Author : United States. Congress. House. Committee on Ways and Means. Subcommittee on Health
Publisher :
Page : 96 pages
File Size : 12,60 MB
Release : 2009
Category : Business & Economics
ISBN :
Author : Agency for Healthcare Research and Quality/AHRQ
Publisher : Government Printing Office
Page : 385 pages
File Size : 24,64 MB
Release : 2014-04-01
Category : Medical
ISBN : 1587634333
This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
Page : 399 pages
File Size : 27,59 MB
Release : 2018-08-23
Category : Medical
ISBN : 0309475201
When is it appropriate to return individual research results to participants? The immense interest in this question has been fostered by the growing movement toward greater transparency and participant engagement in the research enterprise. Yet, the risks of returning individual research resultsâ€"such as results with unknown validityâ€"and the associated burdens on the research enterprise are competing considerations. Returning Individual Research Results to Participants reviews the current evidence on the benefits, harms, and costs of returning individual research results, while also considering the ethical, social, operational, and regulatory aspects of the practice. This report includes 12 recommendations directed to various stakeholdersâ€"investigators, sponsors, research institutions, institutional review boards (IRBs), regulators, and participantsâ€"and are designed to help (1) support decision making regarding the return of results on a study-by-study basis, (2) promote high-quality individual research results, (3) foster participant understanding of individual research results, and (4) revise and harmonize current regulations.
Author : Samiran Nundy
Publisher : Springer Nature
Page : 475 pages
File Size : 37,76 MB
Release : 2021-10-23
Category : Medical
ISBN : 9811652481
This is an open access book. The book provides an overview of the state of research in developing countries – Africa, Latin America, and Asia (especially India) and why research and publications are important in these regions. It addresses budding but struggling academics in low and middle-income countries. It is written mainly by senior colleagues who have experienced and recognized the challenges with design, documentation, and publication of health research in the developing world. The book includes short chapters providing insight into planning research at the undergraduate or postgraduate level, issues related to research ethics, and conduct of clinical trials. It also serves as a guide towards establishing a research question and research methodology. It covers important concepts such as writing a paper, the submission process, dealing with rejection and revisions, and covers additional topics such as planning lectures and presentations. The book will be useful for graduates, postgraduates, teachers as well as physicians and practitioners all over the developing world who are interested in academic medicine and wish to do medical research.
Author : Mark A. Rothstein
Publisher : MIT Press
Page : 320 pages
File Size : 48,69 MB
Release : 2004
Category : Business & Economics
ISBN : 9780262182362
Experts discuss the economic, legal, and social issues surrounding the use of genetic testing in determining eligibility for life insurance. Insurance companies routinely use an individual's medical history and family medical history in determining eligibility for life insurance; this is part of the process of medical underwriting. Insurers have also long used genetic information, often derived from family history, in underwriting. But rapid advances in gene identification and genetic testing are changing the way we look at genetic information. Should the results of genetic testing (which might identify a predisposition toward disease not related to medical history) be available to life insurance medical underwriters? Few if any life insurers currently require genetic testing, but there are no laws or regulations prohibiting its use. Genetics and Life Insurance examines the complex economic, legal, and social issues surrounding the use of genetic information in life insurance underwriting. The contributors are legal scholars, representatives of the life insurance industry (including an actuary and an insurance physician), a geneticist, a genetic counselor, a philosopher, and a consumer advocate. They explore all aspects of an issue that has only recently drawn the attention of policymakers and the public. The book opens with a report on the results of a public opinion poll on genetics and life insurance. Succeeding chapters present the insurer perspective, a discussion of the economics of risk selection in life insurance, background information on the process of underwriting, a scientific analysis of genetic risks and mortality rates, a philosophical discussion of fairness and genetic underwriting, the viewpoints of consumers and genetics counselors, a comparison of different international policy approaches to the issue, and a legal analysis of antitrust implications when insurers collaborate in setting standards for medical underwriting. In the final chapter the editor addresses various policy options, examining the pros and cons of each one and assessing their political feasibility.
Author : Institute of Medicine
Publisher : National Academies Press
Page : 334 pages
File Size : 10,8 MB
Release : 2009-03-24
Category : Computers
ISBN : 0309124999
In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.
Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
Page : 149 pages
File Size : 21,78 MB
Release : 2017-04-21
Category : Medical
ISBN : 0309453291
Advances in genetics and genomics are transforming medical practice, resulting in a dramatic growth of genetic testing in the health care system. The rapid development of new technologies, however, has also brought challenges, including the need for rigorous evaluation of the validity and utility of genetic tests, questions regarding the best ways to incorporate them into medical practice, and how to weigh their cost against potential short- and long-term benefits. As the availability of genetic tests increases so do concerns about the achievement of meaningful improvements in clinical outcomes, costs of testing, and the potential for accentuating medical care inequality. Given the rapid pace in the development of genetic tests and new testing technologies, An Evidence Framework for Genetic Testing seeks to advance the development of an adequate evidence base for genetic tests to improve patient care and treatment. Additionally, this report recommends a framework for decision-making regarding the use of genetic tests in clinical care.
Author : Australia. Law Reform Commission
Publisher : Sydney : Australian Law Reform Commission
Page : 441 pages
File Size : 44,10 MB
Release : 2001
Category : Data protection
ISBN : 9780642732118
13. Law enforcement issues
Author : Department Justice
Publisher : Createspace Independent Publishing Platform
Page : 0 pages
File Size : 25,91 MB
Release : 2014-10-09
Category :
ISBN : 9781500783945
(a) Design and construction. (1) Each facility or part of a facility constructed by, on behalf of, or for the use of a public entity shall be designed and constructed in such manner that the facility or part of the facility is readily accessible to and usable by individuals with disabilities, if the construction was commenced after January 26, 1992. (2) Exception for structural impracticability. (i) Full compliance with the requirements of this section is not required where a public entity can demonstrate that it is structurally impracticable to meet the requirements. Full compliance will be considered structurally impracticable only in those rare circumstances when the unique characteristics of terrain prevent the incorporation of accessibility features. (ii) If full compliance with this section would be structurally impracticable, compliance with this section is required to the extent that it is not structurally impracticable. In that case, any portion of the facility that can be made accessible shall be made accessible to the extent that it is not structurally impracticable. (iii) If providing accessibility in conformance with this section to individuals with certain disabilities (e.g., those who use wheelchairs) would be structurally impracticable, accessibility shall nonetheless be ensured to persons with other types of disabilities, (e.g., those who use crutches or who have sight, hearing, or mental impairments) in accordance with this section.
Author : Janneke H. Gerards
Publisher : Intersentia nv
Page : 254 pages
File Size : 42,5 MB
Release : 2005
Category : Cross-cultural studies
ISBN : 9050954529
During the last decades, a better understanding of the influence of genetic factors on the onset of illness and disease has evolved. Unfortunately, however, the information revealed by genetic tests is not always accurate and reliable and its probabilistic value is often limited. Throughout the world, the possibility of genetic testing and the availability of individual genetic information have therefore caused increasing social concern, especially since many actors outside the medical profession, such as health and life insurance companies and employers, have shown a growing interest in individual genetic information. In many states, as well as on the international level, there is an ongoing debate about the balance that should be struck between the protection of the individual against misuse of genetic information and the interests of social actors and genetic research institutes, and about the policy options that are at hand to reduce the risks that are created by the availability of genetic information. This book offers some clarity as to the choices that have been made in various legal systems, both national and international, with respect to the regulation of genetic information. On the basis of an elaborate analysis of relevant legislation, policy approaches and case-law in the United States, the various European states and on the international level, the book aims to provide insight in the issues that must be deemed relevant in considering and, eventually, introducing regulative measures with respect to genetic information.
