RESUMO
This article aims at opening discussions and promoting future research about key elements that should be taken into account when considering new ways to organise access to personal data for scientific research in the perspective of developing innovative medicines. It provides an overview of these key elements: the different ways of accessing data, the theory of the essential facilities, the Regulation on the Free Flow of Non-personal Data, the Directive on Open Data and the re-use of public sector information, and the General Data Protection Regulation (GDPR) rules on accessing personal data for scientific research. In the perspective of fostering research, promoting innovative medicines, and having all the raw data centralised in big databases localised in Europe, we suggest to further investigate the possibility to find acceptable and balanced solutions with complete respect of fundamental rights, as well as for private life and data protection.
Assuntos
Pesquisa Biomédica , Confidencialidade/legislação & jurisprudência , Gerenciamento de Dados/normas , Disseminação de Informação , Terapias em Estudo , Difusão de Inovações , Europa (Continente) , Humanos , Setor PúblicoRESUMO
Environment perception is crucial for the safe navigation of vehicles and robots to detect obstacles in their surroundings. It is also of paramount interest for navigation of human beings in reduced visibility conditions. Obstacle avoidance systems typically combine multiple sensing technologies (i.e., LiDAR, radar, ultrasound and visual) to detect various types of obstacles under different lighting and weather conditions, with the drawbacks of a given technology being offset by others. These systems require powerful computational capability to fuse the mass of data, which limits their use to high-end vehicles and robots. INSPEX delivers a low-power, small-size and lightweight environment perception system that is compatible with portable and/or wearable applications. This requires miniaturizing and optimizing existing range sensors of different technologies to meet the user's requirements in terms of obstacle detection capabilities. These sensors consist of a LiDAR, a time-of-flight sensor, an ultrasound and an ultra-wideband radar with measurement ranges respectively of 10 m, 4 m, 2 m and 10 m. Integration of a data fusion technique is also required to build a model of the user's surroundings and provide feedback about the localization of harmful obstacles. As primary demonstrator, the INSPEX device will be fixed on a white cane.
RESUMO
Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data manages the risks in the processing of personal data in four steps. It provides notably that data processing presenting specific risks must be subject to prior checking beforehand. The paper investigates the theory of risks in Directive 95/46/EC, together with the criteria allowing to recognize those specific risks. Finally, the paper describes the consequences of such specific risks on the data processing.
Assuntos
Segurança Computacional , Confidencialidade , Informática Médica , Gestão de Riscos , Europa (Continente)RESUMO
We present the 'HealthGrid' initiative and review work carried out in various European projects. Since the European Commission's Information Society Technologies programme funded the first grid-based health and medical projects, the HealthGrid movement has flourished in Europe. Many projects have now been completed and 'Healthgrid' consulted a number of experts to compile and publish a 'White Paper' which establishes the foundations, potential scope and prospects of an approach to health informatics based on a grid infrastructure. The White Paper demonstrates the ways in which the healthgrid approach supports many modern trends in medicine and healthcare, such as evidence-based practice, integration across levels, from molecules and cells, through tissues and organs to the whole person and community, and the promise of individualized health care. A second generation of projects have now been funded, and the EC has commissioned a study to define a research roadmap for a 'healthgrid for Europe', seen as the preferred infrastructure for medical and health care projects in the European Research Area.
Assuntos
Bases de Dados como Assunto , Difusão de Inovações , Informática Médica/organização & administração , Europa (Continente) , Informática Médica/legislação & jurisprudênciaRESUMO
Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data bans the processing of medical data owing to their highly sensitive nature. Fortunately the Directive provides that this ban does not apply in seven cases. The paper aims first to explain the reasons for this ban. Then it describes the conditions under which medical data may be processed under European Law. The paper investigates notably the strengths and weaknesses of the data subject's consent as base of legitimacy for the processing of medical data. It also considers the six other alternatives to legitimate the processing of medical data.
Assuntos
Bases de Dados como Assunto , Informática Médica/legislação & jurisprudência , Privacidade/legislação & jurisprudência , Europa (Continente)RESUMO
The article investigates the issue of knowing whether or not the proposal for a general data protection regulation could improve the patient's safety. This has been analyzed through the four main contributions that should be expected at least from data protection to the patient's safety. In our view, data protection should help supporting efficient information systems in healthcare, increasing data quality, strengthening the patient's rights and drawing the legal framework for performing quality control procedures. Compared to the current legal framework, it is not sure that the proposal might improve any of these contributions to the patient's safety.
Assuntos
Segurança Computacional/legislação & jurisprudência , Confidencialidade/legislação & jurisprudência , Segurança do Paciente/legislação & jurisprudência , União Europeia , Humanos , Direitos do Paciente/legislação & jurisprudênciaRESUMO
Está establecido que existen dos especies distintas de amebas que originalmente fueron conocidas como Entamoeba Histolytica. Ellas son E. dispar (forma no patogénica) y E. histolytica (forma patogénica). La diferencia entre estos dos organismos es de gran importancia clínica desde que son morfológicamente indistinguibles. El diagnóstico diferencial de estas dos especies es esencial para la decisión del tratamiento y la salud pública. Se puede usar un método rápido de extracción de DNA directamente de especímenes suspendidos en formalina éter. La extracción de ADN fue usada para la identificación de las especies existentes en las herramientas por reacción de cadena polimerasa (PCR). Un total de 75 muestras recolectadas aleatoriamente fueron analizadas. Despues de la confirmación por PCR: 7/75 muestras resultaron positivas para E. histolytica, 60/75 muestras resultaron positivas para E. dispar y 8/75 resultaron negativas porque no amplificaron, pudiendo tratarse de otras amebas como E. hartmani. E. iodoamoeba, E. coli, etc. Con estos resultados podemos darnos cuenta de la magnitud de falsos positivos que se generan con los exámenes microscópicos. Estas observaciones implican que el uso del DNA extraído directamente a partir de concentración de quistes para amplificación por PCR, es una herramienta útil para obtener un diagnóstico sensitivo y preciso que puede ser aplicado incluso en epidemiología.
It has been established that two distinct species exist within what was originally known as Entamoeba histolytica. These are E. dispar (nonpathogenic form) and E. histolytica (pathogenic form). Differentiation of these two organisms is of great clinical importance since they are morphologically indistinguishable. Differential diagnosis of this two species is essential for treatment decision and public health knowledge. A simple and rapid DNA-extraction method that can be used directly on formalin-ether stool specimens. The extracted DNA was used for the identification of the species existing in the stools by polymerase chain reaction (PCR). A total of 75 randomly collected stool sample were analyzed. The samples analyzed by microscopic were 75, after confirmation by PCR: 7/75 samples resulting positive for E. histolytica, 60/75 samples resulting positive for E. dispar and 8/75 resulting negative because didn't amplify be able to be other amoebas like E. hartmani, E. iodoamoeba, E. coli, etc. With these results we can realize the magnitude of false positive that are generated with the microscopic exams. These observations imply that the use of the DNA extracted directly of the concentrate of cysts for PCR amplification is a useful tool for obtaining a sensitive and accurate diagnosis that can be applied even in epidemiology.