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Behavior assessment and cross-validation by surrogate measures in drug prevention research.

When used with more orthodox survey or interview techniques, surrogate measures can enhance a study's credibility. Presented is a case report which illustrates the viability of using a surrogate measure to cross-validate self-reports of alcohol consumption by members of a fraternity at a large Midwestern university. As federal authorities continue to scrutinize myriad ways to reduce the nation's health care burden drug abuse research will have an enhanced opportunity to justify its role in that movement. The historical reliance on self-report methods which lack supportive, corroborating evidence of behavior change may jeopardize preventive drug education's opportunity to play a more integral part in influencing health promotion policies.

Alcohol Drinking↗

Quality monitoring, standardized documentation and management with a computerized system in oncology.

Within the last years the prerequisite was prepared to develop a computerized tumor--patient documentation system including quality monitoring and oncological therapy recommendations for every day use. In medicine today, there is an increasing need for quality oriented low cost and transparent management--what is especially true in the field of oncology. The German Federal Authority of Health demands the documentation of all tumor disorders for the establishment of an cancer registry. For these reasons our study group established the program "OncoDoc" in cooperation with the laboratory for Artificial Intelligence of the University Bremen.

Artificial Intelligence↗

Nursing home care: ensuring quality.

There are more than 17,000 nursing homes in the United States providing care for 1.7 million disabled and elderly individuals. Medicare and Medicaid paid $28 billion in 1997 for nursing home services, more than one half of all nursing home expenditures. Improvements in the quality of care in these facilities and ensuring value for public expenditures has been a long sought after goal. Recent actions by the federal government are designed to strengthen state and federal authority and processes to accomplish this goal. Physician leadership in this area is essential to its success.

Aged↗

Federalism and managed care: introductory comments to the American Association of Law Schools' Section on Law, Medicine and Health Care on the role of the states in managed care regulation.

This section of the Annals of Health Law represents a compilation of materials concerning the state regulation of managed care. The following materials were first presented at the annual meeting of the American Association of Law Schools ("AALS"), Section on Law, Medicine and Health Care in January 1999. Chairman John Blum introduces the subject and questions the dual role assumed by state and federal authorities in regulating managed care.

Facility Regulation and Control↗

Bowen v. Kendrick, 29 June 1988.

A group of taxpayers and religious leaders challenged the constitutionality of the Adolescent Family Life Act, which authorizes federal grants to public and nonpublic private organizations for services and research in the area of premarital adolescent sexual relations and pregnancy. They claimed that the Act violated the Establishment Clause of the First Amendment of the US Constitution because the Act provides that the complexity of the problem requires the involvement of religious organizations, and funds had been given to institutions with ties to religious organizations. The Court held that the Act does not violate the Establishment Clause since 1) the passage of the Act was motivated primarily by the legitimate secular purpose of eliminating or reducing social and economic problems caused by teenage sexuality, pregnancy, and parenthood; 2) the Act does not have the primary effect of advancing religion because the services provided are not religious in character; and 3) the Act does not create excessive entanglement of church and state. It remanded the case to the lower court to determine whether the Act was unconstitutional as applied to specific organizations.

Americas↗

Creating a health care agenda for the Department of Homeland Security.

The challenge before us at DHS--to optimize use of our resources to create an effective health response to terrorist incidents--is formidable. After spending several weeks in Baghdad and seeing all the problems that arise in establishing a new government, I found myself thinking, "This is going to take years." Then, when I returned to the United States, Surgeon General Vice Adam. Richard Carmona, MD, MPH, almost immediately assigned me to the new Department of Homeland Security, adding that the problems it faced were probably worse than those in Baghdad. "That is impossible," I thought. "There's no way this could present a greater logistical, organizational, cultural, and administrative challenge than establishing a new government in a country with no democratic tradition in its 5,000-year history!" Within two days of my appointment to the new department, however, I recognized the accuracy of the surgeon general's statement. We will, however, work diligently toward our goals. During the next couple of years, a major DHS priority will be state and local preparedness, which includes rapid identification of epidemics, improved training, the establishment of liaisons with other first responders such as fire, rescue, law enforcement, and emergency medical services teams, and implementing state-of-the-art communication, disease alert, and reporting systems. Table 2 constitutes a checklist for bioterrorism preparedness, from a public health perspective. Local response and coordination with federal authorities and the issues inherent in these efforts are discussed in depth in the presentations that begin on the following page of this publication.

Bioterrorism↗

[Decision-making processes and medical care at the end of life].

The Federal Authority, the Ministry of Public Health and Environment, charged the Ghent University and the Brussels Free University to produce a continuous recording tool of data's concerning the decision-making processes and the medical care at the end of life, after defining the present state of the art. This tool is built up from a glossary and a questionnaire made up of closed questions with a prospective part and a retrospective part, and leaving the possibility of comments. This questionnaire, first submit to experts and two ethic committees, was sent anonymously to a broad sample of doctors of which 193 answered. This study brings out important information on the application of the laws on palliative care, on the rights of the patient and on euthanasia; it would be advisable to organise in the future a further systematic recording of the end of life conditions throughout a standardized questionnaire whose first version is presented here.

Humans↗

Application of control measures against viral haemorrhagic disease of rabbits in the Czech and Slovak Federal Republic.

The first outbreaks of viral haemorrhagic disease (VHD) of rabbits were reported from eastern Slovakia in 1987. In 1988, the infection spread throughout the Czech and Slovak Federal Republic. Electron microscopy was used by the Veterinary Research Institute in Brno to diagnose the disease during the early stage of infection. At present, the regional laboratories of the veterinary investigation services use the haemagglutination and the direct immunofluorescence tests as the principal methods to demonstrate the causal agent. Indirect immunofluorescence and immunoperoxidase techniques have been developed to demonstrate VHD virus, while the enzyme-linked immunosorbent assay (ELISA) has been used to detect antibodies. Diagnostic kits, allowing a wide use of these methods, are now available commercially. Two types of inactivate vaccines were developed and produced in 1988 and 1989. VHD is controlled by vaccination of exposed rabbit colonies. This is accompanied by other preventive and protective measures, directed by district veterinary officers following instructions from federal authorities.

Animals↗

[Which training for the parasitologist of tomorrow?].

The symposium "Which training for Parasitologists tomorrow" tried to define the difficulties met in this field, as well as to prospect the future. Parasitology is actually deeply changing, and its traditional approaches are frequently deserted as new methods look more favourable. The situation was first stated: applied parasitology (particularly medical) contrasts with fundamental. In the first case, there are important needs and training is expected. In the latter, many teams disappear or are included into units bearing different titles. In some fields (particularly systematic), it is no longer possible to find specialists able to secure the basis of the experiments carried out with the new tools. From such observations, the ways to train future Parasitologists, and to give to those who will use parasites as models substantial basis were prospected. An early initiation can be proposed, by choice of parasitic models to demonstrate general biological facts. Beyond, a common language must be acquired by any scientist concerned by parasitism. At the highest level, tools must not overshadow the essential. Moreover, an effort in communication is expected, to promote Parasitology. Under their Federation authority the scientific Societies are encouraged to define the needs in their areas and to organize training.

Parasitology↗

[Prevention of skiing accidents in Switzerland].

In Switzerland, the prevention of skiing accidents has had a long tradition. The prevention of skiing accidents concept is based on three elements: "The facilities (slopes, runs), the equipment, the human-being". Together with partner organisations (the authorities, federal offices, medical circles, trade and sport associations), the Swiss Council for Accident Prevention bfu has put together an extensive package of measures for the increase of safety in skiing. The efforts made over the years are showing results. Since the beginning of the eighties, the number of skiing accidents which take place in Switzerland every year shows a decreasing trend.

Accident Prevention↗

Clinical laboratory regulation under the Clinical Laboratory Improvement Amendments of 1988: can it be done?

This report examines logical but not yet widely recognized ramifications of the Clinical Laboratory Improvement Amendments of 1988 (CLIA'88), federal legislation that will require certification of all laboratories examining human specimens. Examination of the CLIA'88 committee reports and committee hearings suggest that more than the conventional approach to laboratory standards will be needed to meet the public's expectations as articulated by our elected representatives. The conventional approach to clinical testing standards seeks to assure quality by regulating the laboratory analytical process. However, little empirical evidence is available to support or refute this model, which has been used during the past 25 years. One alternative paradigm for laboratory standards is an approach that examines the total laboratory testing process, including the selection, ordering, and interpretation of the test as well as the laboratory analysis per se. The history of controversy over laboratory standards--especially personnel standards, the glacial federal regulatory rulemaking process, public expectations of fail-safe technology, among other factors--suggests the implementation of CLIA'88 will be a lengthy and vigorously debated contest. The risk of a test is seldom inherent in the test itself, but rather is a function of the context in which the test is being used to provide information for medical decision making. Our premise is that diagnostic tests must be examined in the context of the laboratory testing situation. We suggest that now is the appropriate time for laboratory professionals, practicing physicians, and the public to abandon conventional thinking regarding clinical laboratory standards. We believe that CLIA'88 reflects a shift in public expectations toward fail-safe laboratory testing and the need for additional government oversight in laboratory test quality. If these new expectations persist, CLIA'88 represents a potential landmark in the course of federal authority and the practice of medicine in the United States.

Humans↗

Air toxics in the U.S.: magnitude of the problem and strategy for control.

Over the past several years, substantial concern has been expressed by some in Congress, environmental groups, and members of the public concerning the lack of progress in regulating toxic air pollutants by the U.S. Environmental Protection Agency (EPA). As a result, a number of amendments to the Federal Clean Air Act have been introduced to require EPA to regulate in a relatively rapid timeframe, a large number of potentially toxic pollutants that are released to the ambient air. This paper discusses EPA's current understanding of the magnitude and nature of the air toxics problem in the U.S., and the pollutants and source categories that pose the most significant risk to the public. The focus of the discussion is on routine releases, as opposed to catastrophic, accidental releases such as the one in Bhopal, India. The paper then discusses the strategy that EPA has put in place to deal with the problem and presents the status of a number of regulatory and non-regulatory activities under way to better understand the problem and to mitigate it. The strategy involves important roles for: (1) EPA to regulate national problems using a variety of Federal authorities in addition to the Clean Air Act, and (2) States to develop their own air toxic control programs to deal with unique local problems involving high risk point sources and multipollutant, multisource problems in large urban or industrialized areas.

Air Pollutants↗

Arthritis related interests in spinal cord injury.

National concern about traumatic spinal cord injury almost 2 decades ago led federal authorities to establish the Regional Spinal Injury Care Systems and a common database to study this condition. Thirteen years of collaborative data collection have provided valuable experience and information for the planning of spinal cord injury research. This approach may also apply to other categories of patients who have multiple variables associated with the clinical picture, treatment and outcome, and in whom the demonstration of treatment effectiveness requires longterm studies of large numbers of patients. Certain complications seen in patients with spinal cord injury including heterotopic ossification, joint changes, and dermal fibrosis, may provide models for the understanding of certain bone and collagen diseases.

Arthritis↗

Medical examiner/coroner jurisdiction in cases involving federal interests.

Under state laws, a medical examiner or coroner is charged with the investigation of sudden, unexpected, violent, and unexplained deaths. In several situations where there are federal interests, there may be conflict as to whether the jurisdiction belongs to state or federal authorities. Some situations of possible conflict--death on a military installation, military aircraft accidents, mass transportation disasters, and executive and congressional assassinations--are reviewed.

Accidents, Aviation↗

Furunculoid myiasis in a dog caused by Cordylobia anthropophaga.

Two days after returning with its owners from a 60-day visit to Liberia, an 8-year-old 6.5-kg spayed female Miniature Schnauzer was examined by a veterinarian in the United States. A 1.0 x 1.0-cm raised erythematous nodule was noticed on the medial aspect of the right pinna. In the center of the nodule was a 1.0 x 1.0-mm pore from which a 0.5 x 0.5 x 1.0-cm white larva was extracted. The larva was identified as a third-stage larva of Cordylobia anthropophaga, the African Tumbu fly, a fly restricted to sub-Saharan Africa. Cordylobia anthropophaga does have zoonotic potential, but the owners did not have any skin lesions. Detection of C anthropophaga in the United States warranted reports to state and federal authorities and personnel at the Centers for Disease Control and Prevention. The situation described here illustrated the potential of tourists' pets to import foreign diseases.

Alabama↗

Hantavirus pulmonary syndrome. Outbreak of a new disease caused by a new virus.

Only months after the first report of a brief prodromal illness followed by rapidly progressive noncardiogenic pulmonary edema and death, the causative agent was tentatively identified as a previously unknown hantavirus. Although hantaviral infections are well known in Asia, none had ever been reported in the United States. A collaborative effort between local, state, regional, and federal authorities allowed rapid identification of a new set of clinical and laboratory findings, now known as the hantavirus pulmonary syndrome. Inclusion, exclusion, and confirmatory criteria have been established to help identify potential cases. However, tests for the infection are still experimental, so physicians should send samples to the Centers for Disease Control and Prevention for testing in suspected cases. Ribavirin (Virazole) may be beneficial early in the course of hantavirus pulmonary syndrome, and supportive care is essential. Rodents, particularly the deer mouse in the Southwest, are the natural hosts for the hantaviruses. Prevention of this new syndrome centers on avoidance of contact with and inhalation of saliva, urine, and feces of infected rodents.

Adult↗

Management of intracardiac device recalls: a consensus conference.

The incidence of cardiac device recalls seems to be increasing, due in part to increasing complexity, but also to greater public awareness and regulatory overview. Manufacturers are responsible for postmarket surveillance of their implanted products; evidence for poor performance is usually evaluated by a physician advisory committee, and unacceptable failure rates or modes prompt the issuance of a recall. A consensus conference was held March 6, 1995 in Toronto, Ontario to discuss the management of cardiac device recalls after the provincial Ministry of Health issued unique guidelines regarding a recent lead problem. Various stakeholders expressed their views and concerns: the federal regulatory body, the provincial Ministry of Health and hospital association, manufacturers, hospital legal counsel, patient and media advocates and physicians from the United Kingdom, the United States and Canada. Specific recommendations included the establishment of a national (or regional) pacemaker (device/lead) registry interposed between the manufacturer and the federal authority; the creation of a recall task force to deal with specific problems distinct from the manufacturers' physician advisory committee; emphasis on patient responsibility for obtaining regular follow-up and maintaining contact by a pacemaker passport system as exists in Europe; and the fair assignment of costs involved in a recall with specific emphasis on appropriate compensation for physicians and clinic personnel.

Algorithms↗