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

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 In 2018, the council issued a new resolution but it was revoked due to negative repercussions.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.

Forensic mental telehealth assessment (FMTA) in the context of COVID-19.

Due to the present COVID-19 pandemic, forensic mental telehealth assessment (FMTA) is an increasingly utilized means of conducting court-sanctioned psychiatric and psychological evaluations. FMTA is not a novel development, and studies have been published during the past two decades that opine on the positive and negative implications of conducting testing and interview procedures online, in forensic and traditionally clinical matters alike. The present article examines prospects for eventual legal challenges to FMTA, describes considerations for conducting FMTA in both institutional and residential settings, and concludes that FMTA is now-due to predicted accommodations on the part of courts, attorneys, institutions, and professional guilds-a permanent part of the forensic evaluation landscape, even once the present COVID-19 pandemic has subsided.

Medical and Legal Aspects of the Practice of Teledermatology in Spain. / Aspectos medicolegales de la práctica de la teledermatología en España.

Teledermatology is now fully incorporated into our clinical practice. However, after reviewing current legislation on the ethical aspects of teledermatology (data confidentiality, quality of care, patient autonomy, and privacy) as well as insurance and professional responsibility, we observed that a specific regulatory framework is still lacking and related legal aspects are still at a preliminary stage of development. Safeguarding confidentiality and patient autonomy and ensuring secure storage and transfer of data are essential aspects of telemedicine. One of the main topics of debate has been the responsibilities of the physicians involved in the process, with the concept of designating a single responsible clinician emerging as a determining factor in the allocation of responsibility in this setting. A specific legal and regulatory framework must be put in place to ensure the safe practice of teledermatology for medical professionals and their patients.

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.

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.

Dermatology practice in the times of the COVID-19 pandemic.

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is implicated in the ongoing pandemic across the globe since December 2019. It was first notified by China from Wuhan on 31 December 2020 and transmission to healthcare workers was first reported on 20 January 2020. Human-to-human transmission is mainly by droplet infection. At present no effective vaccine is available. Our speciality needs to collectively address the urgent issue of risk of transmission in dermatology practice. A case series of Coronavirus Disease 2019 (COVID-19) from Wuhan described that 41.3% of their patients may have acquired the infection from the hospital. Of all the infected health care workers, 77.5% worked in general wards and departments. These data highlight the significant risk of nosocomial transmission of COVID-19 and also the higher risk in general wards and departments compared to the emergency room or intensive care unit. Dermatology patients are generally seen in clinics and in outpatient departments in hospitals. Patients wait together in the waiting area, intermingle and then are seen by the physician in their chamber. This can cause transmission of the pathogen among patients and from patient to physician. Social distancing, hand hygiene and the use of personal protective equipment are important for preventing the spread of infection and dermatology practices also have to incorporate these aspects. Telemedicine is becoming an important tool for the management of dermatology patients in these times. At-risk patients in dermatology also need to be given priority care. Protocols for the use of immunosuppressants and biologics in dermatology during the pandemic are being developed.

Federal, state, and institutional barriers to the expansion of medication and telemedicine abortion services in Ohio, Kentucky, and West Virginia during the COVID-19 pandemic.

OBJECTIVES: We aimed to characterize the combined impact of federal, state, and institutional policies on barriers to expanding medication and telemedicine abortion care delivery during the COVID-19 pandemic in the abortion-restrictive states of Ohio, Kentucky, and West Virginia. STUDY DESIGN: We analyzed 4 state policies, 2 COVID-related state executive orders, and clinic-level survey data on medication abortion provision from fourteen abortion facilities in Ohio, Kentucky, and West Virginia from December 2019 to December 2020. We calculated the percent of medication abortions provided at these facilities during the study period by state, to assess changes in medication abortion use during the pandemic. RESULTS: We ascertained that COVID-19-executive orders in Ohio and West Virginia that limited procedural abortion in Spring 2020 coincided with an increase in the overall number and proportion of medication abortions in this region, peaking at 1613 medication abortions (70%) in April 2020. Ohio and West Virginia, which had executive orders limiting procedural abortion, saw relatively greater increases in April compared to Kentucky. Despite temporary lifting of the mifepristone REMS, prepandemic regulations banning telemedicine abortion in Kentucky and West Virginia and requiring in-person clinic visits for medication abortion distribution in Ohio limited clinics' ability to adapt to offer medication abortion by mail. CONCLUSIONS: Our findings illustrate how restrictive medication and telemedicine abortion policies in Ohio, Kentucky, and West Virginia created additional obstacles for patients seeking medication abortion during the pandemic. Permanently lifting federal regulations on in-clinic distribution of mifepristone would only advantage abortion seekers in states without restrictive telehealth and medication abortion policies. State policies that limit access to comprehensive abortion services should be central in larger efforts toward dismantling barriers that impinge upon reproductive autonomy. IMPLICATION STATEMENT: We find that abolishing the REMS on mifepristone would not be enough to expand access to patients in abortion-restrictive states with telemedicine and medication abortion laws. While the REMS is a barrier, it represents one of several hindrances to the expansion of telemedicine abortion distribution across the United States.

Use of Telemedicine and Smart Technology in Obstetrics: Barriers and Privacy Issues.

While telemedicine had been utilized in varying ways over the last several years, it has dramatically accelerated in the era of the COVID-19 pandemic. In this article we describe the privacy issues, in relation to the barriers to care for health care providers and barriers to the obstetric patient, licensing and payments for telehealth services, technological issues and language barriers. While there may be barriers to the use of telehealth services this type of care is feasible and the barriers are surmountable.

Abortion exceptionalism and the mifepristone REMS.

Since its initial approval, mifepristone has been regulated with a strictness out of proportion to its risks. This paper explores how the regulation of mifepristone, specifically the Risk Evaluation and Mitigation Strategies (REMS) requirements, are a manifestation of abortion exceptionalism-the phenomenon of abortion being treated differently under the law than other comparable health care. The weight of medical and public health evidence demonstrates that mifepristone is extremely safe and the REMS are unnecessary. In fact, the mifepristone REMS is neither justified by the absolute risk of the medication itself, nor comprehensible as a logical response to the risks actually posed by mifepristone. Nevertheless, the REMS remain in place. From July 2020 through January 2021, enforcement of the REMS elements requiring in-person distribution of mifepristone were enjoined by court order due the COVID-19 pandemic. In other words, COVID-19 created a context so exceptional as to temporarily outweigh abortion exceptionalism. However, the reprieve did not last-in January 2021, the Supreme Court ruled to dissolve the injunction, allowing FDA to resume enforcement of the in-person requirements. In response, advocates called on the incoming Biden administration to direct FDA to suspend enforcement once more. This regulatory whiplash is itself further evidence that the REMS flow from political, rather than scientific, concerns. Abortion exceptionalism is apparent in the specific requirements of the REMS, and it is also apparent in the precarity of the regulatory scheme itself.

Telehealth and the COVID-19 Pandemic: International Perspectives and a Health Systems Framework for Telehealth Implementation to Support Critical Response.

OBJECTIVES: Telehealth implementation is a complex systems-based endeavour. This paper compares telehealth responses to (COrona VIrus Disease 2019) COVID-19 across ten countries to identify lessons learned about the complexity of telehealth during critical response such as in response to a global pandemic. Our overall objective is to develop a health systems-based framework for telehealth implementation to support critical response. METHODS: We sought responses from the members of the International Medical Informatics Association (IMIA) Telehealth Working Group (WG) on their practices and perception of telehealth practices during the times of COVID-19 pandemic in their respective countries. We then analysed their responses to identify six emerging themes that we mapped to the World Health Organization (WHO) model of health systems. RESULTS: Our analysis identified six emergent themes. (1) Government, legal or regulatory aspects of telehealth; (2) Increase in telehealth capacity and delivery; (3) Regulated and unregulated telehealth; (4) Changes in the uptake and perception of telemedicine; (5) Public engagement in telehealth responses to COVID-19; and (6) Implications for training and education. We discuss these themes and then use them to develop a systems framework for telehealth support in critical response. CONCLUSION: COVID-19 has introduced new challenges for telehealth support in times of critical response. Our themes and systems framework extend the WHO systems model and highlight that telemedicine usage in response to the COVID-19 pandemic is complex and multidimensional. Our systems-based framework provides guidance for telehealth implementation as part of health systems response to a global pandemic such as COVID-19.

COVID-19 IN V ACTS.

This article follows almost chronologically the COVID crisis between March and May 2020 during what is called, at least in Europe, the "first wave". Each 'Act' of our internal and external theatre is therefore a moment with a specific date, with the questions that were then pertinent. These 'Acts' were: First was the setting up of remote sessions under health pressures and the recommendations of our psychoanalytic institutions. This change in the frame and its consequences will be presented from various technical points of view, which have ostensibly raised some original metapsychological hypotheses.Then, concerning our profession, its very status as either essential or inessential has been discussed by public authorities, and inevitably by our patients, who will après-coup have to give meaning to our reactions during this crisis.We will next study the effects of remote sessions, particularly from its psychoanalytic 'economic' perspective, and as a kind of 'credit for in-presence' in the early stages of quarantine.We will then be looking at the hypothesis of a maternal element in the sessions, imperceptible in normal times, but suddenly palpable in the context of the absence of physical bodies.Finally, we will propose developments through workshops as an option in order to find a response to this unexpected event at the global scale.

A mixed-methods survey to explore issues with virtual consultations for musculoskeletal care during the COVID-19 pandemic.

OBJECTIVE: To explore orthopaedic and musculoskeletal clinicians' views and experiences of legal, safety, safeguarding and security issues regarding the use of virtual consultations (VC) during the COVID-19 pandemic. A secondary objective was to suggest ways to overcome these issues. METHODS: A mixed method cross-sectional survey was conducted, seeking the views and experiences of orthopaedic and musculoskeletal medically qualified and Allied Health Professionals in the United Kingdom. Descriptive statistical analysis was employed for quantitative data and a qualitative content analysis undertaken for qualitative data. Findings were presented in accordance with the four key issues. RESULTS: Two hundred and ninety professionals (206 physiotherapists, 78 medically qualified professionals, 6 'other' therapists) participated in the survey. Of the 290 participants, 260 (90%) were not using VC prior to the COVID-19 pandemic, 248 respondents (86%) were unsure whether their professional indemnity insurance covered VC, 136 (47%) had considered how they would handle an issue of safeguarding whilst the remainder had not, 126 (43%) had considered what they would do if, during a virtual consultation, a patient suffered an injury (e.g. bang on their head) or a fall (e.g. mechanical or a medical event like syncope) and 158 (54%) reported they felt the current technological solutions are secure in terms of patient data. Qualitative data provided additional context to support the quantitative findings such as validity of indemnification, accuracy of diagnosis and consent using VC, safeguarding issues; and security and sharing of data. Potential changes to practice have been proposed to address these issues. CONCLUSIONS: VC have been rapidly deployed since the onset of the COVID-19 pandemic often without clear guidance or consensus on many important issues. This study identified legal, safeguarding, safety and security issues. There is an urgent need to address these and develop local and national guidance and frameworks to facilitate ongoing safe virtual orthopaedic practice beyond the COVID-19 pandemic.

Health Information Privacy Laws in the Digital Age: HIPAA Doesn't Apply.

The notion of health information privacy has evolved over time as the healthcare industry has embraced technology. Where once individuals were concerned about the privacy of their conversations and financial information, the digitization of health data has created new challenges for those responsible for ensuring that patient information remains secure and private. Coupled with the lack of updated, overarching legislation, a critical gap exists between advancements in technology, consumer informatics tools and privacy regulations. Almost twenty years after the HIPAA (Health Insurance Portability and Accountability Act) compliance date, the healthcare industry continues to seek solutions to privacy challenges absent formal contemporary law. Since HIPAA, a few attempts have been made to control specific aspects of health information including genetic information and use of technology however none were visionary enough to address issues seen in today's digital data focused healthcare environment. The proliferation of digital health data, trends in data use, increased use of telehealth applications due to COVID-19 pandemic and the consumer's participatory role in healthcare all create new challenges not covered by the existing legal framework. Modern efforts to address this dilemma have emerged in state and international law though the United States healthcare industry continues to operate under a law written two decades ago. As technology continues to advance at a rapid pace along with consumers playing a greater role in the management of their healthcare through digital health the privacy guidance provided by federal law must also shift to reflect the new reality.