2020, a state of alarm was declared that lasted for more than three months. This ongoing pandemic has affected a vast number of people. Among the measures taken to reduce the risk of contagion, visits to health centers have been reduced and virtual consultations have increased. Once the pandemic ends, it will be necessary to consider whether telemedicine should be limited to periods of health crises or whether it could become a new way of practicing medicine. Telemedicine lacks specific regulations and has loopholes that leave physicians with a considerable degree of insecurity. This article analyzes the limits, precautions, and legal standards of the use of telemedicine.