Medical Devices Law and Regulation Answer Book

Medical Devices Law and Regulation Answer Book PDF

Author: Susan Onel

Publisher:

Published: 2016-11

Total Pages: 1112

ISBN-13: 9781402427749

DOWNLOAD EBOOK →

This title walks you through the current regulatory requirements and provides in-depth coverage of individual FDA programs that cover everything from conducting clinical trials, preparing successful premarket submissions, adhering to quality system requirements, and fulfilling post-market obligations.

Improving Healthcare Quality in Europe Characteristics, Effectiveness and Implementation of Different Strategies

Improving Healthcare Quality in Europe Characteristics, Effectiveness and Implementation of Different Strategies PDF

Author: OECD

Publisher: OECD Publishing

Published: 2019-10-17

Total Pages: 447

ISBN-13: 9264805907

DOWNLOAD EBOOK →

This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.

Conflict of Interest in Medical Research, Education, and Practice

Conflict of Interest in Medical Research, Education, and Practice PDF

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2009-09-16

Total Pages: 436

ISBN-13: 0309145449

DOWNLOAD EBOOK →

Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.

Medical Licensing and Discipline in America

Medical Licensing and Discipline in America PDF

Author: David A. Johnson

Publisher: Federation of State Medical Boards

Published: 2012-08-10

Total Pages: 391

ISBN-13: 0739174401

DOWNLOAD EBOOK →

Medical Licensing and Discipline in America traces the evolution of the U.S. medical licensing system from its historical antecedents in the 18th and 19th century to its modern structure. David A. Johnson and Humayun J. Chaudhry provide an organizational history of the Federation of State Medical Boards within the broader context of the development of America’s state-based system. As the national organization representing the interests of the individual state medical boards, the Federation has been at the forefront of developments in licensing, discipline, and regulation impacting the medical profession, medical education, and health policy within the United States. The narrative shifts between micro- and macro-level developments in the evolution of America’s medical licensing system, blending national context with state-specific and Federation initiatives. For example, the book documents such milestones as the national shift toward greater public accountability by state medical boards as evidenced by California’s inclusion of public members on its medical board, New Mexico’s requirement for continuing medical education by physicians as a condition for license renewal and the Federation’s policy development work advocating for both initiatives among all state medical boards. The book begins by examining the 18th and 19th century origins of the modern state-based medical regulatory system, including the reinstitution of licensing boards in the latter part of the 19th century and the early challenges facing boards, e.g., license portability, examinations, physician impostors, inter-professional tensions among physicians, etc. Medical Licensing and Discipline in America picks up the story of the Federation and its role in the major issue of licensing and discipline in the 20th century: uniformity in medical statute, evaluation of international medical graduates, nationally administered examinations for licensure, etc.

Complementary and Alternative Medicine in the United States

Complementary and Alternative Medicine in the United States PDF

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2005-04-13

Total Pages: 360

ISBN-13: 0309133424

DOWNLOAD EBOOK →

Integration of complementary and alternative medicine therapies (CAM) with conventional medicine is occurring in hospitals and physicians offices, health maintenance organizations (HMOs) are covering CAM therapies, insurance coverage for CAM is increasing, and integrative medicine centers and clinics are being established, many with close ties to medical schools and teaching hospitals. In determining what care to provide, the goal should be comprehensive care that uses the best scientific evidence available regarding benefits and harm, encourages a focus on healing, recognizes the importance of compassion and caring, emphasizes the centrality of relationship-based care, encourages patients to share in decision making about therapeutic options, and promotes choices in care that can include complementary therapies where appropriate. Numerous approaches to delivering integrative medicine have evolved. Complementary and Alternative Medicine in the United States identifies an urgent need for health systems research that focuses on identifying the elements of these models, the outcomes of care delivered in these models, and whether these models are cost-effective when compared to conventional practice settings. It outlines areas of research in convention and CAM therapies, ways of integrating these therapies, development of curriculum that provides further education to health professionals, and an amendment of the Dietary Supplement Health and Education Act to improve quality, accurate labeling, research into use of supplements, incentives for privately funded research into their efficacy, and consumer protection against all potential hazards.

Testing Treatments

Testing Treatments PDF

Author: Imogen Evans

Publisher: Pinter & Martin Publishers

Published: 2011

Total Pages: 187

ISBN-13: 1905177488

DOWNLOAD EBOOK →

This work provides a thought-provoking account of how medical treatments can be tested with unbiased or 'fair' trials and explains how patients can work with doctors to achieve this vital goal. It spans the gamut of therapy from mastectomy to thalidomide and explores a vast range of case studies.

Health Care Regulation in America

Health Care Regulation in America PDF

Author: Robert I. Field

Publisher: Oxford University Press, USA

Published: 2007

Total Pages: 353

ISBN-13: 0195159683

DOWNLOAD EBOOK →

Regulation shapes all aspects of America's fragmented health care industry. While the health and lives of patients as well as almost one-sixth of the national economy depend on its effectiveness, health care regulation in America is bewilderingly complex. 'Health Care Regulation in America' is a guide to this regulatory maze.