VECTORS OF DEVELOPMENT OF THE UNIFIED MEDICAL INFORMATION SPACE.

AIM: The aim of the article is to analyze the current state of functioning of the medical information space of Ukraine in order to formulate scientifically sound proposals aimed at improving the implementation of medical reform. MATERIALS AND METHODS: The study is based on the analysis of literary sources of Ukrainian and international scientists, Ukrainian and foreign legislation and judicial practice. The article uses general theoretical and special methods of scientific cognition: theoretical analysis, systemic and structural, analysis and synthesis, sociological and statistical, logical and semantic, comparative and legal, method of ascent from the abstract to the concrete, forecasting and generalization. RESULTS: One of the key categories of the reform of the Ukrainian national medical sphere - the unified medical information space and its constituent elements - is studied. The electronic health care system, which stores medical data about patients in a single place and ensures their exchange between medical institutions, is analyzed. Emphasis is placed on the possibilities of using telemedicine and artificial intelligence, which play a key role in the development of the unified medical information space in accordance with global trends. The importance of legislative provision of efficiency and safety of the unified medical space is emphasized. It is about regulating the protection of personal data, establishing technical standards and requirements for medical information systems, ensuring confidentiality, integrity and data availability of the unified medical information space. CONCLUSIONS: Conclusions are drawn about the importance of proper functioning of each of the elements of the unified medical information space, both individually and in conjunction with each other. The authors' vision of improving the existing system of the unified medical information space is presented.

Towards Accountable E-Health Policies in the Nordic Countries.

The Nordic Countries are seen as forerunners in the field of digital health technologies and national implementation has been guided by sector specific strategies for many years. In the context of new European legislation such as the European Health Data Space (EHDS), a review of the existing strategies is indicated. The objective of this policy analysis is to assess and compare the scope, ambitions and extent of accountability in national-level digital health policies in the Nordic countries. The scope of the policies from the five countries were largely centred around a) empowering and activating citizens; b) a shift towards prevention and digital first; c) supporting health operations; d) doing the groundwork; e) making health data more available in research and innovation workflows and f) supporting health personnel. Finland comes out as the most ambitious country with the aim to transform their health system by means of digitalisation. Both Finland and Iceland work towards prevention and the digital first ambition due to large populations in rural areas. These two countries also present the most accountable policies, meaning that their policy documents are the most transparent as to how they arrived at the conclusions and how they are to evaluate the achievements.

[Ethical and legal implications of digital mental health applications]. / Implicaciones éticas y legales de las aplicaciones digitales de salud mental.

The digitization of mental health enables significant shifts in clinical practice by harnessing vast amounts of data derived from the use of apps and wearables to enhance medical research, patient care, and health system efficiency. However, this process brings forth pertinent ethical and legal risks. Ethically, concerns primarily revolve around safeguarding the privacy and confidentiality of sensitive data, alongside the transformation of the doctor-patient relationship through technological interaction. Within the regulatory realm, issues encompass the classification of these tools as medical products, ensuring normative assurance of effective protection of mental health data, and addressing potential legal risks within this domain. This article aims to provide an overarching view of this landscape, serving as a catalyst for the technological, ethical, and legal discourse necessitated by digital mental health.

Impact of State Telehealth Parity Laws for Private Payers on Hypertension Medication Adherence Before and During the COVID-19 Pandemic.

BACKGROUND: Telehealth has emerged as an effective tool for managing common chronic conditions such as hypertension, especially during the COVID-19 pandemic. However, the impact of state telehealth payment and coverage parity laws on hypertension medication adherence remains uncertain. METHODS: Data from the 2016 to 2021 Merative MarketScan Commercial Claims and Encounters Database were used to construct the study cohort, which included nonpregnant individuals aged 25 to 64 years with hypertension. We coded telehealth parity laws related to hypertension management in all 50 US states and the District of Columbia, distinguishing between payment and coverage parity laws. The primary outcomes were measures of antihypertension medication adherence: the average medication possession ratio; medication adherence (medication possession ratio ≥80%); and average number of days of drug supply. We used a generalized difference-in-differences design to examine the impact of these laws. RESULTS: Among 353 220 individuals (mean [SD] age, 49.5 (7.1) years; female, 45.55%), states with payment parity laws were significantly linked to increased average medication possession ratio by 0.43 percentage point (95% CI, 0.07-0.79), and an increase of 0.46 percentage point (95% CI, 0.06-0.92) in the probability of medication adherence. Payment parity laws also led to an average increase of 2.14 days (95% CI, 0.11-4.17) in prescription supply, after controlling for state-fixed effects, year-fixed effects, individual sociodemographic characteristics and state time-varying covariates including unemployment rates, gross domestic product per capita, and poverty rates. In contrast, coverage parity laws were associated with a 2.13-day increase (95% CI, 0.19-4.07) in days of prescription supply but did not significantly increase the average medication possession ratio or probability of medication adherence. CONCLUSIONS: State telehealth payment parity laws were significantly associated with greater medication adherence, whereas coverage parity laws were not. With the increasing adoption of telehealth parity laws across states, these findings may support policymakers in understanding potential implications on management of hypertension.

New Reproductive Privacy Rule to Protect Both Patients and Physicians.

This Viewpoint describes the newly finalized Reproductive Privacy Rule, a HIPAA regulatory update intended to prevent law enforcement in abortion-restrictive states from obtaining reproductive care medical records to prosecute patients and physicians.

Liability of Health Professionals Using Sensors, Telemedicine and Artificial Intelligence for Remote Healthcare.

In the last few decades, there has been an ongoing transformation of our healthcare system with larger use of sensors for remote care and artificial intelligence (AI) tools. In particular, sensors improved by new algorithms with learning capabilities have proven their value for better patient care. Sensors and AI systems are no longer only non-autonomous devices such as the ones used in radiology or surgical robots; there are novel tools with a certain degree of autonomy aiming to largely modulate the medical decision. Thus, there will be situations in which the doctor is the one making the decision and has the final say and other cases in which the doctor might only apply the decision presented by the autonomous device. As those are two hugely different situations, they should not be treated the same way, and different liability rules should apply. Despite a real interest in the promise of sensors and AI in medicine, doctors and patients are reluctant to use it. One important reason is a lack clear definition of liability. Nobody wants to be at fault, or even prosecuted, because they followed the advice from an AI system, notably when it has not been perfectly adapted to a specific patient. Fears are present even with simple sensors and AI use, such as during telemedicine visits based on very useful, clinically pertinent sensors; with the risk of missing an important parameter; and, of course, when AI appears "intelligent", potentially replacing the doctors' judgment. This paper aims to provide an overview of the liability of the health professional in the context of the use of sensors and AI tools in remote healthcare, analyzing four regimes: the contract-based approach, the approach based on breach of duty to inform, the fault-based approach, and the approach related to the good itself. We will also discuss future challenges and opportunities in the promising domain of sensors and AI use in medicine.

Discussion of federal policies affecting broadband expansion and telehealth in Appalachia.

BACKGROUND: There have been 188 rural hospital closures in the United States since 2010 with approximately 20% of these in Appalachia. Telehealth has become a way that nurses can reach rural patients who might not otherwise receive health care. OBJECTIVES: The purpose of this paper is to (1) outline the federal policies enacted during COVID-19 for broadband expansion; and (2) suggest how advanced practice nursing care might be affected by broadband expansion and telehealth in the region. METHODS: A search of PubMed was conducted in January 2023, using the search words, "policy", "telehealth", "broadband", and "Appalachia". FINDINGS: New laws appropriated funds to expand broadband infrastructure that made it possible for telehealth to be used by nurses to deliver health care to rural patients. CONCLUSION: This discussion paper found that broadband legislation was instrumental in expanding telecommunications and telehealth by NPs. There is a great need for broadband to continue to expand and for trained nurses to provide care via telehealth.

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.

EHDS and Free Movement of Patients: What EU Intervention is Needed?

The European Commission issued a proposal for a Regulation on the European Health and Data Space to improve patient mobility. This EHDS Regulation lays down rules for the exchange of digital health data for primary use (treatment) and for secondary use (i.e. research, policymaking). This proposal has far-reaching implications for national healthcare systems. The question arises whether, with this draft, the Commission in fact proposes to overstep the powers of the European Union, as the delivery and organization of healthcare belongs to the competences of the Member States. Furthermore, the (lack of) exchange of digital health data is not the only hinderance for the free movement of patients. The current set-up of the Patient Directive and the Social Security Coordination Regulation also discourages patients from seeking treatment abroad. Therefore, a more integrated approach in the form of a new Patient Regulation is, in our view, needed.

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 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).