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At least 1,657 records · Page 92Linked to original sources
PubMed1995

Maintaining the confidentiality of computerized mental health outcome data.

The emergence of managed behavioral health care has increased the value of data describing outcomes of mental health treatment. At the same time, increased development of the national information infrastructure and other computer linkage systems has facilitated the flow of information among a wide network of data systems. These two developments create a dynamic tension between the need to share information and the need to protect the privacy of mental health clients and the confidentiality of their computerized records. This problem is exacerbated by the cost associated with potential solutions. Unfortunately, policy development in this area has lagged behind rapid developments in technology. The mental health administrator must balance the three components of this conflict (the increasing need for information transfer, the protection of confidentiality, and cost) without a great deal of guidance. This article offers recommendations that may help the mental health administrator manage this conflict.

Computer Security↗
PubMed2005

[Assessment of SUSARs. Clinical evaluation of single cases in terms of regulatory requirements].

In the course of implementing the European directives on pharmaceutical law, focus is set on suspected unexpected serious adverse reactions (SUSARs). SUSARs are essential for expedited reporting to authorities and ethics committees. During on-line monitoring of the study, the investigator documents all adverse events. Serious adverse events are forwarded to the sponsor in due time. The sponsor identifies SUSARs for expedited reporting. Clinical causality assessment between the investigational product and the adverse event is substantial in this process. This requires a balanced clinical assessment of all case relevant aspects and information available reflecting the complexity of the specific case, which cannot be covered by algorithms in general. In the setting of on-line monitoring, SUSARs ensure the safety of the patient and the study. In addition, SUSARs are relevant for generation of the safety profile of the substance.

Algorithms↗
PubMed2005

[The 12th amendment to the German Drug Law. Chances and obstacles for investigator-initiated clinical trials].

The European Union's so called Clinical Trials Directive 2001/20/EC was implemented in national law in Germany in August 2004, leading to the 12th amendment of the German Drug Law (Arzneimittelgesetz). The directive is intended to harmonize the clinical trial's regulatory environment across the European Union and to improve protection of human subjects. It lays down the principles and guidelines of Good Clinical Practice (GCP). As the regulation applies to all clinical trials on medicinal products for human use, and as only non-interventional studies are excluded, academic, investigator-initiated clinical trials will also have to comply with the EU clinical trials directive implemented in the German Drug Law. In an investigator-initiated trial in which the investigator takes the responsibility of a sponsor, the investigator-sponsor must take total legal and financial responsibility for the clinical trial. Since publicly funded clinical trials make a large contribution to improved care, concern has been expressed that non-commercial research projects will be reduced and the vital medical research conducted at academic institutions curtailed. Nonetheless GCP ensures a valid study design, qualified data management, analysis and monitoring of the trial and thereby promotes more valid data and protection of study participants. The trials are more likely to lead to reliable results leading to new therapies, strategies or a better understanding of diseases. What is needed, therefore, is an increase in public funding and the establishment of clinical trial units/organizations associated with the universities or hospitals where independent researchers have the possibility to obtain theoretical advice and practical help, professional training and support. In the end, the directive may serve as a stimulus to build a better national research environment and to promote public funding, and may lead to fewer but more valid clinical trials.

Clinical Trials as Topic↗
PubMed2005

[Ethical and regulatory requirements for conducting clinical trials: patient information and patient informed consent].

Written informed consent must be obtained from legally competent subjects, after having been duly informed verbally and in writing, before participation in a clinical trial with pharmaceutical products or medical devices. For persons or minors incapable of giving their informed legal consent, the written consent of the subject's legal representative is mandatory. The subject's presumed or expressed wish must be considered.

Adolescent↗
PubMed2005

[Networking and integrated disease management. Advantages and disadvantages from the medical point of view].

At the moment the terms "networking", "cost reduction" and "integrated disease management" are frequently discussed in all branches of the German health care system. Unfortunately there are different interpretations of these terms. "Integrated disease management" in the meaning of communication between clinical and outpatient health care has al ready existed for years now. Traditional ways of communication lead to information loss. Losing information is a reason for low cost effectiveness and a prolonged healing process directly harming the patient. A computer network may prevent information loss and may in crease the performance of data transfer. Different sides have al ready started networking, and it is now necessary to bundle the interests. This necessity has been recognized by the German legislative. To lead this project to success it is important to know and to fulfil some medical criteria. Defining and describing these conditions is the topic of this paper. Our special intent is to show that digital technique is necessary to improve cooperation among physicians.

Computer Communication Networks↗
PubMed2005

[Systematic drug documentation].

Medication histories as the most common way to document individual drug use provide a valuable database. Their main purpose is to check the patient's medication for so-called drug-related problems such as interactions, compliance problems, adverse drug reactions, and others. A second concern is to gain epidemiological evidence which increases the knowledge about benefits and risks of drugs including economic consequences. By referring to well-accepted principles of data protection, the documentation of drug use data has to be an essential part of complex care programmes which allows improvement of the individual drug therapy by reducing possible risks and increasing the therapeutic outcome of drug use more effectively. In addition, systematic drug documentation can be used to build structured databases which usually make use of prescription data. Given that principles of data protection, especially with regard to anonymity, are considered such databases provide an opportunity of data linkage with other health-related information such as health care services or number of sick leave days. Regardless of certain methodological limitations, these databases can also be used for health economics research and evaluation.

Computer Security↗
PubMed2005

[Telematics and quality. Implementation of a telematic platform in Hamburg].

Since the end of the year 2000 a group of interested people has been working on the subject of quality improvement in breast cancer. Within this framework the project "improvement of breast cancer treatment by telemedicine" was started. Based on a workflow analysis and interviews with patients as well as health professionals, it turned out that there are gaps and flaws in the communication process. These problems occurred between health professionals involved in the treatment of patients and between health professionals and patients as well. As a result a telemedicine network has been developed which is based on MPLS technology. Within this network a central communication unit facilitates optimization of the workflow for the treatment of breast cancer. It will also be possible to set up groups for integrated care. Currently the system is being evaluated in specific breast centres in Hamburg. As the net is based on a positive business plan, it can be foreseen that a broad implementation will follow.

Breast Neoplasms↗
PubMed2006

[Data sources in epidemiology].

The use of large databases has a high potential for future epidemiological research. Databases consisting of primary data as well as routine data that are mainly collected for administrative purposes will be of interest. This paper presents some large databases and some that are most relevant for epidemiological research, respectively, and shows how they might be exploited for research purposes. To make better use of large databases there are new requirements and challenges that we have to face regarding appropriate methods for their analysis. Some examples of such methods are given. An example of pharmaco-epidemiology illustrates linkage of several administrative databases and specific problems that have to be solved in this context. Finally, future challenges are discussed that have to be overcome on the way towards establishment, maintenance and analysis of large databases, especially regarding data protection, data quality and regular updates.

Computer Security↗
PubMed2001

Networks in the radiology department and the hospital.

Data networks are a basic technology with regard to an appropriate design of the information technology (IT) infrastructure for the hospital. Due to the distributed workflow within the hospital, an integrated Hospital Information System (HIS) is based mostly on a set of network applications facing specific items. Medical communication standards, i.e., HL 7, DICOM, and in the near future the migration towards XML, support the interoperability between the IT subsystems and pave the way to patient information systems with access to unified and complete electronic medical records (EMR). Furthermore, with standardized communication techniques, such as CORBAmed, an object-oriented design of Healthcare applications will be possible in the near future. The intent of this paper is to give an overview of which basic technologies are suitable for building comprehensive, flexible, and reliable hospital networks and which also meet the special demands of the radiology department.

Computer Communication Networks↗
PubMed2005

Scientific Grid activities and PKI deployment in the Cybermedia Center, Osaka University.

The Cybermedia Center (CMC), Osaka University, is a research institution that offers knowledge and technology resources obtained from advanced researches in the areas of large-scale computation, information and communication, multimedia content and education. Currently, CMC is involved in Japanese national Grid projects such as JGN II (Japan Gigabit Network), NAREGI and BioGrid. Not limited to Japan, CMC also actively takes part in international activities such as PRAGMA. In these projects and international collaborations, CMC has developed a Grid system that allows scientists to perform their analysis by remote-controlling the world's largest ultra-high voltage electron microscope located in Osaka University. In another undertaking, CMC has assumed a leadership role in BioGrid by sharing its experiences and knowledge on the system development for the area of biology. In this paper, we will give an overview of the BioGrid project and introduce the progress of the Telescience unit, which collaborates with the Telescience Project led by the National Center for Microscopy and Imaging Research (NCMIR). Furthermore, CMC collaborates with seven Computing Centers in Japan, NAREGI and National Institute of Informatics to deploy PKI base authentication infrastructure. The current status of this project and future collaboration with Grid Projects will be delineated in this paper.

Computational Biology↗
PubMed2005

Privacy, public safety, and medical research.

The increasing storage of vast amounts of information on computers and the rapidly increasing size of the databases stored on-line has the population and even many politicians worried about invasion of privacy. This paper examines some possible ways in which privacy may be invaded by the use of medical databases particularly during analysis and publication of results. The current literature is examined to reveal current practices.

Clinical Trials as Topic↗
PubMed1996

Ethics, genomics, and information retrieval.

The union of genomics and computational information retrieval raises a number of ethical issues, including data sharing, database accuracy, group and subgroup stigma, and privacy and confidentiality. These issues are introduced and assigned a preliminary analysis which, it is hoped, may be of use in more sustained efforts to identify issues, solutions and potential guidelines, to stimulate education, and to strike the most appropriate balance between the rights of individuals and the needs of researchers and society.

Computer Security↗
PubMed1995

European standards development in healthcare informatics: actual and future challenges.

This paper focuses on the current and future standardisation activities in CEN TC251 (European Standardisation Committee, Technical Committee on Medical Informatics). The progress of the Committee's standards development is summarized per working group. The main challenges of the next years are enumerated: coordination across working groups and project teams, quality management, and international harmonisation (especially with the USA).

Accreditation↗