PubMed Health⌕ Search

SEARCH · PubMed Health

Results for “Data Protection Bill”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 55 records · Page 3Linked to original sources

Employer-sponsored insurance: how much financial protection does it provide?

The authors examine the generosity of private employer health insurance coverage using data from two large national surveys of employers. Generosity is measured as the expected out-of-pocket share of medical expenditures for a standard population, given the provisions of the coverage. On average, those covered by employer-sponsored insurance can expect to pay 25 percent of expenditures out of pocket. There is little variability across plans in this share, though plans offered by smaller employers are somewhat less generous than those offered by larger employers. Individuals who incur high costs pay a smaller share of the bill than do those with lower levels of spending. The generosity of employer-sponsored plans increased slightly in the 1990s.

Adult↗

Pharmaco-epidemiological perspectives.

Parallel with increasing concerns about drug safety, the importance of drug surveillance and the application of epidemiologic techniques have grown rapidly during the past decades. The increasing use of computerized health care data facilitates the establishment of populations large enough (millions) to allow epidemiological studies. Such extensive studies are now being done routinely in North America. By the use of computerized pharmacy or billing records, drug exposure is linked to files which include diagnoses. These record-linkage systems provide 'objective' drug histories for pharmaco-epidemiological cohort and case-control studies and these large data bases offer powerful tools for drug evaluation. A number of new drug-disease associations, many of potential importance for European populations, will be discovered through the increased use of large data bases in North America. The European community needs to develop a strategy to respond to these overseas findings to protect the society from either overreaction or underreaction to drug safety issues.

Drug Utilization↗

Texas passes first law for safe patient handling in America: landmark legislation protects health-care workers and patients from injury related to manual patient lifting.

On June 17,2005, Texas Governor Rick Perry (R) signed into law Senate Bill 1525, making Texas the first state in the nation to require hospitals and nursing homes to implement safe patient handling and movement programs. Governor Perry is to be commended for this heroic first stand for safe patient handling in America. The landmark legislation will take effect January 1, 2006, requiring the establishment of policy to identify, assess, and develop methods of controlling the risk of injury to patients and nurses associated with lifting, transferring, repositioning, and movement of patients; evaluation of alternative methods from manual lifting to reduce the risk of injury from patient lifting, including equipment and patient care environment; restricting, to the extent feasible with existing equipment, manual handling of all or most of a patient's weight to emergency, life-threatening, or exceptional circumstances; and provision for refusal to perform patient handling tasks believed to involve unacceptable risks of injury to a patient or nurse. Manually lifting patients has been called deplorable, inefficient, dangerous to nurses, and painful and brutal to patients; manual lifting can cause needless suffering and injury to patients, with dangers including pain, bruising, skin tears, abrasions, tube dislodgement, dislocations, fractures, and being dropped by nursing staff during attempts to manually lift. Use of safe, secure, mechanical lift equipment and gentle friction-reducing devices for patient maneuvering tasks could eliminate such needless brutality. Research has proven that manual patient lifting is extremely hazardous to health-care workers, creating substantial risk of low-back injury, whether with one or two patient handlers. Studies on the use of mechanical patient lift equipment, by either nursing staff or lift teams, have proven repeatedly that most nursing staff back injury is preventable, leading to substantial savings to employers on medical and compensation costs. Because the health-care industry has relied on people to do the work of machines, nursing work remains the most dangerous occupation for disabling back injury. Back injury from patient lifting may be the single largest contributor to the nursing shortage, with perhaps 12% of nurses leaving or being terminated because of back injury. The US health-care industry has not kept pace with other industries, which provide mechanical lift equipment for lifting loads equivalent to the weight of patients, or with other countries, such as Australia and England, which are more advanced in their use of modern technology for patient lifting and with no-lifting practices in compliance with government regulations and nursing policies banning manual lifting. With Texas being the first state to succeed in passing legislation for safe patient handling, other states are working toward legislative protection against injury with manual patient lifting. California re-introduced safe patient handling legislation on February 17, 2005, with CA SB 363, Hospitals: Lift Teams, following the September 22, 2004, veto of CA AB 2532 by Governor Arnold Schwarzenegger, who said he believes existing statutory protection and workplace safety standards are sufficient to protect health care workers from injury. Massachusetts HB 2662, Relating to Safe Patient Handling in Certain Health Facilities, was introduced December 1, 2004. Ohio HB 67, signed March 21, 2005 by Governor Bob Taft (R), creates a program for interest-free loans to nursing homes for implementation of a no-manual-lift program. New York companion bills AB 7641 and SB 4029 were introduced in April, 2005, calling for creation of a 2-year study to establish safe patient handling programs and collect data on nursing staff and patient injury with manual patient handling versus lift equipment, to determine best practices for improving health and safety of health-care workers and patients during patient handling. Washington State is planning re-introduction of safe patient handling legislation, after WA HB 1672, Relating to reducing injuries among patients and health care workers, was stalled in committee in February, 2005. Language from these state initiatives may be used as models to assist other states with drafting safe patient handling legislation. Rapid enactment of a federal mandate for Safe Patient Handling No Manual Lift is essential and anticipated.

Back Injuries↗

Workers' compensation program in the 1970's.

Workers' compensation has become a focus of public attention in the 1970's to a degree unprecedented in its 70-year history. Federal legislation, two national study groups, a rush of State reform amendments, and congressional hearings and bills proposing Federal standards have all contributed to the ferment of inquiry about the relevance and adequacy of the present system of State workers' compensation. Among the questions raised are: Does the system cover all the workers that should be protected? Are the benefits provided adequate? And what are the cost implications to employers of the changing program? For many years, the Social Security Administration has published estimates of the number of workers covered, the benefits paid, and the costs of workers' compensation. This article provides benchmark data to bring coverage and benefit estimates up to date and analyzes statutory provisions measuring several aspects of benefit adequacy.

Costs and Cost Analysis↗

Progress and problems for randomized clinical trials: from streptomycin to the era of megatrials.

Randomized clinical trials (RCTs) are the definitive contributors to evidence-based medicine. RCTs assessing serious outcomes in cardiovascular disease have grown, with 'megatrials' becoming more common with the realization that wrong conclusions resulted from random error in inadequately sized trials. Simple design and a heterogeneous patient population were early features, but multinational trials have increased in scientific, logistical, bureaucratic, regulatory, and legal complexity. These studies now exceed the financial means of academia or medical charities. Governments have left the bill with the pharmaceutical industry, encouraging a symbiosis with academics, who contribute medical and scientific expertise, and access to patients. Industry provides pharmacological, pharmaceutical, technical and regulatory know-how, good clinical practice expertise, and legal assistance during the trial. Study supervision is then in the hands of an independent steering committee and associated subcommittees, until appropriate dissemination of results. Prospectively defined interaction with the sponsor facilitates unbiased design and conduct, but arrangements need careful implementation to avoid conflicts of interest. The patient is protected by a strong data safety monitoring board that is wholly independent. Megatrials are under threat from over-regulation, increasing costs, and difficulties in execution. These issues merit urgent public and political education and debate.

Computer Security↗

[Morphofunctional analysis and trophic adaptations: the case of bill apparatus of Old World flycatchers].

A morphofunctional analysis of the bill apparatus was conducted on some African forest flycatchers (Muscicapidae, Platysteiridae, Monarchidae) in relation to detailed eco-ethological data available on these species. The aim was to evaluate relationships between anatomical structures and habitat constraints and also identify the most pertinent trophic adaptations. If forest Muscicapidae have essentially conserved the generalized passerine structures and occupy open-habitat niches in the forest, Platysteiridae and Monarchidae have adapted to forest conditions and show a key-adaptation based on specific changes in the structure of the bill apparatus in response to particular light patterns and habitat clogginess, constraints that require speed and precision for the capture of prey and protection of the skull against collisions.

Adaptation, Physiological↗

The California experiment: alternatives for minimum nurse-to-patient ratios.

In making policy, it is ideal to study a problem, test solutions, and then implement the best solution. In California there is legislation regarding nurse staffing that requires implementation of a solution before the problem has been accurately stated and before alternative solutions have been tested. Assembly Bill 394 directs the California Department of Health Services to establish "minimum, specific, and numerical licensed nurse-to-patient ratios by licensed nurse classification and by hospital unit" and have these ratios in place January 1, 2002. This law is scheduled for implementation before there is specific evidence of optimal staffing levels for various patient populations. The author presents a comprehensive literature review of activities related to nurse staffing in the United States, provides data related to existing patient classification systems in California, and suggests an alternative to staffing ratios to protect consumers.

California↗

Ethical and legal concerns: reproductive technologies 1990-1993.

After the rapid increase in reports, bills, and regulations on assisted reproductive technologies (ART) in the 1980s, the first 3 years of the 1990s reveal a continuation of this trend notably in three major aspects. First, a certain consistency has developed in terms of the conditions of accessibility to ART, the definition of infertility, the terms of donation, and the primacy of social filiation, so that anonymity remains controversial. Second, the importance of protection of genetic material has been reaffirmed with regard to gamete and embryo conservation, embryo research, and, in particular, the acceptability of preimplantation diagnosis. Finally, the framework of practices concerning accreditation and control, organization of national data, and management of nominative information has been increasingly refined.

Accreditation↗

Implementation of a patient-centred and physician-oriented healthcare information system.

Integration of information has enabled expeditious operation in air transfer, banking, shopping, and stock brokerage, but not in healthcare. Existing health information systems (HIS) are concerned too much with departmental performance and charge billing, and neglect the end users--the patients and the physicians. The resultant HIS then has divergent operation to antagonize the physicians, and has fragmented data to the disadvantage of patients. Recognizing the problems and the trend of HIS, this study proposed and implemented a patient-centred and physician-oriented HIS in a Urology clinic. The proposed HIS had patient care as its core, and accurately coded the patient's diagnoses and therapy information. It also offered a friendly environment and complete function for the physician to administrate medical records and to provide healthcare services. The HIS had client/server structure and an open system to protect the hardware investment and the software implementation. It will be the key to success in complete hospital environments.

Hospital Information Systems↗

Clinical evaluation of the Sorin Synthesis oxygenator with integrated arterial filter.

The use of arterial line filters has long been a standard of practice in the field of cardiopulmonary bypass. Sorin Biomedica has designed an adult hollow-fiber oxygenator that not only incorporates their Mimesys biomimicry coating technology but also has a 40-micron arterial filter as an integrated component of this unique membrane oxygenator. We did a prospective, randomized clinical trial of 54 Synthesis coated oxygenators and compared them with 54 uncoated Monolyth Pro oxygenators, the latter of which incorporated an external arterial line filter with a standard bypass loop There were few statistically significant differences found between the Synthesis group and the Monolyth group with regard to pressure differentials, hemodynamic resistance, and platelet drop. The Synthesis oxygenator did require less priming volume, but the amount was not significant. Platelet counts with the Phosphorylcholine coated Synthesis oxygenators, using crystalloid perfusates, was similar to our previously published data on platelet protection and Albumin perfusates. We conclude that the Sorin Synthesis oxygenator appears to have better flow characteristics than the Monolyth oxygenator, with the potential for lower priming volumes. The most clinically significant benefit comes from the elimination of the arterial filter bypass loop and the avoidance of inverting the arterial filter during priming.

Aged↗

Trauma associated with three- and four-wheeled all-terrain vehicles: is the four-wheeler an unrecognized health hazard?

All-terrain vehicle (ATV) accidents cause 7000 injuries and 20 deaths per month. In this prospective multicenter study comparing three- and four-wheelers, data were obtained on all ATV accident victims treated at 33 participating institutions in 13 Western Michigan counties from July-November, 1986 (N = 143) and on 51 accidents from the preceding 18 months. Of these 194 accidents, 29 per cent involved four-wheelers. In this 78 per cent male population (mean age 21), 23 per cent required hospitalization. One half of these victims sustained a fracture or dislocation and 14 per cent needed surgery. Thirteen per cent had serious neurologic injury. Average hospital bills were $294 for outpatients and $7669 for inpatients. Two thirds of the patients had some disability. Three fatalities were recorded. Analysis of the data showed the following: (1) the three-wheeled ATV design is significantly more unstable than that of the four-wheeler (P less than .001); (2) though more stable, the four-wheeled ATV was still associated with frequent accidents as severe as those involving three-wheelers; (3) riders under age 16 were more likely to be using their ATV improperly (P greater than .05) and had more severe injuries with a higher hospitalization rate, and (4) these ATV riders had inadequate training and protective gear. Lastly, recommendations are made that ATVs need their design flaws corrected for safer use, and that mandatory minimum age requirements, rider education, and helmet use should reduce injuries.

Accidents, Traffic↗

Pharmacoepidemiological perspectives.

Parallel with increasing concerns about drug safety, the importance of drug surveillance and the application of epidemiologic techniques have grown rapidly during the past decades. The increasing use of computerized health care data facilitates the establishment of populations large enough (millions) to allow epidemiological studies. Such extensive studies are now being done routinely in North America. By the use of computerized pharmacy or billing records, drug exposure is linked to files which include diagnoses. These record-linkage systems provide "objective" drug histories for pharmacoepidemiological cohort and case-control studies and these large databases offer powerful tools for drug evaluation. A number of new drug-disease associations, many of potential importance for European populations, will be discovered through the increased use of large databases in North America. The European community needs to develop a strategy to respond to these overseas findings to protect society from either overreaction or underreaction to drug safety issues.

Adverse Drug Reaction Reporting Systems↗

Computer-aided forensics: metal object detection.

Recently, forensic investigators1 have started using diagnostic radiology devices (MRI, CT) to acquire image data from cadavers. This new technology, called the virtual autopsy, has the potential to provide a low cost, non-invasive alternative or supplement to conventional autopsies. New image processing techniques are being developed to highlight forensically relevant information in the images. One such technique is the detection and characterization of metal objects embedded in the cadaver. Analysis of this information across a population with similar causes of death can lead to developing improved safety and protection devices with a corresponding reduction in deaths.

Autopsy↗

PI3K mediates protection against TRAIL-induced apoptosis in primary human melanocytes.

Melanocytes are cells of the epidermis that synthesize melanin, which is responsible for skin pigmentation. Transformation of melanocytes leads to melanoma, a highly aggressive neoplasm, which displays resistance to apoptosis. In this report, we demonstrate that TNF-related apoptosis-inducing ligand (TRAIL), which was thought to kill only transformed cells, promotes very efficiently apoptosis of primary human melanocytes, leading to activation of caspases 8, 9 and 3, and the cleavage of vital proteins. Further, we show that stem cell factor (SCF), a physiologic melanocyte growth factor that activates both the phosphatidyl-inositol-3 kinase (PI3K) and the extracellular regulated kinase (ERK) pathways, strongly protects melanocytes from TRAIL and staurosporine killing. Interestingly, inhibition of PI3K or its downstream target AKT completely blocks the antiapoptotic effect of SCF, while inhibition of ERK has only a moderate effect. Our data indicate that protection evoked by SCF/PI3K/AKT cascade is not mediated by an increase in the intracellular level of FLIP. Further, only a sustained PI3K activity can protect melanocytes from apoptosis, thereby indicating that the PI3K/AKT pathway plays a pivotal role in melanocyte survival. The results gathered in this report bring new information on the molecular mechanisms involved in primary melanocyte apoptosis and survival that would help to better understand the process by which melanomas acquire their resistance to apoptosis.

Apoptosis↗

Why some physicians envy dentists: the applications service provider.

To summarize, here's what I get from my ASP. My staff and I can access our schedules, patient information, etc, any time and from anywhere--not just from the office PC. All I need is a standard Internet browser and a connection to the Internet. Only authorized personnel have access to my data. My online practice management system is password protected and operates with Verisign SSL--the highest level of Internet security. All information is stored in my secure database, which my ASP backs up and replicates continuously. Dental. PackOnline even operates dual servers. In case one server has a problem, they just switch to the other server, so I never have to worry about "down-time." I can give patients access to their own information online-treatment plans, patient education material, balances, etc, in a highly private and confidential manner. I can share patient information, x-rays, and other materials online with colleagues, specialists, and labs, again in a highly confidential manner. I send out billing, recalls, claims, and more automatically because my ASP has real-time connections to service providers. No more time spent printing, folding, stamping cards, billing, or processing claims. This is a tremendous cost and time saver!

Computer Security↗

Adaptation of the clinical trials directive: recommendations on the contents of a dossier for the request for authorisation of the first trials in human subjects.

The European Directive on clinical trials of medicinal products will fall within the scope of the legislation of Member States on 1 May 2004. In France, this adaptation will be carried out by a public health bill concerning, among other things, the reform of the current Huriet-Sérusclat law, and by means of regulations. For trials concerning the initial administration of a product to human subjects, the group suggested the following recommendations: In French texts, to include a deadline of 30 days for the initial authorisation by the competent authority (Afssaps [Agence française de sécurité sanitaire des produits de santé]). To maintain an observed deadline of 20 days (35 official days) for the decision of the Ethics Committee (EC) [Committee for the Protection of Persons (CPP)]. To obtain a more specific evaluation of the pharmaceutical dossier of the investigational medicinal product (IMP) from the competent authority. To provide both bodies with nonclinical and possibly clinical data concerning the IMP information of the participants and their consent. To follow the recommendations posted on the Afssaps website for the entire IMP dossier. To submit a protocol under the International Committee on Harmonisation (ICH) E6 format adapted for phase I and, possibly as a separate document, justification of a certain number of points (a total of ten) that are more specific to this trial phase to facilitate and improve the document review while also providing the expected guarantees. To limit the 'substantial' amendments to those provided for in the European guidelines. To break the blind for every serious event reported to the sponsor by the investigator, and report to the competent authority any serious adverse event related to the IMP or to the trial or without documented cause, while keeping ECs and investigators informed. Furthermore, certain points concerning the authorisations for packaging, labelling and dispensing of the batches of medicinal products for clinical trials will need to be specified for these early studies. All these recommendations are intended to help promote the development of studies involving the initial administration of medicinal products in France.

Clinical Trials as Topic↗

Understanding the diverse needs of the Medicare population: implications for Medicare reform.

Meeting the health care needs of millions of elderly and disabled Americans is central to the debate over Medicare's future. Using data from a nationally representative survey of 3,309 beneficiaries, Medicare's most vulnerable beneficiaries were profiled, examining variations in coverage, satisfaction, access, and financial difficulties. A substantial portion of the Medicare population--two thirds--were found to have health problems or low incomes. The analysis found that about 40% of beneficiaries with incomes below the poverty level, in fair or poor health, or with ADL limitations, have difficulties paying their medical bills or getting needed health care. Medicare's disabled, under-65 beneficiaries are at even higher risk: nearly half (47%) have health care access problems or deal with financial hardship due to medical bills. The diverse needs and experiences of the Medicare population are underscored, providing new insights into the challenge of maintaining or improving protection for those with greatest need while assuring the long-term fiscal viability of the program.

Aged↗

Wages, health benefits, and workers' health.

Employer-based health insurance provides the majority of U.S. workers with access to health care and protection against devastating financial losses. Millions of workers, however, do not receive health benefits from their employers, and few sources of affordable coverage exist outside the employer-based system. This study, based on data from the Commonwealth Fund Biennial Health Insurance Survey, finds a deep divide in the U.S. labor force and an urgent need for expanding access to comprehensive and affordable coverage to working Americans and their families. According to the authors, higher-wage workers are more likely than their lower-paid counterparts to have health insurance and health-related benefits, such as paid sick leave, and to use preventive care services. Low-wage workers, meanwhile, are much more likely to forgo needed health care because of cost and to report problems paying medical bills.

Adult↗