Artificial Intelligence in Medicine: Legal, Ethical and Social Aspects / Inteligencia artificial en medicina: aspectos jurídicos, éticos y sociales / Inteligência artificial em medicina: aspectos legais, éticos e sociais

In this article, the authors reflected the legal, ethical and social aspects of the introduction of artificial intelligence in the field of medicine. The authors used the dialectical method to understand the problematic aspects of qualitative changes in the healthcare system of Ukraine in connection with the quantitative increase in the use of artificial intelligence technology. The system method contributed to determining the nature of the impact of the introduction of artificial intelligence on the transformation of the structural elements of legislation in the healthcare sector. Analytical and formal-logical methods were useful in the process of identifying legal and ethical and social problems from the introduction of artificial intelligence and providing proposals for their solution. Emphasis was placed on the current state of the legal regulation of artificial intelligence in Ukraine and the problems of a legal, ethical and social nature that need to be addressed in the process of its implementation. The authors came to the conclusion that Ukraine is now at the initial stage of introducing artificial intelligence into public life. The problem of the lack of legislative work to streamline public relations associated with the use of artificial intelligence has been identified. Proposals are provided that can help mitigate the risks from the introduction of artificial intelligence.

En este artículo los autores reflejan los aspectos jurídicos, éticos y sociales de la introducción de la inteligencia artificial en el campo de la medicina. Utilizaron el método dialéctico para comprender los aspectos problemáticos de los cambios cualitativos en el sistema sanitario de Ucrania en relación con el aumento cuantitativo del uso de la tecnología de inteligencia artificial. El método sistémico contribuyó a determinar la naturaleza del impacto de la introducción de la inteligencia artificial en la transformación de los elementos estructurales de la legislación en el sector sanitario. Los métodos analíticos y lógicoformales fueron útiles en el proceso de identificación de los problemas jurídicos y éticos y sociales derivados de la introducción de la inteligencia artificial y de aportación de propuestas para su solución. Se hizo hincapié en el estado actual de la regulación jurídica de la inteligencia artificial en Ucrania y en los problemas de carácter jurídico, ético y social que deben abordarse en el proceso de su implantación. Los autores llegaron a la conclusión de que Ucrania se encuentra actualmente en la fase inicial de la introducción de la inteligencia artificial en la vida pública. Se ha identificado el problema de la falta de trabajo legislativo para racionalizar las relaciones públicas asociadas al uso de la inteligencia artificial. Se ofrecen propuestas que pueden ayudar a mitigar los riesgos derivados de la introducción de la inteligencia artificial.

Nesse artigo, os autores refletem sobre os aspectos legais, éticos e sociais da introdução da inteligência artificial no campo da medicina. Os autores usaram o método dialético para compreender os aspectos problemáticos das mudanças qualitativas no sistema de cuidados à saúde da Ucrânia em conexão com o aumento quantitativo no uso da tecnologia de inteligência artificial. O método do sistema contribuiu para determinar a natureza do impacto da introdução da inteligência artificial na transformação dos elementos estruturais da legislação no setor de cuidados à saúde. Métodos lógico-analíticos e formais foram úteis no processo de identificar problemas legais, éticos e sociais para a introdução da inteligência artificial e fornecer propostas para sua solução. Ênfase foi dada ao estado atual da regulação da inteligência artificial na Ucrânia e os problemas de natureza ética, legal e social que necessitam ser abordados no processo de sua implementação. Os autores concluíram que a Ucrânia está agora em um estágio inicial de introdução da inteligência artificial na vida pública. O problema da falta de trabalho legislativo para agilizar as relações públicas com o uso de inteligência artificial foi identificado. Propostas foram fornecidas que podem ajudar a mitigar os riscos da introdução da inteligência artificial.

Legal Regulatory Approach of Germline Cell Gene Editing / 中国医学伦理学

Germline cell gene editing is a potentially revolutionary technology that can be used to treat and prevent many genetic diseases, such as cystic fibrosis and hemophilia. Although this technology has aroused widespread discussion in the medical community and the public, its legal regulatory approach has not yet been fully determined. By summarizing and studying the experience of relevant foreign laws and regulations, this paper analyzed and summarized the current legal situation in China, and explored three ethical topics of social equality, individual subjectivity, and intergenerational rights. Combining the existing legal norms and relevant ethical considerations, the legal regulatory approach for germline cell gene editing was proposed in view of the weak operability of the law, the blurred boundaries of the legislation, and the insufficiently perfect ethical review mechanism. To better ensure that the technology can benefit mankind on the premise of eliminating risks, the following suggestions were put forward: a specialized law should be formulated based on clear legislative principles to adjust and guide the improvement of the ethical review mechanism of germline cell gene editing. It is hoped that promoting the progress of germline cell gene editing technology through in-depth research, and providing useful reference for the formulation of relevant laws and ethical policies.

Research on legal attribute and legal regulation of nurses′ prescription rights / 中华医院管理杂志

With the changing spectrum of human diseases and people′s pursuit of high-quality life, the scope of medical services required of nurses keep expanding. However, the current legislation in China has not yet granted nurses the right to prescribe, and there was no specific law to regulate related issues, which will inevitably limit the development of nursing work in the extended field. Therefore, the authors explored the concept definition and legal attributes of nurses′ prescription rights from a legal perspective, and proposed to regulate them from the legislative, law enforcement, and relevant supporting institutional levels to ensure the standardized exercise of nurses′ prescription rights.

Analysis of the application risks and legal strategies of intelligent medical algorithms / 中华医院管理杂志

Artificial intelligence algorithms play an important role in the medical field with their unique technological advantages and operational logic. However, due to the " black box" nature and security flaws of artificial intelligence algorithms, there were problems in the application of intelligent medical algorithms, such as the alienation of medical personnel′s subject status, the alienation of right to informed consent for diagnosis and treatment, the alienation of health fairness, and the alienation of health information security. At the same time, there were some practical difficulties in the process of regulating risks, such as the difficulty in determining the responsibility of the legal person, the incompleteness of the causal chain, the lag of the scene regulation of laws and regulations, and the increasing difficulty in protecting health information. In order to prevent the alienation of power in medical intelligent algorithms and promote the healthy development of intelligent medicine, the author suggested to adhere to the embedding of tool attributes in the underlying logic of medical algorithms, enhance the interpretability of medical algorithms, improve relevant laws and regulations, and strengthen the risk supervision mechanism of intelligent medical algorithms.

El debate de los principios y reglas en la normatividad contable internacional / The debate on principles and rules in international accounting standards / A discussão de princípios e regras nas normas internacionais de contabilidade

RESUMEN El análisis conceptual de los estándares de información financiera internacional trae implícita una discusión jurídica, que se puede remontar al debate entre el pensamiento iuspositivista - iusnaturalista del derecho, debate que puede dar pautas para dilucidar si los estándares del International Accounting Standards Board (lASB) están basados en principios o reglas, así como también, aportar en la conceptualización del marco teórico de las políticas contables. La discusión sobre las bases de la normatividad contable generalmente carece de una visión transdisciplinar acadêmica y práctica. Se utilizó una metodología conceptual e interpretativa para comprender; desde la teorïa del derecho y desde la perspectiva del análisis económico del derecho, el dilema sobre principios o reglas, esto contribuye a la reflexión sobre la elección de las políticas contables adecuadas para la representación financiera y contable de las organizaciones.

AВSTRАСT The conceptual analysis of international financial reporting standards implies a legal discussion, which can be traced back to the debate between the iuspositivist - iusnaturalist thinking of law, a debate that can provide guidelines to elucidate whether the standards of the International Accounting Standards Board (IASB) are based on principles or rules, as well as to contribute to the conceptualization of the theoretical framework of accounting policies. The discussion on the basis of accounting standards generally lacks a transdisciplinary academic and practical vision. A conceptual and interpretative methodology was used to understand, from the theory of law and from the perspective of the economic analysis of law, the dilemma of principles or rules, which contributes to the reflection on the choice of appropriate accounting policies for the financial and accounting representation of organizations.

RESUMO A análise conceitual das normas internacionais de relato financeiro envolve uma discussão jurídica, que pode ser rastreada até o debate entre o pensamento iuspositivista - iusnaturalista da lei, um debate que pode fornecer diretrizes para esclarecer se as normas do International Accounting Standards Board (IASB) são baseadas em princípios ou regras, bem como para contribuir para a conceitualização da estrutura teórica das políticas contábeis. A discussão com base nas normas contábeis geralmente carece de uma visão acadêmica e prática transdisciplinar Uma metodologia conceitual e interpretativa foi utilizada para compreender a partir da teoria do direito e da perspectiva da análise econômica do direito, o dilema dos princípios ou regras, o que contribui para a reflexão sobre a escolha de políticas contábeis apropriadas para a representação financeira e contábil das organizações.

Legal Regulatory Overview on UK Medicine and Healthcare Products Regulatory Agency and Its Enlightenment / 中国药房

OBJECTIVE：To provide reference for improving the efficiency of medicine regulation in China. METHODS ：The legal nature and functional scope ，regulatory objectives ，methods and legal elements of UK Medicine and Healthcare Products Regulatory Agency （MHRA），and the implementation and effectiveness of the drug regulatory effectiveness improvement plan in the UK were analyzed to put forward the enlightenment for China. RESULTS & CONCLUSIONS ：MHRA belongs to the enforcement agency of UK Department of Health and Social Care ，and its legal responsibility is borne by the Minister of Health. Its functions include the supervision of medicine ，medical devices ，blood transfusion products. Its objectives include the administrative supervision of medicine and medical devices ，the provision of medical information to patients ，and the encouragement of pharmaceutical enterprises to develop new and effective products. Its supervision methods include the supervision of administrative legislation and regulations ，drug early warning ，admission to market and administrative agreement ；the legal elements as openness ， transparence，cooperation and participation guarantee the legitimacy of regulatory actions. MHRA launched the medicine regulatory performance improvement plan in 2005，aiming to reduce unnecessary medicine regulatory burden and achieve moderate ， risk-based，targeted and cost-effective drug regulation. This plan makes medicine regulatory agencies improve efficiency ，reduce burden of pharmaceutical enterprises and protect patients ’health rights and interests. Our country can learn from the experience of MHRA regulatory practice in the UK ，establish modern regulatory concepts such as from passive regulation to active regulation ， from post supervision to risk supervision ，from administrative guidance to cooperative management ，so as to strengthen regulatory responsibility，make full use of modern information technology and big data technology ，so as to improve the efficiency of drug regulation in China and effectively safeguard the public health rights and interests.

Legal Regulation of Health Care Service in Traditional Chinese Medicine / 中国医学伦理学

Objective: To investigate and understand the causes of partial disorder in health care market of traditional Chinese medicine in recent years and put forward relevant countermeasures and suggestions. Methods: A multi-stage stratified random sampling method was used to investigate 410 medical staff and 535 patients in 10 traditional Chinese medicine medical institutions in Beijing. Self-filling questionnaires were used to obtain relevant data on their views on partial disorder of health care services in traditional Chinese medicine. Statistical software SPSS22.0 was used to analyze the data. Results: Firstly, both doctors and patients believed that "unclear functions of supervision department" was the main cause of some disorder in health care industry of TCM. Secondly, medical staff were more inclined than patients to think that the main causes were "lack of access threshold for institutions and personnel", "unclear functions of supervision department"and "lack of basis for law enforcement". Thirdly, 63.0％ of medical staff said that the legal system most needed to promote the healthy development of health care industry in traditional Chinese medicine was "industry standard system". Conclusion: According to the results of the survey, this paper holds that the healthy development of health care services in traditional Chinese medicine should be ensured by standardizing the supervision system of health care in traditional Chinese medicine, strengthening the construction of industry standards, establishing the self-regulatory mechanism of the industry, standardizing the media propaganda of health care in traditional Chinese medicine, and strengthening the ethical constraints of practitioners.

Risks and Legal Analysis of Gene Editing / 中国医学伦理学

With the application of gene editing in medical treatment,food engineering,environmental protection,agriculture and forestry,it gives rise to a wide range of potential social risks.Both the advanced aspects and defects of this technology bring complicated social conflicts.It is undoubtedly crucial to coordinate the conflict of interests of all parties,improve the legal system and avoid the harmfulness and blindness of gene editing.Meanwhile,only that the ethical,legal and social concerns are introduced will govern the technical risk as a necessary condition in order to attain a virtuous cycle of technological improvement and social prosperity.

Preliminary Discussionon the Legal Regulation of Internet Drug Operation / 中国医学伦理学

The legal regulation of Internet drugs in China is facing the dilemmas including that the legal authority is insufficient,the situation of drug safety is not optimistic,the mechanism of legal regulation lags behind,legal regulation content is inadequate and consumers lack trust in the purchase of online drug.Learning from the experience of internet drug regulation in the United States and Britain,our country could seek the rules of law for improving internet drug regulation.It includes establishing and gradually perfecting the regulation system of internet drug,establishing the associative mechanism of relative departments,strengthening the daily supervision,fully guaranteeing the legitimate interests of consumers and clearing the legal responsibilities of licensed pharmacists.

Legal Regulation on the Financial Conflicts of Interests of Researchers in Drug Clinical Trials / 中国药房

OBJECTIVE:To put forward suggestions for the legal regulation on the financial conflict of interest of researchers in drug clinical trials.METHODS:The definition and harm of the financial conflict of interest of the researchers in clinical trials were analyzed,and the legal measures of FDA on regulating and controlling the financial conflict of interest of the researchers were evaluated.RESULTS & CONCLUSIONS:The Chinese legislature should draw useful legal experiences from USA to establish suitable legal measures to regulate and control the financial conflict of interest of researchers in clinical trials,clarify the definition of the financial interest of researchers,require the applicant for clinical trial to disclose his financial interest and the applicants for drug registration to submit the statement about the financial conflict of interest of researchers to the drug administration department.

Legal Issues in Tissue Bank

Tissue transplantation is a modern medical technology which develops rapidly and raises many ethical, legal, and political issues. In Korea, many tissue transplantations are performed and many tissue banks seem to be managed. However, there are no legal regulations and standards which control these behaviors. When we discuss tissue transplantations and tissue banking, the safety of tissues, the respect for donors' autonomy, the proper operation of the tissue bank, and the fair distribution of the tissues must be taken into account. And the autonomic regulation by medical professionals must be considered. An Act that controls tissue transplantation and tissue banking must be established, and must be enforced. The Act must be in harmony with the autonomic regulation by medical professionals. The practices that may pose severe risk to human body or threat to human life must be banned, and persons who perform this kind of practices must be punished. However, if the practices remain within the acceptable range, medical professionals can do their practices legally.

On the Quality-Based Education for Modern Medical Students from the Physician-Patient Relationship / 中国医学伦理学

By studying the physician-related factors in physicianpatient relationship,authors put forwards that excellent medical skill,good medical ethics,favorable communication ability,and adequate knowledge on relevant legal regulations are four key points to handle the physician-patient relationship harmoniously.This article will supply reference from the above aspects for the all-around quality-based education for medical students.

Changes of the Legal Attribute and Regulations of Organs in Organ Transplantation / 中国医学伦理学

Organs experience three states in organ transplantation,including in-vivo state,in-vitro state,and the implanted state.The in-vivo organs can also be divided into two types by their origins,that is,from an intro-vital body or from a mortal body.Organs from an intro-vital body are not merely objects,but the vectors for personality,and therefore in such case the subject only holds the limited autonomy for his/her own organs.Organs from a mortal body are objects,but can not be regarded as the objects of autonomy.They can only be regarded as the objects of disposal right,thus the disposal of mortal organs should obey the pre-death wish of the dead,or the wish of the family members of the dead,and meanwhile obey the norms of custom and social interests.The in-vitro organs are merely objects,thus could be donated and presented,but could never be transacted.The implanted organs enjoy the same attributes and status as those from a living body.

Status Quo and Defects of Legal Regulations on Adverse Drug Reactions / 中国药房

OBJECTIVE:To explore the ways to consummate the current domestic legal regulations on adverse drug reactions(ADRs).METHODS:The status quo and the defects of the current legal regulations on ADRs were analyzed;and taking ADR damage relief systems adopted in some countries as reference,we put forward some suggestions on the improvement of the existing related legal regulations.RESULTS & CONCLUSIONS:The existing related legal regulations should be consummated as early as possible in respect of constitutive requirements of ADRs,legal obligation,identification system etc via suitable legislation channel so as to protect patients' rights.