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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.
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Objective:To establish and evaluate a new real-time quality control method that can identify the random errors by using the backpropagation neural network (BPNN) algorithm and taking blood glucose test as an example.Methods:A total of 219 000 blood glucose results measured by Siemens advia 2 400 analytical system from January 2019 to July 2020 and derived from Laboratory Information System of Beijing Chaoyang Hospital Laboratory Department was regarded as the unbiased data of our study. Six deviations with different sizes were introduced to generate the corresponding biased data. With each biased data, BPNN and MovSD algorithms were used and tested, and then evaluated by traceability method and clinical method.Results:For BPNN algorithm, the block size was pre-set to 10 and the false-positive rate in all biases was within 0.1%. For MovSD, however, the optimal block size and exclusive limit were 150 and 10% separately and its false-positive rate in all biases was 0.38%, which was 0.28% higher than BPNN. Especially, for the least two error factors of 0.5 and 1, all the random errors were not detected by MovSD; for the error factor larger than 1, random errors could be detected by MovSD but the MNPed was higher than that of BPNN under all deviations. The difference was up to 91.67 times. 460 000 reference data were produced by traceability procedure. The uncertainty of BPNN algorithm evaluated by these reference data was only 0.078%.Conclusion:A real-time quality control method based on BPNN algorithm was successfully established to identify random errors in analytical phase, which was more efficient than MovSD method and provided a new idea and method for the identification of random errors in clinical practice.
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Objetivo: análise descritiva e explicativa da Lei nº 13.709/2018, conhecida como Lei Geral de Proteção de Dados, em especial no aspecto do direito à saúde e suas implicações na segurança do tratamento dos dados decorrentes da revolução tecnológica. Metodologia: pesquisa exploratória de caráter bibliográfico e documental, com base em livros, artigos, legislações e documentos.Resultados:a investigação demonstrou que a difusão do uso dos meios digitais na área da saúde e da medicina expõe o paciente, titular das informações, seja pela negligência no tratamento, seja pela comercialização indevida ou pelo vazamento dos dados. Conclusão:o estudo aponta ser imprescindível o consentimento qualificado do titular dos dados sensíveis para o seu tratamento, bem como o uso de sistemas digitais seguros como meios de salvaguardar os direitos fundamentais da pessoa, alertando o profissional e as instituições de saúde para a necessidade urgente de se adequar à Lei Geral de Proteção de Dados.
Objectives: descriptive and explanatory analysis of the General Data Protection Law, Law n. 13.709/2018, especially in the aspect of the right to health and its implications for the security of data processing resulting from the technological revolution. Methods:exploratory research of bibliographic and documentary character based on books, articles and documents. Results:the investigation showed that the widespread use of digital media in the area of health and medicine exposes the information holder (patient), either due to negligence in treatment, or due to improper commercialization or data leakage. Conclusion:the study points out that the qualified consent of the holder of sensitive data is essential for its treatment, as well as the use of secure digital systems as a means of safeguarding the fundamental rights of the person, alerting professionals and health institutions to the urgent need to comply with the General Data Protection Law.
Objetivos: análisis descriptivo y explicativo de la Ley General de Protección de Datos, Ley n° 13.709/2018, especialmente en el aspecto del derecho a la salud y sus implicaciones para la seguridad del tratamiento de datos producto de la revolución tecnológica. Metodología:investigación exploratoria de carácter bibliográfico y documental a partir de libros, artículos y documentos. Resultados:la investigación mostró que el uso generalizado de los medios digitales en el área de la salud y la medicina expone al titular de la información (paciente), ya sea por negligencia en el tratamiento, bien por mala comercialización o fuga de datos. Conclusión:el estudio señala que el consentimiento calificado del titular de los datos sensibles es fundamental para su tratamiento, así como el uso de sistemas digitales seguros como medio de salvaguardar los derechos fundamentales de la persona, alertando a los profesionales e instituciones de salud de la urgente necesidadpara cumplir con la Ley General de Protección de Datos.
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Humans , Commerce , Computer Communication Networks , Computer Security , Confidentiality , Electronic Health Records , Health Information Exchange , Logic , Methods , Politics , Privacy , ProxyABSTRACT
PURPOSE: The aim of this study was to elucidate clinical nurses' ethics germane to information literacy and perception of patient data privacy and thus help nurses to develop more positive and consolidated ethical values. METHODS: For this study a descriptive survey design was used. Participants were 142 nurses who worked in a hospital and completed self-report questionnaires. Data were collected from August 1 to 5, 2016 and were analyzed using independent t-test, ANOVA, Scheffé test, Pearson correlation coefficients, and stepwise multiple regression with SPSS 22.0. RESULTS: Ethical value had a positive correlation with information needs (r=.25, p=.002) in information literacy as well as in direct patient care (r=.27, p=.001), shift work (r=.20, p=.016), patient information management (r=.39, p<.001), and communication (r=.24, p=.004) in perception of patient data privacy. Patient information management, educational background, and age were significant variables predicting the level of ethical values and accounted for 21% of the variance. CONCLUSION: Ethical values education with particular emphasize on managing patient information should be encouraged for nurses who are younger and have a lower education level. Findings indicate a need for education programs to guide clinical nurses to utilize appropriate information when solving ethical challenges in every day nursing practice.
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Humans , Confidentiality , Education , Ethics , Information Literacy , Information Management , Nursing , Patient CareABSTRACT
Objective The main purpose is to establish a simple method of analytical run length definition through combination of control-based quality control(QC) and average of normals method(AON).Methods Eight test items with different analytical performance were chosen.First,the individualized control-based quality control strategy was designed in the direction of sigma metrics,and the suitable AON rules were selected for each analyte.Then,the selected AON rules were applied to the patient data of successive five workdays.Meanwhile,new individualized control-based QC procedures were also used at 8:00,10:00,12:00 and 14:00 in those days.At last,AON QC result were compared with control-based QC result to define the analytical run for 8 items and the strategy through which laboratory can optimize analytical run length.Results The error detection power of AON algorithms was as good as control-based QC whose performance was excellent.Analytical run length for 8 items involved in this study were defined as follows:triglyceride,potassium,total protein: 8 hours,Chlorine: 6 hours,magnesium:4 hours,calcium,carbon dioxide combining power,sodium: 2 hours.Conclusions For the items with performance above 3.5 sigma,the analytical run was defined mainly depending upon control-based QC,and AON QC was just used to validate control-based result.For the items with performance below 3.5 sigma,the analytical run was defined mainly depending upon AON QC.