O consentimento informado consiste em um processo capaz de informar o participante de pesquisa sobre as intervenções médicas previstas a serem aplicadas no decorrer do estudo e faz com que este participe ativamente no processo de tomada de decisão. O Termo de Consentimento Livre e Esclarecido (TCLE) caracteriza-se por ser um documento explicativo, de forma escrita, no qual são abordadas informações referentes ao projeto de pesquisa, com o objetivo de garantir a voluntariedade do indivíduo. A qualidade do TCLE em pesquisa clínica é determinada pelo grau de compreensão que os participantes desenvolvem durante o processo de consentimento informado. O objetivo deste estudo consiste em avaliar o processo de consentimento dos participantes de pesquisa clínica. Trata-se de um estudo híbrido, com coleta prospectiva. Para o seu desenvolvimento dividiu-se nas seguintes fases: Elaboração e validação do formulário, Treinamento da Equipe de Entrevistadores, Estudo Piloto, Coleta de Dados e Avaliação da Legibilidade dos TCLEs. Foi realizada análise descritiva dos dados e comparação entre as variáveis por meio de análises univariadas. Dos 70 participantes que compuseram a amostra, 83% eram mulheres, a média de idade foi de 46,7 anos (S ±13.99 anos), 55,7% eram brancos, 45,75% casados, 52,9% analfabetos ou com ensino fundamental, 49,3% economicamente ativos e renda média de 1496,2 reais. Dos participantes, 35,7% desconheciam o tipo de estudo que participavam 38,6% não sabiam contar sobre a pesquisa que participavam, 64,7% não receberam informações referentes a outros tipos de tratamento, 62,7% não tinham informações sobre indenização, 66,2% não leram todo o TCLE antes de assinar, 86,8% relataram que o documento foi fácil de ser lido, 62,2% acharam o documento longo. Após o cálculo do ILFK dos 12 TCLEs analisados, 100% apresentaram valor de 0 a 30, considerado como leitura muito difícil. É de suma importância incentivar o desenvolvimento de estudos nacionais que avaliem a percepção dos participantes de pesquisa quanto aos seus direitos e a criação de instrumentos que possibilitem essa verificação na população brasileira / Informed consent consists a process that is able to inform, the research participant, of the planned medical interventions to be apply during the course of the study, and actively participate in the decision-making process. The Informed Consent Form (ICF) characterized by being an explanatory document, in written form, in which information about the research project is addressed, with the purpose of guaranteeing the individual\'s willingness. The quality of ICF in clinical research determined by the degree of understanding that participants develop during the informed consent process. The objective of this study is to evaluate the consent process of clinical research participants. It is a hybrid study, with prospective collection. For its development, it divided into the following phases: Elaboration and validation of the form, Training of the Team of Interviewers, Pilot Study, Data Collection and Evaluation of the Readability of ICF. A descriptive analysis of the data and a comparison between the variables performed using univariate analyses. Of the 70 participants, 83% were women, mean age was 46,7 years (S ± 13.99 years), 55,7% were white, 45,75% married, 52,9% illiterate or basic education, 49,3% economically active and average income of 1496,2 Reais. Of the participants, 35,7% didn\'t know the type of study they participated in, 38,6% didn\'t know about the research they participated, 64,7% didn\'t receive information regarding other types of treatment, 62,7% didn\'t have information about compensation, 66,2% didn\'t read the entire ICF before signing, 86,8% reported that the document was easy to read, 62,2% found the document long. After the ILFK calculation of the 12 ICF analysed, 100% presented values from 0 to 30, considered as very difficult reading. It is extremely important to encourage the development of national studies that evaluate the perception of research participants regarding their rights and the creation of instruments that enable such verification in the Brazilian population

O consentimento informado consiste em um processo capaz de informar o participante de pesquisa sobre as intervenções médicas previstas a serem aplicadas no decorrer do estudo e faz com que este participe ativamente no processo de tomada de decisão. O Termo de Consentimento Livre e Esclarecido (TCLE) caracteriza-se por ser um documento explicativo, de forma escrita, no qual são abordadas informações referentes ao projeto de pesquisa, com o objetivo de garantir a voluntariedade do indivíduo. A qualidade do TCLE em pesquisa clínica é determinada pelo grau de compreensão que os participantes desenvolvem durante o processo de consentimento informado. O objetivo deste estudo consiste em avaliar o processo de consentimento dos participantes de pesquisa clínica. Trata-se de um estudo híbrido, com coleta prospectiva. Para o seu desenvolvimento dividiu-se nas seguintes fases: Elaboração e validação do formulário, Treinamento da Equipe de Entrevistadores, Estudo Piloto, Coleta de Dados e Avaliação da Legibilidade dos TCLEs. Foi realizada análise descritiva dos dados e comparação entre as variáveis por meio de análises univariadas. Dos 70 participantes que compuseram a amostra, 83% eram mulheres, a média de idade foi de 46,7 anos (S ±13.99 anos), 55,7% eram brancos, 45,75% casados, 52,9% analfabetos ou com ensino fundamental, 49,3% economicamente ativos e renda média de 1496,2 reais. Dos participantes, 35,7% desconheciam o tipo de estudo que participavam 38,6% não sabiam contar sobre a pesquisa que participavam, 64,7% não receberam informações referentes a outros tipos de tratamento, 62,7% não tinham informações sobre indenização, 66,2% não leram todo o TCLE antes de assinar, 86,8% relataram que o documento foi fácil de ser lido, 62,2% acharam o documento longo. Após o cálculo do ILFK dos 12 TCLEs analisados, 100% apresentaram valor de 0 a 30, considerado como leitura muito difícil. É de suma importância incentivar o desenvolvimento de estudos nacionais que avaliem a percepção dos participantes de pesquisa quanto aos seus direitos e a criação de instrumentos que possibilitem essa verificação na população brasileira / Informed consent consists a process that is able to inform, the research participant, of the planned medical interventions to be apply during the course of the study, and actively participate in the decision-making process. The Informed Consent Form (ICF) characterized by being an explanatory document, in written form, in which information about the research project is addressed, with the purpose of guaranteeing the individual\'s willingness. The quality of ICF in clinical research determined by the degree of understanding that participants develop during the informed consent process. The objective of this study is to evaluate the consent process of clinical research participants. It is a hybrid study, with prospective collection. For its development, it divided into the following phases: Elaboration and validation of the form, Training of the Team of Interviewers, Pilot Study, Data Collection and Evaluation of the Readability of ICF. A descriptive analysis of the data and a comparison between the variables performed using univariate analyses. Of the 70 participants, 83% were women, mean age was 46,7 years (S ± 13.99 years), 55,7% were white, 45,75% married, 52,9% illiterate or basic education, 49,3% economically active and average income of 1496,2 Reais. Of the participants, 35,7% didn\'t know the type of study they participated in, 38,6% didn\'t know about the research they participated, 64,7% didn\'t receive information regarding other types of treatment, 62,7% didn\'t have information about compensation, 66,2% didn\'t read the entire ICF before signing, 86,8% reported that the document was easy to read, 62,2% found the document long. After the ILFK calculation of the 12 ICF analysed, 100% presented values from 0 to 30, considered as very difficult reading. It is extremely important to encourage the development of national studies that evaluate the perception of research participants regarding their rights and the creation of instruments that enable such verification in the Brazilian population

Changes to the technological landscape of the National Health Service (NHS) in the UK have often raised debates on information privacy and patient confidentiality. This has been especially pertinent in the context of HIV health services, where patient records have been historically segregated from hospital notes to protect confidentiality and account for the nature of the condition as a stigmatised terminal illness. However, as current anti-retroviral treatment extends life expectancy, HIV is increasingly managed in ways similar to other chronic conditions and integrated patient management has been proposed as best practice. This shift offers a unique opportunity to study reconfigurations of privacy and confidentiality practices from the perspective of data users. This thesis focuses on a technological integration project between the stand-alone systems used in two HIV specialist outpatient centres and the centralised Electronic Patient Records (EPR) of their respective NHS Hospital Trusts. The case study methodology draws on 46 semi-structured interviews with health and IT professionals, supplemented by an analysis of organisational documents and observation of work practices over a period of six months in the two clinics. In weaving together different theoretical concepts, this thesis contributes to an in-depth, empirically informed understanding of privacy and confidentiality practices in healthcare. Firstly, by looking at how HIV practitioners cultivate their professional identities at the intersection of general medical and HIV-specific confidentiality, this thesis argues that identity work is an important component in the reconfiguration of privacy practices. Secondly, this research draws attention to the role of political negotiations for privacy change, as HIV professionals and EPR developers came in conflict over the ethics of the technological integration project in the hospitals studied here. Thirdly, this thesis illustrates how confidentiality practices are shaped within the co-construction of information infrastructures and medical work, especially in relation to HIV normalisation. A number of implications for practice and policy also emerge from this study.

The world is becoming strongly dependent on computers, and on distributed communication between computers. As a result of this, communication security is important, sometimes critically so, to many day-to-day activities. Finding strategies for discovering attacks against security protocols and for proving security protocols correct is an important area of research. An increasingly popular technique that is used to simplify the design of security protocols is to rely on a secure transport layer to protect messages on the network, and to provide protection against attackers. In order to make the right decision about which secure transport layer protocols to use, and to compare and contrast different secure transport protocols, it is important that we have a good understanding of the properties that they can provide. To do this, we require a means to specify these properties precisely. The aim of this thesis is to improve our understanding of the security guarantees that can be provided by secure transport protocols. We define a framework in which one can capture security properties. We describe a simulation relation over specifications based on the events performed by honest agents. This simulation relation allows us to compare channels; it also allows us to specify the same property in different ways, and to conclude that the specifications are equivalent. We describe a hierarchy of confidentiality, authentication, session and stream properties. We present example protocols that we believe satisfy these specifications, and we describe which properties we believe that the various modes of TLS satisfy. We investigate the effects of chaining our channel properties through a trusted third party, and we prove an invariance theorem for the secure channel properties. We describe how one can build abstract CSP models of the secure transport protocol properties. We use these models to analyse two single sign-on protocols for the internet that rely on SSL and TLS connections to function securely. We present a new methodology for designing security protocols which is based on our secure channel properties. This new approach to protocol design simplifies the design process and results in a simpler protocol.

No description available.

"Mémoire présenté à la Faculté des études supérieures en vue de l'obtention du grade de Maîtrise en LL.M. Droit - Recherche option Droit, Biotechnologies et Sociétés" / Les registres médicaux sont des banques de données, ayant des caractéristiques spécifiques, rassemblant tous les cas d'une maladie sur un territoire précis. Ces informations permettent la mise en place de politiques de santé publique ainsi que l'étude de maladies afin de faire progresser la recherche médicale. La question se pose donc de savoir comment la réglementation concernant le respect de la vie privée s'applique aux particularités des registres. La législation actuellement en vigueur au Québec prévoit l'obligation d'obtenir le consentement du patient avant d'inclure les données le concernant dans le registre. Ces renseignements personnels de santé recueillis dans le registre doivent être protégés afin de respecter la vie privée des participants. Pour cela, des mesures concernant la confidentialité et la sécurité des données doivent être mises en place en vue de leur conservation et durant celle-ci. Après l'utilisation principale de ces données, il est possible de se servir à nouveau de ces renseignements personnels à d'autres fins, qu'il faille ou non les transférer vers une autre banque de données, nationale ou étrangère. Néanmoins cette utilisation secondaire ne peut se faire qu'à certaines conditions, sans porter atteinte au droit des participants concernant le respect de la vie privée. / Medical registries are databases which record aIl cases of a specifie disease found in a given area. Registries provide vital information for public health research and for the implementation of appropriate public policies. The question is : How does the regulation of privacy apply to registries? Legislation currently in force in the province of Quebec requires the consent of a patient in order to inc1ude personal information in the registry. Personal health data in a registry have to be protected to preserve the privacy of research subjects. To ensure data security and confidentiality sorne measures must be taken during their conservation. Secondary use of data is possible under certain conditions aimed at protecting the right to privacy. It is possible to use such personal information again for other purposes even if the data need to be transferred to another national or foreign database.

L'information génétique, de manière intrinsèque, concerne non seulement un individu, mais également les personnes qui lui sont liées par le sang. Dans l'hypothèse où une personne refusait de communiquer des informations cruciales pour la santé des membres de sa famille, les professionnels de la santé qui détiennent ces renseignements pourraient se retrouver confrontés à un dilemme, soit le choix entre le respect de la confidentialité ou la communication des infonnations pertinentes dans l'intérêt de la famille. Ce mémoire propose une analyse des règles régissant la confidentialité des résultats des tests génétiques en regard des droits des membres de la famille et des obligations des professionnels de la santé. Une analyse comparative entre le droit québécois et français est effectuée. La législation portant sur la confidentialité est essentiellement fondée sur la protection des droits individuels. Des exceptions législatives sont toutefois prévues dans l'intérêt de certains membres de la famille, mais elles s'adressent uniquement à la famille biologique. La notion de famille est ainsi restreinte spécifiquement dans le cadre de la génétique. Le bris de la confidentialité ne semble pas la solution optimale pour résoudre le conflit entre les droits de la personne concernée et ceux de sa famille et n'est d'ailleurs pas envisagé par les systèmes juridiques québécois et français. Les professionnels de la santé doivent alors mettre l'accent sur l'information et le dialogue avec le patient, ce qui est davantage garant de la protection des droits de toutes les personnes en cause. / Genetic information, by its very nature, concerns not only the individual, but also the persons related to him by blood. Where an individual refuses to share genetic information crucial to the health of his family members, health professionals who hold such information are faced with a dilemma: they must choose between respecting confidentiality and communicating in the interest of family members. This thesis analyses the rules governing the confidentiality of genetic test results with regards to the rights of family members and the obligations of health professionals. A comparative analysis between the laws of Québec and France is undertaken. Legislation dealing with confidentiality is essentiatly based on the protection of the rights of individuals. Legislative exceptions are nevertheless provided in the interest of certain family members, but they are directed only to the biological family. The concept of "family" is thus restricted in the context of the confidentiality of genetic information. Disregarding confidentiality is not the best solution to the conflict between the rights of the person concerned and of those of his family, and such a solution is not contemplated either in Québec or in France. Health professionals must therefore place emphasis on informing the patient, a solution which offers great protection of the rights of all concemed.

The thesis deals with the rules of the protection of personal data in the process of rendering healthcare. This topic is highly relevant because the act no. 89/2012 Coll., The Civil Code, came recently into force and influenced the topic of this thesis, mainly in case of the settlement called "The Healthcare". The work is divided into four chapters. The first chapter contains the most important legal sources for the protection of personal data in the process of rendering healthcare. The chapter also describes the major decisions of the European Court of Human Rights and the most important decisions of courts in Czech Republic. The second chapter deals with the protection of personality, right to privacy and with the protection of personal data. The protection of personal data in healthcare is undoubtedly a part of above mentioned rights. The third chapter deals with the duty of confidentiality of healthcare workers, the possibility of breaking the confidentiality and the legal liability for breach of a duty of confidentiality. The fourth chapter describes the regulation of medical records. The conclusion includes an evaluation of existing legal regulation and proposals de lege ferenda. The conclusion also contains topics which were not included in the thesis but due to their attractiveness are at...

The Duty of Confidentiality in Health Care (Section 99 of Czech Criminal Procedure Code and other provisions) The aim of the thesis is to introduce the issue of medical confidentiality in Czech Republic. Although most stress is put on the connection with criminal law, the work also explains what medical confidentiality is and outlines some disputable points in this field as well as it further on mentions international treaties, statutes and other sources where the duty of confidentiality is incorporated. The thesis then shows medical confidentiality in connection with the matter of medical records and afterwards focuses on the exceptions when duty of confidentiality can legally be broken and finally a chapter is given to describe the questions of lability for breaching the duty of cofidentiality in health care where criminal law consequences and disciplinary consequences are described. All the matters are discussed in the light of the Health Services Act (372/2011 Coll.) which came into force on April 1, 2012.

In recent years, many health care organizations have begun to take advantage of computerized information systems to facilitate more effective and efficient management and processing of information. However, commensurate with the vastly innovative enhancements that computer technology has contributed to traditional paper-based health care information systems, are security vulnerabilities that have potentially devastating effects on these systems. To ensure the confidentiality, integrity, and availability of information and to ensure compliance with the Security Rule of the Health Insurance Portability and Accountability Act (HIPAA), health care organizations have implemented a number of security controls. Although the objectives of these controls are understood and acknowledged by users of computerized patient care information management systems, the controls are sometimes circumvented or ignored. The purpose of this study was the development of an instrument that measures key determinants of healthcare professionals' prudent access control behavior. The study examined healthcare professionals' prudent access control behavior using a model that integrates the Theory of Planned Behavior (TPB) and the Health Belief Model (HBM). Two additional variables - information security awareness and perceived information security responsibility were incorporated into the model. Rather than focusing on a single behavior or a few specific behaviors, a category of behaviors was proposed. Results of the study indicate that the HBM and TPB constructs as well as the two additional constructs included in the model are indeed key determinants of healthcare professionals' intention to engage in prudent access control behavior that mitigate security threats. Additionally, results of the study provide support for the partial mediating effects of perceived benefits and perceived responsibility for information security on attitude, information security awareness, subjective norm, perceived behavioral control, and perceived severity. The study contributes to the IS knowledge domain by providing theoretically grounded explanations for a subset of prudent information security behaviors of healthcare professionals.