ABSTRACT
Biometric technology has transformed human biological characteristics into a new form of privacy, and the misuse of this technology poses challenges to protecting this new privacy. This article initially defines biometric technology and biometric characteristics, further demonstrating why biometric characteristics belong to personal privacy and how biometric technology poses challenges to its protection. Through analysis, this article argues that the essence of these challenges is the conflicts between the ethical principle of privacy protection and the ethical principle of maximizing social benefits. In order to address these challenges, it is necessary first to weigh the fundamental ethical principles. The two basic principles of privacy protection and maximizing social benefits are not mutual antagonism but hierarchy, and this hierarchy should be based on the principle of practical feasibility. That is, applying biometric technology should first meet the principle of practical feasibility and, on this premise, realize the principle of maximizing social benefits based on not infringing on the principle of privacy protection.
La tecnología biométrica ha transformado las características biológicas humanas en una nueva forma de privacidad, y el uso indebido de esta tecnología plantea desafíos a su protección. En este artículo se define inicialmente la tecnología biométrica y las características biométricas; se demuestra además por qué las características biométricas pertenecen a la privacidad personal y cómo la tecnología biométrica plantea retos para su protección. Este artículo argumenta que la esencia de estos retos es el conflicto entre el principio ético de protección de la privacidad y el de maximización de los beneficios sociales. Para abordar estos retos es necesario sopesar primero los principios éticos fundamentales. Los dos principios básicos de protección de la privacidad y maximización de los beneficios sociales no son antagónicos, sino jerárquicos, y esta jerarquía debe basarse en el principio de viabilidad práctica. Es decir, la aplicación de la tecnología biométrica debe cumplir primero el principio de viabilidad práctica y, a partir de esta premisa, realizar el principio de maximización de los beneficios sociales sobre la base de no infringir el principio de protección de la intimidad.
A tecnologia biométrica transformou as características biológicas humanas em uma nova forma de privacidade, e o mal uso dessa tecnologia apresenta desafios para proteger essa nova privacidade. Esse artigo inicialmente define tecnologia biométrica e características biométricas, demonstrando posteriormente por que características biométricas pertencem à privacidade pessoal e como tecnologia biométrica coloca desafios à sua proteção. Através de análise, esse artigo discute que a essência desses desafios é o conflito entre o princípio ético da proteção da privacidade e o princípio ético de maximizar benefícios sociais. De forma a visar esses desafios é necessário primeiro ponderar os princípios éticos fundamentais. Os dois princípios básicos de proteção da privacidade e de maximizar benefícios sociais não são mutuamente antagônicos mas hierárquicos, e essa hierarquia deve ser baseada no princípio da viabilidade prática. Isso é, aplicar tecnologia biométrica deve primeiro atender ao princípio da viabilidade prática e, nessa premissa, compreender o princípio de maximizar benefícios sociais com base em não infringir o princípio de proteção da privacidade.
ABSTRACT
The privacy problem of facial recognition technology is that commercial companies obtain people's facial information without the consent of individuals and use facial information to infringe on the privacy of individuals. The importance of human privacy in facial recognition technology is reflected through facial ethics, which requires others to perform corresponding obligations to individuals, such as oral care. Through the analysis of the privacy issues of facial recognition technology, it is found that the two elements of "without personal informed" and "without personal consent" together form the basis for commercial companies to violate personal privacy. The principle of informed consent includes the principle of informed and the principle of consent, which is derived from the principle of informed consent in medical ethics. This paper improves the principles of informed consent in medicine and ethics to better address facial recognition privacy issues.
El problema de la privacidad en la tecnología de reconocimiento facial es que las empresas comerciales obtienen información facial de las personas sin el consentimiento de éstas y utilizan la información facial para vulnerar la privacidad de las personas. La importancia de la privacidad de las personas en la tecnología de reconocimiento facial se refleja a través de la ética facial, que exige que otros cumplan las obligaciones correspondientes con los individuos, como el cuidado bucal. A través del análisis de los problemas de privacidad de la tecnología de reconocimiento facial se descubre que los dos elementos de "sin información personal" y "sin consentimiento personal" juntos forman la base para que las empresas comerciales violen la privacidad personal. El principio de consentimiento informado incluye el de información y el de consentimiento, que se deriva del principio de consentimiento informado de la ética médica. Este artículo mejora los principios del consentimiento informado en medicina y ética para abordar mejor los problemas de privacidad del reconocimiento facial.
A questão da privacidade na tecnologia de reconhecimento facial é que as companhias comerciais obtém informações faciais das pessoas sem seu consentimento e usam informação facial para infringir sua privacidade. A importância da privacidade humana na tecnologia de reconhecimento facial é refletida através da ética facial, que exige que se cumpram obrigações correspondentes para com os indivíduos, da mesma forma como com cuidados orais. Através da análise de aspectos de privacidade na tecnologia de reconhecimento facial, encontrou-se que os dois elementos "sem informação pessoal" e "sem consentimento pessoal" juntos, formam a base para companhias comerciais violarem a privacidade pessoal. O princípio do consentimento informado inclui o princípio de informação e o princípio de consentimento, os quais derivam do princípio do consentimento informado em ética médica. Esse artigo melhora os princípios do consentimento informado em medicina e ética para melhor incluir aspectos de privacidade no reconhecimento facial.
ABSTRACT
We report the dilemmas faced by the investigators while conducting a study on the social and environmental factors for protection of the mental health of adolescents placed under State protection in Kerala, India. The proposal received counsel and directives from the Integrated Child Protection Scheme authorities, under the Social Justice Department of Kerala state and the Institutional Ethics Committee of the host institution. The investigator faced and had to reconcile conflicting directives and antithetical field realities, with respect to seeking informed consent from the study participants. The physical act of adolescents signing the consent form, rather than the actual process of assent, received disproportionately more scrutiny. The authorities also questioned the privacy and confidentiality requirements raised by the researchers. Of the 248 eligible adolescents, 26 chose to dissent from participating in the study, demonstrating that choices would be made if they are offered. There is a need for more discourse on achieving steadfast adherence to the principles of informed consent, particularly in research on vulnerable groups such as institutionalised children.
ABSTRACT
This paper scrutinises the Supreme Court Judgment of May 2, 2022, in a vaccine mandate-related petition. The Hon'ble Court’s Order reasserts the primacy of right to privacy and Articles 14 and 21 of the Constitution of India. However, in the interest of protection of communitarian health, the Court felt that the Government is entitled to regulate issues of public health concern by imposing certain limitations on individual rights, which are open to scrutiny by constitutional Courts. However, such mandatory vaccination directives with preconditions cannot invade an individual's right to personal autonomy and right to access means of livelihood, and must meet the threefold criteria laid down in K.S.Puttaswamy, a landmark judgment of 2017. This paper examines the validity of the arguments adopted in the Order and suggests certain infirmities therein. Nevertheless, the Order is a balancing act, and worth celebrating. The paper concludes, as a cup that is “a quarter full”, as a victory for human rights and as a safeguard against unreasonableness and arbitrariness in medico-scientific decision-making that takes the citizen’s compliance and consent for granted. If the State runs amok by way of mandatory health directives, this Order may come to the rescue of the hapless citizen
ABSTRACT
La forma como el clínico percibe al paciente y sus conocimientos sobre el consentimiento informado (CI) se reflejan en prácticas de respeto hacia el paciente, con relación a su autonomía y privacidad, desde un marco ético, deontológico y legal. El objetivo fue analizar las percepciones y prácticas de cirujanos en relación con el respeto de la autonomía del paciente durante el proceso de toma del CI en un hospital de la ciudad de Santo Domingo de los Tsáchilas, Ecuador. Metodología Cualitativa. La muestra fue por saturación, aplicando una entrevista semiestructurada. Los datos se analizaron por medio del programa Atlas Ti 8.0®, utilizando rastreo de categorías estructuradas. La mayoría de los médicos asume el consentimiento como un documento legal y obligatorio, por el miedo a procesos sancionatorios. Además, suele delegar su responsabilidad a otros profesionales, desconociendo componentes estructurales y éticos de la toma del consentimiento informado. Concluimos que la falta de conocimiento sobre CI lleva a percepciones y, por ende, a prácticas que vulneran la autonomía y la confidencialidad, además del respeto de recibir la información por parte del clínico que realiza la intervención.
The way in which the clinician perceives the patient and his knowledge about informed consent (IC) are reflected in practices of respect for the patient, in relation to their autonomy and privacy from an ethical, deontological and legal framework. Objective. Analyze the perceptions and practices by surgeons in relation to the respect of the autonomy of the patient during the process of taking the IC in a hospital in the city of de Santo Domingo de los Tsáchilas / Ecuador. Methodology. Cualitattivo. The sample was by saturation applying a semi-structured interview. The data were analyzed using the Atlas Ti 8.0 ® program using structured category tracking. Result. Most doctors take consent as a legal and mandatory document, for fear of sanctioning processes. In addition, they usually delegate their responsibility to other professionals ignoring structural and ethical components of taking informed consent. Conclusion. It is evident that the lack of knowledge about IQ leads to perceptions, and therefore, to practices that violate autonomy and confidentiality, in addition to the respect of receiving information from the clinician who performed the intervention.
A forma como o médico percebe o paciente e seus conhecimentos sobre o consentimento informado (IC) se refletem nas práticas de respeito ao paciente, em relação à sua autonomia e privacidade a partir de um arcabouço ético, deontológico e jurídico. Objetivo. Analise as percepções e práticas dos cirurgiões em relação ao respeito à autonomia do paciente durante o processo de tomada do IC em um hospital na cidade de Santo Domingo de los Tsáchilas/Equador. Metodologia. Qualitativo. A amostra foi por saturação aplicando uma entrevista semiestruturada. Os dados foram analisados utilizandose o programa Atlas Ti 8.0 ® utilizando rastreamento estruturado de categorias. Resultado. A maioria dos médicos toma o consentimento como documento legal e obrigatório, por medo de sancionar processos. Além disso, eles geralmente delegem sua responsabilidade a outros profissionais ignorando componentes estruturais e éticos de obter consentimento informado. Conclusão. É evidente que a falta de conhecimento sobre o QI leva a percepções e, portanto, a práticas que violam autonomia e confidencialidade, além do respeito ao recebimento de informações do médico que realizou a intervenção.
Subject(s)
Humans , Male , Female , EcuadorABSTRACT
Resumo Este estudo revisa a caracterização dos princípios da privacidade e da confidencialidade em conexão com áreas da medicina em geral e da saúde mental em especial, propondo que a prática dos direitos e deveres envolvidos com os dois princípios deve ser preservada nos moldes ditados pela bioética. Privilegia-se a abordagem do saber psíquico, a fim de ampliar a compreensão da particular importância da confidencialidade nos processos terapêuticos. Salienta-se a conexão entre as mudanças tecnológicas e midiáticas ocorridas nas últimas décadas e o risco de comprometimento do sigilo médico, cuja quebra afetaria em definitivo a confiança do paciente quanto ao resguardo da privacidade de suas informações. Ao final, são feitas reflexões sobre o valor do suporte ético ao profissional de saúde, principalmente nos casos excepcionais em que lhe cabe tomar decisões sobre quebra de confidencialidade.
Abstract This study discusses privacy and confidentiality in the areas of medicine and, particularly, mental health, arguing that the rights and duties encompassed by the two principles should be practiced in compliance to bioethics. Psychic knowledge was adopted to broaden our understanding regarding the importance of confidentiality in the therapeutic process. It emphasizes the connection between the technological and media changes of the last decades and the risk of compromising medical confidentiality, which would definitely affect the patient's trust concerning information privacy. Finally, the text reflects on the relevancy of ethical support for health professionals, especially in cases where they must decide on whether or not to breach confidentiality.
Resumen Este estudio analiza la caracterización de los principios de privacidad y confidencialidad relacionados con los campos de la medicina en general y la salud mental en particular, proponiendo que la práctica de los derechos y deberes respecto a estos dos principios debe preservarse de la manera defendida por la bioética. El enfoque del conocimiento psíquico se privilegia con el fin de ampliar la comprensión de que la confidencialidad es importante en los procesos terapéuticos. Se destaca la relación entre los cambios tecnológicos y mediáticos que se han producido en las últimas décadas y el riesgo de comprometer el secreto médico, cuya violación afectaría definitivamente la confianza del paciente respecto a la privacidad de su información. Por último, se reflexiona sobre el valor del apoyo ético a los profesionales de la salud, sobre todo en los casos excepcionales que involucran su toma de decisión respecto a la violación de confidencialidad.
Subject(s)
Humans , Male , FemaleABSTRACT
【Objective:】 To explore the individual needs and the willingness to actively participate in treatment decision-making and communication among school-age children during hospitalization. 【Methods:】 Using the interview outline containing 11 questions summarized based on literature review, face-to-face interviews were conducted with patients of school-age children, and the contents of the interview feedback were summarized. Guided by Bronfenbrenner’s bioecological model and child-centered care methods, the subjects’ individual needs and willingness to actively participate in treatment decision-making and communication during hospitalization were analyzed. 【Results:】 A total of 40 hospitalized school-age children from January to April 2022 were selected, including 27 males (67.5%) and 13 females (32.5%), with a mean age of (11.8±3.2) years old. Face-to-face interviews were conducted and the results were summarized. The main contents summarized from the interview results included children’s needs for their parents, medical staff, and the hospitalization environment. 【Conclusion:】 School-age children were able to express their various needs and willingness to actively participate in treatment decision-making and communication during hospitalization. School-age children need to be provided age-appropriate opportunities to participate in decision-making to support their reasonable needs.
ABSTRACT
At present, China is still in the exploratory stage in the field of electronic informed consent (eIC), and relevant policies, regulations and application guidelines have not yet been established and improved. While the traditional informed consent supervision system is difficult to meet the needs of the innovative development of eIC, such as subject privacy and data security. Through sorting out and analyzing the legal norms and construction system of eIC supervision in Europe and the United States, combined with the current development status, problems, and challenges of eIC in China, this paper targeted proposed the path to construct the supervision of eIC in clinical research in China from the aspects of restricting the signing form and process of eIC, adjusting the ethical review paradigm of eIC, enhancing the strength of eIC ethical review, improving the construction of eIC legal system, and strengthening the training of relevant researchers.
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At present, there are no laws and regulations, ethical standards, and regulatory requirements related to ethical review of case reports at home and abroad. Whether ethical review is required for case reports, there are different norms in different regions, countries and medical institutions, and the provisions of different journals at home and abroad are also inconsistent. Through the discussion on whether the publication of case reports needs ethical review and approval, this paper summarized the problems of privacy protection and informed consent existing in the publication of case reports, and proposed the key points of ethical review of case reports, including the scientific nature of case reports, patient privacy protection, informed consent and conflict of interest management, with a view to making case reports conform to ethical standards and promoting the development of medical science.
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Blockchain technology has the advantages of decentralization, secure sharing and tamper resistance, and high privacy, which can solve the current problem of sharing electronic medical records in medical institutions in China. A tertiary hospital established an electronic medical record sharing services convenience service platform based on blockchain in collaboration with China mobile gansu company in September 2021. The hardware architecture of the platform consisted of a hospital data warehouse, a local front-end computer and a blockchain platform. The functional architecture included platform front-end services, the blockchain electronic medical record archiving and service platform. The technical architecture included the underlying blockchain, service layer, interface layer and application layer, which was embedded with asymmetric encryption technology, hash algorithm, smart contract and other technical means, ensuring data ownership and on-demand, controllable, real-time and secure sharing of data. Since the operation of the platform in September 2021, as of October 2022, a tertiary hospital had accumulated 21 545 patient medical records on the chain. The overall operation of the platform was smooth, achieving reliable storage and secure sharing of patient electronic medical records, providing reference for further promoting the interconnection trusted sharing of electronic medical records in medical institutions in China.
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Objetivo: analisar a legislação e as principais questões pertinentes ao armazenamento das informações relativas à saúde do paciente em bancos de dados, bem como as exceções ao dever de sigilo, à luz do Regulamento (UE) 2016/679 (novo Regulamento Geral de Proteção de Dados) e da Lei n.º 58/2019. Metodologia: por meio de uma revisão legislativa e doutrinária, confrontamos os dispositivos que abordam o direito à privacidade do paciente, a proteção do sigilo médico e o acesso de dados, analisando as exceções ao dever de sigilo que decorrem da lei e dos estatutos das ordens profissionais que tutelam o exercício das profissões. Resultados: a dispersão das normas que tratam a proteção de dados pode criar obstáculos à efetivação do direito e dúvidas acerca da interpretação do novo Regulamento Geral de Proteção de Dados. Conclusão: o novo Regulamento e a Lei n.º 58/2019 têm o escopo de sistematizar a matéria concernente à proteção dos dados, mas deverão ser confrontadas com a legislação interna portuguesa que aborde outras questões transversais, a exemplo das tratadas na Lei de Bases da Saúde em Portugal, no Regime Geral dos Arquivos e do Património Arquivístico, dentre outros, o que implica uma dificuldade acrescida ao utilizador do direito.
Objective: to analyze legislation and key issues related to the storage of patient data in databases and exceptions to confidentiality under Regulation (EU) 2016/679 (new General Data Protection Regulation) and Law No. 58/2019.Methods: through a review of legislation and doctrine, we contrast the provisions that address the patient's right to privacy, the protection of medical secrecy, and access to data, and analyze the exceptions to confidentiality arising from the law and the statutes of the professional codes that protect the practice of the professions. Results: the scattering of norms dealing with data protection may lead to obstacles in the realization of the right to data protection and to doubts in the interpretation of the new Regulation. Conclusion: the new Regulation and Law No. 58/2019 are suitable to systematize data protection. However, they must be confronted with Portuguese legislation that deals with other cross-cutting issues, such as the Portuguese Basic Health Law, the General Archives Law and others, which creates additional difficulties for the user of the law.
Objetivo: analizar la legislación y las principales cuestiones relevantes para el almacenamiento de información relacionada con la salud del paciente en bases de datos, así como las excepciones a la obligación de secreto, de acuerdo con el Reglamento (UE) 2016/679 (nuevo Reglamento General de Protección de Datos) y la Ley n.° 58/2019. Metodología: a través de una revisión legislativa y doctrinaria, confrontamos las disposiciones que atienden el derecho a la intimidad del paciente, la protección del secreto médico y el acceso a los datos, analizando las excepciones al deber de secreto, que se derivande la ley y los estatutos que protegen el ejercicio de las profesiones. Resultados: la dispersión de normas que tratan de la protección de datos puede generar obstáculos para la realización del derecho a la protección de datos y dudas sobre la interpretación del Reglamento. Conclusión: el Nuevo Reglamento y la Ley n.º 58/2019 tienen el alcance de sistematizar la materia relativa a la protección de datos, pero deben confrontarse con la legislación interna portuguesa que aborda otras cuestiones transversales, como las tratadas en el Ley de Salud en Portugal, en el Régimen General de Archivos, entre otros, lo que implica una dificultad añadida para el usuario del derecho.
ABSTRACT
Resumo A "esfera de intimidade" se apresenta cada vez mais mediada por uma rede sociotécnica, revestida de novos significados e leituras nos jogos amorosos e de sedução. Nessas trocas afetivo-digitais os nudes desempenham importante papel na vinculação de interesse entre parceiros, constituindo também espaços de disputas de poder e violência. O trabalho objetiva analisar as moralidades vigentes, os modos de gestão das emoções e os enquadramentos do corpo na afirmação de autonomia e diversidade presentes nos discursos de jovens que tiveram seus conteúdos íntimos disseminados sem consentimento pela internet. Foram analisados 20 vídeos de jovens youtubers que vivenciaram tal experiência. Os vídeos foram analisados segundo a perspectiva da Análise de Discurso Crítica. Os depoimentos carregam forças discursivas de "desabafo", "testemunho" e, sobretudo, "aconselhamento". Nas experiências narradas, destacamos as dinâmicas da disseminação desses conteúdos íntimos e como afetam diferentemente as representações de face e de reconhecimento social de rapazes e moças. As formas de manejo do sofrimento variam entre a resignação diante de uma ordem patriarcal e de discursos de superação e autonomia. Destaca-se ainda o protagonismo desses jovens diante da gestão das imagens íntimas e um posicionamento político sobre o uso e expressão dos seus corpos.
Abstract The "sphere of intimacy" is increasingly mediated by a socio-technical network inlaid with new meanings and readings in love and seduction games. In these affective-digital exchanges, nudes are essential in linking interest between partners, also setting spaces for power struggles and violence. This work aims to analyze the prevailing moralities, the emotional management, and the inclusion of the body in affirming autonomy and diversity identified in the statements of young people whose intimate contents were disseminated on the internet without their consent. We analyzed 20 videos of young YouTubers who had such an experience from the Critical Discourse Analysis perspective. The statements carry discursive forces of "venting", "testimony", and, above all, "counseling". The narrated experiences highlight the dynamics of disseminating these intimate contents and how they differently affect the representations of face and social recognition of boys and girls. Handling suffering techniques vary between resignation in the face of patriarchal order and overcoming and autonomy discourses. We also highlight the initiatives of these young people in managing intimate images and a political stance on the use and expression of their bodies.
ABSTRACT
Resumen: Este texto aborda el problema de la privacidad de la información en la investigación social de tipo cualitativa que se desarrolla en el contexto del mundo digital. Para ello, se revisa el concepto de privacidad desde una mirada analógica hacia su incorporación en el plano digital con la figura de la privacidad de la información y algunos elementos de la hermenéutica de Gadamer. Primero, se revisa el plano analógico y ético de la privacidad. Luego, se revisa el potencial de la información, la distinción entre información privada y sensible y su aplicabilidad a la investigación social mediante los conceptos de confianza y seguridad. Finalmente se esboza una propuesta para una privacidad renovada que propone rescatar la intersubjetividad que se construye en la relación del participante de la investigación con el investigador.
Abstract: This text addresses the problem of information privacy in qualitative social research developed in the context of the digital world. For this purpose, the concept of privacy is reviewed from an analogical view towards its incorporation in the digital plane with the figure of information privacy and some elements of Gadamer's hermeneutics. First, the analogical and ethical plane of privacy is reviewed. Then, the potential of information, the distinction between private and sensitive information and its applicability to social research through the concepts of trust and security are reviewed. Finally, we outline a proposal for a renewed privacy that proposes to rescue the intersubjectivity that is built in the relationship between the research participant and the researcher.
Resumo: Este texto aborda o problema da privacidade da informação na investigação social qualitativa no contexto do mundo digital. Para o fazer, revê o conceito de privacidade de um ponto de vista analógico para a sua incorporação no plano digital com a figura da privacidade da informação e alguns elementos da hermenêutica de Gadamer. Primeiro, o plano analógico e ético da privacidade é revisto. Em seguida, o potencial da informação, a distinção entre informação privada e informação sensível e a sua aplicabilidade à investigação social através dos conceitos de confiança e segurança são revistos. Finalmente, esboça uma proposta para uma privacidade renovada que se propõe resgatar a intersubjetividade que é construída na relação entre o participante da pesquisa e o pesquisador.
Subject(s)
Humans , Social Sciences/ethics , Qualitative Research , Ethics, Research , Personally Identifiable Information/ethics , HermeneuticsABSTRACT
Este artículo revisa los principales desafíos éticos que plantea la investigación vinculada al genoma humano a la luz de la bibliografía internacional y entrega recomendaciones sobre su abordaje basada en nuestra experiencia en el Comité de Ética para la Investigación en Seres Humanos de la Facultad de Medicina, Universidad de Chile, incluyendo las regulaciones legales nacionales. Los estándares éticos de la investigación en seres humanos deben extremarse para proteger adecuadamente a los participantes en estudios involucrados con la genómica. Especialmente relevantes en este contexto son: la protección de la confidencialidad y anonimato; la política de entrega de resultados y la posibilidad de retirarse del estudio. Compartir datos resultantes de investigaciones genéticas permite optimizar recursos, otorga mayor transparencia y replicabilidad de los análisis y permite descubrir alteraciones genéticas responsables de enfermedades raras y genes involucrados en enfermedades hereditarias multifactoriales, además de contribuir al diseño de medicina de precisión y de nuevas estrategias terapéuticas. Sin embargo, plantea grandes desafíos: proteger la privacidad y evitar la re-identificación de los voluntarios, la entrega de resultados con asesoría pre y post estudio. Estos aspectos requieren la elaboración de un cuidadoso proceso de consentimiento informado para investigaciones genómicas cuyos componentes principales se analizan en este artículo.
This article reviews the main ethical challenges posed by human genome research in the light of the international literature and provides recommendations on how to approach them based on our experience in the Ethics Committee for Research on Human Subjects of the Faculty of Medicine, University of Chile, including national legal regulations. Ethical standards in human research must be extreme, in order to adequately protect participants in studies involving genomics. Particularly relevant in this context are the protection of confidentiality and anonymity; the policy of delivery of results and the possibility of withdrawing from the study. Sharing data resulting from genetic research optimizes resources, provides greater transparency, and replicability of the analyses and makes it possible to discover genetic alterations responsible for rare diseases and genes involved in multi-factorial hereditary diseases, as well as contributing to the design of precision medicine and new therapeutic strategies. However, it poses great challenges: protecting privacy and avoiding re-identification of volunteers, delivery of results with pre- and post-study counseling. These aspects require the elaboration of a careful informed consent process for genomic research, the main components of which are discussed in this article.
ABSTRACT
COVID-19 pandemic has caused disruptions in carrying out research activities in the field. The estab-lished methods of data collection for both qualitative and quantitative research could not be implement-ed. Researchers worldwide adopted contactless data collection methods, including the use of mobile phones for research purposes.This paper presents the experiences of conducting interviews among trib-al population using mobile phones in three villages of Manipur during the pandemic.The interviews proved to be successful and effective. Minor technical glitches were a challenge but were not significant to affect the quality of the data. During unprecedented times such as the current pandemic, conducting interviews via mobile phones could be a viable alternative to face-to-face interviews for collecting quali-tative data from the communities.
ABSTRACT
Resumen: La información genética y genómica requiere regulaciones estrictas para su manejo adecuado con el fin de evitar la divulgación inapropiada y la discriminación secundaria, pues tiene una relación directa con los derechos fundamentales y los principios bioéticos. De ahí la necesidad de evaluar la regulación colombiana existente, por lo que se realizó una revisión sistemática de la literatura en bases de datos del 2000 al 2020, sitios web del Congreso de la República de Colombia, la Comisión de Reforma de la Ley Australiana y la Corte Constitucional de Colombia, para identificar las falencias y los aciertos en la jurisprudencia actual del manejo, el control y la accesibilidad de la población colombiana a las pruebas e información genética. Se toma como referente Australia para comprender y plantear mejoras. Se encontró que en Colombia la información genética se cataloga como sensible (Sentencia C-334-10) con regulaciones inespecíficas sin norma legislativa. En contraste, Australia dispone de directrices bioéticas específicas, penalización y protocolos que abarcan las implicaciones individuales y colectivas descritas en el Privacy Legislation Amendment Act del 2006. Es necesario que en Colombia se cree una regulación jurídica específica para la información genética y genómica con énfasis en pautas de uso sobre la privacidad, la divulgación y la no discriminación.
Abstract: Genetic and genomic information requires strict regulations for its proper handling in order to avoid inappropriate disclosure and secondary discrimination, since it is directly related to fundamental rights and bioethical principles. Hence the need to evaluate the existing Colombian regulation, for which a systematic review of the literature was carried out on databases from 2000 to 2020, websites of the Congress of the Republic of Colombia, the Australian Law Reform Commission and the Constitutional Court of Colombia, to identify the shortcomings and the successes in the current jurisprudence of the management, control and accessibility of the Colombian population to tests and genetic information. Australia is taken as a reference to understand and propose improvements. It was found that in Colombia genetic information is classified as sensitive (Sentence C-334-10) with non-specific regulations without legislative norm. In contrast, Australia has specific bioethical guidelines, criminalization and protocols that cover the individual and collective implications described in the Privacy Legislation Amendment Act of 2006. It is necessary that a specific legal regulation be created for genetic and genomic information with emphasis on usage guidelines on privacy, disclosure and non-discrimination in Colombia.
Resumo: As informações genéticas e genômicas requerem regulamentações rígidas para o seu correto manuseio, a fim de evitar a divulgação inadequada e a discriminação secundária, pois está diretamente relacionada aos direitos fundamentais e aos princípios bioéticos. Daí a necessidade de avaliar a regulamentação colombiana existente, para a qual foi realizada uma revisão sistemática da literatura em bancos de dados de 2000 a 2020, sites do Congresso da República da Colômbia, da Comissão Australiana de Reforma da Lei e do Tribunal Constitucional da Colômbia, identificar as deficiências e os sucessos na jurisprudência atual da gestão, controle e acessibilidade da população colombiana a testes e informação genética. A Austrália é tomada como referência para entender e propor melhorias. Constatou-se que na Colômbia a informação genética é classificada como sensível (Sentença C-334-10) com regulamentações não específicas sem norma legislativa. Por outro lado, a Austrália possui diretrizes bioéticas específicas, criminalização e protocolos que abrangem as implicações individuais e coletivas descritas na Lei de Emenda à Legislação de Privacidade de 2006. É necessário que na Colômbia seja criada uma regulamentação legal específica para informações genéticas e genômicas com ênfase no uso diretrizes sobre privacidade, divulgação e não discriminação.
ABSTRACT
In recent years, foreign countries are gradually implementing broad consent to improve the utilization of medical data and biological samples, but broad consent may face ethical issues such as imperfect notification and affecting the rights of subjects. There are already relevant regulations and practices on broad consent in foreign countries. The concept of broad consent is not clearly defined in China′s laws. At present, the treatment of biological samples can be roughly divided into four categories in practice, and there is potential application space for broad consent. The specific scope of broad consent should be clarified, distinguished from donation behavior, and the implementation of broad consent should be explored on the basis of protecting the rights of subjects.
ABSTRACT
Under the background of " Internet+ medical treatment" and the continuous deepening of face recognition technology research, the face recognition industry has continued to mature, and face recognition has been initially applied in medical fields such as hospital management, auxiliary medical care, and epidemic prevention and control. At the same time, face recognition technology brings problems including error risk, technical cracking risk, privacy risk, equality risk, abuse risk, and other issues in practice, which seriously threaten the personal and property rights and interests of the public. On the basis of summarizing the specific application direction of face recognition technology in hospitals, the authors sorted out the legal regulation of face recognition in China, and proposed that it should be based on technology research and development, strengthen the " gatekeeper" responsibility of medical institutions, improve legal system and recommendations for strengthening judicial leadership in order to improve the legal regulations of face recognition technology, reduce the risk of infringement by medical institutions in the application of face recognition technology, and protect the legitimate rights and interests of citizens.
ABSTRACT
Objective:To analyze data safety problem raised from personal medical data sharing and privacy protection, provide suggestions for improving its application and development.Methods:The personal medical data sharing and privacy protection measures were discussed according to the study of related literatures, typical case analysis, analyzing the current situation and its development trend of legislation status of personal medical data sharing and privacy protection.Results:Medical data is one kind of personal data, but more sensitive than other personal data. The country should strengthen relevant legislation, more clearly define relevant concepts, establish the authority and scope of personal medical data processing, improve the effectiveness and operability of laws, maximize the public interest of data, and ensure the balance between the personal data processing and privacy security.Conclusions:The personal medical data sharing and privacy protection is a systematic project. The solution of the personal security risks is also based on a comprehensive safeguard system which including laws, regulations, management and technology.
ABSTRACT
Resumen: La información clínica que deriva de la atención médica es almacenada en los expedientes clínicos que se encuentran en archivos físicos o electrónicos en las distintas instituciones hospitalarias que se dedican a la enseñanza. Esta valiosa información constituye una herramienta fundamental en la investigación clínica, por lo tanto, debe de ser considerada confidencial desde que el paciente la remite hasta después de finalizar su tratamiento. Cuando los miembros de un hospital-escuela realizan actividades de investigación, utilizan la información contenida en los expedientes clínicos. La confidencialidad de estos registros es protegida por la ley, por esta razón es necesario fundamentar y desarrollar un método que ayude a los investigadores a conocer estos datos clínicos sin violar su privacidad y confidencialidad. Es necesario cuestionarnos si un aviso de privacidad que indique a los pacientes que la información derivada de sus padecimientos puede utilizarse posteriormente para fines de investigación será suficiente para resolver los conflictos relacionados con la obtención de datos. Un aviso de privacidad es un documento legal que se utiliza para la protección de datos de las personas, aplicarlo en las instituciones hospitalarias dedicadas a la enseñanza y a la investigación facilitará el uso de la información derivada de las consultas y mantendrá la confianza de que los datos utilizados en la investigación respetarán, la confidencialidad y la privacidad, a través del anonimato.
Summary: Clinical information derived from medical care is registered in clinical records in physical or electronic files in different hospital institutions dedicated to teaching. This valuable information is a fundamental tool for clinical research; therefore, it should be considered confidential from the moment the patient transfers it, until after the end of their treatment. When members of a hospital-school carry out research activities, they use information contained in clinical records. Confidentiality of these records is protected by law, for this reason, it is necessary to underpin and develop a method to help researchers to learn this clinical data without violating privacy and confidentiality. It is necessary to question ourselves whether a privacy notice indicating patients that the information derived from their conditions may subsequently be used for research purposes will be enough to resolve disputes related to data collection; in this regard, a privacy notice is a legal document used for the protection of people's data; using it in teaching and research hospital institutions will facilitate the use of information derived from consultations and maintain confidence that the data used in research will respect, first and foremost, confidentiality and privacy, through anonymity.
Resumo: As informações clínicas derivadas dos cuidados médicos são armazenadas nos prontuários médicos encontrados em arquivos físicos ou eletrônicos de diversos hospitais que se dedicam ao ensino. Essas informações valiosas são uma ferramenta fundamental na pesquisa clínica, portanto, devem ser consideradas conidenciais desde o momento em que o paciente as envia até o final do tratamento. Quando os membros de um hospital-escola realizam atividades de pesquisa, eles usam as informações contidas nos registros médicos. A conidencialidade desses registros é protegida por lei, por isso é necessário fundamentar e desenvolver um método que ajude os pesquisadores a conhecer esses dados clínicos sem violar sua privacidade e confidencialidade. É necessário questionar se um aviso de privacidade que informe aos pacientes que as informações derivadas de suas condições podem ser usadas posteriormente para fins de pesquisa será suficiente para resolver disputas relacionadas à coleta de dados. Um aviso de privacidade é um documento legal usado para a proteção de dados de indivíduos. Aplicá-lo em hospitais envolvidos em ensino e pesquisa facilitará o uso de informações derivadas das consultas e manterá a coniança de que os dados usados na pesquisa respeitarão, em primeiro lugar, a conidencialidade e a privacidade, por meio do anonimato.