[Results of recent jurisdiction concerning the social insurance of the Federal Republic of Germany (author's transl)].
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The relative proportion of eight polycyclic aromatic hydrocarbons (PAH) in suspended particles from several sampling stations with different level of air pollution (cities and rural districts) was investigated. The PAH-profiles of most samples collected in three winters (1974/75, 1975/76, 1976/77) and in one summer (1975) were very similar. On the other hand the PAH-profiles differ distinctly from those of several exhausts, especially regarding automobiles, coke and oil stoves. It can be presumed, that the mixture of the emissions in the atmosphere leeds to a rather uniform relative proportion of the eight PAH in the immission as much as the difference in stability of the PAH.
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Annuities granted because of unfitness for work in general or unfitness to perform particular professional work are being paid in Germany by a state insurance agency. Unfitness for work has to be ascertained in each individual case as has been ruled by jurisdiction of the Highest German Court. It is the task of the medical expert in the course of this procedure to register the clinical status of the applicants and to reach a medical judgment in regard to fitness for work. This judgment does not rely upon the diagnosis or prognosis of a particular disease; a decreased fitness for work because of a particular disease can only be assumed if the disease has led to long-term irreversible deficient organ functions. Annuities for a limited time period may be granted if there is a chance for improvement of health. Problems of finding expert judgement are reported.
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The Workgroup of the State Measuring Authorities for Chemical Occupational Safety (ALMA) was established in 1987 by the State Committee for Occupational Safety and Safety Technology (LASI) for the purpose of exchanging experiences between the measuring institutes and authorities of the federal states supporting the commercial regulation authorities in the field of dangerous materials. A workgroup was assigned by ALMA in 1995 to determine the theoretical and practical basis for the establishment of an exposure database commonly available to the federal states. In the first stage, the theoretical data structure of the planned database was defined. The purpose of this was to ensure the exchange of exposure data between the federal states in the future and to allow common evaluation of the data. In the second stage, the practical benefits of the database were determined in a trial run. This database makes possible and simplifies the documentation of both the exposure measurements of the state measuring authorities and also those of external (private) measuring bodies.
OBJECTIVE: The author provides an overview of the current status of privacy in psychiatric treatment, with particular attention to the effects of new federal regulations authorized by the Health Insurance Portability and Accountability Act (HIPAA). METHOD: The author reviews the ethical and legal underpinnings for medical privacy, including the empirical data supporting its importance; discusses those portions of the new federal regulations most relevant to psychiatric practice; and suggests steps that psychiatrists can take to maintain their patients' privacy in the new environment. RESULTS: Medical ethics and law, in keeping with patients' preferences, traditionally have provided strong protection for the information that patients communicate while receiving medical care. In general, release of information has required patients' explicit consent. However, limitations of the consent model and technological innovations that permit the aggregation of computerized medical information have led to pressure for greater access to these data. Although the new federal regulations offer patients some additional protections (including security for psychotherapy notes), they also mark a retreat from reliance on patient consent and open up records to previously unauthorized uses, among them law enforcement investigations and marketing and fundraising by health care organizations. However, states retain the power to provide higher levels of protection. CONCLUSIONS: The new regulatory environment is less friendly to medical privacy but still leaves a great deal of discretion in physicians' hands. A commitment to protecting privacy as an ethical norm can be advanced by psychiatrists' requesting patients' consent even when it is not required, by ensuring that patients are aware of the limits on confidentiality, and by avoiding unnecessary breaches of privacy in the course of providing psychiatric care.
The article addresses the requirement to be met for approval of monoclonal antibodies with special emphasis on products coupled with radionuclides and on principles for the conduct of clinical trials. According to the German Drug Law monoclonal antibodies are considered as being sera. Therefore, the Paul-Ehrlich-Institut, Federal Office for Sera and Vaccines, is responsible for marketing authorizations. Sera and vaccines need a special manufacturing licence which is given by the competent authority of the Federal State. Batches of monoclonal antibodies can only be marketed if they have been released by the Paul-Ehrlich-Institut; in connexion with batch control the importance of reference preparations is stressed. The standard requirements for the data to be submitted with the applications for marketing authorizations are in accordance with the EEC Council Directives and Notes for Guidance. For the testing of radioactive monoclonal antibodies in clinical trials, compliance with both the Drug Law and The German Radiation Protection Ordinance must be ensured. In addition to the authorizations required for non-labelled monoclonal antibody products, the use of radioactive substances in diagnosis and therapy requires an authorization by the competent Federal State authority. The main purpose of the planning and performance of clinical trials with new monoclonal antibody in diagnosis and therapy must be the comparison with established diagnostic tools and/or established medicinal products of known effect.
Health information is used for a variety of legitimate purposes, including patient care, quality review, education, research, public health, and legal and financial interests. Regardless of the use or users, patients must be assured that the information they share with healthcare professionals will remain confidential. To protect patients' privacy rights, each healthcare facility must develop policies and procedures for disclosure of health information in accordance with federal and state laws. Careful consideration must be given to any disclosure of health information. Confidential information should be disclosed only as needed for continuing care or upon written authorization by the patient or his legal representative or where such disclosure is authorized by federal or state law, subpoena, or court order.